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Clinton Library
DOCUMENT NO.
SUBJECT/TITLE
DATE
RESTRICTION
AND TYPE
001. list
re: President's Advisory Council on HIV/AIDS (5 pages)
n.d.
P6/b(6)
COLLECTION:
Clinton Presidential Records
Domestic Policy Council
Devorah Adler
OA/Box Number: 20464
FOLDER TITLE:
HIV/AIDS [Folder 2]
2012-0463-S
rc771
RESTRICTION CODES
Presidential Records Act - |44 U.S.C. 2204(a)]
Freedom of Information Act - 15 U.S.C. 552(b)]
PI National Security Classified Information |(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office |(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute ((a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute |(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advice between the President
information |(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes |(b)(7) of the FOIA]
C. Closed in accordance with restrictions contained in donor's deed
b(8) Release would disclose information concerning the regulation of
of gift.
financial institutions |(b)(8) of the FOIA|
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(9) Release would disclose geological or geophysical information
2201(3).
concerning wells |(b)(9) of the FOIA]
RR. Document will be reviewed upon request.
11/06/98 FRI 10:35 FAX
001
OFHEALTH
OF
Office of HIV/AIDS Policy
Office of Public Health and Science
DEPARTMENT HUMAN
Office of the Secretary
USA
200 Independence Avenue, S.W., Room 736-E
Washington, DC 20201
Deliver To:
Weard Adler
Fax:
( ) 496-5557
Phone:
(
)
From:
Deborah von Zinkernagel
Deputy Director for Policy
Phone:
(202) 690-5560
Fax:
(202) 690-6584
E-mail:
[email protected]
Date:
/
/
This fax contains
1
page(s) plus cover
If transmission problems occur, please call: Shellie Abramson @ 202-690-5560
Comments:
California sinch Aggrege estimet
Sn AB1663
11/06/98 FRI 10:35 FAX
002
1,-67-1995 1:42AM
FROM
P.2
Analysis
Page 1 of 1
BILL ANALYSIS
APPROPRIATIONS COMMITTEE FISCAL SUMMARY
AB 1663 (Migden)
Hearing Date: 8/19/98
Amended:
7/6/98
and proposed amendments
Consultant: David Maxwell-Jolly
Policy Vote:
H&HS 5-0
BILL SUMMARY:
AB 1663 requires by 1/1/2000 reporting of HIV cases using a
uniform, statewide system that reports cases based on a unique
code or other method that does not report the names of individuals
infected with HIV. The bill directs the Department of Health
Services to use the data collected on the basis of the reports for
epidemiological studies, to target HIV prevention activities, and
to allocate resources.
Fiscal Impact (in thousands)
Major Provisions
1998-99
1999-2000
2000-01
Fund
Surveillance system
and Task force
550
350
350
General
STAFF COMMENTS:
*Amended to $550, 000 due
SUSPENSE FILE.
to requirement In
Statemide Task Force
12/07/98 21:28 FAX
AIDS Policy
011
Multistate Evaluation of Anonymous HIV
Testing and Access to Medical Care
Andrew B. Bindman. MD: Dennis Osmond, PhD: Frederick M. Hecht, MD: J. Stan Lehman, MPH:
Karen Vranizan, MA; Dennis Keane, MPH: Arthur Reingold. MD:
and the Multistate Evaluation of Surveillance of HIV (MESH) Study Group
Context.Infection with the human immunodefleiency virus (HIV) Is the only in-
tient's name. The vailability of an anony-
fectious disease for which anonymous testing is publicly funded. an exception that
mous HIV testing option has differed
has been controversial.
over time across states and localities.
Objective.-To assess whether anonymous HIV testing was associated with
Currently. 40 states have publicly funded
earlier HIV testing and HIV-related medical care than confidential HIV testing.
anonymous testing sites for HIV, and all
Design-Retrospective cohart.
50 states have publicly funded confiden-
Setting.-Arizona, Colorado. Missouri, New Mexico, North Carolina, Oregon.
tial HIV testing sites-
and Texas.
Participants.-Probability sample of 835 new acquired immunodeficiency syn-
See also P 1421.
drome (AIDS) cases reported to the state health department's HIV/AIDS Reporting
System from May 1995 through December 1996. All had responded to the AIDS
Human immunodeficiency virus is the
Patient Survey: 643 had been tested confidentially for HIV, and 192 had been tested
only infectious disease for which anony-
anonymously.
mous testing is publicly funded, an except
Main Outcome Measures.First CD4- cell count; number of days from
tion that has been controversial Propo-
HIV-positive test result to first HIV-related medical care, from first HiV-related
nents of anonymous testing believe that it
medical care to AIDS. and from first HIV-positive test result to AIDS.
encourages persons who would not oth-
Results.-Persons tested anonymously sought testing and medical care aarlier
erwise seek testing to learn their HIV in-
in the course of HIV disease than did persons tested confidentially. Mean first C04-
fertion status by eliminating the concern
about potential loss of confidentiality.
cell count was 0.427 X 10 º/L in persons tested anonymously vs 0.267x10°/L in per-
Persons tested anonymously who learn
sons tested confidentially. Persons tested anonymously experienced an average
that they are HTV positive may be moti-
of 918 days in HIV-related medical care before an AIDS diagnosis vs 531 days for
vated by their test result to seek medical
persons tested confidentially. The mean time from learning they were HIV positive
care earlier in the course of the di
to the diagnosis of AIDS was 1246 days for persons tested anonymously VS 718
than they might had only confidential
days for persons tested confidentially. After adjustment for the subject's age. sex.
testing been avgilable. Some studies have
race/ethnicity, education, income, insurance status. HIV exposure group, whether
suggested that ananymous testing in-
the respondent had a regular source of care or symptoms at the time of the HIV test.
creases the number of people who are will-
and state residence, anonymous testing remained significantly associated with
ing to be voluntarily tested for HIV. In
North Carolina coundes that offered
earller entry into medical care (P<.001).
anonymous testing experienced greater
Conclusion-Anonymous testing contributes to early HIV testing and medical
growth in testing than did counties that
care.
continued to offer only confidential test-
JAYA 1998:230:1416-1-20
ing.1 Similarly. with the introduction of
anonymous testing in Arizona and Or-
egon, ay more people obtained testing than
BOTH CONFIDENTIAL and anony-
testing, a person's name is linked to the
when only confidential testing was avail-
mous antibody testing for the human im-
specimen, and the test result is recorded
able. However, the findings have not been
munodeficiency virus (HIV) have been
in 1 medical chart with a name. Early in
consistent: the Colorado State Health De-
available at public testing sites in the
the epidemic, the stigma associated with
partment did not detect a meaningful in-
United States since 1985. In confidential
testing positive for HIV focused atten-
crease in HIV testing with the incroduc-
tion on the potential for breaches in the
tion of anonymous HIV testing.
From the Primary Care Research Center (Drs Bind.
confidentiality of an HIV test result Con-
Because people who test HIV positive
man and asmona. Ma Vramean, and Mr Keane) and
carned that anxiety about the potential
anonymously cannot be individually
AIDS Division (Dr Hechti, San Prancisco General Hos-
cital. and Departments of Medicine (Drs Bindmar- and
loss of confidentiality would deter some
tified, reporting systems that rely on the
Heart Mz Visnizan. and Mr Keane) and Epidemplogy
at-risk persons from voluntarily seeking
results of anonymous testing are prone to
eno Biostances (Dre Sindman and Opmand). Unnier-
testing for HIV, many state and local pub-
measurement error. It can be difficult to
sity of California, San Francisco: Division of HIWAIDS
Prevention, Survenlance and Epidemiciogy. Centers for
lic health departments made this test
detect repeat tests, and the potential ex-
Disease Control and Prevention. Adams. Ga (Mr
available on en anonymous as well as a
ISTS for duplicate reporting Anonymous
Lahman): and Department of Epidemiology. University
confidential basis. In anonymous testing,
testing may undermine partner notifica-
of Collfornia, Barkcley (Dr Reingold).
A complete list or the members of the MESH Study
a unique identifier (typically a number)
tion⁵ Furthermore, anonymous testing
Group appears at the end of mis article.
rather than a patient's name is used to
eliminates the opportunity to recontact
Corresponding author: Andrew B. Bindman MD. San
link the specimen and the result to the
persons who do not return for their test
Francisco General Hospital. Bidg 90Mlard 95. TOO!
patient. Anonymous teat results are not
results or to assist HIV-infected persons
Potrero Ave. San Franches. CA 10 10-mail: bromsn
Sites.ucsf.edu).
recorded in a medical chart that has 3 pa-
in obtaining medical care,
1416 JAMA, Cetober 28, "998-Vol 280, No. 16
HIV Testing and Access to Medical Care-Bindman el al
1
TTO
EAS ST:91 10/28/98
12/07/98 21:28 FAX
AIDS Policy
012
Because studies have been small, have
analysis, we calculated sampling fractions
to an explicit question said that they gave
performed in only 1 state, or did little
with the goal of sampling equal numbers
a false name were excluded from the analy-
to control for differences in the character-
from each stratum. Colorado, Missouri,
sis. To assess the validity of our method hr
istics of persons who used anonymous vs
and Oregon sampled MSM and took all
classifying the type of HIV test, we com-
confidential testing, it has been difficult to
cases in the other 3 strata; North Carolina
pared the subject's report of having given
draw clear conclusions about the value of
sampled 8 strata and took all in the other
a number or 8 name to obtain their test re
anonymous HIV testing. We used data cat
stratum; and Texas sampled all 4 strata
sult with the Type of testing site. Assum-
lected as a part of a cooperative project be
Uniform rendom numbers were gener-
ing that testing in a physician's office. hos-
tween the University of California, Barke-
sted for each new case in the 4 strata, and
pital, jal or prison, or blood bank should
ley. the Centers for Disease Control and
new case with random number equal to
have been reported as testing by name
Prevention (CDC), Atlanta, Ga, and sev.
or less than the sampling fraction was se
(confidential testing), we found that 96.4%
eral state health departments to evaluate
lected for the study.
of subjects tested in those settings re-
anonymous HIV testing We assessed the
Sampled cases were considered eli-
ported they had received their results by
association of the type of HIV test (anony-
gible for the study if they were living in
mous or confidential) with when in the
name. Of those who reported that they had
the state, English or Spanish speaking.
received their test result by number
course of the disease persons with ac-
and healthy enough to consent to and
(anonymous testing). only 6.4% reported
quired immunodeficiency syndrome
complete an interview. To avoid biasing
(AIDS) (1) learned of their HIV infection
testing in one of those settings.
our response rate upward by delaying
We limited our analysis to respondents
and (2) sought HIV-related medical care
the performance of the interview, pa-
who first tested HIV positive in the state
THODS
clents who had died before the time of
from which they were sampled, lived in
first contact were counted in the denomi-
states that offered both anonymous and
The AIDS Patient Survey was con-
nator of eligibles if contact bad not been
confidential testing (Mississippi ex-
ducted in Arizona, Colorado, Mississippi,
made within 6 months of report. Public
cluded), and voluntarily sought HIV test-
Missouri, New Mexico, North Carolina, Or-
health surveillance personnel in each
ing as opposed to being required to obtain
egon, and Texas. Because nearly all HIV-
state developed procedures for contact-
a test because of regulations associated
infected persons are thought to progress
ing and interviewing potential subjects.
with prisons, drug Traatment programs, the
to AIDS eventually and because AIDS
All procedures were monitored by the
military. insurance plans, or blood banks.
eillance is estimated to be 80% to 96%
niversity of California and CDC to en-
Thus, subjects were considered volum-
complete,⁶ reported AIDS cases provide
sure uniform methods across the states.
teers for testing if they, in response to a
a population-based sample of the experi-
Surveillance personnel completed an
checklist of questions, reported that their
ence of HIV-infected persons that can pa
outcome report form for each sampled
reason for testing was (1) they felt sick and
tenually avoid blases that may be pres-
case. which indicated the consent pro-
wanted to find out whether they had HIV.
ent in venue-based samples.
cass and the final outcome. Subjects
(2) they thought they might have HTV even
In each state we sought to interview,
were interviewed in either Spanish or
if they did not feel sick, (S) someone told
after obtaining consent, all persons who
English The instrument was translated
them that they should get tested. or (4)
were described as having newly diag-
into Spanish and then back-translated to
someone from the health department told
nosed AIDS in a 1-year period or a prob-
English before B final Spanish version
them that they had had contact with an in-
ability sample of new cases, depending on
was produced. Interviewers and super-
fested sex or needle-sharing partner.
the projected incidence of new AIDS di-
visors from the state health depart-
In comparing the characteristics of per-
agnoses in the state. The sampling frame
ments were trained in joint training 965-
sons tested anonymously persons tested
was persons newly diagnosed as having
sions in conducting X standard interview.
confidentially. we tested differences in the
AIDS reported to the state health depart-
States used between 1 and 4 interview-
proportions by using the * statistic. We
ment through the HIV/AIDS Peporting
ers to administer the survey and all
examined the association of anonymous
System (HARS) from May 1995 through
study sites were visited at least once by
and confidential testing with several in-
December 1996, who were alive at time of
University of California and CDC inves-
tervuls: time from HIV-positive test re-
report, who were at least 18 years old, and
tigators to assess the consistency of their
sult to AIDS and this interval's subeom-
whose AIDS diagnosis had been made
technique. All completed interviews and
ponents: (1) time of HIV-positive test
within 12 months of the date of their re-
outcome report forms were stripped of
result to first HIV-related medical care and
port to the health department.
personal identifiers, copied, and mailed
(2) time from first HIV-related medical
An expected number of persons with
to the University of California for data
care to AIDS We used the date of AIDS
newly diagnosed AIDS was estimated
entry and conversion into electronic Sta-
diagnosis to anchor comparisons of the
from the number reported from the pre-
tistical Analysis System (SAS Institute
HIV-positive test result date and the HIV-
vious year who met the sampling frame
Inc, Cary, NC) files for analysis.
related medical care date, Date of first
criteria. In states with an expected incl-
We compared the characteristics of re-
HIV-positive test result and date of first
dence of fewer than 500 cases, all new
spondents who were tested anonymously
medical care for HIV infection were self-
cases were sampled (Arizona, Mississippi,
with those who were tested confidentially
reported as a month and a year. Time in-
and New Mexico). In the remaining
and examined whether the type of HIV test
tervals used in analysis were constructed
states, a probability sample was stratified
was associated with when in the course of
from these dates and the date of AIDS di-
by 4 HIV mode-of-exposure groups based
the disease a subject sought HIV testing
agnosis as reported to HARS. We com-
on reported behavioral information in
and HIV-related medical care. Date of
pared the mean time intervals among HIV
HARS: (1) men who have sex with men
AIDS diagnosis was extracted from the
testing. HIV-related medical care, and
(MSM), including those with a reported
state HARS databases and combined with
AIDS diagnosis for persons tested anony-
history of injection drug use; (2) hetero-
the interview data for analysis. Type of
mously and persons tested confiden-
sexual injection drug users; (3) cases re-
HIV testing was classified as anunymous
tially. Time intervals that included an
ported with no identified risk; and (4) all
or confidential depending on whether the
AIDS diagnosis were also stratified by
other modes of exposure (heterosexual
subject reported giving a number (anony-
whether the diagnosis was based on an of
contact, transfusion, hemophilia). To get
mous) OF a name (confidential) to get the
portunistic infection or a CD4 cell count
adequate numbers in each stratum for
HIV test result Subjects who in response
of less than 0.20 X 10%L (200/pL).
IAMA. Detober 28. 1998-Val 280. No. 16
HIV Testing and Access to Medical Care-Bindman et al 1417
012
10/28/98 WED 15:17 FAX
12/07/98 21:29 FAX
AIDS Policy
013
Table 1.-Cheractaristics al Persons Voluntarily Tested for Human Virus (HIV)
HM+ First Care AIDS on
Anonymous
Confidential
P
Characteristics
152)
(ne 643)
value
187
531
Age. mean, y
36
38
<001
Male. %
86
"
33
Confidential
(n=643)
718
Race/ginnicity, %
Alrican American
"
R
Mean First CD4* Cell Count= 109/L
Hispanic
17
14
.001
328"
Other
6
3
919t
Wille
12
$
Anonymous
HIV exposure greup- %
(n=192)
1246t
Men who have sex with men
78
58
Mean First CD4* Cell Count=0, X
Injection drug user
B
13
Blood product
,
4
001
Figure 1.-Mean time in days to that human immu-
Health worker
1
a
nodeficiency virus (HIV)-related care and acquired
Meteresexum
4
"
immunodeficiency syndrome (AIDS) diagnosis by
Unknoten
8
12
ananymours and confidential testing. Asterisk indi-
cates P<.01 for confidential VE anonymous testing;
Education. mean. y
13.1
127
.03
dagger, P<001 for confidential us andrymous
Monthly income. mean. $
1390
1450
A1
testing: HIV+. date of knowledge of HIV-positive
Insurance. %
Status; first care. date of fires HIV-related medical
Privaterolher
6B
$
care; and AIDS Dr. date of AIDS diagnosis.
.08
Medicaie
4
g
None
17
42
source of care before their first HIV-pos-
Regular source of care before HIV-positive last result, %
23
51
001
itive test result and to have had HIV-re-
Symptoms an time of H/V-positive lost result, %
50
70
DOT
lated symptoms at the time they received
the test. however, half of the persons tested
We compared subjects on the basis of
into analyses by using log transforma-
anonymously were also symptomatic.
whether they had ymptoms of weight loss
tions of the time intervals and CD4- cell
Persons tented anonymously present-
without diating, fevers, heavy night SWeats,
counts These analyses did not apprecia-
ed earlier in the course of HIV disease for
diarrhea. oral thrush, frequent vaginal
bly alter the significance of the results per-
testing and care than did persons tested
yeast infections, memory problems,
taining to anonymous VS confidential test-
confidentially. The mean time from learn-
shingles, preumania, Kaposi sarcoma, lym-
ing; therefore, for the purposes of
ing they were HIV positive to the diag-
phoma, meningitis. or tuberculosis at the
oviding measures of effect that are eas-
nosis of AIDS was almost a year and a half
time they learned they had HIV- Sub-
fly interpreted we have chosen to display
longer (529 days) for those tested anony-
jects who said yes to any of these condi-
the results based on the nontransformed
mously than for those tested confiden-
tions were considered imptomatic at the
mean time intervals and GD4 cell counts.
tially (Figure 1). The mean time was 1246
time of the first HIV-positive test result.
The study was approved by institu-
days for persons tested anonymously and
To estimate HIV disease severity at the
tional review boards at the University of
718 days for persons tested confidentially.
time of first HIV-related medical care. we
California the individual states that re-
Most of this difference was in the length of
compared the mean self-reported first
quired review, and review boards at local
time in HIV-related medical care. Per-
CD4- cell counts of persons tested anony-
institutions as required within some states.
sons tested anonymously received an av-
mously and persons tested confidentially.
erage of 387 more days in HIV-relared
To estimate the quality of HIV-related
RESULTS
medical care before an AIDS diagnosis
medical care for persons tested anony-
In the 8 participating states. 3821 AIDS
than did persons tested confidentially.
mously and persons tasted confidentially,
cases were sampled from May 1995 through
Comparisons of the median dmes from
subjects were asked to report whether
December 1996; of those, 2801 met eligi-
knowledge ofbeing HIV positive to AIDS
their HIV-related medical care had ever
billey criteria. Overall, 1913 (68.8%) of 2801
were even greater berween persons
included tuberculin skin testing, taking
eligible AIDS cases were interviewed in
tested anonymously and persons tested
zidavudine for at least 1 day, and taking
the AIDS Patient Survey. We excluded
confidentially. The median time was 929
urinmsthoprinm-sulfamethoxazole (Septra,
1078 respondente from the analysis be-
days among persons tested anonymously
Bactrim, Cotrim) or aerosolized pentami-
cause they initially tested HIV positive in
and 90 days among persons tested confi-
dine as a measure of Pneumocystis cari-
a different state from the one in which they
dentially. An additional indicator that
nii pneumonia (PCP) prophylaxis
were sampled (363). they were from a state
persons tested anonymously came earlier
To isolate the independent contribu-
than did not have anonymous testing (262),
for testing and medical care than did per-
tion of the type of testing on the time in-
their reason for testing was not voluntary
sons tested confidentially was the signifi-
tervals and the first CD4 cell count, we
(247), they provided EL false name at a con-
cantly higher first CD4- cell count (0.427
performed multivariate linear regression
fidential testing site (55), of they did not
X 10% vs 0.267 X 10%L) despite the
analyses that controlled for differences in
have complete data for all the variables
longer unadjusted interval between the
the characteristics of persons tested anony-
used in the analysis (151). Of the remain-
HTV-positive result and medical care.
mously vs confidentially. Marginal differ-
ing 835 subjects, 192 (23%) reported that
To isolate the independent contribu-
ences across states were controlled for us-
their first positive test result had been from
tion of the type of HIV test on the timing
ing a state of residence indicator in the
an anonymous rest (Table 1). Persons
of testing and medical care, we adjusted
multivariate analyses. Means from multi-
tested anony mously tended to be younger,
our results to account for differences in the
variate analyses are the estimated least
white, slightly more educated than per-
characteristics of persons who sought
squares means from linear models. Be-
SONE tested confidentially, and more likely
type of test. In the multivariate analysis,
cause the distributions of time intervals
at risk for HIV because they were MSM
several characteristics were associated
and CD4 cell counts were akewed by some
Persons tested confidentially were signifi-
with the length of time between a per-
higher values, we repeated our multiver-
cantly more likely to have had a regular
son's learning of B positive HIV test re-
1418 JAMA, October 28, 1998-Vol 280, No. 16
HIV Testing and Access to Medical Care-Bindman at a)
OTO
10/28/98 WED 15:18 FAX
12/07/98 21:29 FAX
AIDS Policy
014
Table 2-Multivariate Predictors of Number of Days Between Knowledge of Boing Human Immunodefr
Virus (HIV) Positive and Acquired Immunedeficiency Syndrome
HIV+ RKSI Care AIDS R
Characteristics
Mo. of Days (35% CI)
P Value"
202
541
Ago. y
1 (-7 E 9)
78
Male
-183 (408 10 4)
.11
Confidential
Race/einnicity
543)
743
African American
49 (-234 to 137)
G.
Mean First CD4+ Cell
Hispanic
-121 (-332 la 57)
25
Other
65 (-286 to 418)
262
72
762*
White
Referent
Ananymous
HIV exposure group
(n=192)
1014"
Men -no have Bex with men
406 (198 TO 813)
<001
Mean First CD4T Cell Count = 103/L
Injection drug user
349 (Tos to 591)
.005
Other
Referent (...)
Education ,
29 (-4 to 61)
Figure 2.-ACjusted mean time in days to first human
D8
Monthly Income. $
immunodeficiancy virus (HIV)-felated care and ac-
-53 (-130 to 23)
.17
quired Immunodaticiency syndrome (AIDS) diagnosis
Insurance
by anonymous and confidential testing. Values are
Private/other
112 (-52 to 275)
.18
least squares means from a linear regression madel
Medicals
44 (-222 to 311)
74
and are adjusted for age. sex, raca/ethnicity. educa
None
tion, income. insurance status. HIV rigk group. regular
Referent (..)
Source of Care al the time of resting. symptoms WI time
Requisr source of care before HIV-positive TRST result
-21 (-173 to 130)
.78
el HIV-positive test result, and state residence. Aster-
Symplams at time of H/V-posidve lest result
-212 (-953 to -675
<,001
Lsk indicates P<001 for confidential YE anonymous
Anonymous test
272 (101 to 443)
.002
testing: HIV+, date of knowledge of Htw-pasitive sta-
as: first care, date of first Hiv-related medical care:
"A" . 0.24 (including an indicator for respondent's artie residence).
and AIDS DL date of AIDS diagnosis date.
TEMPORS indicate data not applicable.
ord To the extent that persons are mis-
sult and receiving an AIDS diagnosis-
medical care before ALDS diagnosis from
classified by type of testing, this would
Among HIV exposure groups, MSM and
z1 to 230 days.
tend to make the 2 testing groups look
injection drug users had a significantly
Comparisons of tuberculin skin testing
more similar. Acknowledging that there
longer period of knowing they were HIV
and the DEC of zidovadine and PCP pro-
is also likely to be some error in the self-
positive before their AIDS diagnosis
phylaxis suggest that care was similar for
reported first CD4- cell count and dates of
(Table 2). The strongest predictor of the
the 2 testing groups. Ninety-one percent
HIV testing and HIV-related care, we do
length of time between knowledge of HIV
of persons tested anonymously vg 89% of
not have any reasons to suspect that this
positivity and AIDS was having symp-
persons tested confidentially reported that
reporting is bissed by the type of HIV
toms at the time of the HIV-positive test
they had received tubarculin skin testing
test a person received
result Having symptoms at the time of the
during the course of their HIV-related
Anonymous testing was not available
HIV-positive test result decreased the
medical care. Ninety-eight percent of per-
in all the study states in the early years of
length of time between knowledge of be
sons tested anonymously vs 95% of per-
HIV testing. However, since all the re-
ing HTV positive and AIDS by 819 days.
suns tested confidentially were offered
spondents were diagnosed as having
After adjustment for the subject's age.
dovudine, and 73% in each testing group
AIDS within the same year, there is a bias
sex, race/ethnicity, education, income. in-
had been given PCP prophylasis. None of
toward a positive association between
surance status, HIV exposure group. if
these testing or treatment differences
confidencial testing and the longest inter-
the respondent had 2 regular source of
were significant between the 2 groups.
vals between knowledge of being HIV
care or symptoms at the time of the HIV-
positive Lest result, and the state of resi-
COMMENT
positive and AIDS. When we limited our
sample to more recen years in which both
ce, anonymous testing remained sig-
In this multistate study, we found that
anonymous and confidential testing were
nificantly associated with earlier medical
anonymous testing was sought by ap-
available, we find a proportionally even
care Figure 2). Although the difference
proximately a quarter of HIV-positive
greater difference between persons
in the number of days between the posi-
persons who had been tested voluntarily
tested anonymously and persons tested
tive test result and first medical care was
before an AIDS diagnosis. Anonymous
confidentially in the length of time be
no longer significant ween the 2
testing for HIV Infaction was associated
tween knowledge of being HTV positive
groups, the length of time in medical care
with testing and medical care. Ae B.
and AIDS diagnosis (data not shown).
before AIDS was almost 8 months longer
result of this earlier testing and care, per
A question can be raised whether the
(221 days) for persons tested anony-
sons tested anonymously received the pc.
benefit we observed for anonymous test-
mously compared with persons tested
tential benefits of a significantly longer
ing is Hbutable to the availability of this
confidentially. The mean adjusted first
period of HIV-related medical care com-
type of testing or to characteristics of per-
CD4 cell count was also 0,092 X 10%/L
pared with persons tested confidentially.
sons tested anonymously that make them
higher for persons tested anonymously
Although the determination of the type
seek earlier testing and care. For ex-
1
for persons tested confidentially.
of HIV test, CD4 cell counts, and the in-
ample, among HIV exposure groups, MSM
Persons tested confidentially were more
tervals between HIV testing, medical
are more likely to seek anonymous test-
likely than those tested anonymously (354
care, and AIDS are in large part depen-
ing. From & policy perspective the ques-
vs 16%) to have an AIDS diagnosis based
dent on self-repart. we suspect that the
tion is whether same persons who seek
on an opportunistic infection rather than
importance of this information for our re
early HIV testing at anonymous sites
on a CD4- cell count of less than 0.20 X
spondents makes it reasonably likely that
would do 50 at confidential sites if anony-
10°/L. Accounting for this difference in
their reporting was accurate Cunning-
mous testing sites were eliminated." We
how AIDS was disgnosed in the 2 testing
ham et al' found that self-reported CD4-
cannot rule out the possibility that there
groups further expands the adjusted dif-
cell counts were accurate when compared
same persons would have sought early
ference in the duration of HIV-related
with values recorded in the medical rec-
testing and care even if undrymous test-
JAMA. October 28, 1998-Vel 280. No. 16
HIV Testing and Access to Medical Care-Bindman al al 1419
011
10/28/98 WED 15:19 FAX
12/07/98
21:29
FAX
AIDS Policy
015
ing were not available However, we de
We found that after controlling for
reporting policies. the opportunity to dr.
signed our enalysis to isolate the indepen-
whether persons had IV-related symp-
comvent surveillance strategies by using
dent contribution of type of HIV testing
TOTES at the time they received a positive
a false name at confidential testing sites,
to our outcome measures. To avoid a po
HIV test result eliminated the signifi-
and the availability of anonymous home
tentially biased comparison of persons who
cant difference between persons rested
HIV testing kits We were able to adjust
voluntarily sought testing at either anony.
anonymously and persons tesced confi-
formany, but not all, these factors. None-
mous or confidential testing sites with
dentially in the length of their delay be-
theless, we believe that our atudy pro-
those who were required to be tested in
tween learning they were HIV positive
vides the strongest evidence to date that
confidential settings, we limited our analy-
and getting HIV-related medical care.
anonymous testing contributes at a popu-
sis to those whose reasons for testing sug-
However, we were surprised that nei-
lation to early HIV testing and
gested that the action was voluntary. To
ther health insurance nor having a regu-
al care Thus, to achieve the public health
avoid a bias toward confidential testing
lar source of care-2 traditional mea-
goal of providing early access to HIV
among sicker persons who sought medi-
sures of access-was associated with early
ing and HTV-related medical care, public
cal care, included symptoms at the time
HIV testing or IIV-related medical care.
health departments should maintain and
of HIV testing in OUR adjusted analysis. Of
This finding suggests that either physi-
in some instances enhance the broad avail-
the persons tested anonymously, 50% Te
cians are not sufficiently identifying their
ability of anonymous testing options.
ported that they were symptomatic, sug-
high-risk patients and encouraging them
Support For this project was provided by the CDC
gesting that even sick persons were mak-
to be tested early or that patients who
THHS 282-92-0048).
ing testing choices. We also controlled for
have insurance or a regular source of care
The MESH Situdy Group compriss John Ward,
a wide variety of other characteristics that
are reluctant to pursue HIV testing at any
MD. MP and Patricia Fleming, PhD. CDC, Arianta.
entiated persons tested anony-
greater rate than is found among all at-
Ga: Denise K Boyd, MS, MPH and Violica Berisha
mously and those tested confidentially and
MD, MPH, Arizona Public Health Department Phoe-
risk individuals-
nix; Kenneth Gershman, MD. MPH. and Melunie
still found that anonymous testing was in-
WE found. as other reports have sug-
Mattson Colorado Public Health Department Den-
dependently associated with a substan-
gested, that black and Hispanic persons
ver, John Nowman and Craig Thompson, Mississippi
rially higher first CD4 cell count and a
tended to have fewer days ofknowing that
Public Health Department. Jackson Robert Hamm.
longer period of HIV-relared medical care
MD. MPK. Krisdn Wendt MPH and Linda Bell,
they were HIV positive before AIDS and
Missouri Public Health Department Jefrerson City,
before AIDS.
fewer HIV-related medical CAYE days
Michael Samuel, DrPH and Mark Stenver. MS, New
We explored the possibility that the
than whites however. the comparisons
Mexico Public Health Department. Senta Fe; Steven
longer duration of HIV-related medical
with whites were not significant in the ad-
Modesist, RN, MPH, Roger Wire PhD. and David
care for persons tested anonymously could
justed analyses.
Flereing, MD, Orogon Public Health Department,
Portland; and Ann $ Robbins. PhD. Sharon A King.
be due to explanations aside from their
With the development of improved
MA, and Douglus Hamalrer, Taxas Public Health De-
seeking medical care earlier. For ex-
therapies for HIV-infected persons, the ra-
partment, Austin The participants from the North
ample, if persons tested anonymously
tionale for anonymous testing may be wan-
Carolina Public Health Department requested that
their numes TUBL be included.
were diagnosed as having ADS more of-
ing.in In our companion study of persons
ten than persons tested confidentially on
at high risk for HIV, we found that in the
References
the basis of an opportunistic infection as
1990s the annual rate of choosing anony-
1 Hertz-Piodorce L Lee L. Hoye C. HIV Test
opposed to 2 CD4⁻ cell count below
mous rather than confidential testing was
Ing before and after the restriction of anonymous
0.20 X 103/L. this would create a bias to
44% to 58% (mean, 48%) (A.B.B., D.O.,
testing in North Carolina am , Public Health 1996:
50:1446-1450.
ward lengthening the duration of HIV.
FMH,, et al, unpublished data, Decem-
2. Hirano D. Cellert G. Fleming K Boyd D, Bn-
related medical care before an AIDS di-
ber 1995-November 1996). This suggests
glender S. Have H. Anonymens HIV testing. the
agnosis for persons tested anonymously.
that at least through 1996, anonymous test-
impact of availability on demand in Arizona Are J
In general, opportunistic infections occur
Ing has remained a consistently impor-
Public Health 1994:84:2008-2010.
3. Fehrs L, Fuster L. Fax V, Ct al. Trial of anony-
later in the HIV disease course than de-
tant testing option for a significant pro-
mous versus confidential hursan immunodeficiancy
tection of a CD4- cell count below 0.20 X
portion of at-risk persons. It is also possible
virus testing. Lanest 1988-952-379-382
10% Howe since more persons test-
that more at-risk persons will be inter
1. Hexworth T. Modiman R. Cohn D, Davidson a
ing confidentially than anonymously were
ested in anonymous testing now that the
Anonymous HIV teating. AIDS Public Policy, J.
1994;9:182-189.
diagnosed as having AIDS on the basis of
Council of State and Territorial Epidemi-
5. Kagaler W. Meriwether R. Klirnke T, Peterman I.
an opportunistic infection adjusting for
ologists has revised its statement on HIV
Zaidi A Eliminating access to unonymous HIV anti-
this bias merely increases the duration of
reporting to favor name reporting and a
bady testing in North Carolina 5 Acquir formune
HIV-related medical care among per-
growing number ofstates and Congress are
Defie Syndr Hum Retrovired
6. Rosenbaurn S. Serrano R. Magar M. Starn C. Civil
sons tested anonymously compared with
actively considering the implementation of
rights in a changing health care eystem. Health Aif
confidentially. A second explanation for the
HIV name-repor policies To the ex-
(Mailhood). 1997;16:90-105.
longer duration of HIV-related medical
tent that name-reporting surveillance sys-
2 Cunningham W. Rana H, Shapiro M. Hars R Re
care for persons tested anonymously is that
terms create & barrier to HIV testing for
liability and validity of self-report CD4- collnts in per
Sons hospitalized with HIV disease. J Clin Epide
they were receiving better-quality medi-
some persons, anonymous testing might
miol 1997,60,629-885.
cal care than were persons tested confi-
serve BE a "Bafety valve" for those who fear
a. Kegales S. Catania J, Coates T. Pollack L to B.
dentially- However, comparisons be-
that confidential surveillance systems can-
Many people who seek undaymous (Ventibudy
tween persons tested anonymously and
not adequately protect their privacy.
testing would avoid le under other circumstances
AIDS. 1990;4:585-588.
confidentially in their receipt of several ef-
Observational studies may never be able
a Workey P. Che S. Diaz T. et a). HIV testing pat-
fective prevention and treatment ser-
to fully tease apart the contribution that
terms. AIDS.
vices revealed no significant differences,
anonymous tesring makes to the timing of
10. Steinbrook R. Battling HIV on many fronts.
Some of the individual characteristics
HIV testing and to HIV-related medical
N Engl J Med. 1997;237:779-781.
11 CouneD of State and Territorial Epidemiolo-
associated with earlier HIV testing and
are. In reality, there is a complex inter-
gists National HIV Surveillance: Addition to the
HIV-related medical care were expected,
play among the characteristics of persons
National Public Health Surveillance System. At-
but others were not For example, we had
st-risk for HIV, changes over time in the
lanta, Gat Counell of State and Terricorial Epidemi-
anticipated that persons who were symp-
perceived benefit of knowing one's Se-
ologister 1987. Position Statement ID-4.
12 Richardson L Progress on AIDS brings move-
tomatic would seek care more quickly
rostatns, the availability of anonymous
ment for lars secrecy, name reporting urged New
than persons who were asymptomatic.
testing, the implementation of name-
York Time August 21. 1997; section 1:1.
1420 JAMA, October 28. 1998-Vol 280, No. 16
HIV Testing and Access TO Medical Care-Bindman of gli
STO
10/28/98 WED 15:20 FAX
OF
STAFF
Market
DEPARTMENT OF HEALTH & HUMAN SERVICES
Chief of Staff
HEALTH,
,
/
Washington. D.C. 20201
FACSIMILE
DEC 9 1998
DATE:
TO:
Todd Summers
FAX#:
456.2438
FROM: Mary Beth Donahue
Chief of Staff
Phone:
202/690-7431 Fax: 202/401-5783
COMMENTS:
Guidelines du not get published in
TheFed. Regista notice. The 2-par
notice of availability is published,
guidelines must be obtained
from CDL as directed in the
FRnolice
3r Pages (including this cover]
I
FRNShia
Billing Code: 4163-18-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Draft Guidelines for HIV Case Surveillance, Including Monitoring HIV Infection and
Acquired Immunodeficiency Syndrome (AIDS)
AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and
Human Services
ACTION: Notice and Request for Comments
SUMMARY: This notice announces the availability for public comment of a document entitled
"Draft Guidelines for HIV Case Surveillance, Including Monitoring HIV Infection and Acquired
Immunodeficiency Syndrome (AIDS)".
DATES: Comments must be submitted in writing on or before [insert date 30 days after date of
publication in the Federal Register]. Comments should be submitted to the Technical Information
and Communications Branch (Mailstop E-49), Division of HIV/AIDS Prevention, National
Center for HIV, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta,
Georgia 30333; telephone: 404-639-2072; Fax:404-639-2007.
FOR FURTHER INFORMATION CONTACT: Requests for copies of the draft HIV case
surveillance guidelines should be submitted to the CDC National AIDS Clearinghouse, P.O. Box
6003, Rockville, Maryland 20849-6003; telephone (800) 458-5231; or copies can be obtained
from the CDC website at http://www.cdc.gov/achstp/hiv_aids/
SUPPLEMENTARY INFORMATION: From 1995 to 1996, the incidence of both deaths and
opportunistic infections (OIs) due to AIDS declined in the United States for the first time in the
history of the epidemic (6 percent for OIs; 23 percent for deaths) as reported in the September 19,
1997, Morbidity and Mortality Weekly Report (MMWR) (Volume 46, PP. 861-867). These
COTES
2
FR
declines reflect recent advances in treatment of HIV infection and the provision of care and
services that have slowed the progression of AIDS for HIV-infected persons on therapy and the
success of HIV prevention and education efforts that have encouraged early diagnosis and have
helped to reduce the number of Americans becoming infected with HIV.
In response to these changes in HIV treatment practices and new information needs of public
health programs, CDC, the Council of State and Territorial Epidemiologists (CSTE), and most
other public health and AIDS organizations have recommended that all States and Territories
conduct HIV case surveillance in addition to AIDS surveillance. In this manner, the AIDS/HIV
epidemic can be tracked more accurately, and appropriate information about HIV/AIDS can be
made available to policymakers. As of July 1998, a total of 32 States were conducting HIV case
surveillance using the same methods as surveillance for AIDS. Because some States (many with
large numbers of AIDS cases) do not report HIV case numbers, interpretations of available HIV
data are difficult. To gain more reliable information about the prevalence, incidence, and future
directions of HIV infection and the impact on specific populations such as racial and ethnic
minorities and women, CDC is proposing that the current surveillance system be expanded to
include HIV case reporting for all States and is publishing guidelines that States can use to
implement HIV surveillance.
Dated:
Jeffrey P. Koplan, M.D., M.P.H.
Director, Centers for Disease Control and Prevention
Guidelines for National HIV Case Surveillance, Including Monitoring for HIV Infection
and Acquired Immunodeficiency Syndrome (AIDS)
The Centers for Disease Control and Prevention (CDC) recommends that all States and
Territories conduct case surveillance for human immunodeficiency virus (HIV) infection as an
extension of current acquired immunodeficiency syndrome (AIDS) surveillance activities. The
expansion of national surveillance to include both HIV infection and AIDS cases is a necessary
response to the impact of advances in antiretroviral therapy, the implementation of new HIV
treatment guidelines, and the increased need for epidemiologic data concerning persons at all
stages of HIV disease. Expanded surveillance will provide additional data on HIV-infeeted
populations to enhance Federal, State, and local efforts to prevent HIV transmission, improve
allocation of resources for treatment services, and assist in evaluating the impact of public
health interventions. CDC will provide technical assistance to all State and Territorial health
departments to continue or establish HIV and AIDS case surveillance systems and to evaluate
the performance of their surveillance programs. This report includes revised case definitions for
HIV infection in adults and children less than 18 months of age, recommended program
practices, and performance and security standards for the conduct of HIV and AIDS
surveillance by State and local health departments. The revised surveillance case definitions
and associated recommendations become effective
INTRODUCTION
AIDS surveillance has been the comerstone of national efforts to monitor the spread of
HIV infection in the United States and to target HIV prevention programs and health care
services. Although AIDS is the end-stage of the natural history of HIV infection, in the past,
monitoring AIDS-defining conditions provided population-based data that reflected changes in
HIV incidence. However, recent advances in HIV treatment have slowed the progression of HIV
disease for infected persons on treatment and contributed to a decline in AIDS incidence. These
advances in treatment have diminished the ability of AIDS surveillance data to represent trends in
HIV incidence or to represent the impact of the epidemic on the health care system. As a
consequence, the capacity of national, State, and local public health agencies to monitor the HIV
epidemic has been compromised (1-3). In response to these changes and following consultations
with diverse constituencies, including representatives of public health, government, and
community organizations, CDC and the Council of State and Temitorial Epidemiologists (CSTE)
have recommended that all States and Territories include surveillance for HIV infection as an
extension of their AIDS surveillance activities (1,4). In this manner, the HIV/AIDS epidemic can
be tracked more accurately and appropriate information about HIV/AIDS can be made available
to policymakers.
This document provides revised case definitions for HIV infection in adults and children
less than 18 months of age, recommended program practices, and performance and security
standards for the conduct of HIV and AIDS surveillance by State and Territorial health
departments. The HIV case definitions were developed in consultation with CSTE and include
the current AIDS surveillance criteria as a component of the HIV infection case definition (5).
The recommended program practices and program performance and security standards are based
2
on: (1) the established practices of AIDS and other public health surveillance systems;
(2) reviews of State and local surveillance programs, confidentiality statutes, and security
procedures; (3) studies of the performance of surveillance systems; (4) ongoing evaluations of
determinants of test-seeking or test-avoidance in relation to State policies and practices on HIV
testing and reporting, and (5) discussions at a consultation held by CDC and CSTE in May 1997.
A draft of this document was made available for public comment in
1998.
BACKGROUND
History of AIDS Surveillance
Since 1981, population-based AIDS surveillance (i.e., reporting of cases and their
characteristics to public health authorities for analysis) has been used to track the progression of
the HIV epidemic from the initial cases of opportunistic illnesses caused by a then unknown agent
in a few large cities, to the reporting of 641,086 AIDS cases nationally through 1997 (6-9). The
AIDS reporting criteria have been periodically revised to incorporate new understanding of HIV
disease and changes in medical practice (10-13). In the absence of effective therapy for HIV,
AIDS surveillance data have reliably detected changing patterns of HIV transmission and reflected
the effect of HIV prevention programs on the incidence of HIV infection and related illnesses in
specific populations (14-15). Because of these attributes, AIDS surveillance data have been used
as a basis for the allocation of many Federal resources for HIV treatment and care services and as
the epidemiologic basis for the planning of local HIV prevention services.
With the advent of more effective therapy that slows the progression of HIV disease,
AIDS surveillance data no longer reliably reflect trends in HIV transmission and do not accurately
represent the extent of the need for prevention and care services (16-17). In 1996, national AIDS
incidence and AIDS deaths declined for the first time in the HIV epidemic
(Figure 1). These declines have been primarily attributed to the early use of combination
antiretroviral therapy to delay the progression to AIDS and death for persons with HIV infection
(1-3). Revised HIV treatment guidelines recommend antiretroviral therapy for many HIV-
infected persons in whom AIDS-defining conditions have not yet developed (18-19). In response
to these changes in HIV treatment practices and the information needs of public health and other
policymakers, CDC and CSTE have recommended that all States and Territories extend their
AIDS case surveillance activities to also include HIV case surveillance (1, 4).
Current Status of HIV Surveillance
As of July 1, 1998, 32 States had implemented HIV case surveillance using the same
reporting system for both HIV and AIDS cases; 3 of these States conduct pediatric surveillance
only (6) (Figure 2). The 29 States that conduct integrated HIV and AIDS surveillance for adults,
adolescents, and children report only about one-third of total U.S. AIDS cases.
In contrast to AIDS case surveillance, HIV case surveillance can provide data to better
characterize populations newly diagnosed with HIV, particularly those with evidence of recent
HIV infection such as adolescents and young adults (20- to 24-year-olds) (20-21). Of the 52,690
3
HIV infections diagnosed from January 1994 through June 1997 in 25 States that conducted
name-based HIV surveillance throughout this period, 14 percent were in persons aged 13:to 24
whereas of 20,215 persons diagnosed with AIDS in the same areas only 3 percent were in persons
aged 13 to 24. Thus, AIDS case surveillance alone does not accurately reflect the extent of the
HIV epidemic among adolescents and young adults. Compared with persons reported with
AIDS, those reported with HIV infection in these 25 States were more likely to be women and
from racial/ethnic minorities (22) (Table 1). HIV data also show patterns in rates of new
diagnoses and HIV prevalence that are not affected by changes in treatment. For example,
between June 1996 and June 1997, AIDS incidence among white men who had sex with other
men (MSM) decreased more than 30 percent while the number of new HIV diagnoses among this
population remained unchanged (Figure 3). In these States, as of December 1997, the number of
persons (140,585) who were living with a diagnosis of HIV or AIDS was 139 percent greater
than that represented by the number living with AIDS alone (6).
Most of the 32 States with name-based HIV case surveillance systems report all
perinatally exposed children These States have used HIV surveillance data to document a sharp
decline in perinatally acquired HIV infection, an increase in the proportion of infected pregnant
women who have been tested for HIV before delivery; and a high proportion of HIV-infected
pregnant women who accept zidovudine therapy (23-28). These findings all have profound policy
implications that would not have been as easily or quickly detected using only AIDS case
surveillance. CSTE and the American Academy of Pediatrics have recommended that all States
and Territories conduct pediatric HIV surveillance that includes all perinatally-exposed infants
(29).
Persons may choose to be tested for HIV in the following ways: (1) anonymously-
where identifying information including their name and other locating information is not
linked to their HIV test result or included in the surveillance system report (e.g.,
anonymous testing sites), and (2) confidentially-where their HIV test result is linked to
identifying information such as patient and provider names (e.g., medical clinics). In
States that require HIV case reporting, providers in confidential medical or testing sites are
required to report HIV-infected persons to public health authorities. Not all persons
infected with HIV are tested, and of those that are, testing occurs at different stages of their
infection. Therefore, HIV surveillance data provide a minimum estimate of the number of
infected persons and are most representative of persons who have been diagnosed with HIV
infection in medical clinics and other confidential diagnostic settings. The data represent the
characteristics of persons who recognize their risk and seek confidential testing, who are offered
HIV testing (e.g., pregnant women, clients at sexually transmitted disease clinics), who are
required to be tested (e.g., blood donors, military recruits), and who are tested because they
present with symptoms of HIV-related illnesses. CDC estimates that more than two-thirds of all
infected persons in the United States have been diagnosed with HIV in such settings (30). HIV
surveillance data do not represent untested persons or those who seek testing at anonymous test
sites or with home collection kits; such persons cannot be reported through confidential HIV
surveillance systems. However, the availability of these testing venues is highly important in
promoting knowlege of HIV status among at-risk populations and provides an opportunity for
counseling and referrals to appropriate medical diagnosis and care.
4
Despite some limitations, HIV and AIDS case surveillance would provide a clearer picture
of the HIV epidemic than AIDS case surveillance alone. Therefore, CDC and CSTE continue to
recommend that HIV case surveillance be implemented as part of a comprehensive strategy to
monitor the epidemic that includes HIV incidence and prevalence surveys, HIV and AIDS case
surveillance, monitoring HIV-related mortality, supplemental research and evaluation studies
including behavioral surveillance, and statistical estimation of incidence and prevalence of
infection and disease.
AIDS surveillance nationally and HIV surveillance in 32 States is conducted using the
name-based methods for case ascertainment that are used by other public health information
systems. A name-based approach allows providers to report cases directly from their name-based
medical records, facilitates elimination of duplicate case reports, enables cross-matching of HIV
and AIDS data with other name-based public health data (e.g., tuberculosis surveillance) and
permits follow-up with providers to collect HIV risk information and other data of public health
importance. Through follow-up with providers, the AIDS surveillance system has provided an
effective means to identify rare or unusual modes of HIV transmission and infection with rare
strains of HIV and to improve the prevention of AIDS-related opportunistic illnesses (31-35).
Concerns Regarding HIV Surveillance
Since 1985, many States have implemented HIV case surveillance as part of their
comprehensive surveillance programs. The implementation of the 1993 expanded AIDS
surveillance case definition prompted discussions of the rationale and need for data representing
HIV-infected persons who did not meet the AIDS-defining criteria Because many States
considered implementing HIV reporting, in 1993, CDC held a consultation with public health and
community representatives to discuss issues and concerns regarding HIV surveillance.
Community representatives' main concerns were that the security and confidentiality standards of
surveillance programs may not be sufficient to prevent disclosures of information, and that many
persons at risk for HIV infection may delay seeking HIV counseling and testing because of these
confidentiality concerns. The consensus of the consultants was that there were few, if any,
published studies of sufficient scientific quality to provide objective answers to these concerns.
Therefore, the consultants identified several areas that required additional research and policy
development before CDC and CSTE should consider recommending further expansion of HIV
surveillance efforts. These areas included: (1) the impact of reporting policies on testing
practices, including the decreased availability of anonymous testing in some States; (2) the role of
surveillance data in linking reported persons to prevention and care programs; (3) the
development of recommended uses and standards for the confidentiality of publicly held HIV and
AIDS surveillance data; and (4) determining whether alternatives to reporting of patient names
would reduce confidentiality risks while meeting the needs for surveillance data. In response to
the consultants' recommendations, CDC initiated several research projects to:
or START
5
(1) assess the effect of name-based HIV surveillance on persons' willingness to seek HIV testing
and care; (2) evaluate the performance of non-name-based surveillance systems; and (3) review
program practices and legal requirements for the security and confidentiality of State and local
HIV/AIDS surveillance data. Findings from these projects and expert advice from participants at
numerous technical meetings and consultations held during the intervening period have guided the
formulation of the policies and practices recommended in this document. The interim findings
from these projects are summarized in the following three sections:
HIV Surveillance and Testing Behavior
To determine the effect of changes in reporting policies on actual testing behaviors among
persons seeking testing at publicly funded HIV counseling and testing sites, CDC and six State
health departments reviewed data routinely collected from these sites to compare HIV testing
patterns in the 12 months before and the 12 months after the implementation of HIV case
surveillance (36). In these areas, the number of HIV tests increased in four States and decreased
in two States; however, these declines were not statistically significant (Figure 4). Thus, these
data do not suggest that in these States the policy of expanding HIV case surveillance adversely
affected test-seeking behaviors overall, although some variability in testing trends was
observed among racial/ethnic subgroups and HIV-risk exposure categories. CDC recognizes
that careful attention to providing accurate public education, factual mass media messages, and
special efforts to inform vulnerable populations will be important to ensure that adverse
outcomes do not occur in States that implement HIV case surveillance based on these Guidelines.
In addition, CDC is supporting ongoing studies by researchers at the University of
California at San Francisco (UCSF) and participating State health departments to continue to
identify the most important determinants of test-seeking or test-avoidance among high-risk
populations and to assess the impact of changes in HIV testing and reporting policies. Efforts to
expand such studies to all States will assist them in more effectively monitoring the impact of
changing medical interventions, epidemiology, and HIV case surveillance policies on test- and
care-seeking behaviors.
Data from surveys in selected States of high-risk persons about their perceptions and
knowledge of HIV testing and HIV reporting practices found that few respondents had
knowledge of the HIV reporting policy in their State (37-38). In these settings, respondents
reported high levels of testing, with approximately three-fourths reporting that they,have had an
HIV test. The most commonly reported factors that contributed to delays in seeking testing or
not getting tested were fear of being diagnosed as having HIV or belief that they were not at risk
for HIV infection, factors reported by nearly half of respondents. Less than 20 percent
responded that "reporting to the government' was a concern that may have delayed their seeking
HIV testing, 2 percent of the respondents indicated that this was their main concern Among
different risk groups, the level of concern about name-based reporting of HIV infections to the
health department as a concern or as the main reason for delaying or avoiding HIV testing varied
slightly. CDC will continue to assist States to evaluate the impact of policy changes on HIV
testing patterns and HIV/AIDS surveillance data.
6
Surveys of persons reported with AIDS found that persons who recognized their HIV risk
and sought testing at anonymous testing sites entered care at a significantly earlier stage of HIV
disease than persons who were only tested in confidential testing settings including those who
were first tested when they became ill (39). This study emphasizes the importance of anonymous
testing options in promoting knowledge of HIV status and in accessing care in a timely way.
HIV Surveillance Based on Non-name Unique Identifiers
To assess the feasibility of using alternatives to name-based methods for HIV surveillance,
several States implemented reporting of HIV cases or CD4 laboratory results using a variety of
numeric codes. Other States considered or tried to conduct case surveillance without name-
identifiers by using codes that were designed for non-surveillance purposes, e.g., codes that were
intended for use in tracking patients in case management systems (40). CDC convened a meeting
in May 1995 at which these States identified operational, technical, and scientific challenges in
conducting surveillance using non-name codes. In addition, CDC supported research to evaluate
the performance of a coded unique identifier (UI) in two States that implemented a non-name-
based HIV case reporting system while maintaining name-based surveillance methods for AIDS
(41). The evaluations conducted by these States from 1994 to 1996 indicated that social security
number-based UI HIV surveillance systems were limited by the ability of providers to complete
and forward UI-based reports, resulting in incomplete reporting. The evaluations were also
unable to demonstrate that duplicate case reports could be reliably eliminated. For the follow-up
of UI-based cases to collect risk and other epidemiologic data, providers maintained logs or other
forms of documentation linking the UI to the name-based medical records. The willingness of
health care providers to accept the additional disease reporting burden of constructing UI
codes, maintaining logs, and adopting the level of security necessary to reduce the potential
for a breach of confidentiality from such logs, are important considerations in assessing the
utility and acceptability of UI HIV case surveillance systems. Of the two States that
currently conduct HIV case surveillance using unique identifier codes, one has elected to
continue to develop its UI HIV case surveillance system; the other is seeking to discontinue the
use of UI codes and to amend its regulations to begin name-based reporting of HIV infected
persons.
Confidentiality of HIV Surveillance Data
In 1994, CDC and CSTE sponsored a review of State confidentiality laws that protect
HIV surveillance data (42). All States and many localities have legal safeguards of confidentiality
of government-held health data, and these laws were found to provide greater protection than
laws protecting the confidentiality of health information held by private health care providers in
clinical records. Most States have specific statutory protections for public health data related to
HIV and other sexually transmitted diseases. However, State legal protections vary widely, and
CDC is promoting efforts to enhance and standardize privacy protections for public health data,
including HIV/AIDS surveillance data.
7
CDC has also reviewed State and local security policies and procedures. Since 1981,
States have conducted AIDS surveillance, and few breaches of security have resulted in the
unauthorized release of data (43). Because HIV-infected persons are reported earlier in their
disease course than persons with AIDS and many such persons are remaining AIDS-free for
longer periods as a result of treatment advances, information about them may be maintained by
public health surveillance databases for longer periods. This has caused increased concerns about
confidentiality of surveillance data among public health and community groups. Therefore, CDC
has issued technical guidance for security procedures that include enhanced confidentiality and
security safeguards as evaluation criteria for Federal funding of State HIV/AIDS surveillance
activities (44), The receipt of Federal surveillance funding is dependent on the recipient's ability
to ensure the physical security and the confidentiality of case reports. At the Federal level,
HIV/AIDS surveillance data are protected by several Federal statutes, and privacy is also ensured
by the removal of names and the encryption of data transmitted to CDC. Based on the
importance of maintaining the confidentiality of persons who are diagnosed as HIV-infected by
public and private health care providers, CDC is recommending additional practices to enhance
the security and confidentiality of HIV and AIDS surveillance data.
HIV AND AIDS SURVEILLANCE GUIDELINES
HIV/AIDS Surveillance Case Definitions for Children and Adults
CDC, in collaboration with CSTE, has established new HIV case definitions for adults
and children less than 18 months of age that include revised surveillance criteria for HIV
infection and incorporate the surveillance criteria for AIDS (10,13,45) (Appendix). HIV and
AIDS surveillance reports forwarded to CDC should be based on these surveillance criteria. The
HIV and AIDS surveillance case definitions for adults, adolescents, and children greater than or
equal to 18 months of age include laboratory and clinical evidence specifically indicative of HIV
infection and severe HIV disease (AIDS). The HIV surveillance case definition for children less
than 18 months of age updates the definition in the 1994 revised classification system based on
recent data on the sensitivity and the specificity of HIV diagnostic tests and clinical guidelines for
Pneumocystis carinii pneumonia (PCP) prophylaxis for children (13, 46-55) and for the use of
antiretroviral agents for pediatric HIV infection (56) This definition will apply to children less
than 18 months of age, except for those who acquired HIV infection through modes of
transmission other than perinatal transmission (e.g., blood/blood product recipients). The revised
surveillance case definitions for adults and children less than 18 months of age will become
effective
HIV and AIDS Case Surveillance Practices
The following recommended practices update previous recommendations for State and
local HIV reporting systems and are revisions to the CDC Guidelines for HIVIAIDS Surveillance
released in April 1996 as a technical guide for State and local HIV and AIDS surveillance
programs (20, 44).
8
Recommended Surveillance Practices
All State and local programs should collect a standard set of surveillance data for all cases
that meet the reporting criteria for HIV infection and AIDS. The standard data set
includes the (1) patient identifier, (2) earliest date of diagnosis for HIV infection,
(3) earliest date of diagnosis of an AIDS-defining condition, (4) demographic information
(date of birth, race/ethnicity, sex) and residence (city, State) at diagnosis of HIV and
AIDS, (5) HIV risk exposure, (6) facility of diagnosis, and (7) date of death and state of
residence at death In addition to this information, the date of HIV diagnostic testing and
the résults of these tests should be collected for all infants with perinatal exposures to
HIV. To address specific public health information needs, local surveillance programs
may cross-match HIV and AIDS surveillance data with other public health data, such as
for tubérculosis, and collect supplemental surveillance data on all or a representative
sample of cases. CDC will provide technical assistance and standardized surveillance
methods to assist in the collection of supplemental surveillance information Surveillance
information, without patient identifiers, should be encrypted and forwarded to CDC
through the HIV/AIDS Reporting System, as is current practice.
Published evaluations of non-name based HIV surveillance in two States (41) together
with results of meetings and consultations with States that have considered or used non-
name identifiers have highlighted operational difficulties with these systems. Based on
published evaluations CDC has concluded that name-based HIV/AIDS surveillance
systems are the most likely to meet the necessary performance standards (22, 57-61) as
well as to serve the purposes for which surveillance data are required. Therefore, CDC
advises that State and local surveillance programs use the same name-based approach for
HIV surveillance as is currently used for AIDS surveillance nationwide. However, CDC
recognizes that some States have adopted, and others may elect to adopt, non-name case
identifiers for the public health reporting of HIV infection. CDC will provide technical
assistance to all State and local areas to continue or establish HIV and AIDS surveillance
systems and to evaluate their surveillance programs regardless of whether they use name
or non-name based identifiers.
HIV and AIDS surveillance should be used to identify rare or previously unrecognized
modes of HIV transmission, unusual clinical or virologic manifestations, and other cases
of public health importance. CDC will provide technical assistance to State and local
health departments conducting such investigations and will revise public health
recommendations based on the findings, as appropriate.
HIV and AIDS case surveillance efforts should be directed toward the collection of data
from all private and public sources of HIV-related testing and care services. Laboratory-
initiated surveillance methods should be used to collect information for cases that meet the
laboratory reporting criteria for HIV infection and AIDS. Statistics regarding persons
who are tested anonymously should not be reported through the HIV/AIDS Reporting
System These test results are reported anonymously to the HIV Counseling and Testing
database. HIV-infected persons who are initially tested anonymously are only eligible to
be reported to HIV/AIDS surveillance after they have been diagnosed by a health care
9
provider and have test results or clinical conditions that meet the HIV and AIDS reporting
criteria.
All State and local surveillance programs should regularly publish, in print or
electronically, aggregated HIV and AIDS surveillance data in a format that facilitates the
use of these data by Federal, State, and local public health agencies; HIV Prevention
Community Planning groups; academic institutions; providers and institutions that have
reported cases; community-based organizations; and the general public. The presentation
of surveillance data should be consistent with established policies for data release that
preclude the direct or indirect identification of a person with HIV or AIDS.
All State and local surveillance programs should conduct regular, ongoing assessments of
the performance of the surveillance system and redirect efforts and resources to ensure
timely reporting of complete, representative, and accurate data. CDC will provide
technical assistance and standardized evaluation methods to assist States in achieving the
highest possible level of performance.
Performance Standards
For the provision of accurate and timely data to monitor HIV and AIDS trends and to
ensure a reliable measure of the number of persons in need of HIV-related prevention and
care services, State and local HIV/AIDS surveillance systems must use reporting methods
that provide complete (≥85 percent) and timely (≥66 percent of cases reported within 6
months of diagnosis) case reporting and unduplicated (SS percent duplicate case reports)
surveillance data At least 85 percent of cases, or a representative sample, should have
HIV risk information after epidemiologic follow-up is completed. All HIV and AIDS
surveillance systems should collect the recommended standard data in a reliable and valid
manner, allow matching to other public health databases (for example, death registries) to
benefit specific public health goals, and allow identification and follow-up of individual
cases of public health importance.
To assess the quality of HIV and AIDS case surveillance as specified in the performance
standards, States and local surveillance programs must conduct periodic evaluations that
include the use of at least one appropriate population-based data source (e.g., National
Death Index) that is not used for routine case-finding. Program evaluations should also
measure the potential impact of HIV surveillance on test-seeking patterns and behaviors
and review the extent to which surveillance data are being used for planning, targeting,
and evaluating HIV prevention programs and services. The goal of these performance
evaluations is to enhance the quality and usefulness of surveillance data for public health
action. During the next several years, CDC will assist States in transitioning from an
AIDS-only surveillance program to an integrated HIV and AIDS surveillance system
CDC will assist States conducting HIV and AIDS surveillance to evaluate current
performance levels, institute revised program operations and policies as necessary, and
then reassess performance. CDC will evaluate and award proposals for Federal funding of
State and local surveillance programs based on their capacity to meet these performance
10
standards following this transition period. At that time, CDC will require that States
adopt surveillance methods that will enable them to achieve the standards.
Recommended Security and Confidentiality Practices
State and local programs should have a description of their security policies and
procedures available for external review. CDC will require that State and local areas
include their security policy in applications for Federal surveillance funds.
For optimal security, data should be maintained on a single electronic HIV and AIDS
surveillance registry. In accordance with local laws, other files such as paper and
electronic (except for a backup for the central system) that contain personal identifying
information should be eliminated. All States should continue the established practice of
not including personal identifying information in the HIV and AIDS surveillance data
forwarded to CDC.
State and local health departments should review their data retention policies. Policies
should provide the flexibility to remove cases that were reported in eΓΓoΓ. State and local
programs should also consider removing the names from surveillance records that no
longer serve a public health purpose and to identify these cases through other means such
as the use of the alpha-numeric code scheme currently used in HIV and AIDS surveillance,
date of birth, and other data routinely collected in case reports.
State and local health departments should also review their confidentiality statutes to
determine whether additional protections should be put in place before the implementation
of HIV case surveillance. State and local confidentiality laws should include: (1) the
objectives of the collection of personal identifying information; (2) the public health
officials who have access to surveillance information and the justification for this access;
(3) the procedures, including time frame, for expunging personal identifiable information
when no longer needed for the stated purposes; (4) the safeguards against disclosing HIV
and AIDS case surveillance data through subpoena or court order, and (5) the significant
civil or criminal penalties for breaches of confidentiality. The confidentiality laws should
protect surveillance data that are transmitted (in a secure and confidential manner
consistent with CDC's HIV/AIDS surveillance program requirements) to other public
health programs as part of evaluation studies or for follow up of cases of special public
health importance. The penalties under law for violation of privacy and security should
apply to all recipients of HIV and AIDS case surveillance information.
Security and Confidentiality Standards
The security and confidentiality policies and procedures of State and local surveillance programs
should be consistent with CDC standards for surveillance programs. The following standards
must be met as a condition of Federal HIV and AIDS surveillance funding:
CDC requires that electronic HIV/AIDS surveillance data be protected by computer
encryption during data transfer. Paper or unencrypted electronic case reports forwarded
11
by providers should be used by surveillance staff to update the central surveillance registry
and then should be destroyed.
CDC requires that HIV and AIDS surveillance records be located in a physically secured
area to limit and control access to surveillance records and that they be protected by
coded passwords and computer encryption. To further enhance security and
confidentiality of the data, States may elect to implement the use of a double-key
encryption and decryption system, in which identifying information encrypted by the States
using the first key can only be decrypted for access using the second key. CDC is
developing this option to assist States to reassure HIV-infected persons that HIV
and AIDS surveillance data will be held confidentially and will only be used for
public health purposes. CDC will hold the second key under an Assurance of
Confidentiality under Section 308(d) of the Public Health Service Act. Under this
Assurance, the second CDC-held key would preclude States from accessing or releasing
the HIV/AIDS surveillance data for non-public-health purposes.
CDC requires that access to the HIV/AIDS surveillance registry be restricted to a
minimum number of authorized surveillance staff who have been trained in confidentiality
procedures and who are aware of penalties for unauthorized disclosure of surveillance
information. The State Health Officer or other designated authorizing official should
specify the persons who have access to confidential HIV/AIDS surveillance data and the
duties to be conducted. Audit systems should be established to monitor access to and use
of surveillance data.
If State and local health departments develop data bases from the cross-matching of
HIV/AIDS surveillance data with other surveillance data, HIV and AIDS surveillance
records must not be used if the cross-matched data bases do not have equivalent security
and confidentiality protections and penalties for unauthorized disclosure as those for the
HIV and AIDS surveillance data. Such cross-matched data bases should use the minimum
amount of surveillance data necessary to accomplish the specific public health activity.
The use of HIV and AIDS surveillance data for research purposes must be approved by
appropriate institutional review boards, and researchers should sign confidentiality
statements. HIV and AIDS surveillance data made available for epidemiologic analyses
must not include names or other identifying information State and local data release
policies should ensure that the release of data for statistical purposes does not result in the
direct or indirect identification of persons reported with HIV and AIDS. If.a breach of
confidentiality occurs, State and local health departments should impose personnel
sanctions and criminal penalties as appropriate.
State and local health departments must investigate potential breaches of confidentiality,
and impose personnel sanctions and criminal penalties as appropriate. All breaches of
confidentiality are to be reported to CDC immediately. CDC will provide technical
assistance to State and local health departments' investigations of such incidents, develop
recommendations for improvements in local security measures, and provide oversight to
monitor changes in program practices.
12
Relationship to HIV Prevention and Care Programs
The implementation of HIV case surveillance should not interfere with HIV prevention
programs, including those that offer anonymous HIV counseling and testing services.
Unless prohibited by State law or regulation, CDC requires that States and local areas
provide opportunities to receive anonymous HIV counseling and testing services as a
condition of Federal funding for HIV prevention. CDC strongly recommends that States
prohibiting anonymous HIV testing change this practice, given the overriding public health
objective of encouraging knowledge of HIV serologic status.
All HIV testing services should continue to be voluntary and preceded by informed
consent in accordance with local laws (62).
All persons who are diagnosed with HIV infection should be referred to programs that
provide HIV care, treatment, and comprehensive prevention case management services.
Provider-based referrals of patients to prevention and care services provide a timely,
effective, and efficient means of ensuring that individuals who have been diagnosed with
HIV receive needed services. The primary function of HIV and AIDS surveillance is the
collection of accurate and timely epidemiologic data; therefore, State and local HIV and
AIDS case surveillance programs are not directed by CDC to share individual case reports
with prevention or care programs, including those that provide partner notification
assistance, case management, and other services for individual clients. Although some
areas have established direct linkages between surveillance and specific prevention
programs, such linkages do not necessarily improve the provision of HIV prevention and
care services. Areas that elect to establish such linkages must seek the concurrence of
their prevention and care planning groups, require that recipients of surveillance
information be subject to the same penalties for unauthorized disclosure as surveillance
personnel, and evaluate the effectiveness of this public health approach.
COMMENTARY
The Surveillance Case Definition for HIV Infection and AIDS
The revised HIV case definition for adults and children less than 18 months of age
integrates HIV and AIDS reporting criteria in a single case definition and incorporates new
laboratory tests in the laboratory criteria for HIV case reporting. For adolescents and adults, the
1999 HIV and AIDS case definition includes viral detection tests that were not commercially
available when the case definition was revised in 1993. The revised case definition for HIV
infection also permits the reporting of cases based on the result of any test licensed for the
diagnosis of HIV infection in the United States. Although the reporting criteria generally reflect
the recommendations for the diagnosis of HIV infection, the HIV reporting criteria are for public
health surveillance and are not designed for making a diagnosis for an individual patient. The
laboratory criteria include the serologic HIV tests described in the clinical standards for HIV
diagnosis (63-64).
or
13
The pediatric HIV reporting criteria include criteria for monitoring all children with
perinatal exposures to HIV and reflect recent advances in diagnostic approaches that permit the
diagnosis of HIV infection in the first months of life. With viral detection tests, HIV infection can
be detected in nearly all infants 1 month of age or older. The timing of the HIV serologic and
viral detection tests and the number of viral detection tests in the definitive and presumptive
criteria for HIV infection are based on the recommended practices for the diagnosis of infection in
children less than 18 months of age and on evaluations of the performance of these tests for
children in this age group (46-55).
The clinical criteria in the HIV and AIDS case definition are included to ensure the
complete reporting of cases with documented evidence of HIV infection or AIDS-defining
conditions. The AIDS-defining conditions are included as part of the integrated HIV and AIDS
surveillance criteria The presumptive and definitive AIDS-defining criteria have not been revised
since 1993 and continue to include the laboratory markers of severe HIV-related immuno-
suppression and the opportunistic illnesses indicative of severe HIV disease. The development of
AIDS-related opportinistic illnesses greatly increases mortality risks. Almost all deaths among
persons with HIV infection are caused by AIDS-related opportunistic illnesses (65).
Effect of National HIV Case Surveillance on Reporting Trends
The changes in the HIV reporting criteria will have little effect on reporting trends in
States already conducting HIV case surveillance. The number of HIV cases reported nationally
will increase primarily because of the implementation of HIV surveillance by the remaining States
and local areas. Many of the States that will be implementing HIV case surveillance in the future
have high AIDS incidence rates. Similar to the effect on AIDS surveillance trends after the
implementation of the revised reporting criteria in 1993, the initiation of HIV surveillance by
additional States may result in a sudden and large increase in HIV case reports (66). Based on
CDC's estimates that approximately 220,000 HIV-infected persons without AIDS-defining
conditions have been diagnosed with HIV in confidential testing settings and reside in States
that do not currently conduct HIV case surveillance (30), it is possible that this many persons
could be reported with HIV infection from these States in 1999. However, it is more likely that
reporting of prevalent HIV infections will be spread over several years and that the annual
increases will be more modest. Initially, most case reports will represent persons whose HIV
infection was diagnosed before HIV surveillance was implemented. As the reporting of prevalent
HIV cases is completed, the number of HIV case reports will decrease and case reports will
increasingly represent persons with recent diagnosis of HIV infection.
To facilitate the interpretation of HIV surveillance data and given that CDC strongly
promotes the continued availability of anonymous testing options, evaluations of HIV and AIDS
surveillance systems will include assessments of the number of persons reported whose infection
was initially diagnosed at an anonymous site and the time before these persons entered clinical
care for their infection These evaluations will be useful in determining the representativeness of
HIV surveillance data, as well as the effectiveness of program efforts to refer persons into care
services after the diagnosis of HIV infection in anonymous testing settings.
14
AIDS trends have declined nationally; however, because the AIDS surveillance trends are
affected by HIV incidence, as well as the effect of treatment on the progression of HIV disease, it
is not possible to predict future AIDS trends. AIDS surveillance will continue to be important in
evaluating access to care for different populations and in identifying changes in trends that might
signal a decrease in the effectiveness of treatment. The long-term benefits of antiretroviral
therapy and antimicrobial prophylaxis for AIDS-related illnesses continue to be defined, and
various factors such as access, adherence, treatment costs, and viral resistance will influence the
utilization and effectiveness of these therapies and their effects on AIDS incidence and mortality
trends (67-69)
HIV and AIDS Surveillance Practices
Laboratories will be an increasingly important source of information from which to initiate
reporting. HIV infection is frequently diagnosed in the outpatient clinical setting, and laboratory-
initiated reporting will be particularly useful in identifying outpatient sources of HIV testing (60).
Although contact with individual providers is necessary to complete the reporting process, the
routine collection of data from laboratories and managed care organizations promotes simplicity
and efficiency of case reporting to local surveillance programs.
Performance criteria for HIV and AIDS surveillance are necessary to ensure that
surveillance data are of sufficient quality to target prevention and care resources and to detect
emerging trends in the HIV epidemic. Evaluations of HIV and AIDS surveillance programs have
shown that areas should be able to meet these performance criteria (6,22,57-61). According to
these evaluations, the completeness of HIV surveillance (79 to 95 percent) and AIDS surveillance
(85 to 100 percent) is high, and reporting is timely with nearly one-half of AIDS cases and
three-quarters of HIV cases reported to the national HIV/AIDS reporting system within 3 months
of diagnosis (6). In 1996, CDC estimated that the duplication rate of HIV and AIDS cases
reported from different States to the national surveillance data base was less than 3 percent and 2
percent, respectively (6). The performance criteria also reflect the need for public health
surveillance systems to serve as a basis for the identification and follow-up of cases of public
health importance. Based on evaluation studies of non-name-based case identifiers and the
current infrastructure of State and local health departments, name-based methods for collecting
and reporting public health data provide the most feasible and reliable means for ensuring timely,
accurate, and complete reporting of persons diagnosed with HIV and AIDS. Name-based
reporting facilitates followup of perinatally exposed infants to determine their infection status and
of persons reported with HIV to determine progression to AIDS and vital status. (22,28)
The Security and Confidentiality of HIV and AIDS Surveillance
The revision of the HIV reporting criteria provides an opportunity to review and
strengthen State and local confidentiality laws and regulations. Although State HIV and AIDS
surveillance confidentiality laws and regulations adequately protect privacy compared with the
statutory protections of other health care data, State statutes differ in the degree of privacy
protections afforded health information and the criteria for permissible disclosures of personal
15
information. Most State statutes describe some permissible disclosures of public health
information To help ensure uniform confidentiality protections, CDC, CSTE, ASTHO, the
National Conference of State Legislatures, and the Georgetown/Johns Hopkins Public Health
Law Project are conducting a model State privacy law project. This project is developing model
legislative language to protect confidential, identifiable information held by State and local public
health departments against unauthorized and inappropriate use while still allowing the use of
surveillance information to accomplish legitimate public health objectives. This process is
projected to be completed by the end of 1998, and States that plan to implement HIV case
surveillance should consider adopting the model legislation.
Although HIV and AIDS surveillance systems have exemplary records of security and
confidentiality, it is essential for all programs to identify ways to strengthen data protection
because of the greater sensitivity of HIV case surveillance compared with that of AIDS case
surveillance alone. The revised security requirements are based on a CDC review of the security
practices of all State HIV and AIDS surveillance systems. The revised security standards will
result in a reduction in the number of name-based surveillance registries and limitations on how
these registries are used. CDC continues to conduct evaluations of methods to further enhance
data security, including the use of coding and encryption of data collected in the HIV and AIDS
reporting system Based on these evaluations, CDC will provide technical guidance to facilitate
the use of this approach by project areas.
HIV Prevention and Care
CDC has published guidelines concerning the provision and targeting of HIV counseling
and testing services (19, 27, 70-72) and provides support for most public sources of HIV testing.
The availability of anonymous HIV testing services may be particularly important for persons who
delay seeking testing because of a concern that others may learn of their serologic status. Studies
have shown that the availability of anonymous HIV testing is associated with increased numbers
of persons seeking testing services (73-76). Anonymous HIV testing services are a required
element of federally supported prevention programs unless prohibited by State law or regulation.
Currently, 39 States, Puerto Rico, and the District of Columbia provide anonymous HIV testing
services.
CDC advises that the decision about linkage between surveillance systems and prevention
and care services, such as partner counseling and referral services (i.e., partner notification
activities), be made at the local level Voluntary partner notification services provide HIV
counseling and testing to persons who may be unaware of HIV risk exposures, and these services
are a required component of federally sponsored HIV prevention programs (77-78). All such
prevention services are feasible and in well-managed programs have been highly effective without
being directly linked to HIV or AIDS surveillance data Translating surveillance data into
prevention priorities and programs requires informed decision-making by public health and
community partners through the HIV Prevention Community Planning process that should guide
whether and how such linkages are achieved. 'Such linkages should neither compromise the
quality and security of the surveillance system nor compromise the quality, confidentiality, and
voluntary nature of HIV prevention services. The primary function of HIV and AIDS
16
surveillance remains the provision of accurate epidemiologic data for public health information,
planning, and evaluation.
Persons who have been diagnosed with HIV infection at either confidential or anonymous
test sites should be promptly referred to facilities that provide confidential HIV care. Although
not directly responsible for the delivery of medical care, CDC provides Federal direction for State
and local programs that facilitate the referral of HIV-infected persons from counseling and testing
centers and health education/risk-reduction programs to HIV care facilities. CDC has
strengthened its technical assistance to HIV counseling and testing grantees to improve the
referral system between HIV testing sites and care programs, in part by increasing coordination
with the Health Resources and Services Administration and the Ryan White CARE Act grantees,
To provide further guidance, CDC has also undertaken a project to develop model contract
language for Medicaid programs that serve people with HIV.
CONCLUSION
The implementation of a national surveillance network to include both HIV and AIDS
surveillance is a necessary response to epidemiologic trends and new standards for HIV care.
Integrated HIV and AIDS surveillance programs will provide data to characterize persons newly
diagnosed with HIV infection, including those with evidence of recent infection, persons with
severe HIV disease (AIDS), and those succumbing to HIV and AIDS. The revised HIV
surveillance case definitions and the establishment of performance criteria will promote uniform
case ascertainment and will ensure that the surveillance data are of sufficient quality for effective
planning and allocation of resources for prevention and care programs. The successful
implementation of HIV and AIDS surveillance will require that State and local areas further
ensure the security and confidentiality of surveillance data This can be promoted through
enhancements to data systems and confidentiality policies, training and management of public
health personnel, and by use of the HIV Prevention Community Planning process to determine the
appropriate use of surveillance data by prevention and care programs.
Appendix
Revised Surveillance Case Definition of HIV Infection (including AIDS)*
This revised definition of HIV infection, which applies to any type of HIV (e.g., HIV-1, HIV-2),
is intended for public health surveillance only. The revised criteria for HIV infection update the
definition of HIV infection implemented in 1993 (10); the revised HIV criteria apply to AIDS-
defining conditions (10) that require laboratory evidence of HIV. This definition is not presented
as a guide to clinical diagnosis or for other uses (10,12).
I.
In adults, adolescents, or children >18 months of age, a reportable case of.HIV
infection meets any of the following criteria:
Laboratory Criteria
Positive result on a screening test for HIV antibody (e.g., repeatedly reactive
enzyme immunoassay) followed by a positive result on a confirmatory (sensitive
and more specific) test for HIV antibody (e.g., Western blot or
immunofluorescence antibody test), OR,
Positive result on any of the following HIV virologic detection (non-antibody)
tests:
HIV nucleic acid (DNA or RNA) detection (e.g. DNA polymerase chain
reaction (PCR), plasma HIV-1 RNA levels)#
p24 antigen test, including neutralization assay
Virus isolation (culture)
OR
Clinical Criteria (if the above criteria are not met)
Diagnosis of HIV infection documented in a medical record by a physician, OR,
Conditions that meet criteria included in the case definition for AIDS (10,12)
II
In a child <18 months of age, a reportable case of HIV infection meets any of the
following criteria:
Laboratory Criteria
Definitive
Positive results on two separate determinations (excluding cord blood) from one
or more of the following HIV virologic detection (non-antibody) tests:
HIV nucleic acid (DNA or RNA) detection#
p24 antigen test, including neutralization assay
Virus isolation (culture)
OR
Presumptive
Positive results on only one (excluding cord blood) of the definitive HIV virologic
detection tests
OR
Clinical Criteria (if the above criteria are not met)
Diagnosis of HIV infection documented in a medical record by a physician, OR,
Office of HIV/AIDS Policy
Office of Public Health and Science
USA SERVICES DEPART MENT HUMAN OF GENEALTH
Office of the Secretary
200 Independence Avenue, S.W., Room 736-E
Washington, DC 20201
Deliver To:
Todd
Fax:
( ) 456-2438
Phone:
(
)
From:
Deborah von Zinkernagel
Deputy Director for Policy
Phone:
(202) 690-5560
Fax:
(202) 690-6584
E-mail:
[email protected]
Date:
/ /
This fax contains
page(s) plus cover
If transmission problems occur, please call: Shellie Abramson @ 202-690-5560
Comments:
02
FINAL
December 1998
CDC Fact Sheet
CDC Draft Guidelines for Improved Data on U.S. HIV Epidemic
New Systems Urgently Needed to Guide Prevention Efforts
The Centers for Disease Control and Prevention (CDC) has released draft guidelines calling on all
States to track the course of the HIV epidemic as an extension of their AIDS surveillance
programs. To address the urgent need for information to ensure effective targeting of prevention
and care services while recognizing legitimate concerns about confidentiality and access to testing
and care, CDC has called for all States and territories to conduct HIV surveillance in addition to
their AIDS surveillance systems. The guidelines articulate performance standards that all States
must meet within a reasonable time period. The decision on the surveillance system used to
gather those data - either a name-based or an alternative "unique identifier" system - will be left up
to the States. CDC is advising that, based on available evaluations of name-based HIV
surveillance systems, name-based HIV surveillance systems are currently most likely to meet the
necessary performance standards and provide the quality data necessary to direct community
prevention and treatment programs.
The guidelines respond to recent treatment advances that have slowed the progression from HIV
to AIDS for many individuals. Data on AIDS cases alone can no longer be reliably used to direct
prevention efforts to communities currently at greatest risk. The new guidelines address the
urgent need for information to ensure effective targeting of prevention services.
The draft guidelines represent the culmination of a lengthy effort by CDC with communities and
public health partners nationwide to address emerging information needs and issues surrounding
the effective implementation of HIV reporting. The proposed recommendations are designed to
1) provide accurate and reliable data for communities to effectively direct scarce resources for
HIV prevention and treatment; 2) maintain strict confidentiality of HIV data, including controlled
access and strong penalties for abuse; and 3) continue support for anonymous testing options SO
that systems do not deter individuals at risk from accessing HIV testing, treatment, and
prevention services.
As of July 1, 1998, thirty-two states had implemented HIV surveillance using the same reporting
system for both HIV and AIDS cases; three of these states conduct pediatric surveillance only.
Additional states are now working to expand their AIDS surveillance systems to include HIV
cases. The draft "Guidelines for National HIV Surveillance, Including Monitoring for HIV
Infection and Acquired Immunodeficiency Syndrome" are designed to provide states
recommendations on the best practices to ensure both quality and confidentiality of HIV data.
CDC Recommendations
Given the importance of HIV surveillance data for directing services and care to individuals with
HIV infection, the draft CDC guidelines establish specified performance criteria to assure both the
quality and confidentiality of that data. All states will be required to establish an HIV surveillance
system that meets these quality and confidentiality criteria within a reasonable time period. The
decision on the surveillance system used to gather those data - either a name-based or an
alternative "unique identifier" system - will be left up to the states.
Based on available evaluations of name-based HIV surveillance systems, CDC believes that such
systems are currently the most likely to meet the necessary performance standards and provide the
quality data necessary to direct community prevention and treatment programs. However, CDC's
draft policy does allow for flexibility for those states that decide to implement alternative systems
CDC will provide financial and technical assistance to states working to design HIV surveillance
systems, including unique identifier-based and name-based systems.
During the next several years, CDC will assist states in implementing HIV surveillance systems,
evaluating current performance levels, revising systems as necessary and reassessing performance.
After this transition period, CDC will evaluate and award proposals for federal funding of state
and local surveillance programs based on their capacity to meet the performance standards. At
that time, CDC will work with states to adopt surveillance methods that will enable them to
achieve the standards.
Criteria for Quality and Confidentiality
The draft guidance document outlines performance criteria to ensure the quality and
confidentiality of HIV data. These criteria include strict confidentiality procedures and
protections such as using a single registry, eliminating paper reports, using computer encryption
techniques, setting up physical security and limited access to data, and penalties for abuse.
Additionally, the guidelines set quality standards for data to ensure completeness (over 85% of
diagnoses must be reported), timeliness (over 66% of diagnoses of reported within 6 months of
diagnosis), no duplication (less than 5% of cases should be duplicate reports of a single case), and
the ability to follow-up with providers on cases of public health importance (e.g., unusual modes
of transmission or strains).
Efforts to Evaluate and Address Concerns About Name-Based HIV Reporting
CDC recognizes the concerns regarding name-based reporting of HIV infection and the greater
sensitivity of HIV case data. CDC has worked for several years to evaluate and address these
issues and has consulted with a diverse group of individuals and organizations from the scientific,
public health, and AIDS advocacy communities in developing these proposed guidelines. Of
course, CDC will continue to work with states to evaluate the impact of HIV case surveillance as
implemented following these guidelines.
004
The draft guidelines present the results of these assessments in more detail, but several key steps
have been taken, including:
Evaluation of Unique Identifier Systems
CDC has assessed the feasibility of using alternatives to name-based methods for HIV surveillance
by reviewing a number of existing state systems that use a variety of numeric codes or "unique
identifiers" (UI) rather than names.
Most recent evaluations looked at Social Security number-based systems. Several problems were
found with these systems, including a high number of reports with incomplete codes
(approximately 30-40%), low rates of completeness in reporting (approximately 25-50%
complete), difficulty in conducting follow-up on specific cases, and the absence of behavioral risk
data in this system. CDC also found difficulties in assessing the level of duplicate case reports or
the ability to reliably link to other public health databases (e.g. death registries).
In UI-based systems, providers must maintain logs or other forms of documentation linking the UI
to the name-based medical records. This process may pose additional confidentiality risks if
physician-held surveillance registries are not protected by state confidentiality statutes or are
located in non-secure areas.
Support for Anonymous Testing
While studies suggest that name-based HIV reporting does not serve as a major deterrent to
testing, CDC continues to strongly support anonymous HIV testing and recommends that all
states provide anonymous testing options. CDC studies indicate that the lack of anonymous
testing serves as a deterrent to testing in some high-risk populations. Unless prohibited by law,
CDC requires that states receiving prevention funds to make anonymous testing available.
Maintaining anonymous test sites is important for prevention efforts and will not seriously inhibit
efforts to track the epidemic. Most people are diagnosed with HIV infection in confidential care
settings. Moreover, the time between HIV diagnosis and the point at which individuals enter the
care system has become shorter, given new treatment advances. Maintaining an anonymous
testing option may help ensure that more individuals learn their status, and if infected, seek early
treatment and care. HIV home test kits now offer another anonymous testing option in the
United states. And anonymous testing is available in publicly funded counseling and testing sites
in all but eleven states. CDC strongly recommends that states not currently offering anonymous
testing reevaluate their policies on this issue.
Strengthening Systems to Protect Confidentiality
Public health departments have maintained an exemplary record in protecting the confidentiality of
HIV/AIDS data. Since 1981 there have been few reported breaches of confidentiality in state
AIDS reporting systems.
V 005
Over the past few years, CDC has been working to evaluate additional measures at the state level
that could improve confidentiality even further. CDC has recently reviewed state reporting
programs and has developed enhanced standards to be used in developing local confidentiality
plans. Local programs will be required to meet these performance standards and must ensure
confidentiality as a condition of funding. One important security measure CDC is now making
available to states is the option of using a double-keyed encryption program. With this system,
names and other identifying information may only be accessed with both the key (password) held
by the state and the key held by CDC.
To assess the strength of local confidentiality laws that protect HIV data, CDC requested that
Georgetown/Johns Hopkins Public Health Law Project review local laws and regulations. All
states and many localities have legal safeguards of confidentiality for government-held data, and
these laws were found to provide greater protection than laws protecting health information held
by private health care providers. Additionally, most states have specific statutory protections for
public health data related to HIV. However, state legal protections vary widely.
CDC is therefore promoting efforts to enhance and standardize local confidentiality laws. CDC,
in partnership with other public health agencies, the National Conference of state Legislatures,
and the Georgetown/Johns Hopkins Public Health Law Project, is working to develop model
legislative language to protect confidential, identifiable information held by state and local public
health departments against unauthorized and inappropriate use, while still allowing the use of
surveillance information to accomplish legitimate public health objectives.
Request for Public Comment
The draft Guidelines represent the combined efforts of CDC and numerous agencies and
individuals nationwide. CDC is seeking public comment to ensure the final recommendations
promote the best possible approaches to HIV surveillance, as a critical component of future HIV
prevention efforts. After the public comment period, which runs from x date to y date, the
comments will be carefully reviewed and considered. The Guidelines will be modified as needed
before being published in the Morbidity and Mortality Weekly Report. For copies of the draft
Guidelines and information on how to submit comments, call the CDC National Prevention
Information Network at 1-800-458-5231 or send a written request to P.O. Box 6003, Rockville,
MD 20849-6003.
###
I ' RUMAN LEVICES and
DEPARTMENT OF HEALTH & HUMAN SERVICES
Chief of Staff
Washington, D.C. 20201
FACSIMILE
DATE: 12/9/98
TO:
Chris Jennings
FAX#: 456-5557
FROM: Mary Beth Donahue
Chief of Staff
Phone:
202/690-7431 Fax: 202/401-5783
COMMENTS:
This is final paper. It just needs to
go on CDC lettehead
Pages [including this cover]
001
CHIEF OF STAFF
12/09/98 WED 11 10 11:10 FAX 202 4015783
FINAL
December 1998
CDC Fact Sheet
CDC Draft Guidelines for Improved Data on U.S. HIV Epidemic
New Systems Urgently Needed to Guide Prevention Efforts
The Centers for Disease Control and Prevention (CDC) has released draft guidelines calling on all
States to track the course of the HIV epidemic as an extension of their AIDS surveillance
programs. To address the urgent need for information to ensure effective targeting of prevention
and care services while recognizing legitimate concerns about confidentiality and access to testing
and care, CDC has called for all States and territories to conduct HIV surveillance in addition to
their AIDS surveillance systems. The guidelines articulate performance standards that all States
must meet within a reasonable time period. The decision on the surveillance system used to
gather those data - either a name-based or an alternative "unique identifier" system - will be left up
to the States. CDC is advising that, based on available evaluations of name-based HIV
surveillance systems, name-based HIV surveillance systems are currently most likely to meet the
necessary performance standards and provide the quality data necessary to direct community
prevention and treatment programs.
The guidelines respond to recent treatment advances that have slowed the progression from HIV
to AIDS for many individuals. Data on AIDS cases alone can no longer be reliably used to direct
prevention efforts to communities currently at greatest risk. The new guidelines address the
urgent need for information to ensure effective targeting of prevention services.
The draft guidelines represent the culmination of a lengthy effort by CDC with communities and
public health partners nationwide to address emerging information needs and issues surrounding
the effective implementation of HIV reporting. The proposed recommendations are designed to
1) provide accurate and reliable data for communities to effectively direct scarce resources for
HIV prevention and treatment; 2) maintain strict confidentiality of HIV data, including controlled
access and strong penalties for abuse; and 3) continue support for anonymous testing options so
that systems do not deter individuals at risk from accessing HIV testing, treatment, and
prevention services.
As of July 1, 1998, thirty-two states had implemented HIV surveillance using the same reporting
system for both HIV and AIDS cases; three of these states conduct pediatric surveillance only.
Additional states are now working to expand their AIDS surveillance systems to include HIV
cases. The draft "Guidelines for National HIV Surveillance, Including Monitoring for HIV
Infection and Acquired Immunodeficiency Syndrome" are designed to provide states
recommendations on the best practices to ensure both quality and confidentiality of HIV data.
022
CHIEF OF STAFF
12/09/98 WED 11:10 FAX 202 4015783
CDC Recommendations
Given the importance of HIV surveillance data for directing services and care to individuals with
HIV infection, the draft CDC guidelines establish specified performance criteria to assure both the
quality and confidentiality of that data. All states will be required to establish an HIV surveillance
system that meets these quality and confidentiality criteria within a reasonable time period. The
decision on the surveillance system used to gather those data - either a name-based or an
alternative "unique identifier" system - will be left up to the states.
Based on available evaluations of name-based HIV surveillance systems, CDC believes that such
systems are currently the most likely to meet the necessary performance standards and provide the
quality data necessary to direct community prevention and treatment programs. However, CDC's
draft policy does allow for flexibility for those states that decide to implement alternative systems.
CDC will provide financial and technical assistance to states working to design HIV surveillance
systems, including unique identifier-based and name-based systems.
During the next several years, CDC will assist states in implementing HIV surveillance systems,
evaluating current performance levels, revising systems as necessary and reassessing performance.
After this transition period, CDC will evaluate and award proposals for federal funding of state
and local surveillance programs based on their capacity to meet the performance standards. At
that time, CDC will work with states to adopt surveillance methods that will enable them to
achieve the standards.
Criteria for Quality and Confidentiality
The draft guidance document outlines performance criteria to ensure the quality and
confidentiality of HIV data. These criteria include strict confidentiality procedures and
protections such as using a single registry, eliminating paper reports, using computer encryption
techniques, setting up physical security and limited access to data, and penalties for abuse.
Additionally, the guidelines set quality standards for data to ensure completeness (over 85% of
diagnoses must be reported), timeliness (over 66% of diagnoses of reported within 6 months of
diagnosis), no duplication (less than 5% of cases should be duplicate reports of a single case), and
the ability to follow-up with providers on cases of public health importance (e.g., unusual modes
of transmission or strains).
Efforts to Evaluate and Address Concerns About Name-Based HIV Reporting
CDC recognizes the concerns regarding name-based reporting of HIV infection and the greater
sensitivity of HIV case data. CDC has worked for several years to evaluate and address these
issues and has consulted with a diverse group of individuals and organizations from the scientific,
public health, and AIDS advocacy communities in developing these proposed guidelines. Of
course, CDC will continue to work with states to evaluate the impact of HIV case surveillance as
implemented following these guidelines.
003
CHIEF OF STAFF
202 4015783 WED 11:11 FAX 12/09/98
The draft guidelines present the results of these assessments in more detail, but several key steps
have been taken, including:
Evaluation of Unique Identifier Systems
CDC has assessed the feasibility of using alternatives to name-based methods for HIV surveillance
by reviewing a number of existing state systems that use a variety of numeric codes or "unique
identifiers" (UI) rather than names.
Most recent evaluations looked at Social Security number-based systems. Several problems were
found with these systems, including a high number of reports with incomplete codes
(approximately 30-40%), low rates of completeness in reporting (approximately 25-50%
complete), difficulty in conducting follow-up on specific cases, and the absence of behavioral risk
data in this system. CDC also found difficulties in assessing the level of duplicate case reports or
the ability to reliably link to other public health databases (e.g. death registries).
In UI-based systems, providers must maintain logs or other forms of documentation linking the UI
to the name-based medical records. This process may pose additional confidentiality risks if
physician-held surveillance registries are not protected by state confidentiality statutes or are
located in non-secure areas.
Support for Anonymous Testing
While studies suggest that name-based HIV reporting does not serve as a major deterrent to
testing, CDC continues to strongly support anonymous HIV testing and recommends that all
states provide anonymous testing options. CDC studies indicate that the lack of anonymous
testing serves as a deterrent to testing in some high-risk populations. Unless prohibited by law,
CDC requires that states receiving prevention funds to make anonymous testing available.
Maintaining anonymous test sites is important for prevention efforts and will not seriously inhibit
efforts to track the epidemic. Most people are diagnosed with HIV infection in confidential care
settings. Moreover, the time between HIV diagnosis and the point at which individuals enter the
care system has become shorter, given new treatment advances. Maintaining an anonymous
testing option may help ensure that more individuals learn their status, and if infected, seek early
treatment and care. HIV home test kits now offer another anonymous testing option in the
United states. And anonymous testing is available in publicly funded counseling and testing sites
in all but eleven states. CDC strongly recommends that states not currently offering anonymous
testing reevaluate their policies on this issue.
Strengthening Systems to Protect Confidentiality
Public health departments have maintained an exemplary record in protecting the confidentiality of
HIV/AIDS data. Since 1981 there have been few reported breaches of confidentiality in state
AIDS reporting systems.
00
CHIEF OF STAFF
4015783 202 EAX II:II PED
Over the past few years, CDC has been working to evaluate additional measures at the state level
that could improve confidentiality even further. CDC has recently reviewed state reporting
programs and has developed enhanced standards to be used in developing local confidentiality
plans. Local programs will be required to meet these performance standards and must ensure
confidentiality as a condition of funding. One important security measure CDC is now making
available to states is the option of using a double-keyed encryption program. With this system,
names and other identifying information may only be accessed with both the key (password) held
by the state and the key held by CDC.
To assess the strength of local confidentiality laws that protect HIV data, CDC requested that
Georgetown/Johns Hopkins Public Health Law Project review local laws and regulations. All
states and many localities have legal safeguards of confidentiality for government-held data, and
these laws were found to provide greater protection than laws protecting health information held
by private health care providers. Additionally, most states have specific statutory protections for
public health data related to HIV. However, state legal protections vary widely.
CDC is therefore promoting efforts to enhance and standardize local confidentiality laws. CDC,
in partnership with other public health agencies, the National Conference of state Legislatures,
and the Georgetown/Johns Hopkins Public Health Law Project, is working to develop model
legislative language to protect confidential, identifiable information held by state and local public
health departments against unauthorized and inappropriate use, while still allowing the use of
surveillance information to accomplish legitimate public health objectives.
Request for Public Comment
The draft Guidelines represent the combined efforts of CDC and numerous agencies and
individuals nationwide. CDC is seeking public comment to ensure the final recommendations
promote the best possible approaches to HIV surveillance, as a critical component of future HIV
prevention efforts. After the public comment period, which runs from X date to y date, the
comments will be carefully reviewed and considered. The Guidelines will be modified as needed
before being published in the Morbidity and Mortality Weekly Report. For copies of the draft
Guidelines and information on how to submit comments, call the CDC National Prevention
Information Network at 1-800-458-5231 or send a written request to P.O. Box 6003, Rockville,
MD 20849-6003.
###
005
CHIEF OF STAFF
12/09/98 WED 11:11 FAX 202 4015783
12/07/98 21:27 FAX
AIDS Policy
005
Effect of HIV Reporting by Name
on Use of HIV Testing
in Publicly Funded Counseling
and Testing Programs
Allyn K. Nakashima, MD; Rosemarie Horsley; Robert L. Frey, PhD: Patricia A. Sweeney. MPH;
J. Todd Weber, MD; Patricia L. Fleming, PhD
Context-Policies requiring confidential reporting by name to state health de-
these AIDS case reports. In contrast,
partments of persons infected with the human immunodeficiency virus (HIV) have
confidential reporting by name of HIV-
potential to CBUSB some of them to avoid HIV testing.
infected adults and adolescents (aged
Objective.-To describe trends in use of HIV testing services at publicly funded
≥13 years) who do not meet the criteria
HIV counseling and testing sites before and after the implementation of HIV report-
for AIDS (HIV reporting)' has been
ing policies.
implemented less completely; by Janu-
Design and Setting-Analysis of service provision data from 6 state health de-
ary 1998, only 28 states required physi-
partments (Louisiana, Michigan, Nebraska, Nevada, New Jersey, and Tennessee)
cians and other health care providers,
including clinicians, laboratories, and in-
12 months before and 12 months after HIV reporting was introduced.
stitutions (eg, hospitals, clinics). to re-
Main Outcome Measure.-Percent change in numbers of persons tested at
port these cases.² Until recently, AIDS
publicly funded HIV counseling and testing sites after implementation of confiden-
case reporting met most of the informa-
tial HIV reporting by risk group.
tion needs of monitoring and character-
Results.-No significant declines in the total number of HIV tests provided at
izing the HIV epidemic, Because of
counseling and testing sites in the months immediately after implementation of HIV
changes in the epidemic, most notably
reporting occurred in any state, other than those expected from trends present be-
chose related to new therapies. AIDS
fore HIV reporting. Increases occurred in Nebraska (15.8%), Navada (48.4%), New
case reports no longer provide adequate
Jersey (21.3%), and Tennessee (62.8%). Predicted decreases occurred in Louisi-
information, and HIV reporting will be-
ana (10.5%) and Michigan (2.0%). In all areas, testing of at-risk heterosexuals in-
come increasingly important.14
creased In the year after HIV reporting was implemented (Louisiana, 10.5%; Micht
gan, 225.1%; Nebraska, 5.7%; Nevada, 303.3%; New Jersey, 462.9%; Tennessee,
See also P 1416,
603.8%). Declines in testing occurred among men who have sex with men In Loui-
siana (4.3%) and Tennessee (4.1%) after HIV reporting: testing increased for this
One barrier to the adoption of HIV
group in Michigan (5.3%), Nebraska (10,6%), Nevada (12.5%). and New Jersey
reporting has been the concern that such
(22.4%). Among injection drug users, testing declined in Louisiana (15%). Michi-
policies might cause some individuals to
gan (34.3%), and New Jersey (0,6%) and increased in Nebraska (1.7%), Navada
avoid testing or medical care. These
(18,9%), and Tennessee (16.6%).
concerns have been based on
Cenoluolane-Confidential HIV reporting by name did not appear to affect use
of xt-risk populations. Although the
of HIV testing In publicly funded counseling and testing programs.
populations surveyed were at high risk
JAMA 1908:290:1421-1425
for HIV (eg, man who have sex with men
[MSM], they were limited by small num-
bers and narrow geographic coverage.
From the Division of HIV/AIDS Prevention. Nallonal
POLICIES for the confidential report-
Center for HIV. STD. and TB Prevention. Centers for
Most surveys asked people about their
Disease Control and Prevention. Allanta. Ga.
ing by name of persons with acquired
intent to test without verifying testing
Presanted in part at the 12Sm Annual Meeting of the
immunodeficiency syndrome (AIDS) to
behaviors after the implementation of
American Public Health Association. Indianapolis. Ind,
health departments exist in all states.¹
HIV reporting.
November 3-13, 1997.
Reprints: Allyn K. Nakashima, MD. Centers for Dis.
The ability to monitor trands in the epi-
Large-scale, publicly funded HIV coup-
eace Control and Provention. 1800 Cillion Rd. MS E-47,
damic due to the human immunodefi-
seling and testing (CT) programs have
Address GA 30333 (e-mail:
ciency virus (HIV) has been based on
been in place in all states since 1986.13
JAMA, October 28. 1998-Vel 280, No. 16
Effect of HIV Reporting on HIV Testing-Nakashima of al 1421
500
10/28/98 WED 15:11 FAX
12/07/98 21:27 FAX
AIDS Policy
006
These programs were huwany imple-
alone 111
mented to provide alter for HIV testing
departments for HIV CT vices since
data for the 1 th when HIV name re-
other than blood banks and to offer
1986. 18-15 Since 1990, most project areas
porting was introduced were excluded.
anonymous or confidential HIV CT SET-
have sent to CDC data on individual
We excluded CT sites reporting fewer
vices to anyone seeking a test. Approxi-
tests performed. For such test per-
than 50 tests to the client record system
mately 25 million HIV tests are fur-
formed, information Was collected on
during the 25-month period of evalua-
nished by the CT programs each
month and year of test: sex, race or eth-
tion. Because of policy changes, changes
year. less In areas where HIV reporting
nicity, and HIV risk exposure group
in funding, or other program issues, sites
legislation was introduced after imple-
MSM. injection drug use, sex with a per-
may be added or eliminated from &
mentation of CT programs, the date col-
son infected with HIV or at risk for HIV)
state's CT program. To mínimize the ef-
lected by these programs provide a
of the person tested; type of testing wite
fect of changes in sites, we excluded sites
unique opportunity to observe the effect
(stand-alone counseling and testing site,
that reported no tests for any month dur-
of HIV reporting policies on testing. In
sexually transmitted disease clinic, drug
ing the 25-month study period.
this study, we used CT data to compare
treatment center, family planning clinic,
Data on type of test Were available for
the changes in use of HIV testing ser-
community health center, prison or jail,
Louisiana and Nebraska and the per-
vices before and after HIV reporting
other); test result; and type of test
centages of anonymous and confidential
was implemented.
(anonymous vs confidential), added af-
tests before and after HIV name reports
ter 1992.
ing were assessed by sex, race or ethnic-
METHODS
In 5 states. HIV reporting was imple-
ity, and risk exposure group for these
The Centers for Disease Control and
mented after CT data collection was in
states.
Prevention (CDC) has funded 65 project
place. In Louisiana, HIV reporting was
To account for the variations in auto-
implemented in February 1993; in Ne-
correlated data (ie, the underlying sta-
Table 1.-Number of HIV Tests Performed in
brasks, September 1995: in Nevada.
tístical distribution of repeated mea-
Publicly Funded HIV Counseling and Testing Siles
February 1992; in New Jersey, October
sures over time in the same sites), we
the Year Boloro and Allor Implementation of HIV
1991: and in Tennessee, January 1992. In
used & Poisson log-linear model. For this
Reporting by State"
Michigan. HIV reporting was required
model, the number of tests was the re-
No. al H/V THEIR
by regulation beginning in 1988. How-
sponse variable used to compare the
Performed
ever, the health department did not ac-
menths before and the months after
tively solicit HIV case reports from phy-
implementation of HIV reporting.
Before
After
%
P
sicians and other providers, including cli-
Within the model. the generalized esti-
Reporting Reporting Change Valuet
nicians, laboratories, and institutions
mating equations method was incorpo-
Louisiana
45858
36369
-10.6
.20
Michigan
66704
65308
-20
,70
(eg. hospitals, clinics), until April 1992.
rated to fit # correlated response
Nabraska
4348
5036
15.8
<.001
Therefore, for Michigan this date was
model. 10-18 The trends in the number of
Nevada
9813
)4254
48.4
<001
taken 45 the date on which HIV name
tests before and after HIV reporting
New Jersay
61440
74324
21.3
<.001
Теппевене
20684
33575
82.8
-2001
reporting was implemented. In these B
Were also compared by using the model.
states, the number of HIV tests. the
The 3 variables in the model comparing
*Data exclude lests without size numbers, LASIE re-
number of positive HIV teat results, and
trends were time (before vs after HIV
portod from siles win lewer than 50 total IDEIN during the
25-manth study period, and giles reporting no 10613
the distribution of these tests by sex,
reporting), trend (linear trend over 12
during any single month. HIV indicates numan Immu-
race or ethnicity, type of testing site, and
months), and time by trend interaction
nodelkiency virus.
tData are based on regults of Poleson regression
risk exposure group were compared for
(trend same or different before vs after
modeling.
the 12 months before and the 12 months
HIV reporting).
The data used in the analysis were col-
lected to monitor service provision, not
for use in a research study; for example,
Louisiana
Nebraeka
Tennessee
Michigan
New Jorney
Navada
no population sampling was performed.
In addition, because of the large num-
B
Bafore HIV Reporting
After HIV Reporting
bers of tests performed in most areas,
small percentage changes may result in
7
statistically significant differences that
are not practically meaningful. There-
a
fore, we present stratified tables as com-
No. of Tests in Thousands
5
parisons of numbers of tests and per-
centage changes without further statis-
4
tical description.
HIV/AIDS surveillance coordinators
W
and HIV CT program coordinators in
each of the 6 study ВТЕДУ were tele-
2
phoned to obtain qualitative information
about the methods used to inform the
1
general public and health care providers
o
such as physicians and other clinicians,
1
2
9
4
6
a
7
8
a
10
11
12
15
14
16
16
17
18
19
20
21
22
23
24
25
laboratories. and institutions about HIV
Months
reporting, local HIV CT program char-
acteriatics, and occurrences (eg. media
Number of human immunodeficiency WILLIA (HIV) tests performed per month at publicly funded HIV coun-
events. changes in program funding)
sellng and testing sites before and after Implamentation of HIV reporting by state. Dates HIV-reponing-Dy-
name policies ware Implemented were as rellaws: for Louisiana, Pobruary 1993; Michigan. April 1992; No.
that may have influenced counseling and
braska, September 1995: New Jersey. October 1891; Termessee, January 1992; and Nevada, Fabruary
testing trends at the time HIV name re-
1992.
porting was implemented.
1422 JAMA, October 28, 1998-Vol 280, No. 18
Effact of HIV Reporting on HIV Testing-Nakashima et al
900
10/28/98 WED 15:12 FAX
12/07/98
21:27
FAX
AIDS Policy
007
Who Have Sex Whin Men
Injection aug Usera
Before
After
Before
After
Before
After
Reporting
Reparting
% Change
Reporting
Reporting
% Change
Repenting
Reporting
% Change
Louisiana
1332
1274
-4.3
1838
1562
-150
8867
11000
10.5
Michigan
3005
4113
5.3
3419
BM7
-34.3
5758
18844
225.1
Nebraska
480
574
19.8
238
242
1.7
888
239
6.7
Nevada
744
837
12.1
852
1013
18.8
887
3618
303.3
New Jursey
3242
3948
92.4
7051
7011
-0.8
2284
12968
482.05
Tennetsee
2734
2622
-4.1
1508
1758
166
814
6729
603.86
"HIV indicates human Immunodalidancy virus.
fincludes persons with sexually Transmitted diseases. persons who exchanged Monay or drugs for BOL, and persons whose sex partners were at risk for HIV.
*Large increase in this group was due in pan 10 Improved classification of persons initially classified -thoul hak.
$Large Increase in This group coindided with Earvin "Magic" Johnson's enpouncement of HIV infection.
RESULTS
Table 3.-Number of Anonymous and Confidential HIV Tests in ine Year Before and After HIV Reporting far
During the 26-manth period before
Salected Groups in Louisiana and Nebraska"
and after the implementation of HIV re-
No. of Anamous MIV Testa
No. of Confidential HIV Tests
parting. the total numbers of HIV tests
provided through the states in the study
Batare
After
Before
After
Reporting
Reporting
% Change
Reporting
Reporting
% Change
were us follows: Louisiana, BS 794 tests
Louisiana
at 50 sites; Michigan, 138 802 tests at 58
All
8851
4987
-23.0
895
459
-4.6
sites; Nebraska, 9749 tests at Boitos; No-
WITH MSM
448
348
-22.3
150
174
0.8
vada, 25 002 tests at 3 sites; New Jersey,
African American
2156
1814
-24.7
675
22011
-0.8
141 teats at 84 after: and Tennessee,
Injustion drug user
067
268
-27.0
1253
1146
-8.6
721 tests at 29 sites. These tests rep-
Nebraska
resented 63% of HIV tests performed in
All tests
1888
2536
34.3
2386
2444
2.5
publicly funded CT sites in Louisiana
While MSM
271
385
42.1
100
174
-17.0
during this period, 95% in Michigan, 77%
African American
106
152
43.6
225
269
19.6
in Nebraska, 88% in Nevada, 84% in New
Injection drug user
105
118
11.3
124
121
-24
Jersey, and 79% in Tennessee,
When we compared the total number
"Dale exclude DETE for which type of IBFI was unknown or missing (<15% of lotal tests for Louisiana and <2%
for Nebraska). HIV indicates human immunodeficiency virus: MSM, man who have SEX with men.
of tests performed in the year before and
the year after HIV reporting, 4 STATES-
Nabraska, Nevada, New Jersey, and
the level of testing was higher after HIV
creases for this group partly to Earvin
Tennessee-had increases in the num-
reporting.
"Magic" Johnson's announcement of
ber of tests performed after implemen-
Among whites, the number of HJV
his infection in November 1991. IP which
tation (16%, 48%, 21%, and 68%, respec-
tests increased after HIV reporting was
nearly coincided with the implementa-
tively: Table 1). Louisiana and Michigan
implemented in all states but Louisiana,
tion of HIV reporting policies in these
had declines of 11% and 2%, respectively,
which had a 10% decline. The trends for
states,
in the total number of tests; however,
Hispanic persons were similar to those
In Louisiana, both the number of
these declines were not statistically aig-
for whites: a 22% decline for Hispanic
anonymous tests and the proportion of
nificant.
persons Was seen in Louisiana after HIV
total HIV tests that were anony mous do
When linear trends were examined
reporting. Among blacks, the number of
creased after HI reporting was imple-
throughout the study period, there were
tests performed after HIV reporting de-
mented. At the same time, the number
DO large or prolonged declines in the
clined in Louisiana (10%), Michigan
and proportion of confidential tests in-
number of tests performed in any area in
(26%), and New Jersey (2%).
creased (Tuble 3). Opposite trands were
the months immediately after HIV TH-
Among MSM, the risk group that re-
seen in Nebraska (Table 3)- In Nebraska,
porting was implemented (Figure). A
ports have suggested would be the most
at the time HIV reporting was intro-
transient decline in the number of tests
likely to avoid testing if HIV reporting
duced, counselors were instructed to en-
in Michigan in the months immediately
was implemented, the number of tests in-
collrage clients to select anonymous
after implementation of active surveil-
creased in 4 states in the year after HIV
testing. Among white MSMB, in Louisi-
lanco for HIV CARDS had returned to
reporting W88 implemented (Table 2).
ana, there was A decline in anonymous
baseline by the end of the 12-manth pe-
Louisiana and Tennesses experienced de-
testing and un increase in confidential
riod of study. A declining trend in the
creases in testing of less than 5% for this
testing. In Nebraska, the reverse was
number of tests in Louisiana began be-
group. Among injection drug users, de
true. In Louistana, declines were sean
fore HIV reporting was implemented
clines in testing occurred in Louisians and
among blacks both in anonymous and
and continued afterward; the Poisson
Michigan (Table 2). Among at-risk her-
confidential testing after HIV reporting
model showed no statistically significant
erosexuals, which included persons with
began. The decline in anonymous testing
difference in these trends (eg, the slope
sexually transmitted diseases, persons
was greater than the decline in confiden-
of a regression line drawn through num-
who had exchanged money or drugs for
tial testing. Both types of tests creased
ber of tests per month before HIV TO-
sex, and those whose sex partners were
smong blacks in Nebraska. Among in-
porting and the slope after HIV report-
at risk for HIV, increases in testing were
jection drug users, confidential testing
ing were the same). A statistically aig-
seen in all areas after HIV reporting was
decreased in Louisiana and Nebreska af-
nificant difference in the before-and-af-
implemented (Table 2). Counseling and
ter HIV reporting whereas anonymous
tor trends was found in Nevada. New
testing coordinators in New Jersey and
tasting increased in Nehraska and de-
Jersey, and Tennessee. In these S states,
Tennessee attributed the large in-
creased in Louistana.
JAMA, Delabor 28, 1998-Val 28D. No. 16
Ellect of HN Reporting on HIV Testing-Nakeshima el al
1423
007
FAX ST:12 CED 10/28/98
12/07/98 21:27 FAX
AIDS Policy
008
Surveillance Coordinators and MIV 61 Program L'oordinators"
Louisjana
Michigan
Nabraska
New Jaresy
Novada
Tennessee
Modia Deverse and strategies Informing the public
HIV reporting
Newspaper articles
Press conterence
x
Evening lelovision news
X
Radio news
I
Public and educational relevision
Public hearings
x
&
X
X
Strategies used to Introduce HIV reporting
to service providers
Pamphlete and Information shoots
X
Public health, epidemiology, or medical society
X
X
X
newsle and butletins
Latter campaigns (eg. to physicians, laboratories, clinica)
%
Presentations at professional meetings
X
Training courses
X
X
15 anonymous lesting available?
Yes
Yes
Yes
Yee
No
No
Are health department personnel required to notify penners?
No
No
No
No
No
No
How were publicly funded HIV CT shes notified
about HIV reporting?
Lotters to all sizes
X
Training courses
x
x
I
x
X
Involvement in meetings or site wislts
20 discuss HIV reporting
How do HIV counselers inform patients about
HIV reporting requirements?
Pan of Informed consent form
X
I
Part of reutine counseling
X
X
X
Information sheets or pamphiets
X
Other circumbiences coinciding with HIV reporting
- Injuranced CT trends
Earvin "Magic" Johnson's announcement
X
X
Anonymous testing actively encouraged
I
Expansion of CT programs
X
Outroson offers to high-risk populations
I
Efforts to eliminate lesting of low-nisk populations
Y
*HIV Indicates human Immunodeficiancy virus; AIDS, acquired immunodeficiency syndiame; and CT, counseling and lesting.
Counselors informed CT clients about
180 persons surveyed in 1987 and 1988
tested most could not correctly iden-
HIV reporting requirements through
would not be tested if positive results
tify their state's reporting policy." An
verbal counseling. informed consent
had to be reported to health officials or if
analysis of data from the 1988 AIDS
forms, or information pamphlets (Table
partner notification ("contact tracing")
Knowledge and Attitudes Survey of
4). The methods used to inform health
were conducted. These surveys on the
more than 20000 people also found no
care providers and the public about HIV
perceived and hypothetical barriers to
relationship between HIV reporting re-
reporting requirements and the avail-
testing have been reviewed by Burris,
quirements and previous or planned use
ability of anonymous testing services
who detected a number of flaws (some of
of testing.² Our results showing no large
differed among aress (Table 4).
which We discuss later). He concluded
declines in the number of persons (over-
COMMENT
that they do not provide an "account of
all or among high-risk groups) seeking
determinants of the underlying social
testing at publicly funded CT sites after
ConDdential reporting of HIV-in-
risk [to testing] and SQ fail to provide
the implementation of HIV reporting
fected persons by name to health depart-
a basis for properly identifying what
policies complement and confirm these
ments has been controversia) and many
people are afraid of through research."
last 2 studies.
states have been unable to implement
The evidence showing an effect of HIV
One reason for the differences in find-
HIV reporting policies because of oppo-
reporting on actual testing behavior is
ings from these studies is the popula-
sition in the community. One of the key
scantier. In 1988, Johnson et alre showed
tions studied. The studies that focused
concerns about HIV reporting is that it
that the rate of monthly attendance by
on groups (eg, MSM or persons seek-
might deter people at risk from being
MSM at an alternative HIV test site de-
ing anonymous teating that have B.
tested 01 seeking care In a recent posi-
creased 61% in the first 24 months after
granter interest in confidentiality and
tion statement, the American Civil Lib-
the reporting of HTV-positive persons
discrimination issues were more apt to
erties Union stated that "name report-
by name became mandatory in South
find significant concerns about HIV re-
ing is a counterproductive public health
Carolina. In contrast with these reports,
porting. Most of the persons in the 1988
measure that will cause individuals to
B multistate survey of high-risk popula-
general population survey were low-
avoid testing." The evidence on which
tions conducted in 1998 found that only
risk persons who would be less con-
such statements are based consista
2% of people who had not been tested
cerned about HIV reporting. Among
mostly of surveys such as the one re-
said that concern about HIV reporting
highly concerned groups, either there
ported by Kegeles et al, in which 60% of
was the main reason they were not
must be heterogeneity of opinion or the
1424 JAMA, October 28, 1998-Vel 280, No. 16
Effect of HIV Reporting on HIV Testing-Nakashima et al
800
10/28/98 WED 15:13 FAX
12/07/98
21:28 FAX
AIDS Policy
009
perceived risks stated in hypothetical
Many of the early
surveys do not actually result In avoid-
ducted before the highly effective anti-
of CT coordinators and our Bite exclu-
ance of testing, as suggested by the lack
retroviral therapies became available.
sion criteria, to account for some of the
of declines in testing among MSM in our
As therapies have improved, the advan-
main factory that coincided with the
study. We found declines in testing
tages to the patient of early diagnosis
implementation of HIV reporting. Fi-
among blacks and injection drug users in
and treatment can provide a powerful
nally, these data are not representative
Louisiana, Michigan, and New Jersey uf-
incentive to testing. and those advan-
of testing trends in the offices of private
ter HIV reporting began. In New Jer-
tages may outweigh concerns about HIV
physicians or other settings where per-
sey, the declines were less than 2% and
reporting. Since the early years of the
sons may be tested. Despite these lími-
were within the range expected for rou-
spidemic, thore has also been consider-
tations, the number and variety of pub-
tine year-to-year variation. In Louisi-
able experience with the security and
licly funded CT Bites and the large num-
ana, the declines were consistent with
confidentiality of AIDS case-reporting
bers of persons who use those testing
overall declinesin testing that werepres-
data and with issues of discrimination,
services make it unlikely that a large ad-
ent before HIV reporting was imple-
which may have allayed the concerns of
verse effect of HIV reporting on testing
mented, he evidenced by the lack of alg-
persons considering HIV testing. Case-
would have been missed.
nificant differences in trends before and
reporting data for AIDS have been
With the changing trends in clinical
after HIV reporting. The declines in
heavily relied on to allocate resources
AIDS incidence (-6% between 1995 and
Louisiana may have been related to
and services for infected patients. Popu-
1898) and AIDS deaths (-23% between
changes in CT program policy that were
lations who benafit from these services
1995 and 1996) brought about by im-
occurring during the study period. For
may understand the need for this infor-
proved therapies,4 information on HIV-
example, many CT sites in this state had
mation and be willing to provide it.28
infected non-AIDS cases obtained through
to be excluded from the analysis because
Anonymous testing was available in 4
HIV case reporting will be needed for
they had stopped offering testing due to
of the states in our study. Reports have
monitoring, planning, and allocation ofre-
the low number of HIV-positive persons
suggested that the introduction of
sources for prevention and clinical ser
identified. In addition, many CT sites TV-
anonymous testing increases testing in
vices." As states implement confidential
peatedly test low-risk clients; over time,
high-risk populations¹ and the elimi-
HTV reporting policies, these date indi-
these sites may counsel persons at lower
nation of it decreases testing in these
cate that the impact of surveillance on
risk to return for testing less often.
groups. 20-31 In Nevada and Tennessee,
those seeking HIV testing will be small
The declining trends for blacks and in-
where anonymous testing was not avail-
and should not hinder HIV prevention
jection drug users in Michigan were dif-
able, overall testing increased after HIV
efforts.
ficult to interpret because we were not
reporting, however, E small decline in
able to define a date of HIV reporting
testing occurred among MSM in Tennes-
The authors thank the following people for pro-
implementation. Legislation on HIV re-
Bee. If there had been no access to anony-
viding information about their MIV connsellng upd
tasting and HIV surveillance programs: Jeffrey
porting was enacted in Michigan in 1988.
mous testing in the other states, more
Human. MPH. Maria Ludwick, and Sue Troxler.
However, because the health depart-
declines in testing after HIV reporting
Louisiana Department of Health and Hospitals, New
ment had no infrastructure to support ad-
policies might have been sean. In the
Orleans; Garry Goza, MS (Lansing), Kris Judd (Lan-
ditional data collection, HIV case re-
states where we could evaluate anony-
stree). Eve Mokatoff, MPH (Detroit), and Liisa
Randall (Lansing), Michigan Department of Com-
ports were not actively solicited from
mous VS confidential testing, the per-
munity Health; Tina Brubaker, MPH, and Steve
physicians, clinicians, laboratories, and in-
centage of tests that were anonymous
Jackson, Nobraska Department of Health and Ho-
stitutions until April 1992. The active so-
decreased from 15% to 18% in Louisiana
man Services, Lincoln: Bill Hill and Elok Raich,
licitation of case reports was focused
and increased from 43% to 50% in Ne-
Navada Department of Human Resources, Carson
City: Semuel Coara, M.A. and Helene Cross, MA, New
mostly on public providers and was not EC-
braska before and after HIV reporting.
Jarsey Department of Health and Senior Services,
companied by publicity. Most clients at CT
From these results we conclude that
Trenton; Chris Freeman and Herb Stone MSSW,
sites were probably unawars of this
there may be some persons who wish to
Tennessee Department of Health, Nashville.
change in policy. In addition, Magic
test anonymously and concur with the
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Enect of HN Reporting on HIV Testing--Nakachima of al
OTO
10/28/98 WED 15:15 FAX
DEC. 09' 98 (WED) 19:31
OASPA NEWS DIV
TEL: 202 690 6247
P. 002
FOR INTERNAL USE ONLY
December 9, 1998 6:05 p.m.
Q&A on CDC Draft Guidelines for HIV Surveillance
Q: What is CDC recommending and why?
A. CDC is recommending that states implement HIV surveillance systems to build on
their existing AIDS surveillance systems. Treatment advances have slowed the
progression from HIV to AIDS for many individuals, so data on AIDS cases alone
cannot provide adequate information to direct prevention efforts to communities
currently at greatest risk. Without improved data, the nation could be soon fighting an
rapidly evolving epidemic with outdated information.
After extensive work with state health departments and community HIV/AIDS
organizations, CDC has released draft guidelines to assist states in the design and
implementation of effective HIV surveillance systems. These guidelines include very
specific standards for both quality and confidentiality, reflecting CDC's responsibility to
balance the need for better data with legitimate concerns about confidentiality and
security. They also stress the continued importance of anonymous testing as an essential
component of any surveillance system.
While the guidelines set out strict confidentiality and quality standards for HIV
surveillance data, they do not dictate the type of surveillance system used to gather
those data. CDC does believe that, based on its review of currently available studies of
name-based reporting systems, that such systems are most likely to provide data that
meets the quality standards. However, a state can use any surveillance system that
meets the performance criteria specified by CDC. ON we Cre 6 stite
activities to
Q: Will states be required to conduct name-based HIV reporting?
more is the
Anstru
A. No. Our draft policy allows flexibility for states to choose the surveillance systems they
deem most appropriate. The focus is on the quality of the data gathered and the security
and confidentiality of the surveillance system. CDC will provide technical assistance and
funding to states working to design HIV surveillance systems - both those using unique
identifiers or name-based systems.
Lore
CDC believes that name-based systems have a proven track record of providing quality
data in a confidential and secure manner. The AIDS surveillance system, which is in place
in all states, is a name-based system that has produced high quality data with only a few
instances of security breaches.
However, CDC recognizes that some states may choose to design alternative systems that
use unique identifiers instead of names. While CDC has evaluated on type of UI system
DEC. 09 98 (WED) 19:32
OASPA NEWS DIV
TEL: 202 690 624/
P. 003
- 2 .
and found problems in the quality of data produced, there is currently no evidence
suggesting that unique identifier systems cannot be designed and implemented in a manner
that consistently provides state public health officials with accurate and reliable data.
CDC therefore encourages states to develop a surveillance system that best protects the
confidentiality and privacy of their constituents while providing critical data on the scope
of the HIV epidemic. Given the importance of these data for directing services and care
to individuals with HIV infection, all states will be required to meet the specified
performance criteria regardless of the type of system implemented. CDC will provide
technical assistance and support to all the states working to implement new HIV
surveillance systems, including those that are name-based and those that use unique
identifiers.
Q: How will surveillance systems be evaluated?
A. The criteria include strict confidentiality procedures and protections, quality standards
for data to ensure completeness, timeliness, unduplicated reports, and the ability to follow
up with providers on cases of public health importance when additional epidemiologic
information is needed.
CDC will work closely with states through a transition period over the next several years.
When the transition is complete for an individual state, CDC will evaluate and award
proposals for Federal funding of state and local surveillance programs based on their
capacity to meet the performance standards.
Q: Will states that don't implement HIV reporting lose funding?
A. CDC will continue to fund all states to conduct HIV and AIDS reporting. However,
we believe that a state's capacity to accurately monitor and forecast the HIV epidemic on
the local level will be less complete without an effective HIV reporting system. States
relying solely on AIDS reporting may not be able to accurately depict and predict the
course of their epidemics. CDC will work closely with states to help them meet
performance standards. Over time, a state's ability to provide accurate and complete
surveillance will be reflected in the level of CDC funding.
Q: Is CDC setting its standards for quality too high?
A. No. The goal is to collect the data we need for public health, while protecting privacy
and confidentiality. As the nation's prevention agency, CDC must ensure that surveillance
systems provide a reliable means of directing and evaluating HIV prevention and treatment
efforts at a national, state, and local level. At the same time, CDC must balance the need
for data with an equally important obligation to insist that the private information used in
these surveillance systems is gathered and maintained under rigorous standards of
confidentiality and security. The standards articulated in the guidance reflect that
necessary balance. CDC has established standards for the quality of data necessary to
DEC. 09 98 (WED) 19:32
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. 3 .
make informed decisions about fighting the epidemic. Setting standards too high might
force states to implement more intrusive surveillance systems that might cause resistance
to testing and would therefore be counterproductive.
Q. If name-based systems work, why are you allowing states to try unique identifier
systems?
A. CDC believes that the issue here is the quality and security of the data, not the system
to gather those data. This epidemic varies significantly across the country, and states
should have the flexibility to assess their own unique needs and resources and make a
determination as to the kind of HIV surveillance system utilized to collect data CDC
believes that name-based systems have a good track record and can be relied upon to
gather good data. However, some states have expressed an interest in pursuing systems
that use unique identifiers in order to reduce the concerns about confidentiality that might
negatively influence testing behaviors. Because it is so critically important for individuals
at risk to know their HIV status, and for those that are infected to access care as soon as
possible, concerns about confidentiality - whether or not they are justified - must be taken
into account. Therefore CDC will work with those states that want to establish unique-
identifier-based surveillance systems that they believe will help in maximizing access to
HIV testing.
Q: Why are the guidelines being published in draft form?
A. CDC recommendations are often published in draft form to allow for a public comment
period. This process is designed to ensure that the recommendations promote the best
possible public health approaches. We worked with state health departments and local
advocates to draft these guidelines, and we look forward to more input from the public as
the process continues. After the public comment period, which runs from December 10,
1998 to January 9, 1999, the guidelines will be modified as needed and published in the
Morbidity and Mortality Weekly Report.
Name-Based HIV Reporting
Q: Does name-based HIV reporting mean CDC has a list of names of infected
individuals?
A. No. CDC does not now - nor will it in the future - maintain a list of names of
individuals in either AIDS or HIV reporting systems. Names are always removed by state
health departments before any data are sent to CDC.
Q: How do states that already have name-based HIV reporting use the names?
A. State surveillance staff use the names as the identifier to ensure that HIV data are
complete, accurate, and reliable for directing programs and resources. More specifically,
the name is used to identify and eliminate duplicate reports on the same individual; to
DEC. -09 98 (WED) 19:52
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- 4 -
conduct necessary follow-up with the health care provider if additional epidemiologic
information is needed; to link to name-based AIDS and death registries; to link the
information with other name-based public health data systems such as tuberculosis
registries if necessary; and, in some states, to evaluate referrals to prevention and care
services.
Q: Does name-based reporting mean health departments will begin notifying
partners of those Infected?
A. Partner notification and HIV/AIDS reporting are both important, but separate public
health activities. They need not be linked to be done effectively. CDC already requires
states to have voluntary partner notification programs in place and partner notification is
conducted in all states, including those that do not have name-based HIV reporting.
Additionally, these programs are, by definition, voluntary, since the infected person must
choose to participate in discussions about partner notification and provide the names of
partners to be contacted. Partner notification is conducted at both anonymous and
confidential test sites.
Q: Who will have access to the HIV reports that include names?
A. CDC program guidance specifies that only select staff at state health departments
should have access to these data and they should be used only for public health purposes.
All of these individuals must be trained in confidentiality procedures and must be made
aware of penalties for unauthorized disclosure of reporting information. HIV and AIDS
data have the strictest and most comprehensive protections of any health data in the
nation, and efforts are underway to strengthen these protections even further.
Q: What protections are in place to ensure confidentiality of name-based reports?
A. HHS and CDC are extremely concerned about HIV data remaining confidential. The
draft guidance document outlines performance criteria to ensure the quality and
confidentiality of HIV data. These criteria include strict confidentiality procedures and
protections such as using a single registry, eliminating paper reports, using computer
encryption techniques, setting up physical security and limited access to data, and
penalties for abuse.
To date, states have maintained an exemplary record in protecting the confidentiality of
HIV/AIDS data. Since 1981 there have been few reported breaches of confidentiality in
state AIDS reporting systems. However, concerns about confidentiality of HIV/AIDS
status are real, and deserve special consideration.
One important security measure CDC is now making available to states is the option of
using a double-keyed encryption program. With this system, names and other identifying
DEC. -UY 98 (WED) 19:02
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" 5 -
information may only be accessed with both the key (password) held by the state and the
key held by CDC.
Additionally, a review of local laws by the Georgetown/Johns Hopkins Public Health Law
Project found that laws protecting state-held HIV/AIDS data are stronger than the laws
regarding privately held data. CDC is also working with the Georgetown/Johns Hopkins
Public Health Law Project to develop model legislative language to protect confidential,
identifiable information held by state and local public health departments against
unauthorized and inappropriate use, while still allowing the use of surveillance information
to accomplish legitimate public health objectives.
Q: Is name-based reporting used for other STDs?
A. Name-based reporting is routinely used for all reportable STDs and other notifiable
diseases (i.e., chlamydia, gonorrhea, AIDS, tuberculosis, lyme disease, measles, etc.). For
all of these diseases, as well as for AIDS cases, names are collected only at the state level.
CDC does not receive names with the data.
Unique-Identifier Systems
Q: Can a unique-identifier (UI) system be used instead of name reporting?
A. Yes. CDC's draft policy allows flexibility for states to choose the surveillance systems
they deem most appropriate. CDC will continue to provide technical assistance to states
working to design systems that rely on codes or "unique identifiers" (UIs) rather than
names.
Q: Are UI systems anonymous and completely confidential?
A. No, a UI system is not completely anonymous. A UI must contain enough information,
such as all or part of a Social Security Number in combination with other elements to
identify a specific individual. Additionally, for the follow-up of UI-based cases, providers
must maintain logs or other forms of documentation linking the UI to the name-based
medical records. This process may pose additional confidentiality risks if physician-held
surveillance registries are not protected by state confidentiality statutes or are located in
non-secure areas. However, CDC will provide states that choose to use UI with any
technical assistance they need.
Q: Will CDC assist states who choose to implement UI-based systems?
A. CDC has and will continue to provide technical assistance to states working to design
systems that rely on codes or "unique identifiers" rather than names. Over the next several
years, CDC will assist all states in implementing HIV surveillance systems, evaluating
current performance levels, revising systems as necessary, and reassessing performance.
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Testing
Q:
Does HIV reporting require the elimination of anonymous testing?
A. No. Not only does CDC continue to strongly support anonymous HIV testing, but it
requires states to have anonymous testing systems in place, unless they are forbidden by
state law. CDC studies indicate that the lack of anonymous testing options serves as a
major deterrent to testing in some high-risk populations. Maintaining anonymous test
sites is important for prevention efforts and will not seriously inhibit our ability to track
the epidemic. Eleven states currently do not have anonymous testing. CDC has
recommended that these states review and reconsider their policies regarding anonymous
testing.
Q: What are the 11 states that do not offer anonymous testing?
A. Alabama, Idaho, Iowa, Mississippi, Nevada, North Carolina, North Dakota, South
Carolina, South Dakota, Tennessee, and Wyoming.
Q: Does HIV reporting deter people from getting tested?
A. CDC studies conducted to date suggest that name-based HIV reporting has not served
as a major deterrent to testing. For example, CDC has worked with six health
departments to evaluate HIV testing patterns in the 12 months before and the 12 months
after the implementation of HIV reporting. In these areas, the number of HIV tests
increased in four states, and declined in two. The declines were not statistically significant
and followed a decreasing trend in testing that began before the implementation of
reporting.
However, CDC recognizes that for some people name reporting may serve as a deterrent.
The agency therefore strongly supports that anonymous testing be made available. As
additional areas implement HIV reporting, CDC will continue to conduct evaluations to
monitor the impact of policy changes on testing behaviors.
Q: What will be effect of National HIV Case Surveillance on reporting trends?
We expect the number of HIV cases reported nationally will increase primarily because of
the implementation of HIV surveillance by the remaining states and local areas. CDC
estimates that as many as 220,000 have been diagnosed with HIV in confidential testing
settings and reside in states that do not currently conduct HIV case surveillance.
Similar to the effect on AIDS surveillance trends after the implementation of the revised
reporting criteria in 1993, the initiation of HIV surveillance by additional states may result
in a sudden and large increase in HIV case reports. However, it is more likely that
reporting of prevalent HIV infections will be spread over several years and that the annual
increases will be more modest.
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Privacy
Q. How does this fit in with the Department's overall privacy goals?
The guidelines are consistent with the goals Secretary Shalala outlined in her testimony
before Congress on the Health Insurance Portability and Accountability Act (HIPAA).
Briefly, these guidelines say that privacy protections must be balanced with the public
responsibility to support national priorities - like public health, research, quality care, and
our fight against health care fraud and abuse. Data must be available to those who need it
for legitimate reasons, but security measures must be required to protect the information
against improper use by employees, or threats from the outside. Organizations hired by
providers and payers to process information and complete other tasks should also be
bound by these requirements.
###
CRICTOR 707 VVJ 07:11 DRI
CHIEF OF STAFF
V 001
FACSIMILE
DATE: 12/17
TO:
Sarah Bianch /Curis Jennings
FAX#: 456.5557
FROM: Elizabeth Summy
Deputy Chief of Staff
Phone:
202/690-7431 Fax: 202/401-5783
COMMENTS:
HIVIAIDS grant announcement
Please call.
5 Pages [including this cover]
202
4010700
or
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2002
#337
DRAFT
DRAFT: FY 1999 TITLE I FORMULA, SUPPLEMENTAL AND CBC AWARDS
12/10/98
FOR IMMEDIATE RELEASE
Contact: HRSA Press Office
(once cleared & CLO embargo lifted-12-16 or 17)
301-443-3376
$479 MILLION AWARDED FOR HIV/AIDS CARE IN HIGH INCIDENCE AREAS
HHS Secretary Donna E. Shalala today announced nearly $479 million in Ryan White
CARE Act grants to fund primary health care and support services for low-income individuals
and families in 50 eligible metropolitan areas hardest hit by the HIV/AIDS epidemic. Part of
these funds are targeted to 47 EMAs with high numbers of affected African American and
Hispanic populations under a special Clinton administration initiative with the Congressional
Black Caucus to address the greater burden of HIV/AIDS on racial and ethnic minorities.
Under Title I of the Ryan White CARE (Comprehensive AIDS Resources Emergency)
Act, 50 EMAs are receiving formula grant awards based on the number of people in the EMA
living with HIV disease. Competitive supplemental awards based on severe need and other
criteria, also are going to all EMAs except Las Vegas, Nevada and Norfolk, Virginia, which are
two newly designated EMAs and will receive supplemental funding early next year.
"The CARE Act helps us reach those who might fall between the cracks, and Title I is our
primary mechanism for funding HIV care in urban areas with greatest need," said Secretary
Shalala. "Our initiative with the Congressional Black Caucus further targets racial and ethnic
minorities by helping us mobilize effective prevention efforts and provide equal benefits for
minority populations."
-more-
FAA
202
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Title I grants provide essential HIV/AIDS health care and a wide range of support
services to those who lack or are only partially protected by health insurance, including physician
visits, case management, assistance in obtaining medications, home-based and hospice care,
substance abuse and mental health services and other related services. To qualify for Title I
funding, an EMA must have a population of at least 500,000 and have reported more than 2,000
AIDS cases in the most recent five calendar years.
"This marks the first year that we have received extra funds targeted specifically to
African Americans and Hispanics," said Claude Earl Fox, M.D., M.P.H., administrator of HHS'
Health Resources and Services Administration, which oversees the CARE Act through its
HIV/AIDS Bureau. "These funds provide added resources to more than 1,300 HIV care
providers. In 1996, more than 60 percent of their clients were African American and/or
Hispanic."
Other HRSA-administered CARE Act programs fund HIV/AIDS services in states and
eligible U.S. territories (Title II); provide support to public and nonprofit organizations for
outpatient early intervention services and planning grants (Title III); fund special programs for
improving access to care for women, youth, adolescents and families (Title IV); demonstrate and
evaluate innovative models of care for historically underserved populations (Special Projects of
National Significance Program); oversee a regional network for educating and training AIDS
care providers (AIDS Education and Training Centers Program); and provide reimbursement for
uncompensated costs in treating dental patients with HIV (HIV/AIDS Dental Reimbursement
- more -
THU
14:24
FAX
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CHIEF OF STAFF
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DRAFT #337
Program) . Title II also supports the AIDS Drug Assistance Program (ADAP), which helps
support the cost of medications that prolong and improve the quality of life for uninsured
individuals and others unable to pay.
Since FY 1991, the Clinton Administration has awarded close to $6.4 billion in CARE
Act funds. It is estimated that more than 400,000 individuals affected by HIV/AIDS access
CARE Act services each year.
A list of the 50 EMAs and Title I grant awards, which include the CBC awards, is
attached.
###
Note: HHS press releases are available on the World Wide Web at: http://www.hhs.gov.
4010700
or STAFF
VII UU5
Ryan White CARE Act
DRAFT #337
FY 1999 Title I Awards
Eligible Metropolitan Area
Title I Award
CBC Award
Atlanta, Ga.
$13,147,268
($157,991)
Austin, Texas
$3,175,509
($27,997)
Baltimore, Md.
$13,478,549
($202,463)
Bergen-Passaic, N.J.
$4,320,176
($48,163)
Boston, Mass.
$10,647,381
($68,508)
Caguas, Puerto Rico
$1,610,314
($29,348)
Chicago, III.
$18,227,884
($191,570)
Cleveland, Ohio
$2,933,058
($31,148)
Dallas, Texas
$10,164,078
($82,552)
Denver, Colo.
$4,150,341
($19,265)
Detroit, Mich.
$6,585,744
($73,909)
Dutchess County, N.Y.
$1,220,662
($12,153)
Ft. Lauderdale, Fla.
$10,810,324
($118,291)
Ft. Worth, Texas
$2,935,543
($21,606)
Hartford, Conn.
$4,019,409
($48,703)
Houston, Texas
$15,489,996
($177,707)
Jacksonville, Fla.
$3,683,146
($41,591)
Jersey City, N.J.
$5,015,785
($63,737)
Kansas City, Mo.
$2,952,910
($16,204)
Las Vegas, Nev.*
$1,800,211
($25,747)
Los Angeles, Calif.
$33,540,737
($261,519)
Miami, Fla.
$21,248,387
($279,163)
Middlesex-Somerset-Hunterdon, N.J.
$2,555,029
($26,467)
Minneapolis-St. Paul, Minn.
$2,548,603
($12,783)
Nassau-Suffolk, N.Y.
$5,632,012
($49,963)
New Haven, Conn.
$6,100,471
($62,746)
New Orleans, La.
$5,695,360
($68,148)
New York, N.Y.
$96,961,856
($1,260,780)
Newark, N.J.
$14,390,269
($192,110)
Norfolk, Va.*
$1,948,137
($49,963)
Oakland, Calif.
$6,218,532
($55,004)
Orange County, Calif.
$4,300,690
($23,586)
Orlando, Fla.
$4,907,180
($54,824)
Philadelphia, Pa.
$16,011,451
($205,884)
Phoenix, Ariz.
$3,865,319
($19,445)
Ponce, Puerto Rico
$2,487,768
($33,849)
Portland, Ore.
$3,115,251
$0
Riverside-San Bernardino, Calif.
$6,463,388
($36,460)
Sacramento, Calif.
$2,578,873
($12,423)
St. Louis, Mo.
$3,664,771
($33,669)
San Diego, Calif.
$8,872,685
($52,934)
San Francisco, Calif.
$36,218,513
($67,788)
San Jose, Calif.
$2,486,136
($15,214)
San Juan, Puerto Rico
$11,912,865
($217,047)
12/17/98 180 14.24 ГАД 202 4010700
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@000
Santa Rosa, Calif.
$1,127,018
$0
Seattle, Wash.
$5,303,343
$0
Tampa-St. Petersburg, Fla.
$7,236,728
($48,163)
Vineland-Millville-Bridgeton, N.J.
$688,648
($8,732)
Washington, D.C.
$18,322,558
($259,988)
West Palm Beach, Fla.
$6,711,944
($87,953)
TOTAL
$479,482,810
* *Includes formula funding and CBC award only.
Hivacc98 wpd
Page 1 |
The Clinton-Gore Administration:
A Record of Responding
to HIV and AIDS
"Eleven years ago, on the first World AIDS Day, we vowed to put an end to the
AIDS epidemic. Eleven years from now, / hope we can say that the steps we
took today made that end come about."
-- President Clinton, December 1, 1998 (World AIDS
Day)
"We are united in the fight for research, care, and prevention. And we will not
stop until all who need it have access to the treatment they need. We will not
rest until we have a vaccine -- and a cure."
--Vice President Gore,
September 19, 1998
Improving Health Care Quality and Increasing Access
Providing National Leadership. President Clinton has worked hard to invigorate
the response to HIV and AIDS, providing new national leadership, substantially
greater resources and a closer working relationship with affected communities.
Since taking office, funding for AIDS research has increased by over 65 percent,
and funding for HIV prevention has increased 34 percent; funding for the Ryan
White CARE Act has increased by over 240 percent.
Although much work remains to find a cure, progress has been made. In 1996,
the first time in the history of the AIDS epidemic, the number of Americans
diagnosed with AIDS declined. And between 1996 and 1997, HIV/AIDS
mortality declined 47 percent, falling from the leading cause of death among
25-44 year olds in 1995 to the fifth leading cause of death in that age group.
There has been a decline in the number of AIDS cases overall and a sharp decline
in new AIDS cases in infants and children.
Leading the Global Fight Against HIV/AIDS. On December 1, 1998 (World AIDS
Day), the President announced a new $10 million initiative at USAID to address
the growing crisis of children orphaned by AIDS. The United States has invested
over $1 billion in international AIDS relief since the start of the epidemic and
funds 25% of UNAIDS. In fiscal year 1999, the NIH will invest over $164
million in critical research projects aimed at reducing the number of AIDS
orphans by preventing and treating HIV/AIDS internationally.
Hivacc98 wpd
Page 2
Historic $156 Million Effort to Address HIV/AIDS in Communities of Color.
African Americans and other racial and ethnic minorities make up the fastest
growing portion of the HIV/AIDS caseload. As part of the FY99 budget, the
Clinton Administration fought for a comprehensive new initiative that invests an
unprecedented $156 million to improve the nation's effectiveness in preventing
and treating HIV/AIDS in the African American, Hispanic and other minority
communities.
Protecting Medicaid and Social Security Coverage. The President fought for and
won the preservation of the Medicaid guarantee of coverage which serves more
than 50 percent of people living with AIDS -- and 92% of children with AIDS --
who rely on Medicaid for health coverage. He also revised eligibility rules for
Social Security Disability Insurance to increase the number of HIV + persons who
qualify for benefits.
Focusing National Efforts on an AIDS Vaccine. In May of 1997, the President
challenged the nation to develop an AIDS vaccine within the next ten years. He
announced a number of initiatives to help fulfill this goal, including: dedicating an
AIDS vaccine research center at the National Institutes of Health and
encouraging domestic and international collaboration among governments,
medical communities and service organizations. On World AIDS Day 1998, the
President announced $200 million in funding for vaccine research at the NIH, a
$47 million (33%) increase over the previous fiscal year.
Dramatically Increasing Overall AIDS Funding. The Clinton Administration has
responded aggressively to the significant threat posed by HIV/AIDS with
increased attention to research, prevention and treatment. President Clinton
increased public health spending for major HIV/AIDS programs by over 100
percent, funding for the Ryan White CARE programs has increased 266 percent
and support for AIDS-related research has increased by 67 percent.
Increasing AIDS Drug Assistance and Accelerating AIDS Drug Approvals.
Funding for AIDS drug assistance has increased from $52 million per year to
$385 million per year during the Clinton Administration. This program provides
new life-prolonging drugs to people with HIV and AIDS. In addition, President
Clinton convened the National Task Force on AIDS Drug Development, and
removed dozens of bureaucratic obstacles to the effective and decent treatment
of people with AIDS. Since 1993, the Food and Drug Administration has
approved more than a dozen new AIDS drugs and important diagnostic tests.
Making Research a Priority. In one of his first acts in office, President Clinton
signed the National Institutes of Health Revitalization Act of 1993, placing full
responsibility for planning, budgeting and evaluation of the AIDS research
program at NIH in the Office of AIDS Research. The Administration has increased
Hivacc98 wpd
Page 3
NIH AIDS research funds by 67% in five years.
Focusing on Prevention: Supporting the Centers for Disease Control and
Prevention. The Administration has increased funds for HIV prevention at the
CDC by 34% in five years. Under the leadership of the Clinton Administration,
the CDC reorganized its AIDS prevention efforts to foster greater overall
coordination and enhance efforts to reduce sexually transmitted diseases and
tuberculosis.
Hivacc98.wpd
Page 4
Educating Young People about the Dangers of AIDS. The Clinton Administration
launched the Prevention Marketing Initiative, focusing on the risk to young adults
(18-25) with frank public service announcements recommending the correct and
consistent use of latex condoms for those who are sexually active.
Requiring the Federal Workforce to Understand AIDS. The Administration issued
a directive on September 30, 1993, that requires every Federal employee to
receive comprehensive education on HIV/AIDS.
Established a White House AIDS Office and Created a Presidential Advisory
Council. President Clinton created a White House Office of National AIDS Policy
to bring greater direction and visibility to the war on AIDS. Sandy Thurman, the
current director of the office, has broad experience in both domestic and
international AIDS services. At the same time, the Administration has sharpened
the focus of its AIDS programs. The President also created the Presidential
Advisory Council on HIV and AIDS to provide him and his Administration with
expert outside advice on the ways in which the Federal government should
respond to the HIV/AIDS epidemic. Dr. R. Scott Hitt, a California physician
specializing in HIV/AIDS care, chairs the panel.
Convened the First Ever White House Conference on HIV and AIDS. On
December 6, 1995, the President convened the first White House Conference on
HIV and AIDS in the history of the epidemic, bringing together more than 300
experts, activists and citizens from across the country for a discussion of key
issues.
SELECTED HIV/AIDS
FY99
Increase
Increase
INVESTMENTS
from FY98
from FY93
Ryan White CARE Act
$1.4 billion
23%
266%
AIDS Drug Assistance
$461 million
61%
787%*
HIV Prevention (CDC)
$657 million
5%
34%
AIDS Research (NIH)
$1.8 billion
12%
67%
Vaccine Research
$200 million
33%
145%
Housing (HUD)
$225 million
10%
125%
International (USAID)
$131
8%
64%
million * *
*since FY96, when separate program established
* *includes $10 million emergency funding for AIDS orphan initiative
Hivacc98.wpd
Page 5
ATTACHMENTS
Hivacc98.wpd
Page 6
REMARKS BY THE PRESIDENT ON WORLD AIDS DAY 1998
THE WHITE HOUSE
Office of the Press Secretary
For Immediate Release
December 1, 1998
REMARKS BY THE PRESIDENT
AT WORLD AIDS DAY EVENT
Room 450
Old Executive Office Building
THE PRESIDENT: Thank you, Amy, for your magnificent remarks and the
power of your example. Thank you, Cynthia, for coming to this big, scary crowd.
(Laughter.) She was nervous. I said, well, look at the bright side -- at least you
got out of school for a day. (Laughter.)
I thank the other children who are here with us. And I want to thank all the
members of our administration who have helped so much in this cause -- Secretary
Albright; Brian Atwood; Dr. Satcher; our AIDS Policy Director, Sandy Thurman;
members of the Council on HIV and AIDS.
We're glad to have Nafis Sadik here, the Director of the U.N. Population Fund.
Richard Socaridies from the White House, I thank you and all the other members of
the administration. And I, too, want to join in expressing my appreciation to the
members of Congress who Brian
mentioned for their support for AIDS funding.
But I especially want to thank Amy for being here and reminding us of what
this is all about. When she was speaking my mind wandered back to an incident
that occurred when I was running for President in 1992. Some of you have heard
me say this before, but I was in Cedar Rapids,
lowa, a place largely known for its enormous percentage of Czech and Slovak
citizens. And there was in the crowd at this rally where I was speaking a woman
who was either Czech or Slovak, probably, holding an African American baby.
And I said, whose baby is this? She said, this is my baby. And I said, where is
this baby from? She said, Florida, I got her from Florida. (Laughter.)
And it was October in Cedar Rapids and she should have been in Florida,
probably. (Laughter.) She said, this baby was born with AIDS and abandoned and
no one would take this baby. This woman had her marriage had dissolved, she
was raising her own children alone. But
Hivacc98.wpd
Page 7
because she heard about children like this wonderful little girl, she adopted this
baby.
And every year since, about once a year, I see this young child. I've watched
her grow up now and I'm happy to tell you that six years later she's still alive and
doing pretty well. She comes to the NIH for regular check-ups and she comes by
the White House to see her friend.
And every time I see Jimiya I am reminded of what this whole thing is about.
And I think I should tell you one other thing. When Amy was standing up here
with me and I was telling her what a fine job she did, she said, I'm so glad that
Cynthia could be here, and that I could say Carla's name in your presence.
This is, I think, very important for people who have not been touched in some
personal way -- who have never been at the bedside of a dying friend, who have
never looked into the eyes of a child orphaned by AIDS or infected with HIV -- to
understand. And I believe, always, that
if somehow we could reach to the heart of people, we would always do better in
dealing with problems, for our mind always conjures a million excuses in dealing
with any great difficulty.
Let me begin, even in this traumatic moment, to say we have a lot to
celebrate on this AIDS Day. We celebrate the example of Amy and Cynthia. Just
think, a decade ago people really believed that AIDS was unstoppable; the
diagnosis was a virtual death sentence; there was an
enormous amount of ignorance and prejudice and fear about HIV transmission.
Most of us knew people who couldn't get into apartment houses or were being
kicked out or otherwise -- their children couldn't be in school because of fears that
people had about it.
Every day, for people who had HIV or AIDS and their families -- every day was
a struggle a decade ago. A struggle for basic information, for treatment, for
funding, and all too often, for simple compassion.
For six years, thanks to many of you, we have worked hard to change this
picture -- and so have tens of thousands of other people across our country and
across the globe. We've worked hard to draw attention to AIDS and to better
direct our resources by creating the Office of National AIDS Policy and the
President's Council on HIV and AIDS. We had the first ever White House
conference on AIDS. We helped to ensure that people with HIV and AIDS cannot
be denied health benefits for preexisting conditions. We accelerated the approval
of more than a
dozen new AIDS drugs, helping hundreds of thousands of people with AIDS to live
longer and more productive lives.
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Working together with members of both parties in the Congress, we increased
our investment in AIDS research to an historic $1.8 billion. This year we secured
$262 million in new funding for the Ryan White CARE Act, providing medical
treatment, medication, even transportation to
families coping with AIDs. This October we declared that AIDS had reached crisis
proportions in the African American, Hispanic American and other minority
communities, and fought for $156 million initiative to address that. Today the Vice
President is announcing $200 million in
new grants for communities around the country to provide housing for people with
AIDS.
The results of these and other efforts have been remarkable. For the first time
since the epidemic began, the number of Americans diagnosed with AIDS has
begun to decline. For the first time, deaths due to AIDS in the United States have
declined. For the first time, therefore, there is hope that we can actually defeat
AIDS.
But all around us there is, as we have heard from all the previous speakers,
fresh evidence that the epidemic is far from over, our work is far from finished,
that there are rising numbers of AIDS in countries like Zimbabwe, where 11 men,
women, and children become infected every
minute of every day. There are still too many children orphaned by AIDS, tens of
thousands here in America, tens of millions in developing nations around the
world.
And when so many people are suffering, and with HIV transmission
disproportionately high, still, among our own young people here in America, it's all
right to celebrate our progress, but we cannot rest until we have actually put a
stop to AIDS. I believe we can do it -- by developing a vaccine, by increasing our
investment in other forms of research, by improving our care for those who are
infected and our support for their families.
Last year at Morgan State University, I declared that we should redouble our
efforts to develop an AIDS vaccine within a decade. Today I am pleased to
announce a $200 million investment in cutting edge research at the NIH to develop
a vaccine. That's a 33 percent increase
over last year. With this historic investment, we are one step closer to putting an
end to the epidemic for all people.
I'm also pleased to say that there will be more than $160 million for other new
research critical to fighting AIDS around the world, from new strategies to prevent
and treat AIDS in children, to new clinical trials to reduce transmission.
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And as hard as we are working to stop the spread of AIDS we cannot forget
our profound obligation for the heartbreaking youngest victims of the disease -- the
orphaned children left in its wake. Around the world, as we have heard, millions
of children have lost their parents.
Their number is expected to rise to 40 million over the next 10 to 15 years. Some
of them are free of AIDS, others are not. But sick or well, too many are left
without parents to protect them, to teach them right from wrong, to guide them
through life and make them believe that
they can live their lives to the fullest.
We cannot restore to them all they have lost, but we can give them a future --
a foster family, enough food to eat, medical care, a chance to make the most of
their lives by helping them to stay in school. Today, through Mr. Atwood's agency,
we are committing another $10 million in emergency relief that will, though
seemingly a small amount, actually make a huge difference for many thousands of
children in need around the world.
I'm also directing Sandy Thurman to lead a fact-finding mission to Africa,
where 90 percent of the AIDS orphans live. Following the mission she will report
back to me with recommendations on what more we can do to help these children
and give them something not only to live for, but to hope for.
Eleven years ago, on the first World AIDS Day, we vowed to put an end to the
AIDS epidemic. Eleven years from now, I hope we can say that the steps we took
today made that end come about. If it happens, it will be in no small measure
because of people like you in this room, by your unfailing, passionate devotion to
this cause -- a cause we see most clearly expressed in the two people sitting right
behind me.
Thank you all, and God bless you. (Applause.)
END
1:26 P.M. EST
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REMARKS BY THE PRESIDENT ON
HIV CRISIS IN MINORITY COMMUNITIES
THE WHITE HOUSE
Office of the Press Secretary
For Immediate Release October 28, 1998
REMARKS BY THE PRESIDENT
ON HIV CRISIS IN MINORITY COMMUNITIES
Old Executive Office Building
5:16 P.M. EST
THE PRESIDENT: Thank you and welcome, every one of you. I'd like to begin by
welcoming the Mayor of Baltimore, Kurt Schmoke, and the Mayor of East St.
Louis, Gordon Bush. I'd like to thank the members of Congress here behind me
who are so responsible for the purpose for which we are called today. (Applause.)
I want to acknowledge Congresswoman Donna Christian Green, Congressman
Elijah Cummings, Congresswoman Eleanor Holmes Norton, Congressman Donald
Payne. I will say more about Congresswoman Maxine Waters and Representative
Lou Stokes in a moment. (Laughter.) But I want to thank them and all the
members of the Congressional Black Caucus, including all the House members and
Senator Carol Moseley Braun, for what they did.
And then I would like to offer a special word of appreciation to senator Arlen
Specter and Congresswoman Nancy Pelosi, who helped us so much to get this
done. Thank you very much. (Applause.)
I want to thank everyone in our administration who has worked so hard on the
issue of HIV and AIDS, beginning with the Vice President who couldn't be here
today, but who has worked very hard on all these issues; and Secretary Shalala;
our wonderful Surgeon General, David Satcher; the Director of our AIDS Policy
Office, Sandy Thurman, who has literally spent months sounding the alarm about
the growing crisis in communities of color, and working to help achieve these
dramatic funding increases. There is no stronger or more effective advocate. And I
think we ought to thank Sandy Thurman for what she's done. (Applause.)
Finally, I want to thank Denise Stokes for being here. As you will hear in a few
moments, she has been living with HIV for 15 years, and has been giving so much
Hivacc98.wpd
Page 11
of herself to educate others. If we are to stop this cruel disease we'll have to have
brave people like Denise to reach out with candor and compassion to those at risk.
I really admire her very much. And you'll hear from her in a moment, but I think we
ought to give her a hand for showing up today. (Applause.)
We have good reason to feel encouraged that so many HIV-positive men and
women are living longer and healthier lives. We should be proud that we've helped
to speed the development of lifesaving therapies and nearly tripled to support
those with HIV and AIDS.
But the AIDS epidemic is far from over in any community in our country. Today,
we're here to send out a word loud and clear:
AIDS is a particularly severe and ongoing crisis in the African-American and
Hispanic communities and in other communities of color. African Americans
represent only 13 percent of our population, but account for almost half the new
AIDS cases reported last year. Hispanics represent 10 percent of our population;
they account for more than 20 percent of the new AIDS cases. And AIDS is
becoming a critical concern in some Native American and Asian American
communities, as well.
Like other epidemics before it, AIDS is now hitting hardest in areas where
knowledge about the disease is scarce and poverty is high. In other words, as so
often happens, it is picking on the most vulnerable among us.
The fact is HIV infection is one of the most deadly health disparities between
African Americans, Hispanics, and white Americans. And just as we have
committed to help build one America by ending the racial and ethnic disparities in
infant mortality and cancer and other diseases, we must use all our power to end
the growing disparities in HIV and AIDS.
The AIDS crisis in our communities of color is a national one, and that is why we
are greatly increasing our national response. Today I am proud to announce we are
launching an unprecedented $156 million initiative to stem the AIDS crisis in
minority communities. (Applause.)
It is one of the greatest victories in the balanced budget law I just signed. It never
could have happened without the passionate and compassionate leadership of
Maxine Waters, Lou Stokes, and the rest of the Congressional Black Caucus
(applause) -- or the support of senator Specter and Congresswoman Pelosi and so
many others. (Applause.)
Now, this initiative will allow thousands of cities, churches, schools, and
grass-roots organizations to expand prevention efforts and target them to the
Hivacc98.wpd
Page 12
specific needs of specific minority communities such as young men, students,
pregnant mothers. It will allow minority communities to expand treatment for
substance abuse.
It will increase access to protease inhibitors and other new therapies, because
lifesaving therapies cannot be a luxury reserved only for the rich. (Applause.) It will
increase access to skilled doctors and other health care providers. And finally, it
will help us to assemble teams of public health experts from the Centers for
Disease Control and other federal agencies to visit individual communities and
provide whatever technical assistance those communities need. (Applause.)
This new initiative will build on the other historic funding increases in HIV/AIDS
funding we won in the new balanced budget, which Secretary Shalala will talk
about in greater detail in a moment. I'm also pleased that it will build on our race
and health initiative. Congress has taken a first step to fund this initiative, but we
must do more. We are not one America when some of our communities lag so far
behind in health.
Of course, this room looks nothing like a house of worship except for a few collars
I see. (Laughter.) But I'd like to end my remarks today with what I think is quite an
appropriate passage from the First letter of Paul to the Corinthians. "The body is a
unit, though it is made up of many parts. And though all its parts are many, they
form one body. If one part suffers, every part suffers with it. If one part is
honored, every part rejoices with it."
So it is with the body of Americans, and a nation that strives tone one America.
Every one of our communities is inextricably linked, in suffering and rejoicing, in
sickness and in health. And that is why we must work together in every
community to stop this cruel disease. Black or white, gay or straight, rich or poor,
you name it, we have to stop it.
Now I'd like to present America's Surgeon General, our nation's family doctor,
whose deep commitment to advancing our country's health is embodied in the
200-year-old guiding principle of our public health service that you best protect the
health of the entire nation when you reach out to the most vulnerable people.
Dr. David Satcher. (Applause.)
END 5:30 P.M. EST
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PRESS RELEASE ON 1998 WORLD AIDS DAY EVENT
THE WHITE HOUSE
Office of the Press Secretary
For Immediate Release
December 1, 1998
PRESIDENT CLINTON COMMEMORATES WORLD AIDS DAY
BY UNVEILING NEW STEPS TO ADDRESS THE
GROWING CRISIS OF CHILDREN ORPHANED BY AIDS
Today, President Clinton will join Secretary of State Madeleine Albright and
Brian Atwood, Administrator of the U.S. Agency for International Development
(USAID), to commemorate World AIDS Day by launching a series of new
initiatives to address the growing crisis of
HIV/AIDS around the world, particularly the millions of children orphaned by
AIDS. The President will unveil historic increases in funding for research at the
National Institutes of Health (NIH) designed to develop an effective AIDS
vaccine and prevention strategies to help
address the problem of HIV/AIDS throughout the world. He will announce new
emergency funding from USAID to support international AIDS orphan programs.
In addition, he will direct his AIDS policy advisor, Sandra Thurman, to lead a
delegation to Sub-Saharan Africa to assess the growing problem of AIDS
orphans and recommend new strategies for
responding to the crisis.
USAID projects that up to 40 million children will be orphaned by HIV/AIDS by
the year 2010, over 90 percent of whom live in developing countries with few
resources to provide for their care and support. Over 33 million people around
the world are now living with HIV or
AIDS, with another 5.8 million becoming infected every year. As with so many
epidemics, children and young people bear much of the terrible burden of AIDS.
In the United States, as many as 80,000 children already have been orphaned
by AIDS.
Increases in funding by the National Institutes of Health for research to prevent
and treat HIV around the world. The National Institutes of Health will undertake
the largest single public investment in AIDS research in the world by supporting
a comprehensive program of basic, clinical, and behavioral research on HIV
infection and its related illnesses. This program will include:
Hivacc98.wpd
Page 14
$200 million -- a 33 percent increase from last year's funding -- for research
on AIDS vaccines to prevent transmission around the world. The development
of a safe and effective AIDS vaccine is critical to stemming the growing problem
of HIV/AIDS and AIDS orphans internationally. The President will announce that
NIH will dedicate $200 million to vaccine research in Fiscal Year (FY) 1999, a
$47 million or 33 percent increase over FY 1998 and an 100 percent increase
over FY 1995. This investment is critical in meeting the President's challenge to
develop an effective AIDS vaccine.
$164 million for other research critical to addressing the HIV/AIDS
epidemic around the world. The President also will announce that NIH will
invest $164 million in FY1999, a $38 million increase over last year, in critical
research projects aimed at reducing the number of AIDS orphans by preventing
and treating HIV/AIDS internationally. These projects will include: a new
prevention trials network to reduce adult and perinatal transmission of
HIV/AIDS; new strategies to prevent and treat HIV infection in children; funding
to train more foreign scientists to collaborate on this epidemic; research on the
prevention and treatment of the opportunistic infections, such as tuberculosis,
that commonly kill people with HIV/AIDS; and research on topical microbicides
and other female-controlled barrier methods of HIV prevention.
$10 million in USAID emergency relief funding to provide support for AIDS
orphans. USAID will make available $10 million in emergency funding to
support community-based efforts for orphans in the countries most affected by
this problem. These efforts will include training and support for foster families,
initiatives to keep children in school, vocational training, and nutritional
enhancements. In addition, USAID will take steps to help prevent the spread of
HIV from mothers to children and to improve medical care for children already
infected with HIV.
AIDS Policy Advisor Sandra Thurman to lead fact-finding delegation to raise
awareness and make recommendations to address growing problem of AIDS
orphans. President Clinton will ask Sandra Thurman, Director of the Office of
National AIDS Policy, to lead a fact-finding delegation early next year to
Sub-Saharan Africa, where 90 percent of AIDS orphans reside. The delegation
will include representatives from key Congressional offices. Its goal will be to
raise awareness of this emerging problem and to develop recommendations for
action.
New steps to address the continued needs of those living with HIV/AIDS in
the United States. While the problem of HIV/AIDS is particularly acute
internationally, the President will underscore the impact of HIV/AIDS on families
in this country as well. The President will highlight an announcement today by
Vice President Gore of more than $200 million in funds this year for the Housing
Hivacc98.wpd
Page 15
Opportunities for People With AIDS (HOPWA) program to prevent individuals
affected by HIV/AIDS and their families from becoming homeless. The Vice
President will announce these grants at a meeting with local community
leaders who provide housing and other support services for people living with
HIV/AIDS and with several individuals and families who have benefited from
these services.
A solid record of achievement in HIV/AIDS. Today's announcements build
on a deep and ongoing commitment by the Clinton Administration to respond to
the AIDS crisis both in the United States and across the world. The
Administration has fought for other critical investments in HIV/AIDS. This
year alone, the President:
Declared HIV/AIDS in racial and ethnic minority communities to be a
severe and ongoing health care crisis and unveiled a new $156 million
initiative to address this problem. This initiative included crisis response
teams, enhanced prevention efforts, and assistance in accessing
state-of-the-art therapies.
Worked with Congress to secure historic increases in a wide range of
effective HIV/AIDS programs. Increases this year alone include: a $262
million increase in the Ryan White CARE Act; a 12 percent increase in AIDS
research funding at the NIH, totaling nearly $1.8 billion; a $32 million
increase for HIV prevention programs at the Centers for Disease Control and
Prevention; and a $21 million increase in the Housing Opportunities for
People With AIDS (HOPWA) program at HUD.
###
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PRESS RELEASE ON 1998 WORLD AIDS DAY EVENT
VICE PRESIDENT GORE
THE WHITE HOUSE
Office of the Vice President
For Immediate Release
December 1, 1998
VICE PRESIDENT GORE ANNOUNCES $220 MILLION
TO PROVIDE HOUSING, OTHER CRITICAL SUPPORT SERVICES
FOR OVER 65,000 PEOPLE WITH HIV/AIDS
Washington, DC -- Vice President Gore commemorated World AIDS Day today by
announcing that the federal government will provide $220 million in grants for
housing and support services for over 65,000 low-income people with HIV/AIDS
and members of their households.
The Vice President announced the new funds, which the Housing and Urban
Development Department (HUD) will distribute under its Housing Opportunities for
Persons with AIDS (HOPWA) program, at a meeting with people who receive and
provide these critical housing and support services in Washington DC.
"For too many Americans living with AIDS, poverty is nearly as much of a threat
as the disease itself," Vice President Gore said. "Without our help, many would be
forced to live in unfit housing or become homeless. These grants will mean that
people fighting AIDS won't have to also fight to keep a roof over their heads."
HUD Secretary Andrew Cuomo added, "We all know about the terrible toll of
illness and death caused by the AIDS virus. On top of this, AIDS often destroys
the financial health of those with the disease as well, hitting them with huge
medical bills and leaving them too sick towork."
Today, the Vice President:
Unveiled new HOPWA grants that provide critical support to communities in need.
Studies show that people with HIV/AIDS are at increased risk for homelessness
and have more problems obtaining access to affordable housing. This $220 million
in HOPWA funding, a 10 percent increase over last year, provides critical housing
and other support services that:
help people with HIV/AIDS remain in their homes by providing rental
Hivacc98 wpd
Page 17
assistance and supportive services such as meals, transportation, and
counseling; and
provide housing to people with HIV/AIDS and their families facing
homelessness. By providing housing and other critical support services, this
program helps keep families intact, and assures that individuals with
HIV/AIDS have the support they need. Most people that HOPWA serves
have incomes of under $1,000 a month.
Of the $220 million, $200 million will go to states, cities, and communities to
develop effective programs. The remaining $20 million will go to programs
nationwide that have developed particularly effective and innovative approaches to
providing housing and other necessary support services for people with HIV/AIDS.
For example, an innovative program in Savannah, GA enables people with
HIV/AIDS to receive home-based care, and one in Illinois provides innovative
services, including effective mental health services and daily livingservices.
Highlighted Clinton/Gore Administration's ongoing progress in fighting HIV/AIDS.
The Vice President underscored other Administration efforts to improve prevention,
treatment, and research for people with HIV/AIDS. He noted that the President is
unveiling historic new steps
today to help the up to 40 million children who will be orphaned by HIV/AIDS by
2010, including new emergency funding from USAID to support international,
community-based AIDS orphan programs and historic new increases in AIDS
research at the National Institutes of Health (NIH) dedicated to help address the
global problem of HIV/AIDS.
These steps build on the historic progress to combat HIV/AIDS for which the
Administration fought in this year's balanced budget, including: a new $156
million initiative to address the severe, ongoing health care crisis of HIV/AIDS in
racial and ethnic minorities, including crisis response teams and enhanced
prevention efforts across the nation; a $262 million increase in the Ryan White
CARE Act; a 12 percent increase in AIDS research funding at the NIH, a $32
million increase HIV prevention programs at the CDC; and a $21 million increasein
HOPWA.
###
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1998 WORLD AIDS DAY PROCLEMATION
THE WHITE HOUSE
Office of the Press Secretary
For Immediate Release
December 1, 1998
WORLD AIDS DAY, 1998
BY THE PRESIDENT OF THE UNITED STATES OF AMERICA
A PROCLAMATION
On World AIDS Day, we are heartened by the knowledge that our
unprecedented investments in AIDS research have resulted in new
treatments that are prolonging the lives of many people living with the
disease. Thousands of scientists, health care professionals, and
patients themselves have joined together to advance our understanding
of HIV and AIDS and improve treatment options. Because of the heroic
efforts of these people, fewer and fewer Americans are losing their
lives to AIDS, and for that we are immensely thankful.
But the AIDS epidemic is far from over. Within racial and ethnic
minority communities, HIV and AIDS are a severe and ongoing crisis.
While the number of deaths in our country attributed to AIDS has
declined for 2 consecutive years, AIDS remains the leading killer of
African American men aged 25-44 and the second leading killer of
African American women in the same age group. African Americans, who
comprise only 13 percent of the U.S. population, accounted for 43
percent of new AIDS cases in 1997 and 36 percent of all AIDS cases.
Hispanic Americans represent just 10 percent of our population, but
they account for more than 20 percent of new AIDS cases; and AIDS is
also becoming a critical concern to Native American and Asian American
communities. Young people of every racial and ethnic community are
also disproportionately impacted by AIDS, both in the number of new
AIDS cases and in the number of new HIV infections. In fact, the
Centers for Disease Control and Prevention estimate that approximately
half of all new HIV infections in the United States occur in people
under age 25 and that one-quarter occur in people under age 22.
Across the world, the situation is even more grim. As with other
epidemics before it, AIDS hits hardest in areas where knowledge about
the disease is scarce and poverty is high. Of the nearly 6 million
people newly infected with HIV each year, more than 90 percent live in
the poorest nations of the world. Entire communities are threatened by
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December 16, 1998
MEETING WITH THE
PRESIDENT'S ADVISORY COUNCIL ON HIV/AIDS
TALKING POINTS FOR CLOSING COMMENTS
Thank you for all of the good work that you have been
doing.
We have made a lot of progress, and I appreciate your
recognition of that. Together, we have helped get the
resources that have made an incredible difference in the
lives of so many.
Yet I know that there is much more to do, particularly on
prevention and international support. I especially
understand the importance of the HIV vaccine and will
make sure that everyone in this Administration
understands that it is a top priority for us.
You've made a number of good suggestions, and I'm going
to ask Sandy to help us move forward on them.
You have a lot of friends here - the First Lady, the Vice
President, Mrs. Gore, Secretaries Shalala and Cuomo, and
certainly Sandy - you have lots of advocates here who
have done a tremendous amount to increase awareness
of AIDS. I want you to know that we are committed to
the fight.
We may not always agree on how to get there, but you can
be assured that we all share your determination to bring
an end to this epidemic both here and across the globe.
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December 16, 1998
MEETING WITH THE
PRESIDENT'S ADVISORY COUNCIL ON HIV/AIDS
QUESTIONS AND ANSWERS
Q:
Current HHS guidelines encourage early treatment of HIV to forestall the
onset of AIDS, yet access to Medicaid coverage for that treatment is
generally restricted to those who have progressed to AIDS. How are you
going to help increase access to treatment?
A:
This is a difficult challenge and we are taking steps to address it. You know
I tried to solve this problem with universal health care. We wouldn't be
talking about this problem and a lot of other problems had that been
successful.
The Vice President has taken leadership in this area, asking HCFA to look at
solutions. Unfortunately, what we thought might be fixed quickly has turned
out to be more difficult than expected. While we are committed to
continuing our work to look at increasing Medicaid coverage, we've also
been working on interim solutions:
Sandy Thurman has set up an internal task force to develop solutions
we've succeeded in getting significant increases in the AIDS Drug
Assistance Program--$175 million (61%) increase in FY99--and the Ryan
White CARE Act overall--$271 million (23%) increase in FY99 and 266%
since FY93
we strongly supported the Jeffords-Kennedy legislation, which includes a
demonstration program that helps states provide Medicaid coverage to
people with HIV before they get AIDS - I hope you'll continue to work with
us to get legislation like this passed in the coming year
HCFA has been working with States that are seeking to develop waivers
to expand their coverage to people living with HIV. We have talked with
HCFA, and they have assured us that they will continue to aggressively
provide support and assistance to States that want to develop demonstration
programs that work.
I recognize the need and promise you that I and the Vice President will stay
on top of this issue and do everything in our power to see that people with
HIV don't have to get sick before they get treatment.
Q:
We are concerned that our national effort to stop the spread of HIV is not
working, and that the number of new HIV infections in this country has
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Page 2
stayed at 40,000 per year. In addition, at least 30% of those that are HIV
positive don't know it, which means they are likely to continue the activities
that spread the infection. The Council would like to recommend a new
national "get tested" campaign to encourage people at risk to seek HIV
counseling and testing services. Will you support that request?
A:
I think it sounds like a good idea. Let me ask Sandy to take a look at the
proposal and give me her recommendations. I do believe we need to do a
better job with our work on prevention, not only for HIV but for a variety of
preventable illnesses. Secretary Shalala and Surgeon General Satcher have
been focusing a great deal of energy on prevention, particularly in racial and
ethnic minorities. Dr. Satcher has been helping to lead their Race and Health
Disparities initiative, which includes HIV and AIDS as one of six targeted
illnesses.
Young people are also in need of greater attention. I believe that some of the
impact of the anti-drug campaign by our Office of National Drug Control
Policy will help since the abuse of drugs and alcohol plays a key role in young
people taking risks with HIV.
Q:
Last March, you announced your commitment to finding a vaccine for HIV
within ten years. That was 18 months ago. The Council is concerned that
the effort to develop a vaccine is not progressing fast enough. NIH has yet
to hire a director for its new vaccine center and the different Federal
agencies that are involved in vaccine research aren't coordinated. Will you
encourage NIH Director Varmus to get the vaccine center director position
filled? Will you support Sandy Thurman's office in facilitating cross-agency
coordination?
A:
I certainly appreciate the need for an HIV vaccine. This past World AIDS Day
we did an event here that focused on the international epidemic, and I am
just staggered by the impact that AIDS is having on so many nations around
the world. I have asked Sandy to go to Africa in January to look at the AIDS
orphan issue and to report back to me with recommendations on further
actions we might consider. I know that a vaccine is our best and maybe only
hope of stopping this terrible disease.
As for the vaccine center director, we have talked with Dr. Varmus and he
has assured us that he is being very aggressive in his efforts to find just the
right person for the position. Part of the delay has been his commitment to
finding the very best person. He also assures us that the vaccine research
effort has not been slowed down by this vacancy, and that in fact they are
very pleased with their progress. NIH is increasing its vaccine research
funding this year, up $47 million (33%) to $200 million. I also know that Dr.
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Page 3
Nathanson, the new director of the Office of AIDS Research at NIH, is very
committed to vaccine research and is providing great leadership.
As for the interagency coordination, Sandy and Dr. Varmus have talked
about that. I understand that they're initiating regular vaccine research
meetings that will be open to all the different agencies, and the community
groups working on this issue. I will talk with Sandy about this and see if
there is more that we can do.
Q:
While we have had great success in AIDS funding with your leadership, the
Council is concerned that there are still a great many unmet needs. We are
particularly concerned that HIV prevention activities at the CDC and
international assistance through USAID have not received needed increases.
Will you commit to increasing AIDS funding in FY2000, particularly in
prevention and international relief?
A:
We are working on developing the FY2000 budget now, so it is a
work-in-progress. I do know that you have a great team of advocates at
OMB. Jack Lew, Josh Gotbaum, Sylvia Matthews, and Dan Mendelson are
all committed to doing the best that we can in addressing the need for
additional AIDS funding.
With respect to prevention funding, I can say that we fully understand the
need to increase and improve our HIV prevention activities, and to pay
particular attention to communities of color, to women, and to young people
who are at highest risk. We're taking a look not only at the need for
increased funding, but making sure that what we are already investing is
being used most effectively.
As for international funding, we've gotten good support from USAID
although I know Brian Atwood would like more. This is going to be a very
challenging budget year for us, and I don't want to be overly optimistic about
our ability to repeat the kind of increases we were able to obtain in FY99.
Nevertheless, we will do our very best to support appropriate funding levels
for our international AIDS efforts, and the other AIDS programs as well.
SELECTED HIV/AIDS
FY99
Increase
Increase
INVESTMENTS
from FY98
from FY93
Ryan White CARE Act
$1.4 billion
23%
266%
AIDS Drug Assistance
$461 million
61%
787%*
HIV Prevention (CDC)
$657 million
5%
34%
AIDS Research (NIH)
$1.8 billion
12%
67%
Vaccine Research
$200 million
33%
145%
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Housing (HUD)
$225 million
10%
125%
International (USAID)
$131
8%
64%
million**
*since FY96, when separate program established
**includes $10 million emergency funding for AIDS orphan initiative
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this epidemic, and the growing number of children who will lose parents
to AIDS will have a devastating impact on these societies. By the year
2010, there may be as many as 40 million children who will have been
orphaned by AIDS, and developing nations will have to struggle to deal
with the overwhelming needs of a generation of young people left withoutparents.
This year's World AIDS Day theme, "Be A Force For Change," is a
reminder that each of us has a role to play in bringing the AIDS
epidemic to an end. Our response must be comprehensive and ongoing.
It must also be a collaborative one, bringing together governments and
communities in a shared effort to expand prevention efforts, raise
awareness among young people of the risks of HIV infection and how to
avoid it, increase access to lifesaving therapies, and ensure that
those who are living with HIV and AIDS receive the care and services they need.
Developing a vaccine for HIV is perhaps our best hope of
eradicating this terrible disease and stemming the tide of pain and
desolation it has wrought. The global community has joined together in
making the development of an HIV vaccine a top international priority.
Within the next decade, we hope to have the means to stop this deadly
virus, but until we reach that day we must remain strong in our crusade
to prevent the spread of HIV and AIDS and to care for those living with
the disease. In this way we can best honor the memory of the many
loved ones we have lost to AIDS.
NOW, THEREFORE, I, WILLIAM J. CLINTON, President of the United
States of America, by virtue of the authority vested in me by the
Constitution and laws of the United States, do hereby proclaim December
1, 1998, as World AIDS Day. I invite the Governors of the States, the
Commonwealth of Puerto Rico, officials of the other territories subject
to the jurisdiction of the United States, and the American people to
join me in reaffirming our commitment to defeating HIV and AIDS. I
encourage every American to participate in appropriate commemorative
programs and ceremonies in workplaces, houses of worship, and other
community centers and to reach out to protect and educate our children
and to help and comfort all people who are living with HIV and AIDS.
IN WITNESS WHEREOF, I have hereunto set my hand this
first day of December, in the year of our Lord nineteen hundred and
ninety-eight, and of the Independence of the United States of America
the two hundred and twenty-third.
WILLIAM J. CLINTON
Pachabif
Page 1
DRAFT
December 17, 1998
MEETING WITH THE
PRESIDENT'S ADVISORY COUNCIL ON HIV/AIDS
DATE:
December 18, 1998
LOCATION:
Vice President's Ceremonial Office
(OEOB)
BRIEFING TIME:
5:15 pm to 5:30 pm
EVENT:
5:45 pm to 6:15 pm
FROM:
Bruce Reed/Chris Jennings/Sandy
Thurman
I.
PURPOSE
You will be meeting with members of the President's Advisory Council on HIV/AIDS
to discuss the Administration's progress on addressing the AIDS epidemic.
II.
BACKGROUND
The Council requested a meeting with you to address its recommendations on ways to
improve the Administration's response to the HIV/AIDS epidemic. Over the past few
months, the Council has been publicly critical of the Administration, particularly its
commitment to HIV prevention. Most recently, several key Council members reacted
strongly to the release of draft guidelines by the CDC advising states to begin reporting
HIV infections using name-based systems. This meeting would provide an opportunity
for you to personally reaffirm your commitment to the Council and the seriousness
with which you take the issue.
Questions from the Council will focus on four areas:
-- Access to Treatment: The Council will seek your leadership on expanding
access to treatment for indigent persons with HIV who must wait until
they get AIDS to qualify for Medicaid, which covers the treatments that
would likely have forestalled their progression to AIDS. Initial reviews,
prompted by a request by the Vice President, determined that such an
expansion is not cost neutral and therefore cannot be done
administratively. Pending further analysis, the Administration has
supported susbstantial increases in the AIDS Drug Assistance Program.
In addition, the Jeffords-Kennedy legislation includes a demonstration
'Pachabif
Page 2
program that would substantially increase access to Medicaid by persons
who would become disabled but for care. Support of this legislation by
the Council and the AIDS community would be very beneficial.
-- Promoting HIV Testing: Approximately 30% of persons infected with HIV
do not now they are infected, complicating prevention efforts and
delaying helpful treatments. The Council will ask for your support of a
national "get tested" campaign focusing on higher-risk populations (youth,
persons of color, women). This is a reasonable proposal, and one which
is already under consideration.
Vaccine Research: Last spring, you announced your desire to find a
vaccine for HIV within ten years. Two weeks ago, on World AIDS Day,
you announced a 33% increase in vaccine research funding at the NIH (up
$47 million to $200 million). The Council is highly supportive of your
leadership on this issue, but has some concern about the 18 months its
taking find a director for NIH's new vaccine research center and about the
need for increased inter-agency coordination. NIH has assured us that
they are aggressively searching for the best person for the job and that
vaccine research has not been delayed by this vacancy.
Increased AIDS Funding: Funding for HIV/AIDS programs has more than
doubled during your Administration, with Ryan White funding up 266%
and AIDS research up 67%. The Council is concerned that prevention
and international funding have not benefited from similar increases.
CDC's prevention budget is over $640 million and has increased 34%
since you took office; the Administration is focusing on insuring that
prevention funds are used effectively and are targeted to those at highest
risk. As for international funding, USAID's AIDS budget has increased
64% during your Administration. You also just announced on World AIDS
Day a new $10 million effort to help developing countries respond to the
needs of children orphaned by AIDS.
In your closing remarks, you may highlight recent Administration activities on
HIV/AIDS, including:
-- World AIDS Day event at which you announced an AIDS orphan initiative
at USAID, increased vaccine research funding from the NIH, and a
delegation to Africa led by Sandy Thurman.
-- Minority initiative announcement on October 28th at which you declared
HIV/AIDS to be an ongoing and severe crisis in racial and ethnic minorities
and announced $156 million in additional funding to address the crisis.
-- Historic HIV/AIDS funding achievements in the FY99 budget negotiations
Pachabif
Page 3
with Congress.
Pachabif
Page 4
III.
PARTICIPANTS
Briefing Participants:
Bruce Reed
Virginia Appuzo
Karen Tramontano
Chris Jennings
Sandy Thurman
Richard Socarides
Program Participants:
YOU
Sandy Thurman
Bruce Reed
Virginia Appuzo
Karen Tramontano
Chris Jennings
Sandy Thurman
Richard Socarides
Dr. Scott Hitt, Council Chairperson
Members of the Council
IV.
PRESS PLAN
Pool still before start of meeting; closed press thereafter. Transcript to be
provided to press following end of meeting.
V. SEQUENCE OF EVENTS
-- Sandy Thurman will introduce YOU to members of the Council.
--
Dr. Scott Hitt will make a brief opening statement.
-- Council member Rabbi Joseph Edelheit will provide an overview of the
message of the Council to you.
-- Four members of the Council will provide brief background statements
and identify specific issues on which they seek Administration action.
(You will have the option to seek clarification or respond--see attached Q
& A.)
-- YOU will make brief closing remarks, thanking the Council for its hard
work and reaffirming your commitment to continuing the fight against
AIDS--see attached talking points.
VI.
REMARKS
Talking points provided by the Office of National AIDS Policy.
Pachabrf
Page 6
VII. ATTACHMENTS
-- Talking points for closing remarks.
-- Q & A for discussion purposes.
-- List of Council members and brief biographies.
Withdrawal/Redaction Sheet
Clinton Library
DOCUMENT NO.
SUBJECT/TITLE
DATE
RESTRICTION
AND TYPE
001. list
re: President's Advisory Council on HIV/AIDS (5 pages)
n.d.
P6/b(6)
COLLECTION:
Clinton Presidential Records
Domestic Policy Council
Devorah Adler
OA/Box Number: 20464
FOLDER TITLE:
HIV/AIDS [Folder 2]
2012-0463-S
rc771
RESTRICTION CODES
Presidential Records Act |44 U.S.C. 2204(a)]
Freedom of Information Act 15 U.S.C. 552(b)]
P1 National Security Classified Information |(a)(1) of the PRA]
b(1) National security classified information |(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information |(a)(4) of the PRA
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advice between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy |(b)(6) of the FOIA]
personal privacy |(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes |(b)(7) of the FOIA]
C. Closed in accordance with restrictions contained in donor's deed
b(8) Release would disclose information concerning the regulation of
of gift.
financial institutions [(b)(8) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(9) Release would disclose geological or geophysical information
2201(3).
concerning wells [(b)(9) of the FOIA]
RR. Document will be reviewed upon request.
3-15-1995 5:27AM
FROM
P.
SF
AIDS
FOUNDATION
FAX
Date: January 8, 1999
To: Technical Information and
From: Lisa Schneider
Communications Branch
San Francisco AIDS Foundation
P.O. Box 426182
San Francisco, CA 94142
cc: See Below
Phone: 415/487-3034
Phone: Various
Fax: 415/487-3089
Fax: Various
Total Pages: 6
Remarks:
Urgent
X
For your review
Reply ASAP
Please Comment
404/639-7111 Jeffrey Koplan, MD, Director, Centers for Disease Control and Prevention
404/639-8600
Helene Gayle, MD, Director, National Center for HIV, STD, and TB Prevention, CDC
404/639-0910
Kevin DeCock, MD, Director, Division of HIV/AIDS Prevention, Surveillance and
Epidemiology, NCHSTP, CDC
202/690-7755
Kevin Thurm, Deptuy Secretary for Health and Human Services
202/456-2437
Sandy Thurman, Director, Office of National AIDS Policy
202/456-743
Chris Jennings, Deputy Assistant to the Presiden for Health Policy
202/225-8259
Congresswoman Nancy Pelosi, U.S. House of Representatives
202/690-7560
Eric Goosby, MD, Director, Office of HIV/AIDS Policy, HHS
202/690-7098
Marsha Martin, PhD, Special Assistant to the Secretary, HHS
3-15-1995 5:27AM
FROM
P.2
SF
SAN FRANCISCO AIDS FOUNDATION
995 MARKET STREET, SUITE 200, SAN FRANCISCO, CALIFORNIA 94103
AIDS
VISITORS' ENTRANCE: ONE 6TH STREET AT MARKET
FOUNDATION
January 8, 1999
Technical Information and Communications Branch
FAX: 404/639-2007
Mailstop E-49
Email: [email protected]
Division of HIV/AIDS Prevention
National Center for HIV, STD and TB Prevention
Centers for Disease Control and Prevention (CDC)
Atlanta, GA 30333
RE: Comments on the Draft CDC Guidelines for National HIV Case Surveillance
To Whom It May Concern:
The San Francisco AIDS Foundation appreciates the opportunity to comment on the recently
released "Draft Guidelines for HIV Case Surveillance." We are pleased that the draft guidelines
state that flexibility will be given to states to design and implement HIV reporting systems that
best meet the needs of their jurisdictions. However, we believe that the draft guidelines should
be revised to better reflect the scientific research findings on the impact of names-based
reporting on HIV testing and to address the needs of individuals living in communities that are
profoundly affected by HIV.
The Foundation's concerns are as follows:
1. The CDC inappropriately advises states to use names reporting.
Although states are given a choice of using either names or unique identifier (UI) systems, both
the language and the presentation of scientific evidence in the guidelines clearly reflect the
CDC's bias towards names reporting. The guidelines state: "CDC advises that State and local
surveillance programs use the same name-based approach for HIV surveillance as is currently
used for AIDS surveillance nationwide" (p. 8). Such advice is scientifically unfounded (see be-
low). The guidelines should be revised so as not to favor one system over another in order to
provide state health officials true flexibility in designing the system that best meets their com-
munity's needs. To this end, the sentence "advising" names reporting should be eliminated.
Although the draft guidelines appropriately pledge technical assistance regardless of the type of
HIV surveillance implemented, the CDC's preference for names reporting, while not being
overtly stated, appears to be linked to the provision of funds. This bias is apparent in statements
such as: "based on published evaluations, the CDC has concluded that name-based HIV/AIDS
surveillance systems are the most likely to meet the necessary performance standards as well as
to serve the purposes for which surveillance data are required" (p. 8). The CDC actually stated
in a letter to Washington State that supplemental funding for HIV/AIDS surveillance was con-
tingent upon the implementation of names-based reporting. While the statement was later re-
(415) 487-3000
CALIFORNIA HIV/AIDS HOTLINE: 1 (800) 367-AIDS
www.sfaf.org
3-15-1995 28AM
FROM
P.3
tracted, there is an underlying and pervasive impression among states that federal funding is
contingent upon names-based reporting. The CDC should work to reverse this impression by
presenting unbiased information and support to states implementing non-names based systems.
2. Regarding the performance standards, the guidelines do not contain discussion of
sufficient time for implementation.
The guidelines should contain a reasonable transition period for implementation of reporting
systems before any evaluation for funding purposes is completed. Based on the experience of
several states implementing HIV surveillance systems, five years appears to be an adequate
amount of time to establish a system and ensure that it is functioning at the levels set out in the
guidelines.
In addition, at least one of the performance standards must be modified-the requirement that
risk information be gathered on 85% of cases. Most states with names reporting have not met
this criterion and there is little evidence that they will be able to do so, even with years of
experience. Risk information - which is often very difficult for providers to secure-would be
better obtained through representative sample surveys and sentinel studies. This should be
discussed in detail in the guidelines and the 85% requirement should be eliminated.
3. The presentation of research on testing behavior is biased.
The scientific evidence presented to discount the impact of names-based reporting on individu-
als' willingness to seek HIV testing is both biased and flawed. Key studies that demonstrate that
HIV names reporting deters individuals from seeking testing are not mentioned anywhere in the
guidelines (Myers et al 1993; Reed 1996; Kegeles et al 1990; Kegeles et al 1989; Fordyce 1989;
Johnson et al 1988; Judson and Vernon 1988).
Not only are these studies not discussed, but those studies that are cited draw questionable con-
clusions that are not justified by the data and methods used (Nakashima et al 1998; Hecht et al
1997). For example, while the Nakashima study examines testing patterns in states that imple-
mented names reporting, the study did not include comparisons to states that did not implement
such a policy. It is thus impossible for the authors to prove that testing rates might not have in-
creased more dramatically had names reporting not been instituted in those states. In addition,
the study's authors do not examine carefully the experience of key subpopulations that are most
at risk for HIV infection. While Nakashima and colleagues do show that testing increased or
remained stable overall in some states, changes in testing frequency across high-risk groups did
not correspond to the overall change. Contrary to the conclusions drawn by the CDC, Naka-
shima's results suggest that the highest risk groups may be reluctant to test with names report-
ing. These results have very important public health ramifications and raise serious concerns
about the deterrent effect of names reporting for African Americans and, in some cases, injection
drug users. If this study is going to be used in the guidelines, it should be presented fairly, and
the population-specific trends should be presented in greater detail.
The draft guidelines also reference the Hecht study, in which 19% of respondents reported that
"fear of reporting to the government" was a concern that contributed to their decision to delay
testing. Again, the language used to describe the findings reflects bias. This finding is pre-
2
3-15-1995 5: 29AM
FROM
sented as "less than 20%" (versus, for example, "nearly 1 in 5") which intentionally minimizes
the importance of these data. This is especially important because the Hecht study targeted
high-risk populations, which make up a greater percentage of the populations in the states that
have not yet instituted HIV surveillance. In fact, only 6 of the 32 states currently collecting HIV
data with names-based reporting systems have higher-than-average AIDS case rates in their
populations.
Encouragement of names reporting may be particularly dangerous for the remaining states that
have yet to introduce an HIV reporting system. In many of these states, reported AIDS cases are
disproportionately among high-risk groups (as evidenced by figures from 1997). For example,
the proportions of AIDS cases in California and Washington among men who have sex with
men (64% and 55%) are much higher than the national average (35%). Similarly, in Illinois
(30%), Massachusetts (34%) and Pennsylvania (43%), the proportions of cases associated with
injection drug use are greater than the national average of 24%. The proportion of cases among
African Americans in Georgia (72%), Illinois (56%) and Pennsylvania (60%) are greater than
the 45% national average. These discrepancies indicate that encouraging names reporting
among these states may be irresponsible, since their populations may be more likely to be de-
terred by these policies.
Finally, while the CDC's attention to the importance of anonymous testing in the guidelines is to
be applauded, it is inherently contradictory to recognize the importance of anonymous testing
while at the same time call for names-based systems over unique identifier systems. The CDC
acknowledges that anonymous testing has been clearly associated with earlier testing and treat-
ment (Bindman et al 1998). These results prove that some segments of the population are ex-
tremely concerned about the confidentiality of their HIV status. This suggests that these same
individuals would be reluctant to seek testing and or treatment if HIV names reporting was im-
plemented and, in fact, the draft guidelines should make the provision of anonymous testing a
condition of funding.
4. Discussion of ineffectiveness of UI and purported superiority of names-based systems is biased.
The presentation of the evaluation findings on the efficacy of unique identifier systems for HIV
reporting is misleading and outdated. The CDC's criticisms of Maryland's system are based on
evaluation data from 1994-1996. These data do not reflect the progress and evolution of
Maryland's UI system, or the fact that Maryland was not funded by the CDC to implement their
UI system. In reality, recent evidence indicates that Maryland's system provides complete data
at a reasonable cost, comparable to rates found in states that use names-based reporting.
Criticisms of the Texas system must be considered in light of the fact that health officials in the
state were never particularly committed to the implementation of a unique identifier system and
therefore had little incentive to work for the program's success. Reference to "published
evaluations of non-name based HIV surveillance" (p. 8) thus presents an incomplete picture of
the available data on UI systems. Maryland has much more updated information available about
their system that reflects their ability to meet the CDC's criteria and this data should be
incorporated into the guidelines.
The CDC's biased use of conclusions on the efficacy of names reporting is also evident in the
guidelines. The CDC is "advising" names reporting based on what appears to be anecdotal
evidence from the 32 states that currently use names based systems. The CDC does not report
3
3-15-1995 29AM
FROM
performance data on names-based systems that may in fact reflect "operational difficulties" in
those states. The CDC seems to be reasoning that because names based systems are ubiquitous
and because they require fewer contingencies to implement, that they are better. The notion that
ease of implementation is equivalent to superiority is highly problematic because the concerns
about names reporting far outweigh ease of use.
5. The language regarding the linkage of HIV reporting systems and partner notification is weak.
The draft guidelines do not send a clear and compelling enough message to states that they
should not link partner notification and HIV surveillance systems. The draft guidelines state that
the CDC "does not direct" states to link partner notification and HIV surveillance systems and
that doing so "does not necessarily improve the provision of HIV prevention and care services"
(p. 12). This language should be strengthened considerably to encourage states not to link these
distinct systems. The CDC should also discuss research findings that suggest that HIV names
reporting does not improve partner notification or access to care (findings presented by D. Os-
mond to the CDC Consultation on HIV Reporting, May 1997, Atlanta, GA).
6. The guidelines refer narrowly to community representatives concerns' with HIV reporting.
The draft guidelines inaccurately suggest that concerns regarding confidentiality and fear of ille-
gal disclosure of HIV information is only of concern to community groups. In fact, a number of
state and local public health officials share this concern. Positioning these considerations as
merely "community concerns" suggests that there are not legitimate public health consequences
to names-based reporting. The language should be revised to reference the concerns of both the
community and public health officials regarding the deterrent effect of names-based systems.
Thank you for the opportunity to comment on the guidelines. I hope that our comments will
assist the CDC in working to ensure that the important goal of securing improved HIV data is
implemented thoughtfully and responsibly. If you have any questions, please do not hesitate to
contact me.
Sincerely,
Regmia Aragin
Regina Aragón
Public Policy Director
cc: Jeffrey Koplan, MD, Director, Centers for Disease Control and Prevention
Helene Gayle, MD, Director, National Center for HIV, STD, and TB Prevention, CDC
Kevin DeCock, MD, Director, Division of HIV/AIDS Prevention, Surveillance and Epidemiology,
NCHSTP, CDC
Kevin Thurm, Deputy Secretary for Health and Human Services
Sandy Thurman, Director, Office of National AIDS Policy
Chris Jennings, Deputy Assistant to the President for Health Policy
Congresswoman Nancy Pelosi
Eric Goosby, MD, Director, Office of HIV/AIDS Policy, HHS
Marsha Martin, PhD, Special Assistant to the Secretary, HHS
4
3-15-1995 5: 30AM
FROM
P.6
References:
Bindman, AB, Osmond, D., Hecht, FM et al. 1998. "Multistate evaluation of anonymous HIV testing
and access to medical care." Journal of the American Medical Association 280 (October 28): 1416-
1420.
Fenton, KA., Peterman, TA. 1997. "HIV partner notification: taking a new look." AIDS 11: 1535-
1546.
Fordyce E, Sambula, S, Stoneburner R. 1989. "Mandatory reporting of HIV testing would deter
Blacks and Hispanics from being tested." Journal of the American Medical Association 262: 349.
Hecht, FM, Colman, S., Lehman, JS et al. 1997. "Named HIV reporting: HIV testing survey (HITS)"
[abstract]. In Abstracts of the American Public Health Association 125th Annual Meeting and Expo-
sition, Indianapolis, Indiana.
Johnson, HD, Sy, FS, Jackson, KL. 1988. "The impact of mandatory reporting of HIV seropositive
persons in South Carolina." Presented at the IV International Conference on AIDS.
Judson FN, Vernon TM. 1988. "The impact of AIDS on state and local health departments: issues
and a few answers." American Journal of Public Health 78:387-393.
Kegeles, SM, Coates, TJ, Lo, B et al. 1989. "Mandatory reporting of HIV testing would deter men
from being tested." Journal of the American Medical Association 261: 1275-1276.
Kegeles, SM, Catania, JA, Coates, TJ et al. 1990. "Many people who seek anonymous HIV-antibody
testing would avoid it under other circumstances." AIDS 4: 585-588.
Meyer, PA, Jones, JL, Garrison, CZ, Dowda, H. 1994. "Comparison of individuals receiving anony-
mous and confidential testing for HIV." Southern Medical Journal 87: 344-347.
Myers, T, Orr, KW, Locker, D, Jackson, BA. 1993. "Factors affecting gay and bisexual men's deci-
sions and intentions to seek HIV testing." American Journal of Public Health 83(5): 701-704.
Nakashima, AK, Horsley, RM, Frey, RL, Sweeney, PA, Weber, JT, Fleming, PL. 1998. "Effect of
HIV reporting by name on use of HIV testing in publicly funded counseling and testing sites." Jour-
nal of the American Medical Association 280: 1421-1426.
Oxman, AD, Scott, EAF, Sellors JW et al. 1994. "Partner notification for sexually transmitted dis-
eases: an overview of the evidence." Canadian Journal of Public Health S1: S41-S47.
Osmond, D. 1997 (May). Findings presented to the CDC Consultation on HIV Reporting, Atlanta,
GA. Personal communication with SFAF, December, 1998.
Reed, GM 1996. "The impact of mandatory name reporting on HIV testing and treatment." Poster
presented at the XI International Conference on AIDS.
5
002
11/24/99 WED 17:58 FAX 202 986 1345
AAC-AAF
until it's over
AIDS ACTION
November 24, 1999
President Bill Clinton
The White House
1600 Pennsylvania Avenue
Washington, DC 20500
Dear Mr. President:
As we approach the last World AIDS Day of the century, I want to take this opportunity to thank
you for your extraordinary efforts to enhance AIDS research and AIDS health care as well as
your recent efforts to make the fight against the global epidemic a top national foreign policy
imperative.
Until your presidency, the fight against AIDS was virtually absent at the White House. President
Reagan wouldn't even say the word "AIDS" and President Bush only spoke softly.
Since your Administration began, you have spoken forcefully about the need to fight AIDS and
ensured significant and meaningful investments in AIDS research as well as the Ryan White
CARE Act. This leadership contributed to the development of the first effective treatments for
HIV and a subsequent reduction in the AIDS death rate.
Your work to secure better health care access has helped to bring these drugs to low-income
people and we are grateful for your success in securing $250 million for a demonstration project
of AIDS Action's Reinventing Medicaid plan.
In short, your leadership has saved thousands of lives from the ravages of HIV disease.
Your leadership was supported and carried out with great valor by AIDS Czar Sandy Thurman,
Chief of Staff John Podesta and Chris Jennings. In addition, AIDS Action is grateful for the hard
work of the Office of Management and Budget including Jack Lew, Dan Mendelsohn, and Bob
Kyle. Their countless hours of hard work, dedication and commitment have helped to ease the
pain of an epidemic.
Now, in the remaining fourteen months of your presidency and the beginning of the third decade
of the epidemic, we hope you will work to complete your legacy on AIDS by committing to fight
the crisis spot of today's epidemic: HIV prevention and education.
Every hour, two young people are newly infected with HIV. Everyone in the fight against AIDS
is haunted by this statistic and we hope you will end four years of flat-funding at the CDC by
committing to new investments in prevention. There is no shortage of innovative and proven
prevention proposals and there is no shortage of need. But there is a shortage of funds to make
reinvigorated prevention a reality.
1906 Sunderland Place, NW Washington, DC 20036 ? 202 530 8030 F 202 530 8031 www.aidsaction.org
11/24/99 WED 17:58 FAX 202 986 1345
AAC-AAF
E UUJ
President Clinton
Page Two
Thank you again for your leadership in the war on AIDS and we hope you commit to providing
the same kind of leadership for reinvigorated HIV prevention. For our kids.
Sincerely,
Daniel
Danl Zingale Zázola
Executive Director
Tab B
Time Line and Roll-out Implementation Plan for the Final HIV Reporting Guidelines
1998
November
HIV surveillance guidelines package to CDC OD.
HIV surveillance guidelines package to the Department.
Meeting with OS Staff Divisions (including but not restricted to ASL, ASL, ASPA, CDC,
IGA, OPHS) to coordinate Congressional and other communication related to the
guidelines.
Briefing with Secretary Shalala.
December
Briefing for Congressional staff, public health organizations, and advocacy groups.
Letter announcing the publication of the guidelines mailed/ faxed to key CDC partners.
Mail-out of comprehensive briefing materials to State health department personnel and
other key stakeholders. Material available through National Prevention Information
Network (NPIN).
Notice of publication of the final "Guidelines for National HIV Case Surveillance"
published in the Federal Register. Guidelines will also be made available on the
Worldwide Web.
Target month for publication, June 1999.
Notice to readers in Morbidity and Mortality Weekly Report (MMWR).
1999
January
Comment period closed January 11.
Receive and review public comments.
February
Summarize comments; prepare response; revise Guidelines
document.
March - September
Revised Guidelines package to CDC/OD and the Department.
November - December
On December 9, at *10:00 a.m., CDC will conduct briefings for the Office of National
AIDS Policy (ONAP) and Office of Management and Budget (OMB) staff.
On December 9, at *11:00 a.m., CDC will conduct briefings for the members of the
House of Representatives and Senate.
On December 9, at *12:00 p.m., CDC will conduct briefings for partner organizations,
including public health organizations, and advocacy groups (see list below.)
On December 10, 1999, the Guidelines are scheduled to be published in the MMWR
Recommendations and Reports series. Guidelines are effective immediately.
A letter announcing the publication of final Guidelines will be mailed/faxed to key CDC
partners immediately following publication. Briefing materials will also be mailed to
State health department personnel and other key stakeholders and will be available
through the National Prevention Information Network and on the Worldwide Web.
*All times are tentative and are to be confirmed the week of 11/29/99.
Plan to brief key Congressional Contacts on the HIV Reporting Guidelines
HHS (specifically ASL and ASMB) and CDC will make necessary arrangements to brief key
congressional members and staff. These briefings will take place the week before the MMWR Reports
and Recommendations is published (see above). Below is a proposed list of key congressional members.
House of Representatives:
Commerce Committee
Chairman: Representative Tom Bliley, Jr. (R-VA.); Ranking Member: Representative John D.
Dingell (D-MI)
Staff of Commerce Subcommittee: Health & Environment
Chairman: Representative Michael Bilirakis (R-FL); Ranking Member: Representative.
Sherrod Brown (D-OH)
Others
Representative Connie Morella (R-MD); Representative Gary Ackerman (D-NY);
Representative Tom Coburn (R-OK); Representative Henry Waxman (D-CA);
Representative Barney Frank (D-MA); Representative Donna Christian-Greene (D-Virgin
Islands)
Senate:
Labor & Human Resources
Chairman: Senator James Jeffords (R-VT); Ranking: Senator Edward Kennedy (D-MA)
Staff of Labor & Human Resources Subcommittee: Public Health & Safety Subcommittee
Chairman: Senator William Frist (R-TN); Ranking: Senator Edward Kennedy (D-MA)
Other Congressional Members:
Congressional Black Caucus:
Chair: Representative Maxine Waters (D-CA)
Congressional Hispanic Caucus:
Chair: Xavier Becerra (D-CA)
Committee on Indian Affairs
Chair: Ben Nighthorse Campbell (R-CO)
There will also be a briefing offered to staff of members who have a particular interest in matters related
to privacy of health information and/or the use of unique identifiers. This briefing would occur within
1 week after publication of the final Guidelines in the MMWR.
Key staff from the Office of National AIDS Policy and Office of Management and Budget:
OMB: Dan Mendelson, Richard Turman, and Melanie Nakagira
ONAP: Sandy Thurman and Todd Summers
Key partners:
AIDS Action Council
American Public Health and Human Services Association
Asian Pacific Islander Partnership for Health, Inc.
Association of State and Territorial Health Officers
Council of State and Territorial Epidemiologists
National Alliance of State and Territorial AIDS Directors
National Association of City and County Health Officials
National Association of Counties
National Association of Latino Elected and Appointed Officials
National Association of Persons with AIDS
National Association of State Alcohol and Drug Abuse Directors
National Black Caucus of State Legislators
National Conference of Black Mayors
National Conference of State Legislatures
National Governors Association
National League of Cities
National Native American AIDS Prevention Center
National Organization of Black County Officials
National Organizations Responding to AIDS
U.S. Conference of Mayors
Plan to distribute the R&R to other key partners:
In addition to making the R&R document available on CDC's web page, many partners will receive
copies of the document directly from CDC. This list includes but is not limited to:
CDC Advisory Committee on HIV/STD Prevention
Council for State and Territorial Epidemiologists
HIV/AIDS Surveillance Coordinators
HIV Prevention Community Planning Co-Chairs
HIV Prevention Consultants
National Public Health Information Coalition
STD Project Directors
(Many of the partners listed above will in turn disseminate information through their own
communication systems)
[Federal Register: December 10, 1998 (Volume 63, Number 237) ]
[Notices]
[Page 68289]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID: fr10de98-107]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Draft Guidelines for HIV Case Surveillance, Including Monitoring
HIV Infection and Acquired Immunodeficiency Syndrome (AIDS)
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice and Request for Comments.
SUMMARY: This notice announces the availability for public comment of a
document entitled `Draft Guidelines for HIV Case Surveillance,
Including Monitoring HIV Infection and Acquired Immunodeficiency
Syndrome (AIDS)
DATES: Comments must be submitted in writing on or before January 11,
1999. Comments should be submitted to the Technical Information and
Communications Branch, Mailstop E-49, Division of HIV/AIDS Prevention,
National Center for HIV, STD, and TB Prevention, Centers for Disease
Control and Prevention (CDC), Atlanta, Georgia 30333; Fax: 404-639-
2007; E-mail: [email protected].
FOR FURTHER INFORMATION CONTACT: Requests for copies of the Draft HIV
Case Surveillance Guidelines should be submitted to the CDC National
Prevention Information Network, P.O. Box 6003, Rockville, Maryland
20849-6003; telephone (800) 458-5231; or copies can be obtained from
the CDC website at http://www.cdc.gov/nchstp/hiv_aids/dhap.htm.
SUPPLEMENTARY INFORMATION: From 1995 to 1996, the incidence of both
deaths and opportunistic infections (OIs) due to AIDS declined in the
United States for the first time in the history of the epidemic (6
percent for OIs; 23 percent for deaths) as reported in the September
19, 1997, Morbidity and Mortality Weekly Report (MMWR) (Volume 46, pp.
861-867). These declines reflect recent advances in treatment of HIV
infection and the provision of care and services that have slowed the
progression of AIDS for HIV-infected persons on therapy and the success
of HIV prevention and education efforts that have encouraged early
diagnosis and have helped to reduce the number of Americans becoming
infected with HIV.
In response to these changes in HIV treatment practices and new
information needs of public health programs, CDC, the Council of State
and Territorial Epidemiologists (CSTE), and most other public health
and AIDS organizations have recommended that all States and territories
conduct HIV case surveillance in addition to AIDS surveillance. In this
manner, the AIDS/HIV epidemic can be tracked more accurately, and
appropriate information about HIV/AIDS can be made available to
policymakers. As of July 1998, a total of 32 States were conducting HIV
case surveillance using the same methods as surveillance for AIDS.
Because some States (many with large numbers of AIDS cases) do not
report HIV case numbers, interpretations of available HIV data are
difficult. To gain more reliable information about the prevalence,
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incidence, and future directions of HIV infection and the impact on
specific populations such as racial and ethnic minorities and women,
CDC is proposing that the current surveillance system be expanded to
include HIV case reporting for all States and is publishing guidelines
that States can use to implement HIV surveillance.
Dated: December 3, 1998.
Jeffrey P. Koplan,
Director, Centers for Disease Control and Prevention (CDC).
[FR Doc. 98-32617 Filed 12-9-98; 8:45 am]
BILLING CODE 4163-18-P
2 of 2
12/2/99 9:37 AM
1
Guidelines for National HIV Case Surveillance, Including Monitoring for HIV Infection and
Acquired Immunodeficiency Syndrome (AIDS)
The Centers for Disease Control and Prevention (CDC) recommends that all States and
territories conduct case surveillance for human immunodeficiency virus (HIV) infection as an
extension of current acquired immunodeficiency syndrome (AIDS) surveillance activities. The
expansion of national surveillance to include both HIV infection and AIDS cases is a necessary
response to the impact of advances in antiretroviral therapy, the implementation of new HIV
treatment guidelines, and the increased need for epidemiologic data concerning persons at all
stages of HIV disease. Expanded surveillance will provide additional data on HIV-infected
populations to enhance Federal, State, and local efforts to prevent HIV transmission, improve
allocation of resources for treatment services, and assist in evaluating the impact of public
health interventions. CDC will provide technical assistance to all State and Territorial health
departments to continue or establish HIV and AIDS case surveillance systems and to evaluate
the performance of their surveillance programs. This report includes revised case definitions for
HIV infection in adults and children less than 18 months of age, recommended program
practices, and performance and security standards for the conduct of HIV and AIDS
surveillance by State and local health departments. The revised surveillance case definitions
and associated recommendations become effective
INTRODUCTION
AIDS surveillance has been the cornerstone of national efforts to monitor the spread of
HIV infection in the United States and to target HIV prevention programs and health care
services. Although AIDS is the end-stage of the natural history of HIV infection, in the past,
monitoring AIDS-defining conditions provided population-based data that reflected changes in
HIV incidence. However, recent advances in HIV treatment have slowed the progression of HIV
disease for infected persons on treatment and contributed to a decline in AIDS incidence. These
advances in treatment have diminished the ability of AIDS surveillance data to represent trends
in HIV incidence or to represent the impact of the epidemic on the health care system. As a
consequence, the capacity of national, State, and local public health agencies to monitor the HIV
epidemic has been compromised (1-3). In response to these changes and following consultations
with diverse constituencies, including representatives of public health, government, and
community organizations, CDC and the Council of State and Territorial Epidemiologists (CSTE)
have recommended that all States and Territories include surveillance for HIV infection as an
extension of their AIDS surveillance activities (4). In this manner, the HIV/AIDS epidemic can
be tracked more accurately and appropriate information about HIV/AIDS can be made available
to policymakers.
This document provides revised case definitions for HIV infection in adults and children
less than 18 months of age, recommended program practices, and performance and security
standards for the conduct of HIV and AIDS surveillance by State and Territorial health
departments. The HIV case definitions were developed in consultation with CSTE and include
the current AIDS surveillance criteria as a component of the HIV infection case definition (5).
2
The recommended program practices and program performance and security standards are based
on: the established practices of AIDS and other public health surveillance systems; reviews of
State and local surveillance programs, confidentiality statutes, and security procedures; studies of
the performance of surveillance systems; ongoing evaluations of determinants of test-seeking or
test-avoidance in relation to State policies and practices on HIV testing and reporting; and
discussions at a consultation held by CDC and CSTE in May 1997. A draft of this document was
made available for public comment in
1998.
BACKGROUND
History of AIDS Surveillance
Since 1981, population-based AIDS surveillance (i.e., reporting of cases and their
characteristics to public authorities for analysis) has been used to track the progression of the
HIV epidemic from the initial cases of opportunistic illnesses caused by a then unknown agent in
a few large cities, to the reporting of 641,086 AIDS cases nationally through 1997 (6-9). The
AIDS reporting criteria have been periodically revised to incorporate new understanding of HIV
disease and changes in medical practice (10-13). In the absence of effective therapy for HIV,
AIDS surveillance data have reliably detected changing patterns of HIV transmission and
reflected the effect of HIV prevention programs on the incidence of HIV infection and related
illnesses in specific populations (14-15). Because of these attributes, AIDS surveillance data
have been used as a basis for the allocation of many Federal resources for HIV treatment and care
services and as the epidemiologic basis for the planning of local HIV prevention services.
With the advent of more effective therapy that slows the progression of HIV disease,
AIDS surveillance data no longer reliably reflect trends in HIV transmission and do not
accurately represent the extent of the need for prevention and care services (16-17). In 1996,
national AIDS incidence and AIDS deaths declined for the first time in the HIV epidemic
(Figure 1). These declines have been primarily attributed to the early use of combination
antiretroviral therapy to delay the progression to AIDS and death for persons with HIV infection
(1-3). Revised HIV treatment guidelines recommend antiretroviral therapy for many
HIV-infected persons in whom AIDS-defining conditions have not yet developed (18-19). In
response to these changes in HIV treatment practices and the information needs of public health
and other policymakers, CDC and CSTE have recommended that all States and territories
conduct HIV case surveillance in addition to AIDS case surveillance (1, 4).
Current Status of HIV Surveillance
As of July 1, 1998, 32 States had implemented HIV case surveillance using the same
reporting system for both HIV and AIDS cases; 3 of these States conduct pediatric surveillance
only (6) (Figure 2). The 29 States that conduct integrated HIV and AIDS surveillance for adults,
adolescents, and children report only about one-third of total U.S. AIDS cases.
In contrast to AIDS case surveillance, HIV case surveillance can provide data to better
characterize populations newly diagnosed with HIV, particularly those with evidence of recent
HIV infection such as adolescents and young adults (20- to 24-year-olds) (20-21). Of the 52,690
3
HIV infections diagnosed from January 1994 through June 1997 in 25 States that conducted
name-based HIV surveillance throughout this period, 14 percent were in persons aged 13 to 24
whereas of 20,215 persons diagnosed with AIDS in the same areas only 3 percent were in
persons aged 13 to 24. Thus, AIDS case surveillance alone does not accurately reflect the extent
of the HIV epidemic among adolescents and young adults. Compared with persons reported with
AIDS, those reported with HIV infection in these 25 States were more likely to be women and
from racial/ethnic minorities (22) (Table 1). HIV data also show patterns in rates of new
diagnoses and HIV prevalence that are not affected by changes in treatment. For example,
between June 1996 and June 1997, AIDS incidence among white men who had sex with other
men (MSM) decreased more than 30 percent while the number of new HIV diagnoses among this
population remained unchanged (Figure 3). In these States, as of December 1997, the number of
persons (140,585) who were living with a diagnosis of HIV or AIDS was 139% greater than that
represented by the number living with AIDS alone (6).
Most of the 32 States with name-based HIV case surveillance systems report all
perinatally exposed children. These States have used HIV surveillance data to document a sharp
decline in perinatally acquired HIV infection, an increase in the proportion of infected pregnant
women who have been tested for HIV before delivery, and a high proportion of HIV-infected
pregnant women who accept zidovudine therapy (23-28). These findings all have profound
policy implications that would not have been as easily or quickly detected using only AIDS case
surveillance. CSTE and the American Academy of Pediatrics have recommended that all States
and Territories conduct pediatric HIV surveillance that includes all perinatally-exposed infants
(29).
Not all persons infected with HIV are tested, and of those that are, testing occurs at
different stages of their infection. Therefore, HIV surveillance data provide a minimum estimate
of the number of infected persons and are most representative of persons who have been
diagnosed with HIV infection in medical clinics and other confidential diagnostic settings. The
data represent the characteristics of persons who recognize their risk and seek confidential
testing, who are offered HIV testing (e.g. pregnant women, clients at sexually transmitted disease
clinics), who are required to be tested (e.g. blood donors, military recruits), and who are tested
because they present with symptoms of HIV-related illnesses. CDC estimates that more than
two-thirds of all infected persons in the United States have been diagnosed with HIV in such
settings (30). HIV surveillance data do not represent untested persons or those who seek testing
at anonymous test sites or with home collection kits; such persons cannot be reported through
confidential HIV surveillance systems. However, the availability of these testing venues is
highly important in promoting knowlege of HIV status among at-risk populations and provides
an opportunity for counseling and referrals to appropriate medical diagnosis and care.
Despite some limitations, HIV and AIDS case surveillance would provide a clearer
picture of the HIV epidemic than AIDS case surveillance alone. Therefore, CDC and CSTE
continue to recommend that HIV case surveillance be implemented as part of a comprehensive
strategy to monitor the epidemic that includes HIV incidence and prevalence surveys, HIV and
AIDS case surveillance, monitoring HIV-related mortality, supplemental research and evaluation
studies including behavioral surveillance, and statistical estimation of incidence and prevalence
of infection and disease.
AIDS surveillance nationally and HIV surveillance in 32 States is conducted using the
4
name-based methods for case ascertainment that are used by other public health information
systems. A name-based approach allows providers to report cases directly from their name-based
medical records, facilitates elimination of duplicate case reports, enables cross-matching of HIV
and AIDS data with other name-based public health data (e.g., tuberculosis surveillance) and
permits follow-up with providers to collect HIV risk information and other data of public health
importance. Through follow-up with providers, the AIDS surveillance system has provided an
effective means to identify rare or unusual modes of HIV transmission, infection with rare strains
of HIV, and to improve the prevention of AIDS-related opportunistic illnesses (31-35).
Concerns Regarding HIV Surveillance
Since 1985, many States have implemented HIV case surveillance as part of their
comprehensive surveillance programs. The implementation of the 1993 expanded AIDS
surveillance case definition prompted discussions of the rationale and need for data representing
HIV-infected persons who did not meet the AIDS-defining criteria. Because many States
considered implementing HIV reporting, in 1993, CDC held a consultation with public health
and community representatives to discuss issues and concerns regarding HIV surveillance.
Community representatives' main concerns were that the security and confidentiality standards of
surveillance programs may not be sufficient to prevent disclosures of information, and that many
persons at risk for HIV infection may delay seeking HIV counseling and testing because of these
confidentiality concerns. The consensus of the consultants was that there were few, if any,
published studies of sufficient scientific quality to provide objective answers to these concerns.
Therefore, the consultants identified several areas that required additional research and policy
development before CDC and CSTE should consider recommending further expansion of HIV
surveillance efforts. These areas included: the impact of reporting policies on testing practices,
including the decreased availability of anonymous testing in some States; the role of surveillance
data in linking reported persons to prevention and care programs; the development of
recommended uses and standards for the confidentiality of publicly-held HIV and AIDS
surveillance data; and determining whether alternatives to reporting of patient names would
reduce confidentiality risks while meeting the needs for surveillance data. In response to the
consultants' recommendations, CDC initiated several research projects: 1) to assess the effect of
name-based HIV surveillance on persons' willingness to seek HIV testing; 2) to evaluate the
performance of non-name-based surveillance systems; and 3) to review program practices and
legal requirements for the security and confidentiality of State and local HIV/AIDS surveillance
data. Findings from these projects and expert advice from participants at numerous technical
meetings and consultations held during the intervening period have informed the policies and
practices recommended in this document. The interim findings from these projects are
summarized in the following three sections:
HIV Surveillance and Testing Behavior
To determine the effect of changes in reporting policies on actual testing behaviors
5
among persons seeking testing at publicly funded HIV counseling and testing sites, CDC and six
State health departments reviewed data routinely collected from these sites to compare HIV
testing patterns in the 12 months before and the 12 months after the implementation of HIV case
surveillance (36). In these areas, the number of HIV tests increased in four States, and decreased
in two States, however, these declines were not statistically significant (Figure 4). Thus, these
data do not suggest that, in these States, the policy of expanding HIV case surveillance adversely
affected test-seeking behaviors. CDC recognizes that careful attention to providing accurate
public education and factual mass media messages will be important to ensure that adverse
outcomes do not occur in States that implement HIV case surveillance based on these Guidelines.
In addition, CDC is supporting ongoing studies by researchers at the University of
California at San Francisco (UCSF) and participating State health departments to continue to
identify the most important determinants of test-seeking or test-avoidance among high-risk
populations and to assess the impact of changes in HIV testing and reporting policies. Efforts to
expand such studies to all States will assist them in more effectively monitoring the impact of
changing medical interventions, epidemiology, and HIV case surveillance policies on test- and
care-seeking behaviors.
Preliminary data from surveys of high-risk persons about their perceptions and
knowledge of HIV testing and HIV reporting practices found that few respondents' had
knowledge of the HIV reporting policy in their State (37-38). In these settings, respondents
reported high levels of testing, with approximately three-fourths reporting that they have had an
HIV test. The most commonly reported factors that contributed to delays in seeking testing or
not getting tested were fear of being diagnosed as having HIV, or belief that they were not at risk
for HIV infection, factors reported by nearly half of respondents. About one-fifth responded that
"reporting to the government" was a concern that may have delayed their seeking HIV testing; 2
percent of the respondents indicated that this was their main concern. Among different risk
groups, the level of concern about name-based reporting of HIV infections to the health
department, as the main reason for delaying or avoiding HIV testing, varied slightly; for men
who have sex with men, the risk group that had the highest level of concern, "reporting to the
government" was the main concern for 4%. In the context of current changes in State policies,
the relative importance of various determinants of testing behaviors could change, and CDC will
continue to assist States to evaluate the impact of policy changes on HIV testing patterns and
HIV/AIDS surveillance data.
Surveys of persons reported with AIDS found that persons who recognized their HIV risk
and sought testing at anonymous testing sites entered care at a significantly earlier stage of HIV
disease than persons who were only tested in confidential testing sites including those who were
first tested when they became ill (39). This study emphasizes the importance of anonymous
testing options in promoting knowledge of HIV status and in accessing care in a timely way.
HIV Surveillance Based on Non-named Unique Identifiers
To assess the feasibility of using alternatives to name-based methods for HIV
surveillance, several States implemented reporting of HIV cases or CD4 laboratory results using
6
a variety of numeric codes. Other States considered or tried to conduct case surveillance without
name-identifiers by using codes that were designed for non-surveillance purposes, e.g. codes that
were intended for use in tracking patients in case management systems (40). CDC convened a
meeting of these States in May 1995 that identified operational, technical, and scientific
challenges in conducting surveillance using non-name codes. In addition, CDC supported
research to evaluate the performance of a coded unique identifier (UI) in two States that
implemented a non-name-based HIV case reporting system while maintaining name-based
surveillance methods for AIDS (41). The evaluations conducted by these States from 1994 to
1996 indicated that social security number-based UI HIV surveillance systems were limited by
the ability of providers to complete and forward UI-based reports, resulting in incomplete
reporting. The evaluations were also unable to demonstrate that duplicate case reports could be
reliably eliminated. For the follow-up of UI-based cases to collect risk and other epidemiologic
data, providers maintained logs or other forms of documentation linking the UI to the
name-based medical records. This process may pose additional confidentiality risks if
physician-held surveillance registries are not protected by State confidentiality statutes or are
located in non-secure areas. One of the States is continuing to collect case reports and to review
and evaluate the performance of the UI HIV case surveillance system; the other is seeking to
amend its regulations to begin name-based reporting of HIV infected persons.
Confidentiality of HIV Surveillance Data
In 1994, CDC and CSTE sponsored a review of State confidentiality laws that protect
HIV surveillance data (42). All States and many localities have legal safeguards of
confidentiality of government-held health data, and these laws were found to provide greater
protection than laws protecting the confidentiality of health information held by private health
care providers in clinical records. Most States have specific statutory protections for public
health data related to HIV and other sexually transmitted diseases. However, State legal
protections vary widely and CDC is promoting efforts to enhance and standardize privacy
protections for public health data, including HIV/AIDS surveillance data.
CDC has also reviewed State and local security policies and procedures. Since 1981,
States have conducted AIDS surveillance, and few breaches of security have resulted in the
unauthorized release of data (43). Because HIV-infected persons are reported earlier in their
disease course than persons with AIDS and many such persons are remaining AIDS-free for
longer periods as a result of treatment advances, information about them may be maintained by
public health surveillance databases for longer periods. This has caused increased concerns
about confidentiality of surveillance data among public health and community groups.
Therefore, CDC has issued technical guidance for security procedures that include enhanced
confidentiality and security safeguards as evaluation criteria for Federal funding of State
HIV/AIDS surveillance activities (44). The receipt of Federal surveillance funding is dependent
on the recipient's ability to ensure the physical security and the confidentiality of case reports.
At the Federal level, HIV/AIDS surveillance data are protected by several Federal statutes, and
privacy is also ensured by the removal of names and the encryption of data transmitted to CDC.
Based on the importance of maintaining the confidentiality of persons who are diagnosed as
HIV-infected by public and private health care providers, CDC is recommending additional
7
practices to enhance the security and confidentiality of HIV and AIDS surveillance data.
HIV AND AIDS SURVEILLANCE GUIDELINES
HIV/AIDS Surveillance Case Definitions for Children and Adults
CDC, in collaboration with CSTE, has established new HIV and AIDS case definitions
that include revised surveillance criteria for HIV infection and that incorporate the surveillance
criteria for AIDS (10,13,45) (Appendix). HIV and AIDS surveillance reports forwarded to CDC
should be based on these surveillance criteria. The HIV and AIDS surveillance case definitions
for adults, adolescents, and children greater than or equal to 18 months of age includes laboratory
and clinical evidence specifically indicative of HIV infection and severe HIV disease (AIDS).
The HIV surveillance case definition for children less than 18 months of age updates the
definition in the 1994 revised classification system based on recent data on the sensitivity and the
specificity of HIV diagnostic tests and clinical guidelines for Pneumocystis carinii pneumonia
(PCP) prophylaxis for children (13, 46-55) and for the use of antiretroviral agents for pediatric
HIV infection (56) This definition will apply to children less than 18 months of age, except for
those who acquired HIV infection through modes of transmission other than perinatal
transmission (e.g., blood/blood product recipients). The revised surveillance case definitions will
become effective
.
HIV and AIDS Case Surveillance Practices
The following recommended practices update previous recommendations for State and
local HIV reporting systems and are revisions to the CDC Guidelines for HIV/AIDS Surveillance
released in April 1996 as a technical guide for State and local HIV and AIDS surveillance
programs (20,44).
Recommended Surveillance Practices
All State and local programs should collect a standard set of surveillance data for all cases
that meet the reporting criteria for HIV infection and AIDS. The standard data set
includes the (i) patient identifier, (ii) earliest date of diagnosis for HIV infection, (iii)
earliest date of diagnosis of an AIDS-defining condition, (iv) demographic information
(date of birth, race/ethnicity, sex) and residence (city, State) at diagnosis of HIV and
AIDS, (v) HIV risk exposure, (vi) facility of diagnosis, and (vii) date of death and State of
residence at death. In addition to this information, the date of HIV diagnostic testing and
the results of these tests should be collected for all infants with perinatal exposures to
HIV. To address specific public health information needs, local surveillance programs
may cross-match HIV and AIDS surveillance data with other public health data, such as
for tuberculosis, and collect supplemental surveillance data on all or a representative
sample of cases. CDC will provide technical assistance and standardized surveillance
methods to assist in the collection of supplemental surveillance information. Surveillance
information, without patient identifiers, should be encrypted and forwarded to CDC
8
through the HIV/AIDS Reporting System, as is current practice.
Published evaluations of non-name based HIV surveillance in two States (41) together
with results of meetings and consultations with States that have considered or used
non-name identifiers have highlighted operational difficulties with these systems. Based
on published evaluations, CDC has concluded that name-based HIV/AIDS surveillance
systems are the most likely to meet the necessary performance standards (22, 57-61) as
well as to serve the purposes for which surveillance data are required. Therefore, CDC
advises that State and local surveillance programs use the same name-based approach for
HIV surveillance as is currently used for AIDS surveillance nationwide. However, CDC
recognizes that some States have adopted, and others may elect to adopt, non-name case
identifiers for the public health reporting of HIV infection. CDC will provide technical
assistance to all State and local areas to continue or establish HIV and AIDS surveillance
systems and to evaluate their surveillance programs regardless of whether they use name
or non-name based identifiers.
HIV and AIDS surveillance should be used to identify rare or previously unrecognized
modes of HIV transmission, unusual clinical or virologic manifestations, and other cases
of public health importance. CDC will provide technical assistance to State and local
health departments conducting such investigations and will revise public health
recommendations based on the findings, as appropriate.
HIV and AIDS case surveillance efforts should be directed toward the collection of data
from all private and public sources of HIV-related testing and care services.
Laboratory-initiated surveillance methods should be used to collect information for cases
that meet the laboratory reporting criteria for HIV infection and AIDS. Statistics
regarding persons who are tested anonymously should not be reported through the HIV/
AIDS Reporting System. These test results are reported anonymously to the HIV
Counseling and Testing database. HIV-infected persons who are initially tested
anonymously are only eligible to be reported to HIV/AIDS surveillance after they have
been diagnosed by a health care provider and have test results or clinical conditions that
meet the HIV and AIDS reporting criteria.
All State and local surveillance programs should regularly publish, in print or
electronically, aggregated HIV and AIDS surveillance data in a format that facilitates the
use of these data by Federal, State, and local public health agencies; HIV Prevention
Community Planning groups; academic institutions; providers and institutions that have
reported cases; community-based organizations; and the general public. The presentation
of surveillance data should be consistent with established policies for data release that
preclude the direct or indirect identification of a person with HIV or AIDS.
All State and local surveillance programs should conduct regular ongoing assessments of
the performance of the surveillance system and redirect efforts and resources to ensure
timely reporting of complete, representative, and accurate data. CDC will provide
technical assistance and standardized evaluation methods to assist States in achieving the
highest possible level of performance.
Performance Standards
9
For the provision of accurate and timely data to monitor HIV and AIDS trends and to
ensure a reliable measure of the number of persons in need of HIV-related prevention and
care services, State and local HIV/AIDS surveillance systems must use reporting methods
that provide complete (≥85 percent) and timely (≥66 percent of cases reported within 6
months of diagnosis) case reporting and unduplicated (≤5 percent duplicate case reports)
surveillance data. At least 85 percent of cases, or a representative sample, should have
HIV risk information after epidemiologic follow-up is completed. All HIV and AIDS
surveillance systems should collect the recommended standard data in a reliable and valid
manner, allow matching to other public health databases (for example, death registries) to
benefit specific public health goals, and allow identification and follow-up of individual
cases of public health importance.
To assess the quality of HIV and AIDS case surveillance as specified in the performance
standards, States and local surveillance programs must conduct periodic evaluations that
include the use of at least one appropriate population-based data source (e.g., National
Death Index) that is not used for routine case-finding. Program evaluations should also
measure the potential impact of HIV surveillance on test-seeking patterns and behaviors
and review the extent to which surveillance data are being used for planning, targeting,
and evaluating HIV prevention programs and services. The goal of these performance
evaluations is to enhance the quality and usefulness of surveillance data for public health
action. During the next several years, CDC will assist States in transitioning from an
AIDS-only surveillance program to an integrated HIV and AIDS surveillance system.
CDC will assist States conducting HIV and AIDS surveillance to evaluate current
performance levels, institute revised program operations and policies as necessary, and
then reassess performance. CDC will evaluate and award proposals for Federal funding
of State and local surveillance programs based on their capacity to meet these
performance standards following this transition period. At that time, CDC will require
that States adopt surveillance methods that will enable them to achieve the standards.
Recommended Security and Confidentiality Practices
State and local programs should have a description of their security policies and
procedures available for external review. CDC will require that State and local areas
include their security policy in applications for Federal surveillance funds.
For optimal security, data should be maintained on a single electronic HIV and AIDS
surveillance registry. In accordance with local laws, other files--paper and electronic
(except for a backup for the central system)--that contain personal identifying information
should be eliminated. All States should continue the established practice of not including
personal identifying information in the HIV and AIDS surveillance data forwarded to
CDC.
State and local health departments should review their data retention policies. Policies
should provide the flexibility to remove cases that were reported in error. State and local
programs should also consider removing the names from surveillance records that no
longer serve a public health purpose and to identify these cases through other means such
as the use of the alpha-numeric code scheme currently used in HIV and AIDS
10
surveillance, date of birth, and other data routinely collected in case reports.
State and local health departments should also review their confidentiality statutes to
determine whether additional protections should be put in place before the
implementation of HIV case surveillance. State and local confidentiality laws should
include (i) the objectives of the collection of personal identifying information; (ii) the
public health officials who have access to surveillance information and the justification
for this access; (iii) the procedures, including time frame, for expunging personal
identifiable information when no longer needed for the stated purposes; (iv) the
safeguards against disclosing HIV and AIDS case surveillance data through subpoena or
court order; and (v) the significant civil or criminal penalties for breaches of
confidentiality. The confidentiality laws should protect surveillance data that are
transmitted (in a secure and confidential manner consistent with CDC's HIV/AIDS
surveillance program requirements) to other public health programs as part of evaluation
studies or for follow up of cases of special public health importance. The penalties under
law for violation of privacy and security should apply to all recipients of HIV and AIDS
case surveillance information.
Security and Confidentiality Standards
The security and confidentiality policies and procedures of State and local surveillance programs
should be consistent with CDC standards for surveillance programs. The following standards
must be met as a condition of Federal HIV and AIDS surveillance funding:
CDC requires that electronic HIV/AIDS surveillance data be protected by computer
encryption during data transfer. Paper or unencrypted electronic case reports forwarded
by providers should be used by surveillance staff to update the central surveillance
registry and then should be destroyed.
CDC requires that HIV and AIDS surveillance records be located in a physically secured
area to limit and control access to surveillance records, and be protected by coded
passwords and computer encryption. To further enhance security and confidentiality of
the data, the use of a double-key encryption and decryption system, in which identifying
information encrypted by the States using the first key can only be decrypted for access
using the second key to be held by CDC, can be implemented by States using methods
recommended by CDC. The key held by CDC will be protected by an Assurance of
Confidentiality under Section 308(d) of the Public Health Service Act. Under this
Assurance, the second CDC-held key would preclude States from accessing or releasing
the HIV/AIDS surveillance data for non-public-health purposes.
CDC requires that access to the HIV/AIDS surveillance registry be restricted to a
minimum number of authorized surveillance staff who have been trained in
confidentiality procedures and who are aware of penalties for unauthorized disclosure of
surveillance information. The State Health Officer or other designated authorizing
official should specify the persons who have access to confidential HIV/AIDS
surveillance data and the duties to be conducted. Audit systems should be established to
monitor access to and use of surveillance data. Non-surveillance personnel should not
11
have access to HIV and AIDS surveillance files.
If State and local health departments develop data bases from the cross-matching of
HIV/AIDS surveillance data with other surveillance data, HIV and AIDS surveillance
records must not be used if the cross-matched data bases do not have equivalent security
and confidentiality protections and penalties for unauthorized disclosure as those for the
HIV and AIDS surveillance data. Such cross-matched data bases should use the
minimum amount of surveillance data necessary to accomplish the specific public health
activity.
The use of HIV and AIDS surveillance data for research purposes must be approved by
appropriate institutional review boards, and researchers should sign confidentiality
statements. HIV and AIDS surveillance data made available for epidemiologic analyses
must not include names or other identifying information. State and local data release
policies should ensure that the release of data for statistical purposes does not result in the
direct or indirect identification of persons reported with HIV and AIDS. If a breach of
confidentiality occurs, State and local health departments should impose personnel
sanctions and criminal penalties as appropriate.
State and local health departments must investigate potential breaches of confidentiality,
and impose personnel sanctions and criminal penalties as appropriate. All breaches of
confidentiality are to be reported to CDC immediately. CDC will provide technical
assistance to State and local health departments' investigations of such incidents, develop
recommendations for improvements in local security measures, and provide oversight to
monitor changes in program practices.
Relationship to HIV Prevention and Care Programs
The implementation of HIV case surveillance should not interfere with HIV prevention
programs, including those that offer anonymous HIV counseling and testing services.
Unless prohibited by State law or regulation, CDC requires that States and local areas
provide opportunities to receive anonymous HIV counseling and testing services as a
condition of Federal funding for HIV prevention. CDC strongly recommends that States
prohibiting anonymous HIV testing change this practice, given the overriding public
health objective of encouraging knowledge of HIV serologic status.
All HIV testing services should continue to be voluntary and preceded by informed
consent in accordance with local laws (62).
All persons who are diagnosed with HIV infection should be referred to programs that
provide HIV care, treatment, and comprehensive prevention case management services.
Provider-based referrals of patients to prevention and care services provide a timely,
effective, and efficient means of ensuring that individuals who have been diagnosed with
HIV receive needed services. The primary function of HIV and AIDS surveillance is the
collection of accurate and timely epidemiologic data; therefore, State and local HIV and
AIDS case surveillance programs are not directed by CDC to share individual case reports
with prevention or care programs, including those that provide partner notification
assistance, case management, and other services for individual clients. Although some
12
areas have established direct linkages between surveillance and specific prevention
programs, such linkages do not necessarily improve the provision of HIV prevention and
care services. Areas that elect to establish such linkages must seek the concurrence of
their prevention and care planning groups, require that recipients of surveillance
information be subject to the same penalties for unauthorized disclosure as surveillance
personnel, and evaluate the effectiveness of this public health approach.
COMMENTARY
The Surveillance Case Definition for HIV Infection and AIDS
The revised HIV and AIDS surveillance case definition integrates HIV and AIDS
reporting criteria in a single case definition and incorporates new laboratory tests in the
laboratory criteria for HIV case reporting. For adolescents and adults, the 1999 HIV and AIDS
case definition includes viral detection tests that were not commercially available when the case
definition was revised in 1993. The revised case definition for HIV infection also permits the
reporting of cases based on the result of any test licensed for the diagnosis of HIV infection in the
United States. Although the reporting criteria generally reflect the recommendations for the
diagnosis of HIV infection, the HIV reporting criteria are for public health surveillance and are
not designed for making a diagnosis for an individual patient. The laboratory criteria include the
serologic HIV tests described in the clinical standards for HIV diagnosis (63-64).
The pediatric HIV reporting criteria include criteria for monitoring all children with
perinatal exposures to HIV and reflect recent advances in diagnostic approaches that permit the
diagnosis of HIV infection in the first months of life. With viral detection tests, HIV infection
can be detected in nearly all infants 1 month of age or older. The timing of the HIV serologic
and viral detection tests and the number of viral detection tests in the definitive and presumptive
criteria for HIV infection are based on the recommended practices for the diagnosis of infection
in children less than 18 months of age and on evaluations of the performance of these tests for
children in this age group (46-55).
The clinical criteria in the HIV and AIDS case definition are included to ensure the
complete reporting of cases with documented evidence of HIV infection or AIDS-defining
conditions. The AIDS-defining conditions are included as part of the integrated HIV and AIDS
surveillance criteria. The presumptive and definitive AIDS-defining criteria have not been
revised since 1993 and continue to include the laboratory markers of severe HIV-related
immunosuppression and the opportunistic illnesses indicative of severe HIV disease. The
development of AIDS-related opportunistic illnesses greatly increases mortality risks. Almost all
deaths among persons with HIV infection are caused by AIDS-related opportunistic illnesses
(65).
Effect of National HIV Case Surveillance on Reporting Trends
The changes in the HIV reporting criteria will have little effect on reporting trends in
States already conducting HIV case surveillance. The number of HIV cases reported nationally
13
will increase primarily because of the implementation of HIV surveillance by the remaining
States and local areas. Many of the States that will be implementing HIV case surveillance in the
future have high AIDS incidence rates. Similar to the effect on AIDS surveillance trends after
the implementation of the revised reporting criteria in 1993, the initiation of HIV surveillance by
additional States may result in a sudden and large increase in HIV case reports (66). Based on
CDC's estimates that approximately 220,000 HIV-infected persons without AIDS-defining
conditions have been tested confidentially and reside in States that do not currently conduct HIV
case surveillance (30), it is possible that this many persons could be reported with HIV infection
from these States in 1999. However, it is more likely that reporting of prevalent HIV infections
will be spread over several years and that the annual increases will be more modest. Initially,
most case reports will represent persons whose HIV infection was diagnosed before HIV
surveillance was implemented. As the reporting of prevalent HIV cases is completed, the
number of HIV case reports will decrease and case reports will increasingly represent persons
with recent diagnosis of HIV infection.
To facilitate the interpretation of HIV surveillance data given that CDC promotes the
continued availability of anonymous testing options, evaluations of HIV and AIDS surveillance
systems will include assessments of the number of persons reported whose infection was initially
diagnosed at an anonymous site and the time before these persons entered clinical care for their
infection. These evaluations will be useful in determining the representativeness of HIV
surveillance data, as well as the effectiveness of program efforts to refer persons into care
services after diagnoses of HIV infection in anonymous settings.
AIDS trends have declined nationally; however, because the AIDS surveillance trends are
affected by HIV incidence, as well as the effect of treatment on the progression of HIV disease, it
is not possible to predict future AIDS trends. AIDS surveillance will continue to be important in
evaluating access to care for different populations and identifying changes in trends that might
signal a decrease in the effectiveness of treatment. The long-term benefits of antiretroviral
therapy and antimicrobial prophylaxis for AIDS-related illnesses continue to be defined, and
various factors, such as access, adherence, treatment costs, and viral resistance will influence the
utilization and effectiveness of these therapies and their effects on AIDS incidence and mortality
trends (67-69).
HIV and AIDS Surveillance Practices
Laboratories will be an increasingly important source of information from which to
initiate reporting. HIV infection is frequently diagnosed in the outpatient clinical setting, and
laboratory-initiated reporting will be particularly useful in identifying outpatient sources of HIV
testing (60). Although contact with individual providers is necessary to complete the reporting
process, the routine collection of data from laboratories and managed care organizations
promotes simplicity and efficiency of case reporting to local surveillance programs.
Performance criteria for HIV and AIDS surveillance are necessary to ensure that
surveillance data are of sufficient quality to target prevention and care resources and to detect
emerging trends in the HIV epidemic. Evaluations of HIV and AIDS surveillance programs have
shown that areas should be able to meet these performance criteria (57-61). According to these
14
evaluations, the completeness of HIV surveillance (79 to 95 percent) and AIDS surveillance (85
to 100 percent) is high and reporting is timely with nearly one-half of AIDS cases and
three-quarters of HIV cases reported to the national HIV/AIDS reporting system within 3 months
of diagnosis (6). In 1996, CDC estimated that the duplication rate of HIV and AIDS cases
reported from different States to the national surveillance data base was less than 3 percent and 2
percent, respectively (24). The performance criteria also reflect the need for public health
surveillance systems to serve as a basis for the identification and follow-up of cases of public
health importance. Based on evaluation studies of non-name-based case identifiers and the
current infrastructure of State and local health departments, name-based methods for collecting
and reporting public health data provide the most feasible and reliable means for ensuring timely,
accurate, and complete reporting of persons diagnosed with HIV and AIDS. Name-based
reporting facilitates follow-up of perinatally-exposed infants to determine their infection status
and of persons reported with HIV to determine progression to AIDS and vital status.
The Security and Confidentiality of HIV and AIDS Surveillance
The revision of the HIV reporting criteria provides an opportunity to review and
strengthen State and local confidentiality laws and regulations. Although State HIV and AIDS
surveillance confidentiality laws and regulations adequately protect privacy compared with the
statutory protections of other health care data, State statutes differ in the degree of privacy
protections afforded health information and the criteria for permissible disclosures of personal
information. Most State statutes describe some permissible disclosures of public health
information. To help ensure uniform confidentiality protections, CDC, CSTE, ASTHO, the
National Conference of State Legislatures, and the Georgetown/Johns Hopkins Public Health
Law Project are conducting a model State privacy law project. This project is developing model
legislative language to protect confidential, identifiable information held by State and local
public health departments against unauthorized and inappropriate use while still allowing the use
of surveillance information to accomplish legitimate public health objectives. This process is
projected to be completed by the end of 1998, and States that plan to implement HIV case
surveillance should consider adopting the model legislation.
Although HIV and AIDS surveillance systems have exemplary records of security and
confidentiality, it is essential for all programs to identify ways to strengthen data protection
because of the greater sensitivity of HIV case surveillance compared with that of AIDS case
surveillance alone. The revised security requirements are based on a CDC review of the security
practices of all State HIV and AIDS surveillance systems. The revised security standards will
result in a reduction in the number of name-based surveillance registries and limitations on how
these registries are used. CDC continues to conduct evaluations of methods to further enhance
data security, including the use of coding and encryption of data collected in the HIV and AIDS
reporting system. Based on these evaluations, CDC will provide technical guidance to facilitate
the use of this approach by project areas.
HIV Prevention and Care
CDC has published guidelines concerning the provision and targeting of HIV counseling
15
and testing services (19, 27, 70-72), and provides support for most public sources of HIV testing.
The availability of anonymous HIV testing services may be particularly important for persons
who delay seeking testing because of a concern that others may learn of their serologic status.
Studies have shown that the availability of anonymous HIV testing is associated with increased
numbers of persons seeking testing services (73-76). Anonymous HIV testing services are a
required element of federally supported prevention programs unless prohibited by State law or
regulation. Currently, 39 States, Puerto Rico, and the District of Columbia provide anonymous
HIV testing services.
CDC advises that the decision about linkage between surveillance systems and prevention
and care services, such as partner counseling and referral services (i.e. partner notification
activities), be made at the local level. Voluntary partner notification services provide HIV
counseling and testing to persons who may be unaware of HIV risk exposures, and these services
are a required component of federally sponsored HIV prevention programs (77-78). All such
prevention services are feasible, and in well-managed programs have been highly effective
without being directly linked to HIV or AIDS surveillance data. Translating surveillance data
into prevention priorities and programs requires informed decision-making by public health and
community partners through the HIV Prevention Community Planning process which should
guide whether and how such linkages are achieved. Such linkages should neither compromise
the quality and security of the surveillance system nor compromise the quality, confidentiality,
and voluntary nature of HIV prevention services. The primary function of HIV and AIDS
surveillance remains the provision of accurate epidemiologic data for public health information,
planning, and evaluation.
Persons who have been diagnosed with HIV infection at either confidential or anonymous
test sites should be promptly referred to facilities that provide confidential HIV care. Although
not directly responsible for the delivery of medical care, CDC provides Federal direction for
State and local programs that facilitate the referral of HIV-infected persons from counseling and
testing centers and health education/risk-reduction programs to HIV care facilities. CDC has
strengthened its technical assistance to HIV counseling and testing grantees to improve the
referral system between HIV testing sites and care programs, in part by increasing coordination
with the Health Resources Services Administration (HRSA) and the Ryan White CARE Act
grantees. To provide further guidance, CDC has also undertaken a project to develop model
contract language for Medicaid programs that serve people with HIV.
CONCLUSION
The implementation of a national surveillance network to include both HIV and AIDS
surveillance is a necessary response to epidemiologic trends and new standards for HIV care.
Integrated HIV and AIDS surveillance programs will provide data to characterize persons newly
diagnosed with HIV infection, including those with evidence of recent infection, persons with
severe HIV disease (AIDS), and those succumbing to HIV and AIDS. The revised HIV
surveillance case definitions and the establishment of performance criteria will promote uniform
case ascertainment and will ensure that the surveillance data are of sufficient quality for effective
planning and allocation of resources for prevention and care programs. The successful
implementation of HIV and AIDS surveillance will require that State and local areas further
16
ensure the security and confidentiality of surveillance data. This can be promoted through
enhancements to data systems and confidentiality policies, training and management of public
health personnel, and by use of the HIV Prevention Community Planning process to determine
the appropriate use of surveillance data by prevention and care programs.
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21
BOX. Revised Surveillance Case Definition of HIV Infection (including AIDS)*
This revised definition of HIV infection, which applies to any type of HIV (e.g., HIV-1, HIV-2), is
intended for public health surveillance only. The revised criteria for HIV infection update the
definition of HIV infection implemented in 1993 (10); the revised HIV criteria apply to
AIDS-defining conditions (10) that require laboratory evidence of HIV. This definition is not
presented as a guide to clinical diagnosis or for other uses (10,12).
I.
In adults, adolescents, or children >18 months of age, a reportable case of HIV
infection meets any of the following criteria:
Laboratory Criteria
Positive result on a screening test for HIV antibody (e.g., repeatedly reactive
enzyme immunoassay) followed by a positive result on a confirmatory (sensitive
and more specific) test for HIV antibody (e.g., Western blot or immunofluorescence
antibody test), OR,
Positive result on any of the following HIV virologic detection (non-antibody) tests:
HIV nucleic acid (DNA or RNA) detection (e.g. DNA polymerase chain
reaction (PCR), plasma HIV-1 RNA levels)#
p24 antigen test, including neutralization assay
Virus isolation (culture)
OR
Clinical Criteria (if the above criteria are not met)
Diagnosis of HIV infection documented in a medical record by a physician, OR,
Conditions that meet criteria included in the case definition for AIDS (10,12)
II.
In a child <18 months of age, a reportable case of HIV infection meets any of the
following criteria:
Laboratory Criteria
Definitive
Positive results on two separate determinations (excluding cord blood) from one or
more of the following HIV virologic detection (non-antibody) tests:
HIV nucleic acid (DNA or RNA) detection#
p24 antigen test, including neutralization assay
Virus isolation (culture)
OR
Presumptive
Positive results on only one (excluding cord blood) of the definitive HIV virologic
detection tests
OR
Clinical Criteria (if the above criteria are not met)
Diagnosis of HIV infection documented in a medical record by a physician,
OR,
Conditions that meet criteria included in the 1987 pediatric surveillance case
22
definition for AIDS (12,13)
III.
A child <18 months of age born to an HIV-infected mother will be categorized for
surveillance purposes as not infected with HIV according to any of the following
criteria:
Laboratory Criteria
Definitive
At least two negative HIV antibody tests from separate specimens obtained
at ≥ 6 months of age, OR,
At least two negative HIV virologic detection tests** from separate specimens, both
of which were obtained at >1 month of age and one of which was drawn at >4
months of age
AND
No other laboratory or clinical evidence of HIV infection (i.e., has not had
any positive virologic test results, if performed, and has not had an
AIDS-defining condition)
OR
Presumptive
One negative result from an HIV antibody test performed at >6 months of age, OR,
One negative HIV virologic detection test** performed at >4 months of age, OR,
One positive HIV virologic detection test with at least two later negative tests**, at
least one of which is after 4 months of age; or negative HIV antibody test results, at
least one of which is at >6 months of age.
OR
Clinical Criteria
Determined by a physician to be uninfected, and a physician has noted the results of
the preceding HIV diagnostic tests in the medical record
AND
No other laboratory or clinical evidence of HIV infection (i.e., has not had any
positive virologic test results, if tests were performed, and has not had an
AIDS-defining condition)
IV
A child <18 months of age born to an HIV-infected mother will be categorized as
having indeterminate HIV infection if the child does not meet the criteria for HIV
infection (II) or the criteria for the absence of HIV infection (III).
*The revised surveillance criteria for HIV infection were approved and recommended by the
membership of the Council of State and Territorial Epidemiologists (CSTE) at the 1998 annual
meeting. Draft versions of these criteria were previously reviewed by state HIV/AIDS surveillance
staffs, CDC and CSTE laboratory experts; in addition the pediatric criteria were reviewed by an
expert panel of consultants.
23
#Plasma viral RNA nucleic acid tests should not be used as screening tests for the purpose of
diagnosing HIV infection.
** HIV nucleic acid (DNA or RNA) )detection tests are the virologic methods of choice to exclude
infection. Although HIV culture can be used for this purpose, it is more complex and expensive to
perform and is less well standardized than nucleic acid detection tests. The use of p24 antigen
testing to exclude infection is not recommended because of its lack of sensitivity.
DRAFT: December 17. 1999
Dear Addressee:
Human immunodeficiency virus (HIV) case surveillance serves critical public health goals as
have been detailed in the Guidclines for National HIV Case Surveillance and accompanying
materials. For example, HIV case surveillance enhances local, State, and Federal efforts to
prevent HIV transmission. It also helps public health authorities evaluate the impact of public
health interventions.
On December 10. 1999, the Centers for Discase Control and Prevention (CDC) published
"Guidelines for National HIV Case Surveillance. Including Monitoring for HIV Infection and
Acquired Itnmunodeficiency Syndrome" in the Morbidity and Mortality Weekly Report (MMWR)
Recommendations and Reports. These Guidelines can be accessed at www.cdc.gov. The
Guidclines include a revised case definition for HIV infection in adults and children.
recommended surveillance program practices, and performance and security standards for
conducting HIV/AIDS surveillance by local, State. and territorial health departments. HIV case
surveillance must also protect the confidentiality of personal data. The purpose of this letter is to
clarify and emphasize key points in the Guidelines related to confidentiality and security.
As you may be aware, on November 3, 1999, the Department of Health and Human Services
(HHS) published a Notice of Proposed Rule Making regarding Standards for Privacy of
Individually Identifiable Health Information. This proposed rule is mandated by the Health
Insurance Portability and Accountability Act of 1996 (HIPAA). The rule provides privacy
protections for personal medical information held by covered health care providers. health plans.
and health care clearinghouses. The proposed rule would not preempt State public health
reporting laws or more stringent State privacy protections.
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To help ensure the security and confidentiality of HIV surveillance data under State
confidentiality laws, the CDC Guidclines include a recommendation that States and territories
consider implementing the "Model Public Health Privacy Act" (Model Act), if necessary. to
strengthen their current public health laws. This Model Act was developed by Georgetown
University. at the request of the Council of State and Territorial Epidemiologists (CSTE). to
promote minimum standards for the protection of publicly held public health surveillance data
The provisions of the Model Act would enhance the confidentiality of surveillance data.
strengthen statutory protections against disclosure, and preclude the unauthorized use of
surveillance data.
Additionally, the Model Act contains strong penalties for unauthorized disclosure of personal
identifying data by public officials. It also permits access to civil remedies (e.g. compensatory
and punitive damages) to any person aggrieved by disclosure of protocted health information in
violation of the Model Act. As part of the surveillance program. CDC offers to States the option
of requesting that CDC and the State jointly restrict access to HIV/AIDS surveillance data
through the implementation of a dually-held cncryption-decryption code that would be legally
protected under a Federal assurance of confidentiality as authorized under Section 308(d) of the
Public Health Service Act. 42 U.S.C. 242m(d).
In addition to legal protections of surveillance data, CDC's HIV Surveillance Guidelines set forth
minimum standards for the security of HIV/AIDS surveillance data to establish a minimum level
nationwide, consistent with individual State laws. The security requirements were developed
with input from the States following visits by CDC staff to all State health departments. CDC
provided 1998 supplemental funding to States, to help them comply with the standards. States
are required to meet these standards in order to receive Federal funds under the HIV/AJDS
surveillance cooperative agreement, effective January 1, 2000, the same date the Guidelines
become effective. All States have met CDC's minimum security requirements by providing
CDC with a written certification and designating an Overall Responsible Party for the security
and confidentiality of HIV/AIDS surveillance data,
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Two key points in the Guidelines Minimum Security and Confidentiality Standards are
highlighted below:
Access to the HIV/AIDS surveillance registry should be restricted to a minimum number
of authorized surveillance staff, who are designated by a responsible authorizing official,
have been trained in confidentiality procedures, and are aware of the penalties for
unauthorized disclosure of surveillance information. The State Health Office of other
designated authorizing official should specify the persons who have access to confidential
HIV/AIDS surveillance data and the duties to be conducted. Audit systems should be
established to monitor access to and use of surveillance data. Non-surveillance personnel
should not have access to HIV and AIDS surveillance files.
State and local health departments must investigate potential breaches of confidentiality,
and impose personnel sanctions and criminal penalties as appropriate. All breaches of
confidentiality are to be reported to CDC immediately. CDC will provide technical
assistance to State and local health departments' investigation of such incidents. develop
recommendations for improvements in local security measures, and provide oversight to
monitor changes in program practices.
CDC recognizes that some States have elected and others may elect to use patient codes when
implementing HIV case reporting. Regardless of the type of patient identifier (names of codes)
that States use, CDC will provide funds to any State whose reporting system meets the
qualifications set out in the Guidelities. CDC will work with States that wish to develop non-
name-based reporting systems that qualify for Federal funding. CDC will also share information
on these reporting systems with other interested States. CDC affirms its commitment to the
security and confidentiality of personally identifying HIV/AIDS surveillance data by
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recommending the Model Act for consideration by States where existing State statutes are less
stringent, and by requiring States to most minimum security standards.
Sincerely,
Jeffrey P. Koplan, M.D., M.P.H.
Director
CC:
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