Presidential Advisory Council on HIV/AIDS

**Twentieth Meeting**

June 21-22, 2002

The Wyndham City Center Hotel

Washington, DC

**Minutes**

*Members Present:*

Thomas A. Coburn, M.D., Co-Chair

Louis W. Sullivan, M.D., Co-Chair

Stuart C. Burden

Philip P. Burgess, R.Ph., M.B.A.

Joseph A. Christina

James P. Driscoll

Vera Franklin

Mildred Freeman

John F. Galbraith

Cynthia A. Gomez, Ph.D.

Cheryl-Ann Hall

Karen Ivantic-Doucette, M.S.N., F.N.P., A.C.R.N.

Joseph Jennings

Rashida Jolley

Caya B. Lewis, M.P.H.

Abner Mason

Sandra S. McDonald

Joe S. McIlhaney, M.D.

Hank McKinnell, Ph.D.

Brent Tucker Minor

Dandrick Moton

Nathan M. Nickerson, R.N., M.S.N.

John A. Perez

Debbie Rock

Rev. Edwin Sanders II

Prem Sharma, D.D.S.

Lisa Mai Shoemaker

Anita Smith

M. Monica Sweeney, M.D., M.P.H.

*Members Not Present:*

Hon. Ronald V. Dellums

Ingrid M. Duran

Mary Fisher

Katryna Gholston

# 

# Friday, June 21, 2002

# Morning General Council Session

# Opening Remarks

Co-Chair Louis Sullivan noted that the Hon. Ronald Dellums was
unexpectedly unable to attend this meeting. Dr. Sullivan extended his
congratulations to Dr. Sharma, who will receive the William John Jeeves
\[sp\] award, the highest recognition given by the American College of
Dentists, at that group's annual congregation in October in New Orleans.

Dr. Sullivan explained that he would preside over most Council business
today and Co-Chair Thomas Coburn would preside tomorrow, switching as
necessary. On the subject of rapid testing and oral testing, Dr.
Sullivan recused himself because he has served as an advisor to Orasure.
Dr. Coburn will chair during that time.

Dr. Coburn welcomed the Council and noted he looks forward to a
successful meeting.

Dr. Sullivan reminded Council members that Executive Director Patricia
Ware requires all members to complete and return their ethics forms.

Dr. Sullivan called for review of the minutes from the last Council
meeting. Mr. Burden noted that he had recommended a course of action,
and although no action was taken as a result, he requested that the
minutes reflect his recommendation (\$1 billion in international funds
for AIDS). The minutes were so amended. Mr. Minor moved to approved the
minutes; Dr. Sharma seconded. The minutes from the last Council meeting
were approved as amended.

# Short-Term Solutions to ADAP Shortage

Dr. Sullivan recognized Dr. Coburn, who opened the discussion regarding
the continued shortage of funding in AIDS Drug Assistance Program (ADAP)
by inviting Council members to discuss possible options and
recommendations the Council could make between now and start of the next
fiscal year (a period of about 5 months). Several pharmaceutical
companies have contributed money and product to several programs. In
addition, there is approximately \$200-300K in unspent Ryan White CARE
Act (RWCA) money this year, but these funds are not available to the
ADAP. There are some states (e.g., certain areas of Florida) where an
excess of monies from other programs is being sent to their ADAP fund.
Dr. Coburn stated that the Council Chairs are open to any ideas for
action or recommendation.

Dr. Hank McKinnell noted that his company, Pfizer, instituted a pricing
freeze, which was followed by Roche & Abbott, who announced a 2-year
pricing freeze; Bristol-Myers (1 year); and Glaxo Wellcome (2 years).

Dr. Driscoll noted that it would be beneficial if the Council were able
to persuade the administration to put ADAP higher within administrative
priorities. He recommended that the Council prepare a letter to
President Bush urging such. Congress, Dr. Driscoll said, needs a signal
from the White House that ADAP funding needs to be better addressed.

Mr. Burgess noted that his organization, Florida AIDS Action (a
recipient of ADAP funds), is asking pharmaceutical companies to come
down to half price for AIDS drugs. Considering that the RWCA is
administered under the U.S. Public Health Service, there should be some
negotiating power. While appreciative that several major pharmaceutical
companies have frozen their prices, the Council should be tougher in
negotiations.

Brent Minor noted that many states have limited formularies, so that,
even in places where funds are available, many states are still not able
to obtain certain drugs. Mr. Minor suggested this issue be part of the
discussion. He said there seem to be two tracks on which to proceed: one
pursuing more Federal funding (petitioning Congress and the White House
administration), and the other working with pharmaceutical companies.
Mr. Minor said that a letter from the Council to both entities would be
the most sensible route, and recommended that a subcommittee draft a
letter to be reviewed and approved by the Council.

Dr. Coburn stated that an important piece of every Government program is
to plan for careful oversight so that monies, whether for prevention,
care, housing, or medications, are spent wisely and efficiently. Enough
funding currently exists to be applied to ADAP; the third piece of the
equation is efficiency and oversight: the ability to improve purchasing
power.

Dr. Sullivan asked what other actions can be suggested, beyond the
pricing freezes undertaken by the pharmaceutical companies. Mr. Minor
agreed that the pricing freezes should be recognized as such; the next
step might be to invite pharmaceutical industry representatives to
address the Council and to discuss whether they can reduce drug
prices---and if so, why? and if not, why not? The Council's requests
need to be based in reality: pharmaceutical representatives may be able
to offer the Council insights into what is practical and logical. A
simple request to cut all drug prices in half might sound good, but not
be practical or achievable.

Dr. Coburn cautioned against creating an impression that the
pharmaceutical industry has not been doing a great deal to help with the
epidemic, when they have provided a great deal of product for indigent
persons without reimbursement. Unfortunately, some people are on waiting
lists, and some cannot get the medications they need even with ADAP
assistance; it is important that such situations do not occur in the
United States. Dr. Coburn noted that the President accepts the priority
of ADAP funding, even though the need was not clear to him at the time
the last budget was formulated.

Dr. McIlhaney stated that there are also health care providers who are
unaware of the ways they can access drugs for patients. He suggested it
might be appropriate for the Council to ask the American Medical
Association (AMA) and the Centers for Disease Control and Prevention
(CDC) to create an information campaign on how to access drugs. Dr.
McIlhaney asked whether Dr. Coburn was suggesting that the Council
should recommend additional oversight on the expenditure of ADAP funds.
Dr. Coburn replied that he was not; rather, there is ongoing oversight
at DHHS right now, from which a final report is due soon.

Mr. Burgess noted that each state has its own way of administering its
ADAP program. Several states cannot provide services because of how the
programs are structured. The Council should look at variances between
the states, study best practices, determine which states work best, and
share this information with the other states. Mr. Burgess noted there is
also a problem with patients moving from one state to another. He asked
whether there should be a separate task force to investigate this
problem.

Dr. McKinnell noted that ADAP programs are difficult to navigate. The
antitrust laws prohibit pharmaceutical companies from publicizing their
drug donation programs. However, he noted, Pharmaceutical Research and
Manufacturing Association (PhRMA) is creating a Web site that will link
to all the pharmaceutical companies' sites and provide information on
their donations. This should be ready in 2 to 3 months. Dr. McKinnell
said the Council might recommend this process be accelerated.

Ms. Ivantic-Doucette stated that the Council should look at State funds
as well as Federal funds. Wisconsin, for example, is a low prevalence
state with a limited formulary; yet the State put additional ADAP money
into the program to avoid a shortfall. Another point to consider
regarding medication donations is the waste in the medications
prescribed now---whether paid for by insurance companies or Title
19---for example, patients who receive a month's worth of meds and
subsequently have a change in prescription. There is no "drug return
protocol" to deal with such situations. Dr. Coburn noted that a Federal
law prohibits drug returns.

It was also noted that the RWCA has a 3 percent set-aside for states in
trouble; it may be possible to target more money in that set-aside.
While some states like Wisconsin are dealing with the situation, others
are having more difficulties. The task is to find a way to get funds
into the neediest states. It was agreed that there are three pieces to
the problem: Federal funding, the pharmaceuticals industry, and the
elimination of waste/setting priorities. Any successful approach will
involve all three pieces.

It was noted that the Council talked briefly at its last meeting about
decreasing the burden in applying for Medicaid waivers. Maine will soon
be coming online with this; is there a way to fast-track other states
that are interested in Medicaid waivers? Dr. Coburn noted this was part
of the Council's earlier recommendations, to which there has not yet
been a response from the White House.

Mildred Freedman suggested having shortfall states publicly announce
their shortfalls and ask for assistance in the last quarter of the
fiscal year. The public and the state legislatures need to be made aware
of the shortfalls. Rev. Sanders questioned whether it is appropriate to
petition elected State officials to assist with a Federal funding gap.
Dr Sullivan stated that this is an appropriate action for individual
citizens to undertake; however, it would be difficult and awkward to get
the weight of the Council behind such a move.

Ms. McDonald noted that, as more people are tested and identified as
HIV-positive, the shortfall will continue to get worse. The Council
should therefore start thinking about longer-term strategies as well.

Dr. Sullivan asked the Council for a consensus that the suggestions
offered here be incorporated into a letter of recommendation to be sent
to the President. The Council agreed on this course of action.

# RAPID TESTING

**Dr. Bernard Branson** of the National Centers for Disease Control and
Prevention spoke first, providing an overview and description of rapid
testing, to summarize the public health need, to illustrate difficult
concepts regarding the test's predictive value, and to review its
current usage.

There are currently an estimated 850,000 to 900,000 HIV-infected persons
in the United States, and an estimated 40,000 new infections per year.
The CDC estimates that 25 percent of HIV-positive persons do not know
they are infected. Standard testing, with centralized labs and complex
equipment suitable for high volume testing, is time consuming and
technically demanding. After explaining the steps required, Dr. Branson
noted that the results from an ELISA (enzyme-linked immunosorbent assay)
test may not be known for a few days to even a week or two. By contrast,
simple or rapid assays are done at the point of care and allow for
same-day results. These tests can be run on small numbers at a time.
SUDS, the only current rapid test available, is rapid (about 25 minutes)
but not simple and tests serum, which requires a centrifuge. The test
also has its shortcomings. The product Oraquick, under FDA review, is
done with a finger stick, and the results can be read in 20 minutes. The
test produces different results for positive and negative, as well as a
separate result if the test was performed incorrectly.

The public health need for rapid testing is dire: the percentages of
persons tested but not receiving their results are very high. There are
several circumstances in which there is an immediate need (e.g.,
pregnant women). In addition, it is important to have rapid testing in
outreach settings for people who do not typically access the health care
system. At publicly funded sites with standard testing, 30 percent of
people who test positive and 40 percent of those who test negative fail
to return for their results, because it takes 1 to 2 weeks to get the
results. In an STD (sexually transmitted disease) clinic, 79 percent of
the positives got their results, but only half of these came back on
their own; clinic staff had to find the rest.

By comparison, with rapid testing the CDC has found that 93 percent of
tested persons received their results the same day. (Some people refuse
to wait for even 20 minutes.) Also, 97 percent received preliminary
rapid test results and came back for their Western blot results.

Dr. Branson noted graphically how many more people could have known
their serostatus and thus represent an increase in individuals who might
not have infected others. Given the fallibility of tests, The World
Health Organization (WHO) recommends combinations of simple and rapid
tests, confirming an initial positive result with a different test. CDC
currently supports this globally for both volunteer HIV counseling and
testing and to screen pregnant women. Other examples of where rapid
testing makes a difference includes emergency rooms and clinics. Since
1994, emergency room and clinics in high incidence settings recommend
screening for all patients. Studies have shown dramatic increases in HIV
infection being identified when screening is done in emergency
departments. The CDC is doing one other large screening test, in
cooperation with the FDA, to screen pregnant women in labor who have not
been tested ahead of time.

The CDC considers an increase in serostatus knowledge important; it is
the second goal of its 5-year plan to increase from 70 to 95 percent the
proportion of HIV-positive persons who know they are infected. Other
goals are to increase the motivation of at-risk individuals to know
their status, to decrease barriers to testing, and to improve access to
voluntary client-centered counseling and testing.

**Dr. Edward Baker**, the Assistant Surgeon General, spoke on the
Clinical Laboratories Improvement Act (CLIA). He noted that the CDC
supports rapid testing as a major technological advancement that will
save lives, noting that the issue of accuracy must be addressed. While
no test is perfect, CLIA tries to improve the accuracy of testing. CLIA
works closely with the Centers for Medicare and Medicaid Services (CMS;
formerly the Health Care Finances Administration \[HCFA\]). CLIA's law
applies to almost all facets of human testing. The CLIA standard is
based on the complexity of the testing; the more complex, the more
requirements are in place to ensure accuracy. The guiding principle is
to ensure quality testing without interfering with access.

The complexity model is as follows:

-   Simple and safe (waived): requires registration, staff must follow
    manufacturers' testing instructions

-   Moderately complex: quality control and quality assurance measures,
    proficiency testing (PT), limited personnel, requires biennial
    inspections

-   Highly complex: quality control and quality assurance measures, PT,
    stringent personnel, biennial inspections.

Simplicity is the crux of the issue: How simple does a test have to be?
The responsibility for classifying testing protocols has been
transferred to the Food and Drug Administration (FDA). In all, 3 percent
of tests have been waived; 73 percent are considered moderately complex.
If a test is approved by the FDA for home use, it is immediately waived.
If DHHS determines that a test is simple and has an insignificant risk
of erroneous result it receives a waiver (including those that employ
simple, accurate methodologies with a negligible likelihood of erroneous
result, or no unreasonable risk of harm to the patients if the result is
incorrect).

It is important to think about the total testing process in terms of its
simplicity: pre-analytical, analytical, and post-analytical. Limited
public health testing is done in the nonprofit; such entities can
conduct waived or moderately complex tests at multiple fixed sites
(e.g., Michigan) under the oversight of one responsible party. A number
of nontraditional sites have been certified for moderately complex
testing, including rural clinics, correctional facilities, environmental
labs, health fairs, home health agencies, medical foundations, mobile
units, nursing homes, physician office labs, schools, and student health
services.

**Dr. Judith Yost** presented some studies from CMS and other sources on
waived laboratories. As Dr. Baker stated, the intent of CLIA is to
ensure accurate lab testing while maintaining access. There are
currently 175,000 labs enrolled. CLIA dictates that waived tests are
simple and accurate and have insignificant risks of erroneous results.
About 94,000 (54 percent) of CLIA labs do *only* waived testing. CLIA
does not distinguish between screening and diagnostic testing, and does
not discriminate by location (the requirements focus only on
complexity).

Dr. Yost said CMS is in support of quality, point-of-care rapid testing.

There is no routine oversight of waived tests, but there is a provision
in CLIA to initiate oversight if needed. Waived labs have only one basic
requirement: to follow the manufacturer's instructions. Therefore, it is
important how each lab performs the test and how they ensure it is
working properly.

In 1999-2000, pilot studies were performed in 500 waived labs.
Approximately 50 percent of the labs had testing problems (e.g., no
quality control, not following manufacturer's instructions, etc.).
Additionally, based on the pilot studies in Colorado and Ohio, the
Office of the Inspector General also did a study, as did the CDC CLIA
staff. All studies found similar, problematic results. CMS selected
eight additional states in which to visit waived labs to make sure the
findings were not an aberration. Quality problems were again found in
many of the 270 labs visited, although in Maryland, New York,
Pennsylvania, and Idaho---states that have their own state lab licensure
programs---the problems were fewer. The problems break down as follows:

The Office of Inspector General (OIG) study had similar findings.

CMS recommendations for improving the system include:

-   Institute an education program for waived labs and validate its
    effectiveness;

-   Compile existing education programs into a clearinghouse for the
    CLIA Web site;

-   Survey a percentage of waived labs annually to gather additional
    data and provide education;

-   Develop self-assessment tools for waived labs;

-   Provide information on CLIA requirements to newly enrolled labs; and

-   Work with testing system manufacturers to clarify instructions and
    to provide initial training following a sale.

Dr. Yost noted that issues are also exacerbated by turnover in lab
personnel.

CLIA-regulated labs demonstrate improved performance over time due to
the educational approach and oversight. CMS found that of those
regulated labs visited biennially, 35 percent were also not following
the most recent manufacturer's instructions. These significant findings
have serious implications for patients. For example, in one lab that
performed simple occult blood tests, staff were using expired reagents
and not performing quality control checks. In one case, a diagnosis of
GI cancer was delayed for this reason. Lab experts agree that any
incorrectly done tests have the potential for some harm.

Dr. Yost discussed moderately complex tests v. waived tests (myths
versus facts).

Quality assurance (QA) is ongoing (continuous quality improvement) to
monitor the lab's overall quality of operation. CMS inspects labs
routinely every 2 years. CLIA minimum standards provide a low cost and a
low burden to laboratories. Technical assistance (TA) is available from
CMS and state agencies. Ten years' worth of data shows that
CLIA-regulated labs have improved and are doing well. The educational
approach has improved performance in labs significantly. The problem
rate has dropped from 35 percent to 9 percent. A New York study of
HIV-positive patients showed an increased in access and earlier
treatment/intervention.

The Blood Products Advisory Committee and one other advisory committee
recommended that SUDS not be granted a CLIA waiver. Pre- and post
analytical concerns have to be considered, including patient counseling,
confirmatory testing, and public health reporting. HIV testing
encompasses a broad spectrum of social and legal issues as well as
public health issues. The SUDS test does not demonstrate minimal risk of
harm; it is not always simple to perform, and it is not always accurate.
As findings and concerns show, this is a truly complex issue, and
deserves careful consideration.

**Dr. Elliot Cowan** discussed the FDA review and approval process for
rapid HIV testing, including the timeline, the measures that FDA has
taken to facilitate approval for new rapid tests, and a report of
progress made.

Within FDA, all HIV tests are reviewed in the Center for Biologics and
Research's Office of Blood Research and Review. Rapid tests are reviewed
as Class III devices. Pre-market review is necessary to provide a
reasonable assurance of safety and accuracy.

-   The regulatory scheme he discussed was for a rapid HIV test to be
    used as an aid in diagnosis. Trials are conducted to determine
    effectiveness; the process requires the filing of an investigational
    device exemption application (IDE), per 21 CFR 812. Data accumulated
    in the course of the clinical trials is put into a pre-market
    approval application (PMA), per 21 CFR 814.

Dr. Cowen discussed the three-part process:

-   For the IDE review, the decision must be made by the FDA within 30
    calendar days following receipt of the application. If approved,
    clinical studies can proceed. If the application is deemed "not
    approvable," a new IDE submission needs to be filed.

-   The timeline for approved IDEs is driven by the applicant: once
    studies are complete, the applicant assembles the study data for
    submission. FDA encourages pre-PMA meetings to help with this step.

-   PMA review: the decision must be made within 180 calendar days of
    receipt of a completed PMA. There are four possible outcomes for the
    PMA review: "not approvable," "not approved," "approvable," and
    "approved." The first three require additional information and/or
    review.

An inspection of the manufacturer's facility provides evidence that the
manufacturer has a quality system for the design, production, packaging,
labeling, storage, installation, and servicing of finished medical
devices (per 21 CFR 820). Inspection occurs after most review issues are
resolved. The FDA determines whether the manufacturer is in compliance
with regulations or not. This is a critical part of the process. As
desirable as rapid tests are, the FDA and the public need to be assured
of a reasonable certainty that the product will remain available as
needed.

Dr. Cowen outlined the steps taken by the FDA to facilitate the review
process for rapid HIV testing: rational standards for approval,
simplified clinical trial requirements, and prioritizing review of rapid
HIV test submissions. Since the FDA is prohibited from releasing any
information related to test submissions, the discussion was limited to
public health information and information authorized for release.

On 1 May, Orasure announced that Oraquick is approvable, but needs to
submit product labeling and resolve some review issues.

In closing, Dr. Cowan said the FDA is committed to bringing safe and
effective rapid tests to the market as quickly as possible. Through
industry contacts, FDA has sought input and solutions regarding
perceived barriers to obtaining pre-market approval.

**Dr. Frances Pouch Downes**, Director of the Public Health Laboratories
in Michigan, spoke on the public health impact of rapid testing for
infectious diseases. American Public Health Laboratories (APHL) labs
have nearly 20 years of experience conducting HIV tests, developing
testing guidances, etc. APHL labs have worked with the broader public
health community to ensure services are available to the public. An
increasing number of rapid care tests (including HIV, influenza, Lime
disease, etc.) are being developed for use in emergency settings,
physician offices, public health centers, and nontraditional sites. As
has been noted, law provides exemptions for simple and safe test
products with insignificant risk. When a test is granted a CLIA waiver,
it can be performed by anyone in any setting. Proficiency testing,
external controls, and oversight are not required. The only regulation
is that manufacturer instructions be followed.

In Michigan, Dr. Downes noted, another option is used, a limited public
health certificate, ensuring that non-lab professionals working in local
health agencies can perform moderately complex and waived testing. The
certificate allows for up to 15 waived and/or moderately complex tests
to be performed by nurses and medical assistants, while trained
professionals review the training and quality control measures. As new
testing methods are developed, it is important that an appropriate
system is in place to ensure quality. While APHL supports the use of
rapid HIV tests and other rapid tests if they ensure reliability, many
such tests are not sufficiently accurate. CLIA-waived tests should be
sufficiently simple as to require no training, and they should be
accurate. HIV and other rapid tests do not fall into this category. By
contrast, in Michigan, 10 years of CMS surveys have rarely identified
any deficiencies. This points to the need for appropriate training and
oversight, reporting practices, etc.

Dr. Downes stated that the nature of rapid HIV testing requires the
establishment of quality control and assurance procedures, which
regulations for waivers do not include. Only simple, highly accurate
tests should be appropriate for a CLIA waiver. APHL believes that rapid
HIV tests are moderately complex in nature and should be performed under
appropriate CLIA regulations for moderate complexity. High quality tests
can be performed in STD clinics, etc., under a CLIA-limited public
health testing certificate. Access to testing will not be compromised by
using this certificate. APHL recommended that, whatever the complexity,
data should be collected to determine how the test is performing and ask
critical questions on access. APHL stands ready to work with leaders to
assist with CLIA certificates, TA, and quality assurance.

**Dr. Mark Loveless**, Medical Epidemiologist and Director of the
HIV/STD/TB Program of the Oregon Health Department, addressed the
Council representing the National Alliance of State and Territorial AIDS
Directors (NASTAD). Dr. Loveless noted he recently found out he is a
CLIA-regulated lab director.

-   Dr. Loveless spoke in favor of maximum access to HIV rapid tests,
    and of the critical importance of a CLIA waiver, which NASTAD
    supports for an extensive list of reasons, inclluding improving
    testing access and reducing disparities in the test's availability.

Dr. Loveless addressed a number of concerns and misconceptions regarding
a CLIA waiver. (1) "HIV is a life-threatening disease that is too
significant for a waived test." (the seriousness of the epidemic is the
reason for widespread access to testing and other diseases that are
life-threatening have waived test status); (2) "A waived test does not
mean everybody's going to do it" (Widespread utilization is the goal of
the industry); (3) "Too many false positives" (Evolving technology has
dramatically reduced false positives); (4) "CLIA offers the only
protection against the misuse of HIV rapid tests" (HIV testing is the
most regulated and scrutinized medical lab test in use, CLIA is by no
means the only HIV test regulatory process, and CLIA has no authority
over issues such as the quality of test interpretation and subsequent
patient education, counseling, and referral); (5) "There would be no
safeguards that persons receive counseling and referral" (CLIA has no
authority to ensure this post-test process and therefore does not have
relevance); and (6) "There would be no oversight to ensure tests are
performed correctly" (Newer technology minimizes the chance for error).

Regarding the "limited public health use" exception Dr. Downes
discussed, Dr. Loveless stated this cannot be replicated in Oregon. Such
an arrangement would increase the cost and complexity of the testing
system without a documented benefit to the patients and testing sites.

In summary: NASTAD strongly supports a CLIA waiver for HIV rapid
testing. NASTAD is committed to continuing high quality management of
federally-funded HIV counseling and testing systems; they are also
committed to working with public health labs and local lab directors to
improve the quality and performance of CLIA-waived labs, whether doing
HIV testing or not.

# Questions and Answers on Rapid Testing and CLIA Requirements

A director of a CLIA-regulated complex lab noted that it is considered a
quality problem if the piece of paper that came with the test is not
sitting out next to the test during oversight. She asked what are the
consequences of a failure in quality, noting that both waived and
nonwaived tests need better oversight in the United States.

Dr. Joe McIlhaney asked Dr. Branson whether the CDC is able to do all
the studies they need on rapid testing. Dr. Branson noted that because
the test is not currently approved, it has to be treated as highly
complex (with respect to sensitivity and specificity). As a result, the
CDC cannot gather data on how the rapid test might work in a waived
setting.

Rev. Edwin Sanders suggested that today's discussion should move toward
specific recommendations, and that questions should be framed
appropriately. He suggested one recommendation might be developing
uniform guidelines for testing and quality control.

Dr. Monica Sweeney asked whether the push is to have a quick HIV test
available at the local pharmacy (like pregnancy tests). Increasing the
percentage of people who get HIV test results is important; however,
even when somebody gets a negative result they see a counselor for
information and interpretation. This service would not be available with
a home test kit. Dr. Baker noted there are no applications for home use
products at the present time. The distinction to be considered here is
whether the CLIA requirements should be waived for lab use, which itself
would entail no requirements for counseling and testing. Once the test
is waived, it can be done anywhere and by anyone. Dr. Cowan noted that a
home *collection* product is currently available, but the results are
read remotely.

Dr. Cynthia Gomez stated that the Council's primary purpose is to
increase access. Today's disagreement is about how soon everyone can be
comfortable with disseminating rapid testing in the best interest of the
people. From all the information presented, Dr. Gomez said, sufficient
risk was not demonstrated that would outweigh the benefits of
CLIA-waived rapid testing. The risks have been known for a long time.
The Council should discuss a timeline by which the country's labs would
be comfortable implementing rapid testing safely and accurately. The
various parties should work together to improve quality assurance at all
times and in all locations. Dr. Downes suggested that the lab community
is already in agreement, that rapid testing needs to be implemented now.
Nonetheless, rapid testing can and should be done in settings where
quality is assured. Dr. Downes said this can be done with many different
options in many settings, not just the Michigan model discussed.

Dr. James Driscoll said that a CLIA waiver would considerably expand the
market. It is startling, he said, that there are tests available in
hundreds of countries but not the United States. With current testing
available, everyone will be given other confirmatory tests; indeed,
additional tests are in development that will allow two tests at once.
Rather than 1 in 1000 false readings, the results will be closer to 1 in
100,000. He noted there are many places where people cannot afford
medical care---underserved populations living at the margins of society.
These people are being excluded; it is a barrier to health care.

Lisa Mai Shoemaker asked how hard it would be to ensure that those
administering rapid tests would be certified. Dr. Branson responded that
each state has its own certification regulations. There is no Federal
provision for certifying people, for example, on administering Orasure
tests.

Karen Ivantic-Doucette noted that rapid tests still check for the
presence of antibodies, so there is still a window of inaccuracy
immediately following infection. It is not clear that people understand
this point: rapid testing serves no more purpose to the very recently
infected than traditional testing. Dr. Coburn stated, however, that
testing would be greatly beneficial to health care workers who have had
exposure via an HIV-positive patient. He also stated that persons who do
counseling and testing are well aware of the window period, and it is a
standard part of the counseling technique in delivering negative
results.

A council member asked whether any data exist on false negatives (e.g.,
how rapid tests compare with other tests on this point). Dr. Branson
responded that since the CDC has been evaluating tests, some show no
false negatives, while others do. An FDA decision will need to be made
on this issue. However, Dr. Branson said, difficulty with false
negatives arises only in extremely high prevalence populations (much
higher than in the United States).

Stuart Burden asked whether the Council is comfortable with safeguards
against abuses that can come with HIV positive tests, regarding
discrimination in employment, immigration, travel, etc. There are no
legal assurances against such discrimination. There is a greater stigma
around HIV positivity than around the test itself. While the point was
made people can be taught to administer the tests properly, that is very
different from providing appropriate counseling. Dr. Baker responded
that one consideration CDC gives in waiving a test for any circumstance
is to create a series of scenarios in which false results can be used
improperly. Secondly, he said, it is important to note that once a test
is waived, it is practically unheard of to "unwaive" it.

Debbie Rock said the Council is putting barriers in its own way. A lot
of the testing being discussed will be in places where states and
community-based organizations (CBOs) are doing collaborative efforts. In
Baltimore, for example, Ms. Rock collaborated with Johns Hopkins
University (JHU); they took 6 months to train the Department of Social
Services on HIV education. This is a point of entry for many at-risk
populations. Ms. Rock said this setup has been working well: JHU does
the testing and her outreach staff walk the patients through. The point
is to get high-risk persons accessing medical care quicker, and working
collaboratively can facilitate that goal.

Nathan Nickerson reminded the Council that a CLIA waiver status speaks
to who can perform the test and in what settings; it does not refer in
any way to the counseling and testing context of the test. If a CLIA
waiver is granted, states can still structure their own requirements for
counseling and testing. Dr. Baker reinforced the point, noting that if
rapid testing were approved as moderately complex, the tester would have
to be trained and have a high school education, and there would be
quality assurance measures. CLIA-waived rapid testing would be
appropriate in a voluntary counseling and testing setting, but there are
cost implications for doing this. Basically, performing more testing
(and counseling) will require more resources. Dr. Branson said this also
affects how results are given out. Very often, the person who
administers the test is different from the person who gives the results.
In a waived setting, the same person would more often do both.

Dr. Yost noted that not all states have requirements for counseling and
testing or oversight. There are about 12 states that have their own lab
programs, but many states defer to CLIA or other organizations.

Sandra McDonald suggested the Council should return to the "human" part
of HIV. With approximately 950,000 HIV-positive Americans, of which
perhaps a third do not know their status, it is imperative, she said,
that every tool possible is utilized to access these people, find out
their status and refer them for care.

Brent Minor said it is very hard not to be persuaded by rapid testing.
It is important, he said, to ensure that counseling and testing is as
good and well researched as the test itself. A lot of work has already
been done on that side. The benefits include seeing more HIV-negative
persons and giving them valuable information as well as to those who are
HIV positive. Mr. Minor agreed with Dr. Loveless that "normalizing" HIV
testing in society is a great and positive thing; such a stigma exists
about getting tested---some people don't even want their clinician to
know.

Ms. Shoemaker noted it is important for people to get tested whether
they are high-risk or not. The epidemic affects everyone. She said that
until improved testing comes, the Council should push on with rapid
testing.

Dr. Gomez stated that the main reason for this test is the high
percentage of patients who do not get their results. Issues of
counseling and testing continue to be important in terms of quality,
even under current testing mechanisms; these issues need to be addressed
generally, irrespective of any one test's waived status. Of most
importance is getting more people to agree to be tested and stay for
their results. Dr. Gomez noted that she brings hundred of people into
her lab (with the assistance of CBOs) who would not ever go into a
clinical care setting. Being able to provide test results before the
individual leaves the room is an incredible opportunity.

Philip Burgess noted that pharmacists have been very involved in dealing
with HIV infection; they are among the most readily available
professionals to assist the community. Pharmacists interact with
customers---they know the drugs, the latency periods, etc., and can play
a vital role in providing counseling. Mr. Burgess said he strongly
supports getting rapid testing fully implemented.

Mr. Burden reiterated that there is potential for misuse and abuse of
test results; he recommended that the Council reaffirm its insistence on
privacy and confidentiality safeguards. One Council member responded
that there are laws in existence in all 50 states that address privacy
and confidentiality concerns.

Vera Franklin noted that rapid testing would be extremely beneficial to
Native American communities, where social and logistical barriers
prevent most people from returning for their HIV test results.

Dr. Sullivan thanked all Council members and guests for their
contributions to the discussion.

**REMARKS TO THE COUNCIL**

**Eve Slater**

**Assistant Secretary of Health, U.S. Public Health Service**

Dr. Sullivan then introduced Dr. Eve Slater, who was appointed Assistant
Secretary of Health in February; prior to that, she worked for Merck
handling external policy and corporate affairs. On behalf of Secretary
Tommy Thompson and the Administration, Dr. Slater expressed her
gratitude to the Council for dedicating their time and service, their
collective experience, and their intellect. She noted her informal
comments today would address where departmental policies are with
respect to HIV/AIDS. The Department's priorities include:

-   Reduction of HIV incidence as rapidly as possible to as low a level
    as possible (ideally targeting a reduction of 50 percent by 2005;

-   To engage the maximum number of HIV-positive persons into the health
    care system as early as possible;

-   To provide, whenever feasible, resources directly to people living
    with HIV/AIDS (PLWH/A) so overhead is reduced, as are disparities;

-   To integrate domestic and global efforts as much as possible; and

-   To strengthen the scientific base of all agencies dealing with
    HIV/AIDS.

Dr. Slater asked the Council to consider how the Department's objectives
can be reached. She said that President Bush is pragmatic; he wants to
rebuild infrastructure to deliver services---hence the Healthy Community
Innovation Initiative. Various communities throughout the United States
will be targeted to rebuild local health care delivery systems; it is
the Department's job to facilitate implementation of community programs,
study best practices and models that work, and replicate the successes.
Dr. Slater also noted the President is committed to doubling the NIH
budget to \$2.7 billion, much of which is targeted toward vaccine
research.

In her current position, Dr. Slater and her colleagues have a series of
small, low-budget offices with the responsibility of developing HIV
policies across agencies. Deputy Secretary Claude Allen has also
reviewed the trans-agency plan, which will soon be formulated as
deliverable to Secretary Thompson. This plan is an attempt to overview
the Federal monies being spent on HIV/AIDS across all agencies and to
ensure that as many of the dollars as possible get to the patients that
actually need them. Dr. Slater said she will be convening a work group
that will systematically review the objectives and funding within each
agency and look toward eliminating redundancies. Although the term
"management review" often evokes suspicion, Dr. Slater said the
presumption is that the monies will not leave the HIV field, but rather
be targeted more efficiently. It is not only HIV programs that will be
considered in this "one-agency" review; the Secretary has merely
designated HIV as the first.

The President has pledged a half billion dollars to the Global AIDS
Fund. Dr. Slater said she is chagrined at the partisan commentary evoked
about the fund. Everyone knows the money needs to be spent; and, in
fact, this is nowhere near the amount that will be necessary in the long
run. However, better infrastructure is needed, and the United States is
in an evolving stage concerning global assistance. The President and the
Secretary and everyone in HHS share concern for infected children: the
estimates are 2.7 million children under 15 with HIV, and potentially 44
million orphans by 2010.

**Afternoon Session**

**PANEL PRESENTATIONS: HIV/AIDS PREVENTION**

**Overview of Prevention Issues**

# Karen Ivantic-Doucette, M.S.N., F.N.P., ACRN

# Marquette University College of Nursing

Ms. Ivantic-Doucette stated there are many things the Council agrees
upon, but what constitutes prevention is not one of them. At the
International Conference on AIDS in Durban 2 years ago, Dr. Peter Piot
stated that the global prevention effort requires every person, public
or private, coming from every arena---heath, education, policy,
economics---to begin dealing with prevention issues. Perhaps this year
as the Barcelona conference approaches, the community can report it is
closer to a consensus on prevention.

Ms. Ivantic-Doucette said she focuses on breaking out of the traditional
ways of thinking of prevention, and considers diagnosis and treatment as
part of prevention. Normally one thinks of three layers of prevention:
Primary (stopping the onset), secondary (testing and diagnosis), and
tertiary (treatment and prevention of complications).

Treatment includes antiretroviral therapy (ARTs) as well as strategies
or medications for tuberculosis (TB). Any use of medicine can translate
into prevention. An example of primary and tertiary prevention together
is perinatal transmission prevention, which is primary prevention for
the infant and tertiary for the mother. Perinatal prevention also has
another level: reducing the social problem of orphans, so it is a kind
of preventive care for families.

With respect to primary prevention, the keystone has been education,
defined as the sum of all influences that collectively determine
knowledge, beliefs, and behaviors. There are two domains of learning:
the cognitive domain (intellectual knowledge) and the affective domain;
the latter is the "feeling domain," subject to attitudes and beliefs.
For example, a person may have a cognitive understanding of condoms and
their use in prevention, but also have affective barriers resulting from
religious dogma or a disbelief in their efficacy.

Ms. Ivantic-Doucette noted that malnutrition is the primary cause of
immunosuppression. Access to basic health care is another important
factor (e.g., gynecological care). A final factor is policy guidance.
Policy and regulations are not often thought of as prevention, but a
survey of the health care field demonstrates that the crisis shortage of
health care professionals is exacerbated by the number of persons
unwilling to work with PLWH/A---despite advances in postexposure
prophylaxis (PEP) for needle stick occurrences, etc. Policy becomes part
of the prevention picture when the CDC writes guidelines, sets up a PEP
hotline, etc., thereby reducing both fear and the risk of new infections
among health care workers.

# Diagnosis Is Prevention

# Franklyn Judson, M.D.

# Director, Denver Public Health Department

Dr. Judson was involved with the first reported case of AIDS in Colorado
in May 1982. His department is heavily involved in clinical care,
prevention research, and policy and law development. Over the 20 years
since the first Colorado case, the department has conducted half of all
publicly funded HIV counseling and testing in Colorado. The staff
currently manages about 1,200 PLWH/A, or about half of those in
treatment for HIV in Denver.

Dr. Judson reviewed some fundamentals of what drives epidemics. The HIV
epidemic is simply another very serious communicable disease. Whether
any such disease advances or not depends on how infectious it is (and
whether it varies at different stages of its natural history); how long
the infection is transmissible; and, for sexually transmitted diseases
(STDs), the numbers of partners and rates of partner change. The spread
of the epidemic is primarily a function of multiple concurrent sexual
partners or injection drug use (IDU) partners during the early and
highly infectious stages of the disease. During the first weeks or
months of infection, HIV may be 100 to 1,000 times more communicable
than it is later on. In dealing with the problem of multiple, concurrent
partners, early diagnosis, early treatment, and early behavioral change
are very important.

Dr. Judson said there was an informal, unfounded, non-governmental
intervention that was incredibly effective: "fear of AIDS." Nothing was
more effective in changing behavior. It worked best on those at greatest
risk at the time, namely, educated gay men in the developed world. The
result was a decline in new infection rates of 15 to 20 percent per
year, totaling a more than 95 percent reduction in new incidence rates,
as well as a parallel drop in the rates of other STDs in the same
population.

Having a test that allows identification of exposure is an important
step in the control of any epidemic; yet rather than make the tests
widely available to everyone, some states (e.g., New York), under
pressure from "activists," began to write laws restricting the use of
the HIV tests. Supply and access were limited; the result was that many
people were denied the use of this key diagnostic test, sometimes for
years.

The next logical step was to confidentially report infections, keeping
natural history statistics. It was imperative that results be kept
completely confidential and private. Colorado moved to become the first
state requiring confidential reporting of all HIV tests in 1985. At this
point, the State was no longer evaluating the epidemic solely by doing
an AIDS body count. By 1987, HIV reporting regulations were turning into
laws. At present, between 36 and 40 states have HIV reporting laws.

Between 1986 and 1995, partly for political reasons, the emphasis on
Government-funded HIV counseling and testing programs was on counseling.
This is fine if counseling is shown to be the most effective part of the
intervention; but that is probably not true. Dr. Judson said that there
is little evidence that information dissemination is effective in
changing behavior. As far back as 1985, a random sampling revealed that
people knew what AIDS was and how it was transmitted.

One issue to consider is the extent to which knowing one's status
affects behavior. For negative tests, the evidence is mixed on whether
behavior becomes less or more risky. For positives, almost all studies
show an elimination of denial and a change of behavior. The duty to warn
(partner notification, etc.) comes into play. This duty applies first to
patients, then to the health care providers, then to public health
entities.

Since 1995, the country has had both Government-funded counseling and
testing programs and RWCA treatment programs. Early diagnosis can only
have positive benefits; it leads to early intervention, which benefits
the PLWH/A's partners and society. There is currently a change in the
approach of Government and the public health arena to prevention in the
age of treatment. The old method was an oddity: by comparison, public
health entities never sought out all people negative for TB and
counseled them on staying that way, while ignoring the TB-positives.
Now, public health is trying to work prevention back into patient care,
making sure PLWH/A take on the responsibility of preventing
transmission.

**Treatment Is Prevention**

**Federico Cruz-Uribe, M.D.**

**Director of Health and Health Officer, Tacoma-Pierce Health
Department**

Dr. Cruz-Uribe discussed how his health department combined communicable
disease approaches with new treatment modalities. Tacoma-Pierce is the
second largest county in Washington State, with a population of 715,000.
There have been slightly more than 1,200 cases of HIV since tracking
started. The epidemic is following the national trend: the bulk of cases
is still men who have sex with men (MSM), but prevalence is increasing
in communities of color and women. Like many local health departments,
Tacoma-Pierce suffered hardships in funding. Ten years ago there was a
serious budgetary problem and a resulting loss of public confidence and
credibility; Dr. Cruz-Uribe was hired to redefine how the department did
its work. The vision he instituted was to get back to basics: to focus
their limited resources on primary prevention and disease control.

The department shifted significant resources toward prevention; it had
been the safety net for indigent care in the county. The department put
together a business strategy and structure for a disease control system.
Dr. Cruz-Uribe developed relationships with private providers, asking
them to be proactive in disease control; instead of just occasional
reporting, providers were asked to test, treat, and report. This allowed
the department to do more prevention and to ensure comprehensive
clinical services were being provided in the community. As a result, the
capacity for indigent care in the county has nearly tripled.

Dr. Cruz-Uribe stated that HIV should be treated like any communicable
disease, the theme used for the entire process of the Tacoma-Pierce
Health Department's restructuring. New policies were developed that
helped target and access high-risk populations that typically did not
get tested: injecting drug users (IDUs), persons with multiple sexual
partners, etc. The department is implementing an ongoing case management
system; as with other communicable diseases, the health care system
works with patients until they are no longer infected (which means an
ongoing relationship for HIV cases).

It has been a major challenge to work with the private sector, which had
previously ignored the public health department. The critical piece was
getting providers to test patients and report, and getting them active
at managing patients with HIV infection. Surveillance, ongoing
intervention, and treatment were also important: the department
committed to having structures in place to ensure that each important
step was met with every HIV patient. Most health departments do
surveillance and outreach, but Tacoma-Pierce added an element they
learned from the pharmaceutical companies: establishing a cadre of
senior public health nurses who function as public health
representatives, selling public health to private providers. This team
visits practitioners every 90 days. The first message centers on
reporting, that is, making sure everyone is aware of treatment protocols
and encouraging active involvement in prevention campaigns.

The State of Washington got involved late with the epidemic.
Tacoma-Pierce County passed a reporting and partner notification
requirement 2 years before the State did. The County board also
instituted a policy for an early intervention/case management program.
This helped get people into care and monitoring. More important from a
prevention standpoint is behavioral changes. Case managers stay with
their patients as long as they live in the county.

The department had trouble accessing persons with multiple sexual
partners and pregnant women. The county board passed a regulation that
physicians confronting symptoms of any STD were required to offer HIV
testing. The county is currently looking at a policy to have HIV testing
be part of plea bargains.

Dr. Cruz-Uribe then discussed directly observed therapy. Treatment
failures lead to dramatic increases in cost; as a result, the health
department looked at using videophone equipment to connect with
patients. No more than 5 minutes with a patient every day is needed to
ensure compliance. This program has been very popular and is much easier
on staff than traditional home visits. Although the program is only 6
months old, private providers who have treatment failures have been
referring patients to the department, resulting in a remarkable
turnaround in lowering viral loads to undetectable.

# Monica Sweeney, M.D., M.P.H.

# Vice President for Medical Affairs, Bedford-Stuyvesant Federal Health Center

Dr. Sweeney framed her remarks in the context of the "Baby AIDS Bill,"
the focus of which was perinatal prevention: the infant was the primary
prevention target (secondary prevention for the mother). Treatment
extended through the prenatal, birth, and infant care periods. In New
York City, a cohort of 843 infants were followed for about 2 years
(1994--96). The transmission rate was 13 percent for treated infants,
and 26 percent for nontreated infants. In 1995, another study of 943
infants showed a transmission rate of 6.3.

From 1987 to 1997, New York State had the highest number of pediatric
AIDS cases. In the same decade, testing was ongoing as a blinded study
with those infants. The mothers were not informed that the tests were
being done, and results were not given to anyone. In 1993, a state
assemblywoman, Nettie Mayerson, drafted legislation to unblind the
testing, a move which AIDS activists fought on the grounds that it would
prevent women from coming in for treatment. When one mother took home a
baby that was later diagnosed with full-blown AIDS, there was a media
uproar, which helped fuel Mayerson's bill. In 1996, Governor George
Pataki signed the bill into law. The bill provides for routine
counseling for pregnant women. It does not force testing, but a woman
who refuses testing must sign her name to that refusal. In addition, all
babies need to be tested when born, with or without the mother's
consent. The mother or guardian is given the test results. Also in the
bill is language requiring referrals to be made for positive women and
infants.

Dr. Sweeney said that in the center where she works, counseling is done
for all women and only two refused testing last year. One woman insisted
she had just been tested and the results were pending; the other simply
did not want to know. More than 99 percent of the pregnant women in New
York State are now tested.

The *New York Post* called this the "Infant AIDS Miracle." Governor
Pataki stated in 1993 he wanted to reduce the infection rate in newborn
infants to below 5 percent. The "Baby AIDS Bill" resulted in a reduction
from 25 percent to 3.5 percent. It is considered a major success.

Dr. Sweeney said that she and Nettie Mayerson also worked on name
reporting, partner notification, and contact legislation. It is
surprising, she said, that only 38 or 40 states have reporting.

Another issue where treatment needs to be more aggressive is injection
drug use and sex with IDUs. IDUs are driving the epidemic in New York
City. Most children born with AIDS now are the result of injection drug
use by their parents. There are currently three states with compulsory
testing for children: results have to be given to their parents or
guardians. A bill has been introduced in Congress, which looks much like
the New York State bill, to have all pregnant women counseled and
tested. It has been recommended that this be a requirement for Federal
funding for prenatal care.

**Education Is Prevention**

**Ann Peterson, M.D.**

**Assistant Administrator for USAID Bureau for Global Health**

Dr. Peterson noted that in places where same-day testing is available,
clinicians have found that twice as many people are willing to come in
and be tested. She then noted that roughly 70 percent of USAID (U.S.
Agency for International Development) funds are focused on programs that
stress the ABC approach: Abstinence, Be faithful, and Condoms. She saw
her first AIDS case in Zaire in 1982; months later, she saw a second one
in Stonybrook, New York. She did her first prevention work in Kenya. It
is important to note, she said, that knowledge does not automatically
equal behavior change and prevention. In Kenya, 85 to 89 percent of the
people know about HIV; the medical community, however, is reluctant to
discuss the problem, even with U.S. outreach and education workers. It
is not clear what can be done to remedy this barrier. Clearly, expansion
of the epidemic needs to be arrested, and that means changing behaviors.
Treatment alone will not prevent new infection. One key piece is to have
the right data that are appropriate to the audience and are thus
important to tailoring education efforts. Citing statistics that women
tend to become HIV positive at 20 to 24 years old, while men are 30 to
39 years old, she noted that behavior change is challenging. Youth is a
key focus, especially internationally.

Dr. Peterson spoke of Uganda as a success story. She noted that
clinicians there measure new infections in 16- to 19-year-olds; the
overall prevalence lags slightly behind this particular population.
Prevention efforts in Uganda focus on three behaviors: delay in the
onset of sexual activity (one to two years); a reduced number of
partners; and condom use, complementary to the other two behaviors. The
reported number of partners has changed as a result: 30 percent of the
married population in one small village in Uganda had one partner
besides spouse; another 30 percent had two to four partners. However, in
the early to mid 1980s, only 10 percent of this population was
completely faithful. Education was part of prevention efforts long
before testing was ready, and behaviors were already starting to change.

Condom use was a factor in the changed behavior, seen in specific
populations such as urban sex workers. Other factors that lead to
behavioral changes include strong political leadership; the openness of
public discourse; concerned efforts to reduce HIV stigma; the
involvement of grassroots community organizations, schools, CBOs, and
PLWH/A. Clear messages have been sent, for example, "zero-grazing,"
which means putting a stake in the ground and allowing a cow to graze
only within the length of the rope. These efforts are not just in
schools; partner reduction is promoted in adults as well, and these
efforts also serve to protect youth.

While mass media can be a factor in changing social norms, it has been
found that interpersonal communication is more effective. Dr. Peterson
exhibited a slide in which a "sugar daddy" leers at a teenage girl; she
noted she has shown this slide to boys and asked what their
responsibility is to their sisters, girlfriends, etc. This actually made
them think about important questions. Talking in small groups works
well; the difficulty comes when education efforts need to be scaled up.

USAID is working to maintain the priority of prevention efforts,
expanding to new groups, and making sure messages are appropriately
balanced. The agency is trying to finalize reliable, measurable
indicators for the A and the B of the ABC approach. Success stories are
starting to be seen, and USAID will look to what can be learned. The
government of Haiti wants to know from U.S. agencies what worked in
Uganda. USAID needs to analyze the results, learn from the data, and
disseminate and adapt successful programs: to replicate successes.

**Comprehensive Sex Education**

**Dorothy Mann**

**Executive Director, Family Planning Council, Philadelphia**

Ms. Mann stated that her organization maintains 85 clinic locations,
providing a range of community-based HIV and STD services, screening and
treatment, as well as administering Title IV RWCA funds for Women,
Infants, Children, and Youth (WICY). Ms. Mann also chairs the Government
Affairs Committee board of directors, is involved with AIDS Alliance,
and served on the CDC Advisory Committee on HIV, STD, and TB prevention.

Ms. Mann noted the AIDS Alliance and other organizations worked
successfully to ensure the reauthorized CARE Act in 2000. Different
groups working together on controversial issues ended up doing very
important work by compromising and listening to each other.

Ms. Mann said her remarks are not just about comprehensive sex
education, or abstinence education; too often, people working on
prevention education find themselves in camps using buzzwords, but the
fundamental goal is the same: to stop the spread of the epidemic and
preserve the health of youth. This is far more important than
ideological arguments. Ms. Mann argued that accurate information must be
made available to the nation's youth about maintaining their health and
avoiding risks.

Of the estimated 40,000 new HIV infections each year, half are among 18-
to 24-year-olds. Ms. Mann noted that the U.S. teen birth rate has
declined, despite the old conventional wisdom that nothing could be done
about teen pregnancy until poverty was solved. Yet while the country has
not "solved poverty," important strides have been made in reducing teen
birth rates. Nonetheless, the U.S. rate of teen pregnancy is still the
highest in the developed world by far, as is the rate of HIV infection.

Ms. Mann addressed sexual behavior in young people: 65 percent report
having had sex by the age of 18; by 19, the figure is 80 percent. Ms.
Mann said these facts call for a broad approach to educating youth about
sex, to ensure they grow into physically and mentally healthy adults. It
is critical to give them accurate and comprehensive information about
prevention. Federally funded abstinence programs teach youth that a
monogamous heterosexual relation within marriage is the norm and is
expected of them. This is a noble goal, but the reality is that the
average age at which people marry is currently 27 for men and 25 for
women. It is not realistic to expect single persons of such age to
remain abstinent until marriage. Abstinence-only sex education programs
also fail to acknowledge that there are gay and lesbian youth who
legally can never marry. Programs that rely solely on abstinence fall
short of realistically addressing the needs of the majority of U.S.
youth. Rarely does a "one size fits all" approach reach everyone.

It is generally felt that encouraging young people to delay sexual
initiation is appropriate and wise; the data are clear that youth who
delay sexual initiation have fewer partners and are less likely to
contract HIV and other STDs (or to have an unplanned pregnancy). Ms.
Mann noted that education efforts in Philadelphia high schools discuss
abstinence and delaying initiation (as the only way to be 100 percent
safe); however, the fundamental difference in the approach of
abstinence-based education acknowledges that many teenagers can and will
be sexually active before marriage.

Ms. Mann argued that sex education approaches must be based on sound
evidence that enjoys a scientific consensus. For example,
abstinence-based programs teach that, for those who choose to have sex,
condoms will protect them against HIV. There is a scientific consensus
on the usefulness of condoms as a preventive measure. Conversely, there
seems to be no scientific consensus that sex outside of marriage is
psychologically damaging.

Some proponents of abstinence-only education maintain that high teen
pregnancy rates are the result of comprehensive sex education; however,
there are no data to support this assertion. Indeed, studies show that
comprehensive sex education---even condom distribution---does not induce
earlier sexual initiation. The pregnancy and STD rates were virtually
identical across controls. It may be that the increasing HIV rate in
youth is the result of increased screening.

Comprehensive abstinence-based education is attuned to the vast majority
of public opinion: a poll by the Kaiser Family Foundation found that 81
percent of Americans believe that sex-ed programs should teach about
contraception.

Regarding the moral debate that underlies this discussion, young and old
people frequently make choices that many do not agree with or engage in
behaviors many do not approve of, yet they cannot be abandoned.
America's values do not permit throwing people away. Those working in
HIV prevention remain engaged: educating, persuading, and informing. Ms.
Mann said her deepest concern about abstinence-only programs is that
they may abandon those who behave outside their lines---gay and lesbian
youth, and the sexually active. A medically accurate curriculum that
promotes abstinence but includes other pieces is the best approach to
saving young people's lives.

Ms. Mann noted she had five recommendations, which she would provide in
writing.

**Abstinence Education**

**Joe S. McIlhaney, M.D.**

**President, The Medical Institute for Sexual Health**

Dr. McIlhaney's presentation was titled "Sexual Abstinence and Monogamy:
Exploring Co-Interventions for the HIV Pandemic." He noted that one
problem with the debate on sex education is that people often take
sides, with each side characterizing the other inappropriately. Some
people immediately react badly to mention of "abstinence"; indeed, there
are ongoing efforts to devise a new term for it.

Dr. McIlhaney stated that, among his OB/GYN patients, none has ever
reported having been warned that her sexual activity could result in
sterility. Consistent 100 percent condom use has only 85 percent
efficacy, and condom use is often less than consistent. The most
optimistic study data is from the Saracco study of 1993, in which 56
percent of respondents reported using condoms consistently. (The cohort
was monogamous adults, some serodiscordant, who knew they were in a
study.) Condoms are much less effective against diseases more infectious
than HIV (e.g., herpes, gonorrhea, and chlamydia), for the last of which
they offer only a 55 percent risk reduction. Further, they offer no risk
reduction for human papillomavirus (HPV) infection. STD infection also
increases susceptibility to HIV.

The fact remains, Dr. McIlhaney said, that condoms have a limited role
and a limited effectiveness, which could help explain the continued
spread of the epidemic. Even given optimism regarding consistent condom
use, co-interventions are needed.

The single greatest risk for STD/HIV infection is an increased number of
lifetime partners. Monogamous sexual activity between two uninfected
partners prevents both from becoming infected. Even if one is infected
from a previous relationship, monogamy allows only one other person to
become infected, hampering the spread of the epidemic. Avoiding sexual
activity until entering a lifetime sexual relationship offers the
greatest hope of an STD- and HIV-free lifetime monogamy.

Dr. McIlhaney cited a study that compared women who became sexually
active later in life to those who started earlier: women who started
sexual activity before 16 had more lifetime sexual partners by far than
whose who delayed initiation.

Regarding safer sex programs (also called dual-message programs), no
curriculum based on these messages has been shown to decrease pregnancy
or STD rates. The outcomes usually measured are: reduced frequency of
sex, reduced number of partners, and increased contraception use. By
contrast, modern abstinence programs are much more sophisticated; they
use modern learning theories. Furthermore, they *do* teach about condoms
and contraceptives using accurate data on rates of success.

Dr. McIlhaney cited the ADD health report on virginity pledges: 15
percent of girls and 10 percent of boys have taken an abstinence pledge.
In another site, the "Not me, not now" program has reduced teen
pregnancy rates from 63.4 to 49.5 per 1,000 girls.

Uganda has had success in reversing its HIV epidemic. This is a
stand-out achievement; Paul DeLay has said what is happening in Uganda
is almost a miracle. It is the responsibility of the PACHA to thoroughly
understand the implications of its efforts with respect to sex education
programs. HIV was entrenched in Uganda as early as 1980; 18 of 60
military officers tested were infected in 1986. President Museveni
started the ABC program; his speeches emphasized abstinence until
marriage. As a result, the HIV rate dropped among women, despite the
fact that Ugandans never really took to using condoms. By far the most
striking feature of the success in Uganda is the drastic reduction in
multiple sexual partners. Other positive trends include a decline in MSM
multi-partnering; the increase in age of female sexual initiation; and
higher marriage rates for women. Dr. McIlhaney said that the fact that
some people do not or cannot get married is not grounds to ignore
important evidence that promoting marriage, fidelity, and abstinence has
worked.

Dr. McIlhaney closed with the quote: "When two elephants fight, it's the
grass that gets hurt." When HIV prevention advocates fight over such
issues, he said, it's the kids that get hurt. He suggested that as the
Council reviews the available data together, it will find the best way
to proceed.

**Sex Education Funding**

**Maggie Wynne**

**Legislative Analyst, Office of the Assistant Secretary for
Legislation, DHHS**

Ms. Wynne provided a breakdown of Federal efforts toward HIV prevention.
The General Accounting Office (GAO) identified nine different Government
departments, with most of the HIV efforts concentrated in DHHS. Ms.
Wynne broke this information down into abstinence-only efforts versus
other prevention efforts.

Much of the federally funded work in abstinence education has been
congressionally earmarked; all of this has been directed toward
adolescents (e.g., Title X of the Public Health Service \[PHS\] Act in
the early 1980s). The "Adolescent Family Life Act" has abstinence as one
minor part. Only \$2 million per year was spent on abstinence education
until the late 1990s. The annual spending is now about \$12 million. In
1996, Congress passed the Welfare Reform law, which includes a Title V
program on abstinence, providing for a State grant program at \$50
million distributed over 5 years. (One State, California, does not
accept this money.) This program inserted a definition of abstinence
education, defining it by eight elements, often referred to as A through
H: abstinence until marriage; no mixed-message programs. This is also a
matching grant program; the State has to match \$3 for every \$4 Federal
dollars.

In addition, community-based abstinence programs were put into place
just recently. Last year the funding was \$20 million (to a fraction of
the 360 applicants); this year, due to significant interest, funding has
doubled. The President and Secretary Thompson supported \$73 million for
this year's budget. The family planning/sex education program has
different earmarks, particularly with respect to sex-ed per se: much of
this work takes place in medical settings (programs in clinics or in
schools). The bulk of this is from the Title X Family Planning Program;
this fiscal year (FY) the allocation was \$266 million, comprising
one-third for adolescents. The bulk of this funding comes from Medicaid.
Federal funds provide 90 percent of Medicaid family planning funding;
the States provide 10 percent.

The 1996 Welfare Reform law also provided for pregnancy prevention
efforts; States get \$16.5 billion annually, 1.4 percent of which (about
\$230 million) is for pregnancy prevention. Social Services Block Grants
provide another \$1.7 billion, of which \$42 million is for pregnancy
prevention. The General Accounting Office (GAO) identified about 27
programs (CDC has others). Of the many health programs and education
programs in DHHS, only 2 of the 27 are abstinence-only; the others
provider broader prevention messages.

# Council Discussion of Prevention Issues

Mr. Nickerson commented on abstinence versus comprehensive sex
education. One presenter made the point that condom use requires 100
percent adherence in order to be effective; Mr. Nickerson suggested that
abstinence requires 100 percent adherence as well. He said that every
bit of information is important. The disparities in philosophy between
the presentations were not as pronounced as they are in the political
and ideological world at large. Mr. Nickerson asked whether it is true
that Federal funding policies of the Bush administration prohibit any
discussion of condoms. Ms. Wynne replied discussion of condoms is not
prohibited. It is prohibited, within abstinence-only programs funded by
the Government, to promote their use. One Council member stated that
condom use can only be discussed in terms of ineffectiveness. Dr.
McIlhaney disagreed: people do and can talk about contraceptives.

Dr. Coburn noted he has made a similar observation to that made by Mr.
Nickerson: that people on different sides of the issue say essentially
the same thing. However, there is a lack of trust now because the sides
are so polarized. The other issue to consider, Dr. Coburn said, is that
of "informed consent"; one presenter, for example, made a statement that
"condoms prevent HIV transmission," without any qualification. He said
American youth can hear everything sex educators want to tell them about
condoms, but the information needs to be the truth, and the truth in
this case is that condoms have an 85 percent success rate even when used
100 percent of the time. It is also true that delaying onset of sexual
activity is a key factor in decreasing the lifetime number of sexual
partners. Dr. Coburn said if everyone could agree on that one point,
transmission of STDs in the United States could be reduced by
two-thirds. He also noted he teaches about condoms in all education
efforts, but only after teaching about the other pieces. Dr. McIlhaney
agreed, arguing that, for both heterosexual and homosexual youth,
neither should be having sex as adolescents. Marriage is not even a
factor to consider at that age.

Ms. Mann stated this is exactly the kind of constructive dialog the
Council needs on the issue. She agreed with Dr. Coburn that all
information given to youth should be accurate. She noted her
organization provides accurate information on birth control methods
(comparing different techniques). She noted, however, that she has tried
to access abstinence-only funding, and found it was unavailable to
programs that do not dictate to youths, "You must be abstinent until
marriage." The rigidity of this message (or "sex outside of marriage is
harmful") is problematic.

Ms. Rock stated that she is a licensed child care provider; in her state
there is a law that prohibits an adult with a communicable disease from
working in a child care environment. This provides a legal framework for
discrimination. Ms. Rock said she asked 3 years ago for public
policymakers in her state to rescind this law. In this context, she
asked Dr. Cruz-Uribe what he meant by saying that HIV is just like any
communicable disease. Dr. Cruz-Uribe responded that such a law doesn't
exist in his state, and he certainly would not support it. He said he
suspects that law was written in the early stages of the epidemic.

Mr. Nickerson said that a lot depends on how people process the
information they receive. If the only information given to someone about
condoms is that they don't work, he asked, what is the takeaway message
for a young person who is simply not receptive to an abstinence-only
message?

Dr. Coburn reminded the Council that Federal abstinence money is tiny in
comparison to other sex education monies available. Also, educators can
talk about the effectiveness and ineffectiveness of condoms. Dr. Coburn
said he wrote the law, and that grantees are talking about effectiveness
and ineffectiveness. The issue of concern here is that there has not yet
been a good study on the efficacy of abstinence-only education in the
United States. This effort should be given a fair try based on
preliminary results.

Mr. Burden stated that this is good news, and that the message needs to
be disseminated to the community; at least some Council members were
misinformed. Mr. Burden noted that almost all the presenters on rapid
testing stated, "No test is perfect"; in the same context, certainly
condoms aren't perfect either.

Mr. Burden requested donating the rest of his discussion time to the
recommendations Ms. Mann did not have time to enumerate in her
presentation. Ms. Mann listed some:

-   Strengthen Federal funding for sex education programs requiring that
    all information disseminated is medically accurate.

-   Give states more flexibility in using abstinence money.

-   Support HIV prevention for school-age children with the proviso that
    curricula are medically accurate.

-   Provide more and better training for parents, to educate them on the
    normal sexual development of their children and how to be better
    parents.

**PANEL PRESENTATIONS: INTERNATIONAL ISSUES**

**DHHS Global Health Issues**

**William Steiger**

**Special Assistant to the Secretary for Global Health, DHHS**

Mr. Steiger provided an update on the Global AIDS Fund. As of the last
PACHA meeting, the fund had just received proposals and was in the
process of reviewing them. In all, 385 proposals were received from 101
countries, totaling 1.15 billion in requests. Of these, 145 proposals
met the eligibility criteria. The review panel was composed of 17
independent experts, who rated proposals according to several criteria
and forwarded their recommendations to the Global Fund board at their
April meeting. Secretary Thompson represented the United States. The
fund agreed to support 40 proposals in the short term, over 2 years, for
a total of \$378 million. Grants were made for a 2-year period with a
chance to renew to ensure that program milestones and accountability
criteria are met. The Fund also approved an additional 18 proposals for
another \$238 million. The totals are \$616 million for 58 programs in
approximately 42 countries. This summer, the Fund will ask for
additional information from many of the proposals that were funded.
(Only one of the 58 approved proposals was judged to need no further
adjustments---a malaria program in Tanzania.) Within the next month, the
Fund will issue a second call for proposals (and will also entertain
reapplied proposals from the first round that needed extensive
reworking). The majority (53 percent) of the funding is going to combat
HIV/AIDS.

In April, Richard Feecham was selected as Executive Director of the
Fund. He will come on board sometime in July, but has begun working with
the Fund's secretariat, many of whom are on loan from institutions in
several governments. The Fund has issued a number of recruiting
announcements. (Council members are encouraged to contact the fund
([www.globalfundatm.org](http://www.globalfundatm.org/)) for job
announcements in grants management, financial arrangements,
communications, and outreach.) The Fund's secretariat has been small,
and as a result they have had trouble getting accurate information out
on a timely basis. At a September board meeting, the Fund will make some
policy decisions around governance issues: making the board more
transparent and efficient; how to monitor and evaluate grantees;
outcome-based disbursement of future funding, fiduciary arrangements
(the World Bank is the trustee, but down-flow is not yet settled);
resource mobilization, etc.

Regarding the Fund's financial stability, public and private
partnerships have pledged a total of about \$2 billion. At this point,
\$443 million of that money is on deposit at the World Bank, including
\$250 million from the United States. Another \$50 million is
outstanding, equally shared by DHHS and USAID. Dr. Peterson has been
instrumental in getting this money moved into the World Bank. An
important consideration is that the U.S. share of cash on hand is above
60 percent. Other donors are talking about paying for administrative
costs; the United States certainly does not want to shoulder the entire
bill for administrative costs. For calendar year 2002, \$770 million is
available for disbursement; for 2003, \$450 million; for 2004, \$150
million. The Fund will have to recapitalize itself within the next year
or so. Mr. Steiger said he and his colleagues are confident they can
fund this and the next grant cycle without a problem. They also expect
good things of Dr. Feecham, who met last week with Secretaries Thompson,
Powell, and O'Neill. The Fund is impressed with the steps Dr. Feecham
has taken in terms of staffing and policy.

The United States is the only nation or institution that has submitted a
second pledge to the Fund; President Bush will encourage his colleagues
to step up and commit more for Years 3 and 4 of the Fund's life.

Mr. Steiger discussed the mother-to-child prevention initiative.
President Bush announced a major initiative to expand the scale and
scope of prevention efforts around the world: \$500 million new dollars
over next several years. The \$200 million for FY2002 and FY2003 are in
congressional appropriations and are not yet signed; in addition to
this, the President has committed to donating \$300 million in new
funding for the future. To give a sense of scale: the annual budget of
the Elizabeth Glaser Pediatric AIDS Foundation---the main private sector
partner---is about \$10 million in grants, or one-fiftieth the resources
being committed here. Perhaps \$50-\$75 million is being spent in much
of the developing world. Mr. Bush's initiative is certainly an
exponential increase. The initiative entails both secular and
faith-based organizations, NGOs, cooperative agreements with
governments. Funding is earmarked for eight sub-Saharan countries:
Botswana, Côte D'Ivoire, Ethiopia, Kenya, Mozambique, Rwanda, South
Africa, and Uganda; funding is also going to Guyana, Haiti, and
Trinidad, and, in 2004, Namibia, Tanzania, Zambia, and one other
country. It is no accident that the countries listed are those with the
highest seroprevalence. The desired impact, when the program is fully
rolled out, is the treatment of one million mothers per year and the
reduction of transmission by 40 percent in these countries.

The mother-infant program will focus on treatment for mothers and
infants, and on building capacity to prevent perinatal transmission. The
programs will be based on existing programs in the public and private
sectors. The programs will also provide care for families and education
on prevention. Some more highly developed countries will have
comprehensive therapy; where less infrastructure exists, the focus will
be on short-course therapy (e.g., Navirapine and/or AZT to mother and
child). Two innovative pieces are also included: a hospital and clinic
twinning program, matching a number of U.S. hospitals with counterparts
overseas; and a travel program in supported clinics to build capacity
and train native health care workers. This is a major step forward in
international AIDS programming.

Mr. Steiger noted that Sec. Thompson will be leading a delegation of
senior U.S. officials---including Dr. Sullivan, Dr. Coburn, Dr. Slater,
Scott Evertz, Dr. Biato, Claude Allen, and Mr. Steiger---to the
International Conference on AIDS in Barcelona. The Secretary will
present at the conference, with Dr. Feecham and the director of the WHO,
on increasing and enriching public/private partnerships.

**CDC -- Global Initiatives**

**Julie Gerberding, M.D., M.P.H.**

**Acting Deputy Director for Science and Public Health, DHHS**

Dr. Gerberding noted she started her internship almost exactly 21 years
ago today: the year the first AIDS patients were detected. In the years
since, the epidemic has become one of the biggest health problems the
world has ever faced. What is really new about AIDS, she said, is the
medical knowledge that has come out of it: the amazing discoveries made
in molecular biology over the last two decades. The other news is that
500,000 new cases are predicted per year. In reflecting on what is
really known about prevention, Dr. Gerberding said, there are some
lessons or recommendations to take back to CDC:

-   Evaluate the research portfolio: ensure that ongoing research
    adequately addresses the problems.

-   Look at how to improve access to diagnosis and treatment. Now that
    drug treatments are prolonging lives, it is a tragedy that the
    intervention potential has been missed. Step back and take a
    pragmatic and objective look at what programs are supporting and
    identify which strategies are truly reducing incidence.

-   Look to expand on what works; document the "return on the
    investment," and reinvest. The HIV research and care community needs
    to admit that some attempted strategies do not work.

The Global AIDS program is exemplary in terms of following this
framework. It is not certain yet to what extent program goals succeed,
but there are lessons to be learned from Thailand, Senegal, and other
successes.

**Dr. Eugene McCray**

**Director, Global AIDS Program, National Center for HIV, STD, and TB
Prevention**

Dr. McCray distributed a map of 25 countries in which the Global AIDS
Program (GAP) is currently operating: 17 in Africa, 5 in Asian, and 3 in
South America. The GAP is very new; it first received emergency funding
in July 1999---a \$35 million appropriation of emergency funds for
programs in 14 countries. This funding has increased to approximately
\$144 million this fiscal year; GAP is slated for level funding in
FY2003.

The GAP Program Model entails Surveillance; Primary Prevention; Care and
Treatment; and Capacity and Infrastructure development underlying all
other areas (labs, information systems, monitoring and evaluation,
training and technical assistance, etc.).

The process for establishing a GAP program starts with working with
USAID on eligibility criteria (involving prevalence and the country's
political commitment; whether there is already a GAP presence there);
and a needs assessment (entailing a 2- to 4-week visit). The GAP
assistance plan is based on priorities identified through a dialog with
the host country. The most frequently expressed needs are around
surveillance, voluntary counseling and testing, improving care for
PLWH/A, strengthening lab capacity, perinatal prevention, and training
for all these activities.

CDC staff members are currently assigned to 19 of the 25 GAP countries;
it is hoped that staff will be assigned to an additional 5 countries by
the end of 2002. Of the current projects, 18 technical strategies have
been developed; 25 countrywide program assessments have been conducted;
and 19 GAP country Program Plans have been developed.

A number of mechanisms help with the GAP's work, such as collaboration
with many partners (USAID is main partner in most countries). GAP also
works closely with HRSA, and Department of State, and the National
Institute on Drug Abuse (NIDA). Cooperative agreements exist with a
number of partners, and 46 awards have been made to domestic and
international organizations including AHPL and NASTAD.

One concrete example of a successful GAP program is Botswana, where CDC
has a presence. Botswana is one of the top four hardest hit African
counties: 39 percent of the native women are HIV positive. The estimated
life expectancy was 70 years; now it is 39. GAP is involved in several
major program areas: working closely with the government to implement a
"Know your status" campaign to ensure that 100 percent of Botswanans are
tested; setting up voluntary testing sites in each district;
mother-to-child transmission prevention; and working with State and
Defense Departments to add counseling units to all maternal and child
health clinics. In addition, a media campaign is underway to effect
behavioral change, using the national broadcast system to run a radio
series with AIDS-related information. GAP is working closely with an NGO
called Population Services International, as well as a large youth NGO
called YOHO, which targets 15- to 29-year-olds. Other efforts include
peer outreach; CDC support drama groups; door-to-door education; and
condom distribution. Comprehensive care and treatment efforts in
Botswana include supporting Isoniazid Preventive Therapy for TB (IPT).

Monitoring and evaluation are also strong components in which many
partners are engaged; this has been adopted and is being implemented in
many GAP program countries.

Dr. McCray discussed future challenges. The GAP has grown very quickly,
and has had to respond both to demands placed by partners in the United
States and by non-GAP countries interested in their support. The GAP
needs to be intelligent in planning for future growth, and needs to meet
demands in a reasonable way. The CDC has a reputation for providing
high-quality TA, the goal of which is to have programs increase their
capacity to do their own work; to increase communications and to
communicate effectively within and without DHHS so people will know what
the GAP is doing, how to access services, and how the GAP works
internationally. The GAP also needs to establish priorities and planning
systems, and to review and evaluate them on annual basis. Changes need
to be dynamic whenever possible; at present the focus is on hands-on
training and TA---recruiting and training locally. However, as the
epidemic matures, the GAP's role may change significantly to a more
advisory capacity.

**DHHS Caribbean Visit**

**Cheryl-Anne Hall**

**Sunset Park Family Health Center Network, Brooklyn, New York**

In June 2001 \[?\], Secretary Thompson learned about the dramatic
increase in the number of Caribbean nationals seeking HIV treatment in
New York, especially in Brooklyn. As much as 30 percent of the
population may be positive but have not been tested. Ministers have
shared the difficulties they have had in arresting the spread of HIV in
the Caribbean. Secretary Thompson promised at that meeting that he would
convene a follow-up meeting in the Caribbean; Ms. Hall said she was
invited as part of his delegation, which includes USAID, Scott Evertz,
and other DHHS representative. The group convened in Guyana on April 20.
The day was spent developing strategy, and culminated in the signing of
a pan-Caribbean partnership agreement. Sec. Thompson deployed staff from
the CDC and other agencies to Haiti to provide assistance and to help
develop infrastructure, and to provide technical assistance to help with
their proposal to the Global AIDS Fund (which was not approved in the
first cycle).

Ms. Hall noted the WHO has been attempting to stop recruitment of nurses
from the Caribbean; many countries are recruiting nurses there. Many of
the recruited nurses serve as providers of health care in rural areas in
their host countries, but this leaves a dearth of qualified nurses in
the Caribbean.

Following President Bush's mother-to-child prevention program
announcement, Sec. Thompson agreed to hold a follow-up meeting and
promised to continue to work on behalf of the Caribbean nations.

**Panel Discussion of International Issues**

Dr. Sharma noted that the success in Uganda has been quite apparent; he
asked Dr. McCray if those methods are being applied in Botswana and
elsewhere in Africa. Dr. McCray responded that this is so: one thing
they tried to do (partners in the CDC, USAID, and United Nations Joint
Programme on HIV/AIDS \[UNAIDS\]) is to look at successes in Uganda and
elsewhere and document best practices. Uganda was a perfect example:
they began very early in the epidemic to encourage people to know their
status. Voluntary counseling and testing was championed in Uganda, even
before the GAP existed.

Dr. Sweeney noted that there have been efforts to educate mothers as
well as young men and young women; yet one image shown today depicted a
"sugar daddy" and teenage girl, denoting sexual predation. Dr. Sweeney
asked if any efforts have been made to target that group of men, who are
a common problem both in Africa and in inner cities in United States.
Dr. McCray responded that this was a piece of population-based
education, targeted primarily at educating young women. There are also
some programs targeted at men, although in Africa, in general, it is not
easy to access men. However, because people are interested in the media
campaign, one approach is to access men through the women. It is a
difficult process because many clinics are not perceived to be very
male-friendly.

Mr. Burden said he fully supported the public/private partnerships that
have been mentioned, and asked Mr. Steiger for word of the new
initiative last year, between Rockefeller and others called MCHT
(Mother-to-Child Transmission Plus). Mr. Steiger said this is clearly a
potential partner to look toward, and said that such initiatives are
good to build on rather than "reinventing the wheel."

Dr. McKinnell reported having seen impressive work going on in every
country he visited in Africa: several U.S. Government agencies, foreign
governments, and local governments had initiatives. There were 1,600
NGOs operating in Uganda. Dr. McKinnell asked when there will be
accurate data on how much money is being spent, how many people are
being tested, and what is the cost per test and per treatment. Mr.
Steiger responded that these are President Bush's questions as well, and
the Global AIDS Fund is in the process of developing ways to measure
these things. They are asking potential partners to work in ways they
have not done before. There is a lot to learn, Mr. Steiger said, but
this is precisely the kind of accountability that is needed.

Ms. Ivantic-Doucette thanked the various participants for their
collaboration in these efforts. She noted she has been working with the
CDC and USAID for years to push to train new nurses, as well as on the
hospital twinning project. The absence of nurses from developing
countries is another layer of complication. Recruited nurses from the
Caribbean and elsewhere are filling the U.S. shortage but leaving a gap
in developing countries. Ms. Ivantic-Doucette also a caveat about
praising the work in Botswana: this nation has a population of 1.4
million people, is rich in resources and has less poverty than other
African nations. It does not compare to a large, more complex, and
poorer country. Mr. Steiger noted the Global AIDS Fund is concerned
about the nursing shortage internationally. The Secretary has been
focused on nursing education and expanding the pool domestically to
combat the problem.

Dr. McCray stated that the Global AIDS Program is doing everything it
can to make sure everybody understands that this is a 10- or 20-year
proposition, not just a project for the next 2 or 3 years.

**Announcements from Executive Director**

Ms. Ware asked members to complete their activities disclosure forms.
She stated that members who do not return this form would not be
permitted to attend further meetings. She also asked Council members to
complete and return to her or to her assistant their 2002 annual ethics
training form. She noted the Council would review ethics issues tomorrow
morning. She also said that the event on Monday with Secretary of State
Colin Powell is not an official PACHA event; the Council cannot pay
member expenses for those who choose to stay in Washington to attend. To
such persons, Ms. Ware offered registration forms.

The proceedings adjourned at 4:49 p.m.

**June 22, 2002**

**Morning Session**

Dr. Coburn called the meeting to order. He noted the Council had a
productive session yesterday, and outlined the schedule for today.
Following Ms. Ware's presentation of some ethics training issues, the
floor will be opened for discussion. There will be a period of time for
public comment, after which any final business can be conducted.

**ETHICS ISSUES**

Ms. Ware noted that most Council members received ethics training in the
Council's first meeting; for those who have not had training, this is a
very important Federal requirement.

Ms. Ware reminded the Council that no member can represent him or
herself as a PACHA member when expressing individual opinions. Unless
there is a consensus on the Council, individual members cannot state an
opinion as a stated member of the Council. Even if a member does not
explicitly state he or she is speaking on behalf of PACHA, if introduced
as a PACHA member, the assumption (e.g., on the part of the press) will
be that he or she is representing the Council. This is important to keep
in mind as many members travel to Barcelona. As an example of consensus,
Ms. Ware cited the Council's decision about increasing funding for ADAP;
members are free to relate the Council's unanimous recommendations
regarding ADAP.

Ms. Ware also discussed members' conversations with Government
officials. No member can discuss any issues with Federal employees
without going through PACHA. In one recent situation, a Federal employee
called one of the Co-Chairs to ask to speak at this meeting. Ms Ware
stated that Federal employees need to arrange to speak through her
office only. Dr. Coburn qualified this issue by stating that PACHA
members still have every right to have discussions with Federal
employee, but only with the verbal disclaimer that they are not speaking
on behalf of PACHA.

Ms. Ware noted that there should always be a PACHA staff person present
at subcommittee meetings; meetings conducted by conference call should
be arranged through and attended by someone from the PACHA office. When
a member receives questions from the press or public, Ms. Ware said,
they can always contact her or her staff. Serving on this Council does
not prohibit members from functioning within their agencies and
organizations as normal. For example, one member wrote an article and
sent it to Ms. Ware for clearance because he listed his position as a
PACHA member. It was decided in this case that the gentleman use his
private (organizational) title first, thus not to represent himself as
speaking for PACHA.

Ms. Ware said any member questions on these issues should be directed to
her. Dr. Coburn further advised the Council to request a written
response from Ethics if they feel something is questionable.

One member asked what represents an official PACHA position; Ms. Ware
responded any issue that has been voted on or on which consensus has
been reached. These issues will always be listed in the minutes and
transcripts. Mr. Burden noted this is an important point: to be sure
which items have reached consensus and which are still in discussion
would be good to review as a matter of course in the meetings. Dr.
Coburn agreed that a review of the consensus point should be done for
every discussion.

Ms. Ware shared her recent activities with the Council. She noted she
has traveled across the country extensively talking about the
President's HIV agenda. She has attended board meetings to update many
people on PACHA activities and answer questions, in the process
developing respect for the work the Council is trying to accomplish. She
has met with pharmaceutical company representatives to develop a rapport
and to let them know what the Council is doing. She has met with
organizational and Government officials, who now understand that PACHA
is serious about its assignment. Ms. Ware stated she has two new
assistants on staff: Dr. Elizabeth Onjoro and Gail Wilkins. Now that Ms.
Ware has support staff, she said she hoped communication and information
dissemination to the Council would be quicker.

Regarding Federal regulations on travel, Ms. Ware urged Council members
to be patient and to continue to contact her as needed. Ms. Ware will
attempt to find a way to help members do what they need to do.

Ms. Ware addressed members unable to sign the document attesting that
they had been briefed on ethics because they were not at the last
meeting; statements are needed on how these members receive this
briefing. PACHA staff asked Ethics to do a makeup briefing, but no one
was available during this meeting. Those who were unable to attend the
last meeting have regulations in their notebooks; perhaps a conference
call can be arranged with an Ethics person on the line. It is not
sufficient to attest merely to having read the regulations; nor will
previous briefing (i.e., from the previous Council) suffice, inasmuch as
regulations have recently changed. The information presented today by
Ms. Ware may be enough of an update, but this is not certain; Ms. Ware
said she would let the Council know next week.

Dr. Coburn noted that, because he cannot operate on a short timetable,
proposed dates for next year's meetings will be sent out soon. Council
members are asked to communicate back on their preferred dates. If
feedback is not received, the Co-Chairs will decide the schedule based
on their own availability. In any case, by October's meeting a complete
schedule for next year will be available. Dr. Coburn said he also hopes
to build a better-structured organization that will allow members to
bring their thoughts and assets from their organizations.

Ms. Ware noted the Council's August meeting was canceled due to budget
considerations. Dr. Coburn noted the August meeting was an extra meeting
anyway, and was based on extra budget money that subsequently
disappeared. Still, should the Council need to communicate in the
meantime, it can certainly be done (e.g., via e-mail). The next meeting
will therefore be October 24 and 25. At least two meetings will be
scheduled for next year, possibly three.

Ms. Ware asked members to share their Barcelona schedules with her so
that she can plan a reception for one evening.

**Open Council Discussion**

Dr. Coburn commended Ms. Ware for the variety and balance of yesterday's
panel discussion. He stated that the Council will not close out anyone's
input; everyone will be heard. Dr. Coburn gave the floor to Ms. Ware to
discuss a subject she believed the Council missed during yesterday's
session.

Ms. Ware stated that she has been neutral and objective in running the
Council; however, the issue of marriage received insufficient discussion
during yesterday's prevention presentations. She stated she has a few
thoughts on marriage as related to abstinence funding and the criteria
for funding. Ms. Ware stated she spent hours with the first lady of
Uganda in an attempt to generate and achieve a cultural paradigm shift;
as a result, the people of Uganda changed their way of thinking about
sex and marriage. This is apparently what Congress was trying to achieve
in putting the A through H criteria on sex education monies. The
literature is replete with data indicating that young people do better
when they are raised in households with two biological parents. It has
been seen, particularly in African American communities, that when
families break down, the children suffer: there is more drug use and
abuse, more teen pregnancy, etc. This is not to say that every child in
a two-biological parent household will do well, but it does speak to the
astronomical risks for broken homes.

Ms. Ware said the emphasis must be on solid families: marriage,
monogamy, more black men back in their homes as loving husbands and
fathers. Society must help its young from an early age to understand the
importance of this and thereby acquire the qualities it takes to grow
and to develop lifelong, committed relationships. Going from one broken
sexual relationship to another impedes the ability to commit, to bond,
and to trust. This is what the Million Man March and the Million Family
March were about.

Dr. Gomez spoke on a point of order: The Council is supposed to hear
issues, and members should have the ability to express opinions.
Yesterday, however, there was a cutting off of some people's opinions,
while Co-Chair Coburn interjected his own opinions. Dr. Gomez stated she
was dissatisfied with a process that did not allow full expression of
some opinions while seeming to preference others.

Dr. Coburn responded by noted he was not chairing the meeting yesterday
in which he expressed his opinions; rather, he participated outspokenly
as a PACHA member. In addition, Dr. Coburn noted he has deferred to Ms.
Ware this morning because she saw an area she did not feel was
adequately covered. There has been an attempt to ensure a balance. Dr.
Coburn noted also that the Council agreed yesterday that delaying sexual
activity was an important message. Nevertheless, he said, criticisms on
process will be noted and attended to when he sits as chair.

Karen Ivantic-Doucette noted she was in Uganda when the constitution was
written and the marriage law was passed. Uganda, which had had polygamy
for centuries, went to a one man/one woman system. \[?\] said it is too
early to know whether marriage in Uganda will decrease HIV rates; what
it has done, on the other hand, is to outlaw polygamous households with
no social sequali. Although it was the right move, \[?\] said, people
should be cautious in applying the Ugandan model in the United States:
Uganda has different concepts of prevention and a very different
society. Furthermore, the marriage law has served to disempower the
women in Uganda. Prevention researchers are trying to figure out how to
provide social modeling to young people. The most important bases of
behavior are the modeling learned before age of 6; that whole component
is not being addressed here.

Ms. Ware said there is also a public health issue to be considered. It
is clear that one risk factor for any STD is multiple sexual partners.
There is also a protective factor in communities with two-parent
households. The Ugandan experience limited the practice of having
multiple sexual partners.

Caya Lewis spoke to underscore the previous comments on Council process.
The Council must have time for discussion and contemplation, she said;
after 10 presentations yesterday, the Council entertained only about 3
questions. Ms. Lewis also noted she is looking forward to getting
agendas earlier and being able to provide suggestions and feedback as to
who will present at Council meetings. Because the discussion yesterday
was curtailed, Ms. Lewis said, more information is needed on
comprehensive sex education, including results of studies. Some studies,
for example, have shown that kids who get abstinence-only education use
condoms a third less than those who receive comprehensive sex education.
This constitutes an additional health risk. As researchers try to limit
partners and delay the onset of sexual activity, those in the public
health arena need to talk about the social reality, which is that the
majority of young people do have sex before leaving high school. When
abstinence fails, they need all the information. Ms. Lewis said she
looks forward to talking further with Dr. Coburn about the legislation,
in light of Ms. Mann's stated inability to get Federal monies for
comprehensive sex education. Right now, the legislation seems to
stipulate that people may not stray from the A through H criteria.

Dr. Coburn stated that no presenter was scheduled this morning
specifically because the Council clearly needed time for discussion. He
said he would talk with Co-Chair Sullivan about allotting more time for
discussion following each presentation or series of presentations. The
Council is not perfect, Dr. Coburn said, but he is working to improve
it.

Joseph Jennings introduced himself and noted that he lectures to
motivate kids. He said many young people are making decisions about
their lives based on a lack of information. There is a tendency to think
that kids are stupid or cannot make up their own minds. He said he has
talked to 6 million kids in 15 years, imparting the message that they
have the right to do anything they want, as long as they understand
there is a price they have to pay for their actions. He urged the
Council to present youth with all the available information. In the
black community there is a particular lack of information; it is
500-year-old information that conditions the community, resulting in so
much sex and so many babies.

Mr. Perez echoed Dr. Gomez's concerns about Council process. The Council
needs to speak to the Chairs on practical recommendations and work to
arrange the agenda to allow for full discussion of issues.

Ms. Rock suggested that the human side of PLWH/A issues was missing from
yesterday's presentations. Teenagers, she said, speak well and will tell
researchers what they do and do not do. Some teenagers, for example,
report that their parents introduced them to drugs. Ms. Rock stated she
would like to hear more from consumers, and from the people who work in
the counseling and testing field, including those doing rapid testing.
It would benefit the Council and the FDA to hear the human side of these
issues.

Mr. Ware said these concerns were duly noted. She explained that, of all
the invitations to present to the Council, very few persons could show
up to present on Saturday, so all presentations were scheduled for
Friday. Today's meeting was left today open specifically to engage in
discussion. While this arrangement is not ideal---inasmuch as the
presenters are not present today to hear the discussion---Ms. Ware noted
that the FDA sent someone to take notes. The intention of the meeting's
setup was not to limit dialog.

Dr. Sweeney recommended switching the meeting schedule back to Thursday
and Friday if people cannot attend on Saturdays. Didactic lectures and
panel presentations should be broken up and followed with discussion.
Ms. Ware noted she tried to schedule for Thursday and Friday; however,
these were the only two consecutive dates on which the Co-Chairs were
both free. It is clear, Ms. Ware said, that the Council really should
meet on weekdays. Dr. Coburn agreed that there was never an intention to
hold regular Saturday meetings.

Mr. Minor said that the issue of changing behaviors is really the
discussion that must happen here---not just about setting up rules, but
a real behavioral shift, with its difficulties and its benefits. He
noted he is in full agreement with the importance of changing behaviors;
however, some of the language used yesterday---notably, "unhealthy
homes" and "marriage as the preferred option"---is problematic. Mr.
Minor asked how this language applies to an 18-year-old or to Mr. Minor
himself as a gay man. He said the Council must consider gay and lesbian
youth and not marginalize them. The GLBT community must be part of the
cultural paradigm being striven for.

Dr. Sharma said he would also like to echo the recommendations that more
time be allotted for discussion. The Council's first meeting in March
was instructive; there was a good structure to the presentations. This
Council represent a variety of views; Dr. Sharma said he would like the
Council to focus more on what its charge is. There are 35 different
views in this room, and agreement on everything cannot happen, but the
Council must focus on what can be done to minimize the impact of the
AIDS epidemic.

Ms. McDonald said that the discussions have been enlightening, and
concurred with Dr. Sharma that the Council must agree to disagree on
certain points. Ms. McDonald said she does not prefer abstinence-only
education because it is labeling and exclusive. She noted that, despite
the extensive discussion about adolescents, there are none present.
Adolescent voices are needed to explain what it means to them when they
are told that abstinence is the only option. Ms. McDonald recommended
bringing in "MTV people," and looking at the broader culture in which
sex is hot or important for young people. She stated that she is not
interested in making recommendations that are doomed to failure before
they leave the room.

Dr. Driscoll echoed the concerns that the Council needs to keep GLBT
youth central to the deliberations. Not only are gay people not able to
marry, he said, there are many other reasons for both homosexuals and
heterosexuals not to want to marry. There is a tremendous legal angle,
Dr. Driscoll said, which is "as bad as being a doctor." The important
thing is to encourage stable partnerships. The Council and the community
need to be flexible on this point: the important thing is limiting
partners and opportunities for infection.

Ms. Franklin stated she has appreciated all the comments so far. She
noted she has gone from executive director of an HIV program to a tribal
leader; in the latter role, she said, she can impact her community in a
different way. Ms. Franklin said that, after listening to the discussion
yesterday and today, it all begins with commitment. She noted that her
personal experience has shown that it absolutely makes a difference for
children to have two parents. Ms. Franklin said she truly appreciates
being on this Council and listening to all points of view.

Dr. Coburn said it is important the Council remember there are two
members selected especially because they are young people. He encouraged
these members to speak and be heard.

Mr. Jennings asked, in light of Mr. Minor's comments and
self-identification, whether the Council is now focused on gay HIV
issues. It was his understanding, he said, that the Council is not
pushing an agenda, and wondered if the discussion of gay issues is
consistent with Council boundaries and rules. Dr. Coburn responded that
the Council is a diverse group of people, each bringing a different set
of experiences, values, etc., whether black, white, Latino, gay,
straight, etc. He added that the Council decided at its first meeting
not to squelch any issues. The Council shares one desire: to make
recommendations that will ensure that the next person does not get HIV.
Dr. Coburn stated he is a conservative, hard-nosed Republican
congressman. Yet the Council is going to try to build consensus on
important issues, with the power of diversity behind its decisions. Mr.
Jennings asked, given the conflicting views on marriage as a part of the
social foundation and the fact that homosexuals cannot legally marry,
whether the Council should seek an answer to that issue. Dr. Coburn said
that the Council would not; HIV is the focus of discussion. While there
are many impacting tangential issues, it is the Council's goal to
prevent the next person from getting HIV. Mr. Jennings opined that all
the Council's rules should be on the table.

Ms. Lewis said this is an opportune time to bring up a process point,
with respect to talking about building consensus and speaking up as
active participants. Ms. Lewis said she had issues with the process by
which the Council's first set of recommendations to the President was
developed. Because the first set of recommendations were developed
post-meeting and sent around on e-mail, the response seems to have been
limited. This is not an ideal consensus process, she said. Dr. Coburn
responded that not everyone used "reply all" in response to the e-mailed
recommendations, but several members sent responses to the Co-Chairs.
Not many negative comments were received. In the future, Chairs should
recommend that all members reply to the entire Council. Dr. Coburn
stated also that a committee of 35 members cannot collaboratively draft
an entire letter.

Ms. Lewis agreed that e-mails should go to the entire Council so
everyone can react. It is also important to the consensus process, she
said, that when ideas or feedback are incorporated into a Council
document, the membership needs to see a revised version before it is
made final. Dr. Coburn responded in defense of the Chairs' position,
noting that he and Dr. Sullivan were instructed to get the letter out
quickly. The Council developed six or seven goals, based on which the
Chairs developed a draft, distributed it, received comments, revised the
letter, and sent it; as a result they communicated the intent of the
Council to the President's administration. Ms. Lewis responded that it
is not her desire to send out recommendations, no matter how quickly or
how slowly, that are not constructed under a valid consensus process.
She stated she hoped this situation will improve now that the
subcommittees are functional.

Dr. Coburn offered one cautionary note: striving for 100 percent
consensus leaves a committee with nothing. He insisted that this
committee must accomplish something or else it will be disbanded. There
are issues to be dealt with more important than anyone's particular
agenda. As Co-Chair, Dr. Coburn said, he will help to build the best
consensus achievable; if some disagree with the results, that is what
America is all about. The fact is, HIV infections are still increasing
in the United States; the measure of whether of not this Council is
effective is whether infection rates are lowered.

Dandrick Moton noted he is the director of a community youth group
started in Arkansas in 1991 and that he is not an expert on HIV/AIDS,
but has read up on the subject. As a guest speaker at an Arkansas AIDS
conference, he made front-page news. He cited an analogy his mother made
regarding teaching young people about "healthy choices": he said the
truth he teaches young people is like a safety net---it will catch all
the people who do not make those healthy choices (i.e., the sexually
active).

Ms. Shoemaker reminded the Council that she and several other members
are consumers and can offer personal information on what it is like to
live with HIV. She stated there has been too much talk for the last 20
years; of primary concern is that the Council is an advisory board and
needs to have the tools to put out there in the communities. As a
Council, it is important for each part to work together. Ms. Shoemaker
said that "we are all human beings"; the disease affects every single
person.

\[One member\] asked whether a response has been received from the
President regarding the Council's first set of recommendations. Dr.
Coburn responded that there has been no word from Scott Evertz of the
Office of National AIDS Policy. Dr. Coburn received a fax from a
presidential aide; it is not clear whether this is meant as formal
response, but it is not satisfactory. Dr. Coburn said he intends to
clarify the intent from the White House before distributing the fax.
\[The Council member\] opined that someone from ONAP needs to attend
PACHA meetings---if not Mr. Evertz, then a designee.

Rashida Jolley asked the Council to consider further involvement of
youth in Council meetings.

Dr. McKinnell reminded the Council of one simple fact: since the Council
convened yesterday, there have been 30,000 new HIV infections worldwide.
He stated there has been too much politics being discussed; the focus
should be on practical, workable solutions.

Mr. Nickerson said he hopes the Council will not approach HIV like drug
use\[?\]. Evaluation has demonstrated that prevention efforts primarily
reach low-risk youth. The Council really needs to think about who is at
risk: certain populations have been disproportionately affected. Mr.
Nickerson noted that the word gay was not even used in Council until
today. There has been no mention of needles in prevention discussions,
although needles have been in the picture since the epidemic started. It
is important to concentrate on where the infections exist.

Dr. Sweeney noted that she talked about IDUs in yesterday's
presentation. Drug use is certainly driving the epidemic in certain
populations. She noted she distributed articles this morning from MMWR
and HRSA on drug use and how it drives the epidemic. She recommended
that the topic be further discussed in the prevention committee.

Ms. Ivantic-Doucette brought up another issue raised yesterday: the
linking of diagnosis and treatment to prevention. When regulations
around interventions are developed, she said, they are broken into the
areas of primary prevention, diagnosis, and care and treatment. This has
limited how people can implement new programs. Even new monies from the
Minority AIDS Initiative have actually served to exclude minorities from
receiving quality care. She asked the Council to talk about the way
prevention has been interpreted, to rethink the use of care and
treatment monies, and to consider new, creative interventions. Dr.
Coburn recommended working on such issues in the prevention committee.

**Follow-up Discussion on Rapid Testing**

Dr. Coburn called for a Council consensus on rapid testing. He asked
whether the Council should formulate this as a recommendation, and if
so, how.

Dr. McKinnell noted he does not care whether rapid testing receives a
CLIA waiver or is designated moderately complex. The urgent thing is to
get it out quickly and widely. Mr. Burgess said that, clearly, allowing
rapid testing to be waived will increase access. He recommended waiving
it.

Dr. Driscoll noted there is an apparent contradiction for the United
States to push for rapid testing throughout the world and denying it to
African Americans and other Americans here. When a highly beneficial
drug is approved, by comparison, obviously its advocates want it
approved for broad usage; the alternative is Viracept approved for
last-ditch efforts. Dr. McKinnell countered that the Council should not
get bogged down in the process of telling the FDA how to do its job, and
recommended letting the President decide on the issue.

Ms. Ware reminded the Council that the FDA representative wanted to make
it clear that discussion of the CLIA waiver will not hinder the approval
of rapid testing. It was his estimation that it would take no more than
3 weeks after approval to determine whether or not CLIA regulations will
be waived. CMS will set regulations for how rapid tests will be used;
FDA will then determine whether CLIA will be waived.

Dr. Sweeney noted that the prevention committee met this morning and
decided on a recommendation that the full Council urge approval and a
CLIA waiver for rapid testing. Rapid testing should be made available as
soon as possible, maintaining all confidentiality and counseling and
testing guidelines applicable to existing tests. This recommendation was
motioned and seconded.

Dr. McKinnell noted there are several FDA advisory committees that have
recommended otherwise. He said he would much rather focus on the
outcome; working on the details of how to get there leads to a morass
that is more appropriate to the President or the Secretary of DHHS.
While he agrees that rapid testing should be immediately and broadly
accessible, Ms. McKinnell recommends that the Council not urge a CLIA
waiver.

Dr. Sweeney noted the prevention committee engaged in extensive
discussion this morning and determined that increased availability of
rapid testing is a part of the reason for recommending a waiver. Mr.
Nickerson agreed that this strategy would provide wide access. It may be
the case that a moderately complex rating would not impede access, but
that is unclear. Mr. Nickerson said he supports a recommendation to
waive CLIA requirements.

Dr. Gomez said that the Council has been given enough information to
make an informed decision and assume a position. While the Council has
been told the lack of a CLIA waiver will not be a barrier, several of
the presenters yesterday disagreed. Dr. Gomez said she feels the Council
is meant specifically to recommended "waived" versus "non-waived."

The Council's vote was held momentarily for a process question: will the
full Council reconvene following committee meetings this afternoon? The
answer was no.

The vote for the proposed recommendation was carried unanimously.

**PUBLIC COMMENT**

Dr. Coburn noted that each member of the public will be limited to five
minutes.

**Mary Hess**

Ms. Hess is President of Minority Health Care Communications, a
nonprofit TA and marketing organization whose goal is to help nonprofit
organizations reach pharmaceutical allies more successfully. Ms. Hess
said her career has always been focused on pharmaceuticals in HIV and
cancer. She has attended many meetings with pharmaceutical companies
(Bristol Myers Squibb, etc.). While she had not intended on making
public comment, Ms. Hess said, Council members should be aware that
Oraquick is not an oral fluid test: it is a whole blood test requiring a
finger stick, collection with a lancet and a blood loop. It also has
multiple steps. A CLIA waiver would enable people with no background in
multiple-step lab processes to administer this test. As a former
employee of Orasure, Ms. Hess said she strongly believes in rapid
testing, but Oraquick is not based on the same testing process. She
recommended arranging a product demonstration with Orasure management.

Ms. Hess's second recommendation, related to prevention messages and the
continuing concerns about reaching the target constituencies with
prevention messages, is to create an "ad council working group" with a
voluntary membership comprised of various marketing experts and
marketing staff from the pharmaceutical companies currently working on
HIV (Glaxo Wellcome, Bristol Myers Squibb, Smith Kline, etc.) to
participate collaboratively with a CBO membership to develop prevention
messages. Ms. Hess said she would be willing to help create an
infrastructure for such a project.

**Dr. Geneviève Flanvielle**

Dr. Flanvielle noted that, with respect to rapid testing, the Council
selected a limited range of persons to speak. In considering a topic
like rapid tests, everyone involved in the debate should speak,
providing all the information needed to make a decision.

As an openly gay, unmarried woman, Dr. Flanvielle said, her 10-year
relationship was truly a marriage in the full definition of the word.
She recommended that the Council use the term "relationship" not
"marriage." The important thing is the quality of the relationship. Dr.
Flanvielle said that "ethics, principles, and values" are the key words
that children and adolescents need to be taught. It is not the logistics
of a relationship, but its quality, that matters. She recommended
teaching values: what is appropriate and what is not. Youth should be
taught that abstinence is better; however, if they are sexually active,
they need to know to use condoms. Youth should be taught the whole
truth. Dr. Flanvielle noted that 3 or 4 years ago in a prevention
convention in Los Angeles, with 5,000 attendees, there was only one
session on ethics. It was attended by 10 people, 7 of whom were
educators. Youth expect to be led; adults should lead by teaching
values, ethics, and principles.

**Dr. Eugene Capello**

Dr. Capello, who is the Executive Director of Florida AIDS Action and
works with the University of South Florida College of Medicine, said the
research community had the foresight to create a structure with
lifesaving medications for AIDS. Within Title II of the Ryan White CARE
Act, ADAP completes this function; however, some states have waiting
lists, including Florida, where there is great concern about ADAP. Dr.
Capello applauded the Council for its recommendation that the President
address the issue; emergency allocations are needed to fund ADAP in FY
2002 and 2003.

Regarding rapid testing, Dr. Capello thanked the Council for the
recommendation just passed, including a CLIA waiver. This is an
important tool for outreach workers to reach the most difficult-to-reach
populations, such as sex workers, the homeless, and chronic IDUs. One
story from Tampa reported on a outreach person searching 8 months to
find a lost positive. Dr. Capello asked how many new infections that
positive might have caused in that time. Rapid testing in a counseling
and testing context, with immediate entry into treatment, will assist in
reaching the key goal of the CARE Act. Dr. Capello thanked the Council
for its leadership and commitment.

**Frederica Wilson**

Ms. Wilson noted she came to convince the Council to do what it has
already done, that is, recommend approval of rapid testing. Ms. Wilson
is the State Representative for District 104 in North Miami, Florida;
she is also founder and Executive Director of 5,000 Role Models of
Excellence, a mentoring program in Miami-Dade County public schools.
Dealing with African Americans, this program involves 10,000 children
and 15,000 men who serve as mentors. Ms. Wilson said the HIV rapid
tests, with properly trained and supervised outreach workers, will be an
incredible tool. Too many HIV-positive persons do not return for their
test results and may be infecting many others in the meantime.
Unreceived results also become a burden to the agency trying to find the
PLWH and get them into care. African Americans and other
disproportionately affected populations have been statistically less
likely to return for their results. Florida has the number 1, 3, and 4
cities for HIV infection rates in the United States. During the past
session, Ms. Wilson said, she had a victory in passing a difficult bill
that deals with the testing of inmates on release from prison. Governor
Jeb Bush signed the bill in May. The bill states that, 60 days prior to
release, each inmate in Florida will be tested for HIV/AIDS; if
positive, they will be counseled, medicated, and linked to care in the
city of their relocation. Ms. Wilson thanked the Council for its time
and commitment to this cause.

Regarding youth prevention: With child statistics rising on a daily
basis, and with teenage mothers and fathers in the public schools across
the county, Ms. Wilson said, these is no such thing as an
abstinence-only curriculum. HIV infection rates in youth need to be
addressed. Young people are not "cookie cutter" people.

**Frederick Wright**

Mr. Wright noted he is happy to celebrate the fact that he is alive; in
part because of people like the Council members standing up for people
like Mr. Wright. As a moderate Republican, Mr. Wright commended
President Bush's work on the global AIDS issue. He noted that in the
Christian faith, Jesus was clear on the point of feeding all his
children; he did not distinguish between 12, 20, or 55 years old. Mr.
Wright said Africa's problems stem from its having been so long
exploited by imperialists from other countries, including the United
States. Mr. Wright noted that Haiti has been occupied three different
times; history shows that, as capitalism pushes other societies, they
have cultural problems. Mr. Wright said Americans, especially as
Christians, have the responsibility to address these problems.

Mr. Wright said the World Health Organization should provide more money
for global HIV. Two years ago, Sandy Thurman said that \$30 billion will
be needed to address AIDS globally; yet there is only \$1 billion
available. Mr. Wright asked the Council to recommend that President Bush
put more money into the Global AIDS Fund. He also noted that the G7 is
meeting today, and the United States should urge Great Britain and other
G7 nations to support the Fund. Last year, Terry Anderson called global
AIDS "industrial genocide." Mr. Wright said he hoped a cure is found
soon and this Council can be disbanded, but for the time being, he hopes
to convince all leaders on this Council to lean toward more money for
global AIDS.

**Marcia Martin**

Ms. Martin referred the Council to a quote from Secretary Thompson,
stating that the danger of HIV "is getting worse. The worst mistake we
can make right now is to let our guard down, for AIDS is still a
wretched killer and too many lives are at stake." Sec. Thompson was
quoted in the book "Fiscal Year 2003 HIV/AIDS Appropriations
Recommendations," published by the National Organizations Responding to
AIDS (NORA). Ms. Martin said she had some concerns that she hoped the
Council would think about as they decide the direction in which to
proceed. For example, she asked the Council to stop thinking in terms of
"instead of" and always think "in addition to." The HIV community has
been stuck with "this *or* that" for 20 years.

Having worked in the Federal Government for 8 years, Ms. Martin said,
simply getting more money is not the answer. In discussing prevention,
there are many options: condoms, needles, abstinence: no one is paying
attention to the practical applications. AIDS Action is thinking about
how to participate in the national conversation. It is a totally
different environment from what it was 20 years ago. Strategies need to
be updated; it may be time for the "old folks" to get out of the way if
they are still working from old ideas. Ms. Martin provided a few newer
ideas for consideration:

-   Prescriptions for prevention: prevention plans should be different
    for different people. If marriage is claimed as an effective tool,
    then gay marriage would be just as effective. This can be researched
    and tested. Ms. Martin noted she cannot speak to what a 14-year-old
    needs to know about HIV, but this information should be tailored, as
    compared, for example, to what a 37-year-old needs to know.

-   "Can you package it?" Ms. Martin asked how to ensure that care is
    available to everyone---regardless of how it is financed. A goal of
    this Council and the community must be to assure that care is
    available for all PLWH.

-   Communities can help. Communities have always done some of the best
    work around the epidemic. It has been the communities that built the
    initial response to the epidemic; Government needs to support these
    communities.

Ms. Martin praised the Council's diversity and said this is an example
of "in addition to" rather than "instead of." She said the HIV
bureaucracy knows more now than 20 years ago about effective
prescriptions for prevention, but it still has not given itself
permission to write them.

**Closing Comments**

Ms. Ware thanked all the public speakers.

Ms. Ware also announced that Ethics has decided that Council members who
have not received an ethics briefing will be permitted to sign their
ethics forms attesting that they have read and understood the printed
materials.

**ADDITIONAL COUNCIL DISCUSSION**

Council staff distributed copies of notes from the June 21 discussion
regarding the ADAP shortage. Dr. Coburn noted he asked Mr. Minor and Dr.
McKinnell to look at options. Dr. Coburn noted they have had discussions
with the Appropriations Committee on next year's ADAP budget; the
purpose right now is to alleviate the extreme shortage for this fiscal
year. Knowing how such things have worked in the past, Dr. Coburn said,
it will be very difficult to get results from the Government in the next
4 months. The Council is therefore asked to consider what can be done in
conjunction with Pharma in terms of non-Government strategies.

Dr. Coburn noted that any ideas from yesterday's discussion asking for
Government action should be communicated to the White House, while the
Council, the pharmaceutical companies, and other entities should do what
they can. For example, there is no reason the AMA and specialty medical
associations cannot send out information on how to access programs
outside of ADAP, as recommended. Dr. Coburn said he hoped the Treatment
Committee will be responsive to these recommendations. There are
approximately 1,300 people on waiting lists in the United States
(although, Dr. Driscoll said, it is hard to get exact statistics at any
one time---there are close to 500 in North Carolina alone). Dr. Coburn
asked the committee to understand that, in terms of Federal authorizing
legislation interfacing with State regulations, just putting more money
into ADAP may not solve the problems. In some cases money may be sent to
States not suffering an ADAP shortage because of better State-level
participation. A better response and a smarter, more refined process are
needed in the short term.

Dr. Sweeney asked to be reminded about the recommendation yesterday when
someone put together a reference for all mechanisms for accessing care
programs across the United States; Dr. McKinnell stated that a Web site
listing such resources will soon be online.

Dr. Driscoll suggested that the Council send a letter to the White
House, and empower Ms. Ware or designee to seek a meeting on the subject
of that letter with White House staff member Aaron Phelps.

\[WHO?\] explained that some States have really good models and manage
their money well; those models need to be shared with or replicated in
the shortfall states. In addition, because this is the fourth quarter of
the fiscal year, emergency funding is needed to get the shortfall states
through the crisis. Dr. Coburn said this is an excellent suggestion, but
the Council needs to consider how to carry it out. He said that the
emergency bill in Congress right now has no additional ADAP money in it.

Mr. Nickerson stated that, although short-term solutions are needed at
present, the Council needs to consider the entire ADAP model as
appropriate for dealing with a long-term disease. Part of the problem
may be the simplicity of the model. Dr. Coburn agreed, and said the next
generation of drugs will only exacerbate that problem.

Dr. Driscoll suggesting looking at RWCA States that are in trouble. He
recommended authorizing Ms. Ware to continue discussions with WHO to see
what can be done about putting more targeted money into troubled states.

Dr. Coburn asked whether the Council could depend, on a regular basis,
on the Treatment Committee to determine appropriate courses of action
and get recommendations to the Executive Director. Mr. Minor noted that
the Treatment Committee will be meeting at noon today and can begin work
on this immediately. He suggested that the committee draft a response
and send it to Ms. Ware and the Co-Chairs. Dr. Coburn explained that he
does not believe the situation permits a full Council review of the
Treatment Committee's recommendations, given the dire need to inform
State medical associations on how to access drugs outside of ADAP; he
therefore asked the Council to trust the Treatment Committee to draft
recommendations.

Ms. Ware cautioned that Council members cannot interact directly with
State agencies: all communications need to come through the PACHA
office.

Dr. Gomez moved, and Ms. Rock seconded, to grant the Treatment Committee
authority to execute recommendations to go to the Co-Chair and
thereafter be sent off as appropriate.

Mr. Minor brought to the Council's attention the letter from Paul Kawata
of National Minority AIDS Council (NMAC) that was distributed this
morning, regarding an interactive session at the U.S. Conference on AIDS
(USCA) between PACHA and conference attendees. The idea is to have an
opportunity for this Council to go to USCA and listen. The majority of
people who attend and who are served by the attending agencies are
people of color. Attending will be executive directors, case managers,
and front-line providers. Mr. Minor noted he was not asking that PACHA
pay for the conference or associated travel expenses; however, as a
number of members will be attending anyway, the thought is to serve as
members of PACHA in the public view. Mr. Minor said it is a key part of
Council members' job to hear what is being said in the community and
bring it back to the Council. USCA represents a great opportunity to say
to the community, "We want to hear you."

Dr. Sullivan noted he will have to check whether he can rearrange his
schedule to attend the USCA; he recently accepted an invitation to
lecture at a university on the same evening as the scheduled session. In
general, however, he said the Council should respond to this invitation,
and if he is unable to attend, that is all the more reason other Council
members should go. Dr. Sullivan noted the Council has a very limited
budget; if members can attend on their own budgets, that would be
excellent.

Ms. McDonald said this would be a great occasion for PACHA to step up
and hear front-line stories. Since several members are already planning
to attend, the Council can make a decent showing.

Dr. Coburn noted he has a conflict that cannot be resolved during the
USCA, but said that it is a great idea for Council representatives to
attend and listen to conference participants. He cautioned, however,
that listening is all such members can do in this context; members
cannot expound on PACHA policy or opinion. He asked for a showing of
which members will be attending; eight members so identified.

Mr. Minor noted that Mr. Kawata has already designated the time and date
for this "town hall meeting." He said the idea is to document all
comments and distribute them to the Council, so if the Co-Chairs cannot
attend, at least they will see the comments.

Dr. Coburn called for a motion to authorize this action, with the
understanding that members will not be put in a position in which they
have to respond to public comments or questions. Ms. McDonald so moved,
and Mr. Perez seconded. Discussion on the motion followed:

Ms. Rock recommended alerting NMAC in writing in advance of the USCA
that Council members cannot respond on behalf of the PACHA. Dr. Coburn
assured the Council that there will be appropriate interaction between
the PACHA executive staff and Mr. Kawata to that effect, making sure to
satisfy both parties and observe ethical concerns. Mr. Minor noted he
has already informed Mr. Kawata that whatever was agreed upon by the
Council would have to go through Ms. Ware's office.

Dr. Coburn called for a vote; the motion passed unanimously.

Dr. Sullivan related to the full Council his comment to the
International Committee yesterday, regarding President Bush's \$500
million initiative on global AIDS. Although this pledge is just a start
in dealing with the global AIDS crisis, Dr. Sullivan suggested that the
Council start by sending a letter of commendation to the White House,
and noted that more money is needed. The Council's role, he said, is not
only to criticize when it disagrees but also to commend when it agrees.
Mr. Perez agreed with Dr. Sullivan's recommendation, and asked if it
were appropriate to attach a secondary request for a formal response to
the last set of Council recommendations.

The Council discussed the pros and cons of including both positive and
negative feedback in the same letter. Dr. Sullivan noted he has received
many comments about the absence of a representative from the Office of
National AIDS Policy. It is important for such a person to attend to
ensure communication from this Council back to the White House.

Mr. Burden asked whether it would be appropriate to set a target for
international AIDS funding from the United States. Dr. Sullivan
explained why he discourages this idea: the President has a whole range
of issues he needs to deal with. If PACHA were to establish a target,
Dr. Sullivan said, he would be concerned about it becoming a bone of
contention; he would rather leave it open to future communication and
discussion. The point right now is to recognize the first step of \$500
million and to note that additional funding is needed. Mr. Burden said
his concern is that only the commendation section of such a letter would
be read, and the section on insufficiency would not be noted.

Mr. Nickerson noted that *The Washington Post* ran several editorials
yesterday observing that public perception is that the \$500 million
should be spent this year rather than spread over 3 years. The letter to
the President needs to speak to the need for more money. Mr. Nickerson
said there was definitely a process that was interrupted in Mr. Bush's
allocation of funds. Dr. Coburn cautioned that the Council does not know
what took place behind the scenes regarding that allocation, and
therefore cannot speak of such in the letter. The previous PACHA pointed
out that infrastructure is one of the most important pieces. Dr. Coburn
said the Council cannot be made a political football between the press
and the White House. Mr. Nickerson stated this was not his intention,
but suggested the Council should express its enthusiasm for more
international AIDS funding. Dr Sullivan began suggesting language: "We
recognize that the allocation will not solve the global crisis..."

Ms. Ivantic-Doucette recommended framing the letter in terms of
leadership on the issue. The letter can include discussion of the need
for ONAP's visible leadership to continue supporting the President.

Abner Mason said it is appropriate to send a letter commending the
President; it is a dramatic step, the import of which is not always
recognized by the Council because the issues are so large and complex.
It would be a shame to miss the opportunity to say to the President,
"That's the kind of leadership we want," and to pledge the Council's
continued commitment to work with the Administration on implementation.
In addition, Mr. Mason said, the Council should send separately a letter
on the other identified issues (e.g., requesting a response to the
previous recommendations or the participation of ONAP). The commendation
letter, he said, should be stand-alone. Dr. Sullivan said this
recommendation is acceptable.

Dr. Driscoll suggested that any communication to the President should
discuss the number of AIDS cases rather than the number of dollars
recommended. The Council should target numbers of people to be helped in
period of time, not how much should be spent.

Dr. McKinnell moved to draft a letter to the President, and Dr.
McIlhaney seconded. Discussion on the motion followed:

Mr. Perez asked for clarification that the Council will draft a letter
of commendation only, and offered a friendly amendment asking for a
separate letter to ask for a response to the previous Council
recommendations. Dr. Coburn gave his personal assurance that he will
seek and garner a response from somebody in White House on the previous
recommendations. He then called for a vote; the motion passed
unanimously.

Ms. Ware noted that the intention is not to reconvene as a full Council,
but to have committee chairs report back to the plenary via e-mail. She
stated that there will be a more thorough agenda for the October
meeting, and said she hopes the subcommittees will be able to meet by
conference call in the meantime.

One Council member recommended putting any major items for action or a
vote on the agendas ahead of time. Regarding public comment, today the
Council heard comments on issues that had already been voted on; it
would be more appropriate to hear from the public before a vote. Dr.
Coburn added it may be possible to gather public comment before the
Council even convenes, and publish this comment in advance.

Ms. Rock noted that members of two different populations---the deaf and
hearing impaired, and seniors---asked her to convey to the Council that
their populations are not getting appropriate HIV services. The deaf
sometimes have communications problem with clinicians, especially those
that cannot write in English.

Dr. McKinnell stated that committee conference calls are a good idea,
but the committee chairs need guidance on budget matters. Dr. Coburn
assured the Council that the Chairs will ensure committee members are so
guided. Ms. Ware noted that a line item exists for conference calls; she
will look at the budget to see how many calls it will support, for how
many people, and for how long.

Ms. Ware noted there has been a recommendation to record the committee
meetings and include minutes along with the plenary session minutes. Dr.
Coburn noted that this would entail three transcribers; Ms. Ware
suggested that each committee designate someone to take notes. Dr. Gomez
requested that a staff member be designated for all committee conference
call; Dr. Coburn agreed that there should be a designated staff person
on all conference calls. Dr. Coburn also said support staff should be
appointed to take committee minutes. Ms. Ware will arrange for support
staff to attend this afternoon's committee meetings and take notes.

Ms. McDonald asked whether substance abuse will be one of the main
points of the next meeting, and volunteered to help coordinate
presentations on the topic. Dr. Coburn offered his thanks.

Dr. Coburn thanked the members for their service and commitment. He said
the Chairs' goal is improvement in each and every meeting.

Ms. Ware reminded everyone that committee meetings are not open to the
public.