# Presidential Advisory Council on HIV/AIDS (PACHA)

# 24th Meeting

**Hubert Humphrey Building**

**200 Independence Avenue, S.W.**

**Room 705A**

**Washington, DC 20201**

**Monday, June 28, 2004, and Tuesday, June 29, 2004**

**Council Members---**

**Present June 28 and June 29**

Co-Chair Louis Sullivan, M.D.

Rosa Biaggi, M.P.H., M.P.A.

Jacqueline S. Clements

Mildred Freeman

John F. Galbraith

Edward C. Green, Ph.D.

Cheryl-Anne Hall

Jane Hu, Ph.D.

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

Rashida Jolley

Abner Mason

Joe S. McIlhaney, Jr., M.D.

Henry McKinnell, Jr., Ph.D.

Brent Tucker Minor

Dandrick Moton

Jose Montero, M.D., F.A.C.P.

Beny J. Primm, M.D.

David Reznik, D.D.S.

Deborah Rock

Rev. Edwin Sanders II

Prem Sharma, D.D.S., M.S.

Lisa Mai Shoemaker

Anita Smith

Don Sneed

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

Ram Yogev, M.D.

**Staff---**

**Present June 28 and June 29**

Joseph Grogan, Esq., Executive Director

Dana Ceasar, Program Assistant

# *DAY 1*

**MORNING SESSION**

Dr. Louis Sullivan, PACHA Co-Chair, called the meeting to order at 8:45
a.m. and welcomed members of the Advisory Council and guests. The
meeting began a bit late, he said, because of the swearing-in of several
new members. He welcomed Joseph Grogan, new executive director of PACHA,
and thanked outgoing executive director Josephine Robinson for her
service to the Council.

Dr. Sullivan also thanked several members of the Council who have
completed their service: Dr. James P. Driscoll, Katryna Gholston, Joseph
Jennings, and

Nathan M. Nickerson. He welcomed the new ideas and perspectives of three
new members to the Council---Dr. Jose Montero, Dr. Ram Yogev, and Dr.
Cheryl Bowers-Stephens (who was not present)---and asked Drs. Montero
and Yogev to introduce themselves.

## Remarks

Dr. Montero is a native of Tampa, Florida, a physician at Tampa General
Hospital specializing in infectious disease, and a faculty member at the
University of South Florida Center for HIV Education and Research. His
HIV practice is mostly with inpatients in the hospital setting. He
thanked the Council for making him part of this "prestigious and
important" group.

Dr. Yogev is professor of pediatrics at Northwestern University and
medical director for pediatric and maternal HIV infection at Children's
Memorial Hospital, Chicago, Illinois. His main interest is pediatric
HIV; as chair of the committee within the Pediatric AIDS Clinical Trials
Group (PACTG) that decides which studies will be done, he is working
with international efforts in South Africa and Thailand. He said that he
hopes he will mesh with the "important people" of this Council.

Dr. Sullivan announced that public comment will begin at 10:30 a.m. The
agenda of this meeting covers a variety of topics, including HIV/AIDS in
the African American community, the Ryan White CARE Act, and the
HIV/AIDS epidemic in India.

**Joseph Grogan, Esq.**

Mr. Grogan said he was excited and happy to be the new executive
director of the Council. He noted that he met some Council members at
the Prevention and Treatment and Care Subcommittees meeting and thanked
those who have helped him become oriented to his new position, including
Dana Ceasar, PACHA program assistant, for her outstanding work. Although
Josephine Robinson, the previous executive director, has moved on to
another position, she has always been available to provide help when
needed.

### **Josephine Robinson**

Ms. Robinson thanked the Council for what she said has been probably one
of the best work experiences she has ever had. She said she is saddened
to leave the group, and many Council members have become dear friends
and colleagues. She moves on to serve as chief of staff of the Office of
Public Health and Science (OPHS), U.S. Department of Health and Human
Services (DHHS), which oversees PACHA, so she will remain involved. She
noted that National HIV Testing Day, a campaign to spread the message
about the importance of HIV testing, was yesterday (June 27), and free
HIV testing continues for the next 2 days in the Hubert Humphrey
Building. She urged all to know their HIV status and to encourage others
to do so also. She added that that she was not saying goodbye to PACHA,
but rather "thank you."

Dr. Sullivan also welcomed Carol Thompson, director of the White House
Office of National AIDS Policy (ONAP).

### **Carol Thompson**

Ms. Thompson has been ONAP director since February 2004 and acting
director since August 2003, and she looks forward to meeting all those
on the Council she has not already met. She thanked Ms. Robinson for her
exceptional diligence in her leadership of PACHA and congratulated Mr.
Grogan on taking over the job.

Last week was an exciting week for those at the White House involved
with HIV/AIDS, Ms. Thompson said, with the President promising strong
support for reauthorization of the Ryan White Comprehensive AIDS
Resources Emergency (CARE) Act. Three main principles will guide the
work of ONAP: (1) to bring the focus back to critical care and
treatment, ensuring that lifesaving drugs get first to the people who
need them; (2) to facilitate that by giving more flexibility to the
DHHS, and specifically to the Health Resources and Services
Administration (HRSA); and (3) to recognize the need for State and local
planning, to understand that what works in Cincinnati may not work in
Manhattan and Des Moines. It is important to show the American taxpayer
that the Office is on track to make sure resources get to where they are
most needed.

The President's recent announcement that \$20 million will be diverted
to 10 States to help the AIDS Drug Assistance Program (ADAP) will be a
big help, although everyone involved in the fight against HIV/AIDS
recognizes that more needs to be done. An important aspect that will be
emphasized is the need for focus on AIDS in the African American
community---for African Americans between the ages of 25 and 44, AIDS is
the second leading cause of death.

ONAP is also focused on vaccine development. Finding a vaccine for the
virus is a long way off, but progress is being made. The President also
issued a proclamation supporting National HIV Testing Day.

Internationally, the United States has designated \$500 million to fight
AIDS in Africa and the Caribbean, and clearly India is another crucial
area affected by the pandemic. India is the largest nonfocus country for
the United States, with \$20.5 million spent there in fiscal year 2004.

Ms. Thompson concluded her remarks by thanking the Council for its
service to everyone who is suffering with this disease.

### **Discussion**

Dr. Sullivan asked Ms. Thompson to comment on the President's decision
to make Vietnam the 15th focus country in the President's Emergency Plan
for AIDS Relief (PEPFAR), the 5-year global plan, when the problem is
more severe in populous countries such as China and India, where efforts
are needed to get ahead of the virus. Ms. Thompson said that they were
trying to focus on where U.S. resources would

go furthest and the countries in greatest need, and felt that Vietnam
was the right place to go. While there are now an estimated 130,000 to
300,000 cases of HIV/AIDS in Vietnam, the number is projected to reach 1
million by 2010, and 80 percent of transmission is from sexual contact.
The challenge is to keep the epidemic in Vietnam from spreading to the
general population, and the United States thinks it can influence the
prevention effort, working with faith, community-based, and
nongovernmental organizations (NGOs). India is the largest nonfocus
country, but a significant amount of global work is going on there,
including the work of the Global Fund and the Gates Foundation.

Dr. David Reznik asked how the \$20 million designated for ADAP will be
disbursed, and if drugs would be provided at special pricing and
distributed to the States. Ms. Thompson responded that the actual
mechanism is yet to be worked out. States and organizations in most need
will be able to get drugs directly, but it is doubtful there will be
special pricing. Ms. Robinson added that in the 10 identified States,
the \$20 million is to purchase drugs to alleviate the immediate
emergency needs of individuals on waiting lists to receive drugs.

Dr. Yogev asked for clarification that appropriate attention will be
given to the adolescent population in African American communities,
because that is often where the disease begins, in adolescents as young
as 12 and 13 years old.

Jacqueline Clements asked how long it would take for people in the
States to get medications, since States are going to get the drugs, not
money, and a process to identify the individuals who need the
medications will be necessary. Ms. Thompson said that the specific
intent is to eliminate excessive bureaucracy, and that is why States
will get medications rather than money. Christopher Bates, acting
director of the DHHS Office of HIV/AIDS Policy, said that drugs will be
issued based on formularies of the States, and the intent is to
facilitate movement of these drugs, for better prices and to avoid
adding an administrative burden in responding to an emergency situation,
and to move people off the waiting lists.

Brent Tucker Minor, Chair of the PACHA Treatment and Care Subcommittee,
thanked Ms. Thompson for her remarks, and said it is apparent that the
Federal Government has heard the need and responded, and this is good
for people with AIDS. Regarding reauthorization of the Ryan White CARE
Act, he said that many on the Council see this as a crossroads for good
care and treatment, and asked what the role of the Council should be.
Ms. Thompson responded that her Office will rely on PACHA and its
experience for advice on moving forward. The President has opened the
dialogue about what needs to be done, and she welcomes input about
reworking the program, what needs to be fixed, and how to fix it, with
the principal focus on primary care. She looks forward to hearing from
members of the Council over the next months and year regarding specific
roles they can take.

## Agenda

# PREVENTION PRESENTATIONS

-   The State of HIV/AIDS Among African Americans: A Demographic
    Overview and CDC Methodology. Janet Cleveland, Centers for Disease
    Control and Prevention (CDC), presenter.

-   Update on the Status of HIV Reporting in the United States. Dr.
    Matthew McKenna, CDC, presenter.

**Panel Discussion:**

-   Understanding the Down Low Phenomenon and Why Incidence of HIV/AIDS
    Is Higher Among African Americans. Greg Millet, CDC, presenter.

-   Barriers to Treatment of HIV/AIDS in African Americans: Including
    Addiction and Mental Health Issues Specific to African American Men.
    Dr. David Malebranche, Emory University School of Medicine,
    presenter.

-   African American Women's Issues and HIV. Dr. Jean R. Anderson, Johns
    Hopkins University School of Medicine, presenter.

Dr. Sullivan noted that the Prevention Subcommittee, chaired by Anita
Smith, organized the agenda for this meeting. Ms. Smith said that the
agenda is a joint effort of the Prevention and Treatment and Care
Subcommittees, whose members felt it was important to address the issues
of both these groups. This meeting's presentations began with an
epidemiological overview of HIV/AIDS in African Americans, because data
are needed to start the conversation. In the afternoon, after the three
speakers, the presenters answered questions together, as a panel.

The first presenter, Janet Cleveland, deferred briefly to Mr. Bates who
informed the Council that DHHS Secretary Tommy Thompson has expanded
rapid HIV testing with oral rapid testing, an accurate test that does
not require drawing blood. This has provided expanded opportunities for
testing and increased ability to learn who is HIV-positive and connect
him or her with services. The Substance Abuse and Mental Health Services
Administration (SAMHSA) has become involved with this effort and will be
using rapid

testing kits employing both blood and saliva at methadone clinics. These
are major developments in advancing the work of identifying individuals
who are HIV-positive and connecting them with services.

Dr. Reznik clarified that it is oral mucosa that is tested, not saliva.
He emphasized that this is an important differentiation, made to avoid
rekindling fears that HIV is spread through saliva. Dr. Sullivan noted
that one of the advantages of rapid testing is that a patient can get
immediate counseling, but it is not clear how that will be an advantage
for those who do not return to the clinic.

Karen Ivantic-Doucette asked if guidance would be provided to States
about new rapid testing. Mr. Bates said that guidance packages about
using the new technology will be put together and distributed, and
information will be disseminated through train-the-trainer programs.
Just fewer than 1,000 persons have been trained, and progress is being
made, but no final protocol is yet in place. His Office is working with
the CDC and others to give guidance in clinical settings. Ms. Cleveland
added that the CDC is planning to train trainers associated with SAMHSA
in methadone clinics. Dr. Monica Sweeney said that the issue is not so
much technical training, but to readjust thinking, so counselors can
quickly assess a client's coping skills---instead of a week, they have
20 minutes to adjust to a diagnosis. Counselors need to be retrained to
deal with that, she said, and mental health backup onsite should be
available for people who need it.

# The State of HIV/AIDS Among African Americans:

# A Demographic Overview and CDC Methodology

# Presenter: Janet Cleveland, Deputy Director for Programs, Divisions of HIV/AIDS Prevention, National Center for HIV, STD, and TB Prevention, CDC

Looking at cases, deaths, and persons living with AIDS in the United
States from 1986 onward, there has been a steady rise in newly diagnosed
cases. In 1993, when the actual definition was implemented, and shortly
thereafter with the advent of protease inhibitors, the numbers of newly
diagnosed cases and deaths started to decline, but the number of persons
living with AIDS has continued to increase.

Great disparity is seen when comparing rates by race and ethnicity. The
rate of cases in African Americans far exceeds rates in other groups; it
is 10 times the rate of whites. There has been considerable discussion
about the disproportionately rising rates among African American women,
which are thought to be largely the results of injecting drug use (IDU)
and being partners of IDUs. From 1999 to 2002, the estimated number of
HIV/AIDS diagnoses in African American women, derived from 30 areas
supplying confidential HIV reporting since 1998 (29 States and the U.S.
Virgin Islands), was more than five times the number of white women and
more than three times the number of Hispanic women.

Looking at numbers of diagnoses by mode of exposure, the rates among men
having sex with men (MSM) has gradually increased in recent years, with
a 17 percent increase between 1999 and 2002. The number of diagnoses in
IDUs has stayed relatively stable,

with a slight decrease recently in IDU cases. The number of cases due to
heterosexual contact has remained stable, as has the number of
individuals classified as both MSM and IDU.

More than 65 million people in this country are currently living with an
incurable sexually transmitted disease (STD), with approximately 18.9
million additional infections each year. In addition to HIV/AIDS,
African Americans in the United States are also disproportionately
affected by other STDs, specifically chlamydia, syphilis, and gonorrhea.
This is an issue of great concern.

A closer examination of the impact of HIV/AIDS in African Americans
shows that

50 percent of the more than 42,000 AIDS cases diagnosed in 2002 in the
United States were in African Americans. The leading cause of HIV
infection in African American men is sexual contact with other men,
followed by IDU and heterosexual contact. Heterosexual contact is the
leading cause of HIV infection in African American women. People might
want to believe that women who contract HIV/AIDS are of a certain
socioeconomic status (SES), but infected African American women are
found in all strata of life. HIV/AIDS is among the top three causes of
death for African American women aged 35 to 44 and African American men
aged 25 to 54. In 2002, 62 percent of children born to HIV-infected
mothers were African American. However, perinatal prevention has been
one of the great success stories in the AIDS epidemic in this country.

By age, gender, or however the HIV/AIDS data are interpreted, there is a
huge discrepancy related to race in the United States. From 1998 to
2002, African American men and women were infected at a considerably
higher rate than white men and women. In 2002 the racial breakdown in
diagnoses was 54 percent African American, 32 percent white, and 12
percent Hispanic. Looking at MSM, 60 percent of cases reported through
2002 have been in African American men.

The CDC has responded to the epidemic in the African American community
in a number of ways. A minority initiative began in 1988, with funds for
national and regional minority organizations to provide technical and
capacity building assistance to community-based organizations serving
communities of color. That effort continues today. Since 1989, the CDC
has funded HIV prevention efforts by some 142 organizations. The CDC
also provides national oversight and guidance for State and local health
departments, which play a crucial role. The Division of Adolescent and
School Health (DASH) takes the lead in this endeavor, and since 1990,
the CDC has funded State and local education agencies to ensure that
every child in the United States is provided effective education to
protect themselves and others from HIV now and all their lives.

Goals of CDC's HIV strategic plan through 2005 for prevention are to
decrease new infections; increase knowledge of serostatus; increase
linkage to prevention, care, and treatment; and strengthen monitoring,
capacity, and evaluation.

The Advancing HIV Prevention (AHP) initiative offers new strategies for
a changing epidemic. The prevention strategy is a three-pronged approach
comprised of HIV counseling, testing, and referral; prevention with
persons living with HIV; and prevention

with persons at high risk for HIV. These approaches, working with other
Federal partners such as HRSA and SAMHSA, have the purposes of reducing
barriers to early diagnosis of HIV infection and increasing access to
and use of quality medical care and treatment and prevention services
for persons living with HIV. Prevention for high-risk individuals who
are seronegative and people with HIV infection is an important
component.

The four priority strategies of AHP are to:

1.  Make voluntary HIV testing a routine part of medical care.

2.  Implement new models for diagnosing HIV infections outside of
    medical settings. The CDC is working with community-based partners
    and training personnel to promote this effort.

3.  Prevent new infections by working with persons diagnosed with HIV
    and their partners.

4.  Further decrease perinatal HIV transmission. The goal is zero, and
    there is no reason this cannot be achieved.

DASH works closely with the Divisions of HIV/AIDS Prevention to ensure
that the prevention message is getting to school youth. It targets more
intensive prevention efforts to youth at highest risk for HIV infection
and conducts behavioral research to learn why youth are at risk and
provide a science base for effective policies and programs.

Another CDC effort is targeted to the South. For a long time, many
thought HIV was not a problem in the South, but it is clear that trends
have moved southward, particularly in African Americans. Looking at
estimated diagnoses by region, numbers were relatively stable from 1999
to 2002, with a slight incline in the West, a decline in the Northeast,
and a steady incline in the South, enough to raise some concern. In a
study of people with AIDS in four southern States (Delaware, Georgia,
South Carolina, Florida), most were infected in metropolitan urban
settings, most had moved back to southern communities to be closer to
their families, and most did not believe they were at risk for HIV.

High-risk behavior was reported in both southern and urban settings.
Those infected from urban areas were more likely to engage in alcohol
and drug use, exchange sex for money and drugs, and have a partner who
was an IDU. Issues related to prevention and care need to be rooted in
considerations of where resources will come from for people who are
infected in urban settings and return to their families in less urban
areas, without the resources of big cities, and what impact that has on
the South.

The CDC recently investigated an outbreak of HIV in North Carolina that
had been widely reported in the media. The situation began in November
2002 with the identification of two cases of acute HIV infection in
African American college students in the State. In May 2003, 56 cases
were identified in college students. In African American college
students and nonstudents, 49 cases of HIV were diagnosed among MSM. In
August 2003, the CDC was invited to assist in an epidemiological
investigation. A number of schools were involved, including but not
limited to historically African American colleges and universities.

Based on a case-control study to assess the differences between
HIV-positive and

HIV-negative MSM, the CDC concluded that high-risk behaviors are
occurring in young African American MSM college and noncollege students.
But venues for meeting partners are not limited to college campuses,
providing ample opportunity for sexual mixing. A plethora of complex
issues is involved. Prevention messages need to be related not only to
HIV but also to other STDs. And men who have sex with men but do not
self-identify as gay or bisexual may have casual or steady female sexual
partners and function as a vector to the female community. \[These men
were examined more thoroughly at this meeting in a subsequent report on
the "Down Low."\]

The CDC responded to the North Carolina outbreak with funding to the
State's DHHS to adapt a community-level intervention, which relies on
trained peer volunteers to endorse safer sexual behaviors, diffuse these
messages to their social network through casual one-on-one
conversations, correct misconceptions, and promote HIV prevention. The
CDC is also increasing its efforts among historically African American
colleges and universities and currently funds nine governmental
organizations to strengthen the schools' HIV prevention services. The
CDC also will provide \$450,000 to conduct a survey among students
attending historically African American colleges and universities about
HIV knowledge, attitudes, risk behaviors, and prevention and testing
services on campus. A group of schools in Atlanta recently took a lead
in these efforts, with a policy discussion convened by local
representatives to Congress on how they can lead the prevention
initiative and diffuse knowledge around the country.

Ms. Cleveland ended her presentation with a quote about hope from
Frederick Douglass that underscores the severity of today's epidemic and
the role of personal responsibility in combating it:

*Notwithstanding the great and all-abounding darkness of our social
past, notwithstanding the clouds that still overhang us in the moral and
social sky ... it is the faith of my soul that this brighter and better
day will yet come. But whether it shall come late or come soon will
depend mainly upon ourselves.*

#### ***Discussion***

Don Sneed asked what percentage of the recent community-based testing
initiative is focused on testing individuals, compared to other efforts.
Ms. Cleveland responded that testing is an integral part of the program,
with about one-third of the funded organizations specifically working on
testing and counseling, and others that may also do prevention work.
Counseling and testing is the main thrust of the CDC prevention program,
she added.

Mr. Sneed followed up with a question about the large number of African
Americans still living in the South, and the history of racism in that
part of the country. He asked if there is evidence that racism and
discrimination in the gay community affect resource allocation, citing
an article from the June 27, 2004, New York Times, "For Young Gays on
the Streets, Survival Comes Before Pride." Ms. Cleveland said she would
defer to

other members of the Council on this question, and Mr. Sneed said he
knows there is indeed an impact. Ms. Smith said there would be further
opportunity to discuss this issue in the afternoon session.

Ms. Clements asked if the CDC would do the same for other States that
identified unexpected, acute cases as it did for North Carolina. Ms.
Cleveland said it was her educated guess that it would, and it depended
on available resources. She asked Dr. Matthew McKenna, also of the CDC,
to respond. Dr. McKenna said that the North Carolina program uses a test
that picks up components of the virus and identifies infected persons in
1 week, while others take several weeks, and this is extraordinarily
expensive technology, costing \$100,000 to \$200,000 per case. He added
that the CDC will do other demonstration projects in other arenas as
proof of the concept. One of the issues is that even with identification
of infected individuals, this test finds only a fraction of what is
found with a standard test.

Dr. Henry McKinnell commented that the quote from Frederick Douglass is
meaningful, but in his experience, action precedes hope. He said that
the first thing to do is consider the goal to reduce new infections---in
running his business \[he is chairman and chief executive officer of
Pfizer, Inc.\] the only goals that would be acceptable, for example,
would be reducing transmission from mother to child to 0, and 100
percent of people knowing their serostatus, and an AIDS-free generation.
In fighting a war, he emphasized, it is necessary to know the enemy, but
the enemy now being fought is the enemy described 10 years ago, and
fresher data and an updated perspective are necessary.

Dr. Sullivan said that he was part of the session at Atlanta University
where a group of college presidents said they had not seen any sort of
HIV outbreak as described in North Carolina. He asked if the CDC's
survey would cover all traditionally African American colleges and
universities or just a sample, and Ms. Cleveland said the plan is to
cover all in the United States, but it may be necessary to take a
sampling, depending on the accessibility of the schools. She thanked Dr.
McKinnell for his input on the need for real goals, but added that this
initiative complements the strategic plan, which is available on the CDC
Web site: *www.cdc.gov/nchstp/od/hiv_plan/Table%20of%20Contents.htm*.

Dr. Sweeney said that prevention efforts seem to be mostly secondary and
tertiary, and keeping this focus is not the best way to get ahead of the
epidemic. Also, she asked about infection in women as IDUs or sex
workers or in correctional institutions. Ms. Cleveland responded that
she is aware of the issue of secondary and tertiary prevention, and it
is the reason for a focus on prevention in people living with AIDS and a
commitment to prevention in people at high risk. Unfortunately, there
are limited national resources, and the CDC must look at the epidemic
from a national perspective. Local jurisdictions need to meet their own
local needs in prevention, working with community-based organizations
that are funded from a national level.

Regarding female IDUs and sex workers, Ms. Cleveland said, a greater
number of African American women are becoming infected with HIV through
heterosexual transmission, and IDU cases are declining. Sex workers are
definitely another facet of

transmission, as well as persons trading sex for drugs, and the CDC
funds organizations that address prevention needs of sex workers and
others who put themselves at risk. But she emphasized that the overall
national picture shows African American women contracting HIV from
heterosexual transmission.

## Introduction of Motions

Mr. Minor said that some of the proposed motions require changes,
particularly the one concerning ADAP, since funding has been announced.
Few amendments are expected from the Council, so rather than introducing
them at this point in the meeting, they will be introduced at tomorrow's
session. Dr. Beny Primm noted that the Council requested \$25 million
for ADAP and \$20 million was granted, and he would like to go on the
record as asking for the remainder. Dr. Sullivan said that will be
discussed tomorrow.

## Public Comment Session

# Public Speaker #1

**Dr. Gene Copello, executive director, The AIDS Institute**

Dr. Copello applauded the Council for the advisory role it played and
continues to play in communicating to the President and DHHS the needs
for life-saving medications of low-income Americans living with
HIV/AIDS. ADAP, a component of Title II of the Ryan White CARE Act, is
in a serious crisis, he said, with more than 1,600 low-income Americans
on waiting lists and many more ineligible for services. This is one of
the most pressing issues facing domestic AIDS policy. The AIDS Institute
is encouraged by the President's announcement on June 23, 2004, to
provide \$20 million in immediate assistance to reduce the ADAP waiting
list. The Institute hopes this is only a beginning to finding a
long-term and sustained solution to the crisis. Consistent access to HIV
antiretroviral drugs, as outlined by Public Health Service (PHS)
guidelines, is recognized as the central component of HIV medical care
today. Consistent access to these medications and the primary medical
care needed for their appropriate delivery extends life, improves
quality of life, and serves larger public health concerns.

Recently the Institute of Medicine (IOM), in its study "Public Financing
and Delivery of HIV/AIDS Care: Securing the Legacy of Ryan White,"
documented the need for consistent access to substance abuse treatment
and mental health services as important modalities for client adherence
to HIV antiretroviral drug therapy, Dr. Copello continued. A large
percentage of Americans living with HIV/AIDS are dealing with substance
abuse and mental health concerns. The treatment of these conditions
should be considered key if increased availability of HIV antiretroviral
drugs is to have its greatest impact. The AIDS Institute endorses this
view and encourages the Council to consider recommendations for the full
integration of these modalities into the national HIV/AIDS health care
delivery system.

Consistent and coordinated access to substance abuse and mental health
treatments, along with consistent access to primary medical care and
medications as outlined in the PHS

guidelines, need to be considered as part of the HIV/AIDS standard of
medical care. The AIDS Institute encourages the Council to consider
these issues as it makes recommendations about reforming the domestic
HIV/AIDS health care system, including discussion of the 2005
reauthorization of the Ryan White CARE Act.

# Public Speaker #2

# Laura Hanen, Director of Government Relations, National Alliance of State and Territorial AIDS Directors (NASTAD)

Ms. Hanen thanked the Council for the opportunity to present comments.
NASTAD represents HIV/AIDS directors in the States and Territories who
have programmatic responsibility for HIV prevention and care programs
and who coordinate programs across the continuum of HIV prevention and
care, including administration of ADAPs funded through Title II of the
Ryan White CARE Act.

State HIV/AIDS programs face a number of important issues, and Ms. Hanen
highlighted three of them. The first is the recent announcement by the
Administration of the purchase of \$20 million in drug therapies for the
10 States that currently have ADAP waiting lists. The State AIDS
directors and NASTAD are extremely thankful for President Bush's and the
Administration's commitment to increasing access for Americans to
lifesaving treatments. NASTAD is also appreciative of President Bush's
comments supporting the reauthorization of the CARE Act.

HRSA has begun to consult with the 10 eligible States. NASTAD, while
appreciative, is concerned about the time and effort it will take to put
this effort into operation. The eligible ADAPs are expected to determine
the treatment regimens of more than 1,600 individuals and administer the
delivery of HIV therapies. This means that States must work with their
case managers and treatment providers to determine the current treatment
regimens for every person on their waiting lists. While this may not be
too difficult in States like Iowa or Alaska, with fewer than 10
individuals on their waiting lists, it could easily overwhelm a State
such as North Carolina, which must determine the treatment needs of more
than 700 individuals. It is unclear how long these individuals will
receive treatment and what will happen if their treatment regimen should
change. States will require technical assistance to implement this
unique and complex effort. NASTAD plans to work with HRSA and State AIDS
programs to ensure this process goes as smoothly as possible.

While those who administer State AIDS programs are thankful that
treatment will now be available for those on waiting lists, NASTAD
cautions that this will not solve the ongoing structural deficit that
ADAPs continue to face. There are a number of States on the verge of
instituting waiting lists, and those patients will not receive this
relief. There are currently 10 States that anticipate new or additional
access restrictions before the ADAP funding year ends on March 31, 2005.
The future of ADAP will very much depend upon a continued Federal
commitment in FY 2005 and FY 2006.

The second matter for attention is the notification NASTAD recently
received about HRSA's decision to discontinue funding NASTAD as a
technical assistance (TA) provider to State AIDS programs. This has been
a decade-long relationship. This is extremely alarming to State AIDS
directors, who are in the midst of an ADAP crisis and about to embark on
the reauthorization of the CARE Act. HRSA has informed NASTAD that it is
not funding any agency to specifically provide TA to States or
specifically address the needs of ADAP program coordinators. This is
troubling, as Title II is the largest title of the CARE Act and begs the
question as to whether HRSA recognizes the legal responsibility of
States as the central authorities of the Nation's public health system.
Ms. Hanen pointed out that it is the State AIDS directors through NASTAD
who created the ADAP Crisis Task Force, which saved the Federal
Government \$65 million through its negotiations with the manufacturers
of antiretrovirals to maximize the resources available to all State
ADAPs.

Ms. Hanen also drew attention to the development and implementation of
the Medicare Part D Prescription Drug Benefit. NASTAD, along with the
HIV/AIDS community, has been following the issue closely and asks that
PACHA place this on its agenda for consideration. The Notice of Proposed
Rulemaking (NPRM) will be out sometime this summer, and Ms. Hanen
requested that members of PACHA submit comments that will ensure that
people living with HIV/AIDS who take part in the Part D benefit have
access to plans that include all medically necessary drugs to treat HIV
on their formularies. NASTAD is waiting to see how ADAPs will be handled
in the NPRM. The Alliance would like ADAPs to be recognized as State
pharmacy assistance programs or SPAPs and allowed to wrap around the
Medicare Part D Drug Benefit. If this does not occur, ADAPs will only be
allowed to fill in coverage gaps in the benefit, but these expenses to
ADAP will not be counted towards an individual's out-of-pocket expenses,
which are needed to hit their catastrophic limit. Therefore, ADAPs will
see little savings from low-income individuals leaving their rolls to
enroll in the Part D benefit and may choose to cover co-pays and
out-of-pocket expenses for those whose Medicaid program had once picked
up these costs.

# Public Speaker #3

**Dr. Rita Wutoh, African Futures Forum, Inc.**

Dr. Wutoh said she appreciates this timely Council meeting to discuss
the President's plan on HIV/AIDS in Africa. A cursory review of the
President's plan shows a crucial gap in the future implementation of
programs. Dr. Wutoh considers the role of youth and youth organizations
to be critical and necessary.

For example, African Futures Forum, Inc., a voluntary youth-based
organization that she represents, is partnering with other African youth
organizations to sponsor workshops on youth leadership development and
their role in HIV/AIDS. This includes proposal writing and funding for
community initiatives.

This initiative, Dr. Wutoh added, is a window of hope for youth to be
involved in changing the course of this devastating disease affecting
youth and the workforce. She urged the Council to consider how youth can
be integrated into the President's plan on HIV/AIDS.

# Public Speaker #4

**Diana Bruce, National Family Planning and Reproductive Health
Association (NFPRHA)**

Ms. Bruce expressed concern about the language in the draft motion about
mother-to-child transmission; specifically, the limitation to married
and monogamous women in the second "whereas." Public health messages
should be crafted to address all women at risk, she emphasized, and
messages that exclude the realities of many women's lives are dangerous
to women and their children. She recommended that the second "whereas"
be revised to delete "within marriage or monogamous relationship."

# Public Speaker #5

# Bill Arnold, director, ADAP working group

Explaining that his group is a coalition of AIDS organizations, service
providers, and pharmaceutical groups that manufacture AIDS drugs, Mr.
Arnold thanked the Council for getting ADAP on the President's agenda.
However, he emphasized that the \$25 million requested to clear the
waiting lists was not an arbitrary figure, and the \$20 million promised
can take care of people on the waiting list today, but within days or
weeks the list will return. He said \$20 million will not fix the
problem over the next 12 months, and additional appropriations are
needed for FY 2005. There are no shortcuts, and if the money is not
spent here, someone else will have to spend it somewhere else.

Dr. Sullivan thanked all the public speakers and said that their
comments would be taken under advisement.

## Agenda

# HIV Reporting in the United States

Presenter: Dr. Matthew McKenna, chief, HIV Incidence and Case
Surveillance Branch, Divisions of HIV/AIDS Prevention, CDC

An enormous amount of data from his unit is available, Dr. McKenna said,
and his primary intent at this meeting is to discuss the process of
reporting and the difference between HIV and AIDS reporting and to
comment on CDC activities to achieve a national HIV reporting system.

Looking at AIDS rates compared to HIV rates, AIDS data underestimate the
true burden of the disease. In a survey of 25 States, in only one
case---a State with an older epidemic---do AIDS cases outnumber HIV
infection. It is clear that just counting AIDS does not accurately
describe the environment.

In AIDS case data, the proportional distribution by behavioral risk
factor declines in the 1990s in MSM categories and increases in
heterosexual contact transmission. States with long-time HIV reporting,
however, are seeing upticks in MSM cases. Increases in the dual MSM/IDU
transmission category are seen since 1999, and this is of great concern.
There has also been an increase of syphilis in this period. In IDU
transmission, there has been a modest decrease, and a modest increase is
seen in heterosexual transmission.

The HIV and AIDS numbers differ because they encompass conceptually
difficult issues. HIV infection is an occult event, and epidemiologists
will always be estimating behind the curve. The measures of HIV/AIDS are
morbidity and mortality. In the early years of the epidemic, young men
were developing unusual opportunistic infections (OIs); now it is
possible not only to measure when people develop OIs, but also when they
have immunologic AIDS, with a T-cell count under 200. This allows health
care providers to do a better job at moving earlier in the spectrum of
disease, but medicine is still burdened by some anachronistic concepts
that created the distinct HIV/AIDS categories. For example, when a
person has T cells of 201, he or she does not have AIDS, but AIDS is the
diagnosis if the count is 199. This is an artificial boundary. It would
be ideal to know the rate of transmission, when the virus moves from one
person to another, just as the business world has real-time information
about sales. But the ability to measure incident HIV infection is
relatively recent and still evolving.

The cycle of HIV disease, depicted as buckets that feed one into another
into another, begins with an infection rate that remains at about 40,000
new infections per year. Undiagnosed cases are estimated at about
240,000 in total, but because of the large pool of previously
undiagnosed cases, more are diagnosed each year than infected. About
one-quarter of HIV diagnoses each year are in individuals who have gone
undetected and already have AIDS, with compromised immune systems and
OIs.

The challenge at the national level is to pull together the data needed
to make decisions. This means addressing the basic tenets of national
surveillance programs. The word "health" does not appear in the U.S.
Constitution, and most of the health authority resides with State
governments. State governments establish all reportable disease programs
and diseases (i.e., AIDS, anthrax, syphilis, breast cancer) reported by
patient name, except for HIV infection not yet classified as AIDS. The
CDC provides funding and technical assistance and coordinates activities
with States for aggregation of data to achieve a national system.

A long tradition of confidentiality and privacy rules is associated with
HIV/AIDS surveillance data. State and Territorial laws for protection of
public health data apply to HIV/AIDS. The CDC requires explicit physical
security for records---that they be maintained in physically secure
environments with limited access by authorized personnel only, with
sanctions imposed if breaches occur. State surveillance programs certify
that they meet program requirements, and identify an overall responsible
party for ensuring confidentiality, with written confidentiality
policies in place. Patients' and physicians' names and other personal
identifiers are not sent to the CDC, only randomly assigned numbers.
These files are also protected from the Freedom of Information Act.

Community resistance to HIV reporting is based on a number of factors,
which might or might not be valid. Communities fear that inappropriate
release leads to stigma and discrimination. Dr. McKenna has investigated
charges of inappropriate release and found only one to be true in 20
years. When information is released inappropriately, the source is
usually social networks or providers or other sources, not State
agencies. Another fear is that requiring HIV reporting will delay
testing and diagnosis, but that has been investigated and is not
corroborated. People experience anxiety about testing, but not about
reporting; in fact, most people don't know if reporting occurs. The most
legitimate concern is that data will be used for prosecutorial purposes.
This is a violation of guidelines and frowned upon, but it does happen;
there have been cases of surveillance personnel required to testify in
attempted murder trials, for example, but this is rare.

Implementation of HIV surveillance has been staggered, and there has
been some controversy about some of the systems. Some of the largest
morbidity States only recently put systems in place. New York put a
confidential name-based system in place in June 2000; California started
its system using a code in July 2002; Pennsylvania in October 2002, but
without contributions from Philadelphia until about 6 weeks ago; and
Georgia in January 2003, with a name-based system. Currently, Kentucky
is one of three areas moving from a code-based to a name-based system.
Surveillance in Maryland and Texas has been code-based, but gross
underreporting of HIV was detected. Texas reverted to name-based, but
Maryland still has code. Oregon is the only State that has gone from
name to code, converting for long-term storage purposes. Currently, 35
States or Territories use names, 8 and the District of Columbia use code
exclusively, 5 use a name-code, and 2 use some combination.

A limited but growing number of States have quality HIV surveillance
systems in place, but HIV data in general are not representative of the
high-morbidity States of New York and California. There are other
limitations---AIDS surveillance measures only late-stage disease, and
HIV data measure diagnoses, not new infections, so that all infections
are incompletely enumerated, and the number is affected by access to
care and testing, and transmission rates.

The CDC laid out precepts for developing a single integrated HIV/AIDS
reporting system in Morbidity and Mortality Weekly Report (MMWR) in 1999
(48:1--31). The guidelines recommended an integrated HIV/AIDS case
definition; advised use of confidential

name-based reporting; recommended criteria for evaluating important
attributes of HIV surveillance, regardless of reporting method; and set
standards for security and confidentiality.

Funding to develop and pilot standard evaluation methods of HIV case
surveillance began in 2002 for 10 States (7 name, 3 code), and data are
anticipated by late 2004. Intra-State standards are for:

-   Completeness of reporting (\> 85 percent)

-   Behavioral risk factors (\> 85 percent)

-   Accuracy (\< 5 percent duplicates or false matches)

On a national inter-State level, evaluation indicates the overall
duplication rates of HIV meet the standard, with 35 States exceeding the
standard. AIDS duplication rates meet the standard in all States. As the
Nation enters the chronic care disease model with HIV/AIDS, people are
likely to be reported multiple times during the course of the disease,
and this must be coordinated and adjusted for. Some people have been
counted as many as eight times, which is very problematic for
distribution of funds. It is up to the CDC to ensure that people who
receive care in multiple areas are counted just once, and the agency has
done a rigorous evaluation and developed a code using the Soundex
Indexing System. Timeliness of reporting has been good with name-based
systems. However, there are 14 different codes in States that use codes,
so that not only are States with codes unable to exchange or coordinate
information with States that use names, they usually can't communicate
with other States that use code either.

In summary, requirements for an equitable national reporting system
include:

-   Standard methods of evaluation and quality control

-   Adherence to ethical and legal principles of public health practice,
    especially for confidentiality and security

-   Standards for data presentation and dissemination

-   Single patient identifier

    -   By name is the only scientifically mandated and validated
        method, and this will take a 2-year implementation period.

    -   Code or name-to-code requires validation, and implementation
        will require resources for studies and at least 6 years.

#### ***Discussion***

Ms. Smith asked Dr. McKenna to address categories of patients, and if
the high percentage of no-identified-risk people skews data. Dr. McKenna
said that the program standard is for 85 percent of records to identify
risk factors, and currently only about 50 percent of reports do so. One
of the reasons is that as areas have transitioned from AIDS reporting to
lab reports of CD4 counts, health departments must identify providers
and query them, and some areas are much better at this than others. In
some cases, the information is provided at a later stage, and that is
used to make inferences about that totality of data. Statistically that
is a valid approach, Dr. McKenna said, but it does not

provide the full impact of real people living with real disease. The CDC
is about to provide \$250,000 to States to improve collection of these
data. Dr. McKenna agreed that persons with HIV/AIDS may be identified in
more than one way, and that someone who was reported with HIV very well
might be counted again when he or she was reported with AIDS years
later.

Rev. Edwin Sanders asked if there is a chronological overlay that can be
applied to the graphic of the spectrum of HIV/AIDS morbidity and
mortality. Dr. McKenna commented that there are many fascinating data
implied by this graphic. One is the difference in the length of time
from reporting HIV to converting to AIDS. At the beginning of the
epidemic, the average time from AIDS diagnosis to death was 18 months;
today 80 percent of patients are alive 5 years postdiagnosis, an
enormous improvement. A person diagnosed today is looking at living with
HIV/AIDS at least 20 years, and that is with no further advances in
treatment. Rev. Sanders said that he is concerned about what happens
after diagnosis, and that a statistical basis for significance is
needed. He added that the decline in IDU cases can be attributed to
syringe exchange, and the numbers could be decreased even more if
funding was provided for syringe exchange, a proven method of HIV/AIDS
prevention.

Dr. Yogev said that he is concerned that data do not come from all
States and questioned whether the increase in the South is an actual
increase or a reflection of lack of treatment. Dr. McKenna said that he
hoped his presentation communicated his concern that only 25 States are
reporting. If it were possible to obtain data from all States with
confidential name-based reporting, which takes 2 to 3 years to get in
place, it would capture 70 percent of cases. He said the CDC is working
on this, but nonetheless assured Dr. Yogev that he shares his anxieties.
Dr. Yogev added that there is a perception that pediatric AIDS has been
conquered, but an estimated 15,000 young people are infected but are not
dying from AIDS and he did not see that in the report.

Dr. Reznik said that he has some concerns that the epidemiological
presentation hasn't changed much in 5 years, and the conversation of
names versus identifiers has been going on for many years. There is
confusion about the number of cases, he added---the number of cases
continues to rise, the number of cases coming into the system and the
number of people with AIDS is going up, yet it still doesn't go over 1
million. He noted that the recent IOM report, "Measuring What Matters,"
says that the number of cases is an important statistic. Dr. McKenna
responded that he worked closely with the IOM on that report, and he
does think that its recommendations are being followed. In terms of
reaching 1 million cases, there are still 15,000 people with AIDS dying
each year, so if there are 40,000 new cases, that means an increase of
25,000. The million mark may be reached this year.

Lisa Mai Shoemaker said that she learned that her own diagnosis had
progressed from HIV to AIDS about 4 1/2 years ago, and even if her CD4
count goes up, her diagnosis will remain AIDS. Her question was about
cases being counted multiple times---she tested positive for HIV in
1989, but that test result was lost; she was tested twice more in
Florida, then in Michigan, and then again when her diagnosis changed.

Does that mean she has been counted five times? That is impossible to
say, Dr. McKenna responded. If this scenario had happened in the past 2
or 3 years, she could likely have been counted multiple times. Systems
are now in place to help the States communicate and keep that from
happening. He added that the issue of labeling patients is a real one,
and at a recent World Health Organization (WHO) meeting, it was
recommended that the definition of AIDS be expanded to help in the push
to disseminate antiretroviral medications. But others thought that the
AIDS label should be removed altogether, and references should just be
to the spectrum of HIV infection.

Mr. Minor asked if there are any reasons other than funding to report
HIV numbers rather than AIDS numbers. He noted that the IOM report said
that the formula rather than actual numbers drives funding, and also
that using only AIDS numbers is probably undercounting people of color
with HIV/AIDS. Dr. McKenna said that the advantage to reporting HIV is
having good information, the best science and epidemiology, including
information about methods of transmission. Looking at just AIDS is like
looking at the stars light years in the future, he said. To understand
the true burden of the epidemic, the earlier it is studied, the better.
From his perspective, he said, as a representative of an agency that
deals with prevention, and as a clinician, the AIDS numbers are not
telling him what he needs to know. It makes scientific sense that HIV
counts are needed to put a system of prevention in place. In terms of
numbers driving CARE Act funding, the talk is of how to divide up the
pie, but if people knew how severe the hunger is, the pie might get
larger.

Dr. McKinnell asked, if one believes that only that which can be
measured can be managed, what impact on data quality, accuracy, and
timeliness would reportable versus nonreportable disease have? Dr.
McKenna said that, first, he disagrees with Dr. Reznik that this is the
same conversation as 5 years ago. Today all States have reporting
requirements, although methods are still variable. Dr. McKinnell
interjected that we live in a world where five cases of West Nile virus
on Staten Island would be reported. Dr. McKenna said that the Federal
Government does not mandate these data; it is States that require
reporting of West Nile.

Karen Ivantic-Doucette commented that there are new ways of thinking
about reporting, but there is a lack of clarity about HIV/AIDS,
including the inability simply to keep track of a patient who moves from
State to State. This is embarrassing from an international perspective
because the United States is considered a leader in data collection. She
asked Dr. McKenna what his "dream steps" would be to get closer to
capturing the real numbers of this epidemic. Dr. McKenna answered that
the country is moving in a positive direction, and the CDC has worked
very hard to put data management into place. In the past 18 months, work
has continued to identify exactly the cases that Ms. Ivantic-Doucette
referenced, and by the end of the year systems will be in place to track
these people. Confidentiality and security issues can be tricky, but
getting communication between States the best it can be is happening.
The insurmountable dimension is ensuring that everyone is using the same
system. The same scientifically validated name-based system needs to be
used everywhere, to get everyone to the same place.

Dr. Edward Green asked if the increase in MSM noted is in diagnoses or
cases. Dr. McKenna said he thinks it is a genuine increase in number of
diagnoses, although it is not clear whether that is because of an
increase in cases or because more people are getting tested. Dr. Green
added that numerous surveys show an increase in promiscuous sex in this
group, possibly related to disinhibition resulting from the availability
of antiretrovirals. Dr. McKenna said that antiretroviral therapy became
available in 1996, but widespread implementation took a little longer.

Dr. Sweeney noted that the epidemic can't be measured without the data,
and name reporting is the best method and should be encouraged. She said
that it is the responsibility of the Federal Government in general and
the CDC in particular to make sure the best science is used. The CDC and
PACHA should advocate for name reporting nationwide. Regarding the cases
in historically African American colleges and universities, she said
that most people in those environments believed they were not at risk.
Another problem is the success in treatment, which in some ways serves
to defeat prevention efforts.

Mr. Sneed said that his personal belief is that science is not
necessarily the salvation of humankind, and as an African American
same-gender-loving individual, he sees the epicenter of the epidemic. He
suggested calling upon some of the techniques and strategies that were
used in the civil rights movement. He also asked, how many of the 16,000
deaths from complications from AIDS in 2002 were of people who were on
antiretroviral drugs? Dr. McKenna responded that the larger question is
why does *anyone* die of AIDS anymore? He answered his own question:
because people develop drug-resistant infections, because they don't
have access to treatment, because they don't trust the system, because
they are not treated appropriately. A number of studies have looked at
this difficult question. Also, he said, it is difficult to classify
someone as having been or currently being on highly active
antiretroviral therapy (HAART) because people move in and out of care.
Why someone dies of AIDS is multifactorial; a current study on morbidity
monitoring is looking at this question.

Dr. Primm commented that the majority of people dying from AIDS are
dying from hepatitis C, even though they are on HAART. He asked why
there is a decrease in the AIDS rate in a State with longstanding
reporting. That is a State with a large number of IDUs, Dr. McKenna
said, and the decrease can be attributed to a package of interventions,
including needle exchange. The State is New Jersey. New Jersey does not
have a syringe exchange program, Dr. Primm said. Rev. Sanders noted that
they do not have a *legal* syringe exchange program, but they do have
people in the State who recognize the significance of this particular
intervention.

Rev. Sanders added that the issue of syringe exchange is clearly one of
the "elephants in the room," something unacknowledged but with a
tremendous impact. Many issues relate to race, Rev. Sanders continued,
including the issue of reporting. As the complexion of the disease
changes, the stigma is still very real, and many people with HIV/AIDS
also have to deal with the larger element of race. This continues to
drive some apprehension about a more open system of identification, he
said, and safeguards need to be

established. He contrasted immigration laws---a gay male of European
ancestry who wants to enter the United States can get in by simply not
disclosing his sexual preference, but someone from an African country
such as Uganda cannot get into the United States.

Dr. Primm said the HIV/AIDS rate among African Americans in Utah is the
second highest in the Nation, and asked how the CDC is addressing that.
Ms. Cleveland responded that the CDC must distribute dollars based on a
national perspective. It is the responsibility of the community to
address local needs, and groups in Utah should work together to
comprehensively address the epidemic in that area.

Dr. Sullivan concluded the morning session with the comment that it had
been a stimulating session, and the number of elephants in the room
keeps growing all the time. The session that followed was an ethics
briefing during a working lunch.

# AFTERNOON SESSION

Mr. Minor introduced the panel of speakers, noting that the presentation
was in panel format because the reports are related.

# The "Down Low": More Questions than Answers

Presenter: Greg Millet, Epidemiology Branch, Divisions of HIV/AIDS
Prevention, National Center of HIV/STD/TB Prevention, CDC

Mr. Millet thanked PACHA members for inviting him to speak about the
Down Low

(DL), a phenomenon that has sparked controversy in the African American
community and elsewhere. The Down Low today poses more questions than
answers. Also called "on the low" or "low low," or "men on the DL," it
refers to heterosexually identified African American men who have sex
with men but don't tell their female partners. There are a number of
popular assumptions associated with it. One set relates to identity:

-   African American

-   Male

-   Heterosexually identified

-   Masculine

-   Shun mainstream gay culture

-   Transitional rather than permanent status.

Another set of assumptions about men on the DL refers to their partners
and practices:

-   Casual male partners

-   Steady female partners

-   Nondisclosure of MSM activities

-   Unprotected sex with both female and male partners

-   Unawareness of HIV status. If they do know they are HIV-positive,
    they do not disclose it to their sexual partners.

Cultural assumptions are of the DL as an African American phenomenon,
but other racial and ethnic groups engage in identical behaviors. It has
become identified to African American culture because the term arose
from the African American MSM community, the general African American
community identifies the DL as a problem, press about the DL has focused
on African American men, and African American men on the DL identify
with the term.

DL has become a focus of debate in the African American community. J.L.
King, an African American author and public health educator who was
formerly on the Down Low, shocked a public health conference with this
announcement:

I sleep with men, but I am not bisexual and I am certainly not gay. I am
not going to your clinics, I am not going to read your brochures. I am
not going to get tested. I assure you that none of the brothers on the
down low like me are paying the least bit of attention to anything you
have to say.

While the public health community is just beginning to learn about the
Down Low, the term dates to the late 1980s and early 1990s, when authors
such as E. Lynn Harris and James Earl Hardy wrote novels about aspects
of the culture. In the 1990s, musicians including R. Kelly and TLC
attracted broader attention to the DL. Elevated rates of HIV infection
in young African American MSM have been noted in the mainstream press;
one recent episode of NBC's "ER" mentioned a connection between an
African American DL rapper and HIV. By mid-2003, there was an explosion
of publicity about the the DL, including a magazine article in the New
York Times in August 2003 and an article in the Washington Post.

The resultant discussion has been sometimes acrimonious. Responses to
the New York Times Magazine article, "Double Lives on the Down Low,"
raised an uproar about the threat this brings to African American women.
"We will continue to lose sisters because men will not come out," J.L.
King wrote. And a comment posted on the New York Times Web forum
contended that the issue may not be exactly what it seems: "too often
the DL brother is constructed as the vessel of contagion ... beyond this
... \[is a\] heterosexual assumption that AIDS is born and bred in gay
communities, then venomously spread to pure, sterile black communities
... \[the fact is\] that many ... straight black people are HIV-positive
and spreading the disease among themselves without any help from 'evil'
black gay men."

In the 14,334 cases of AIDS in African American men reported by the CDC
in 2002, exposures were 32 percent through MSM, 19 percent through IDU,
14 percent through heterosexual contact, and 4 percent both MSM and IDU.
Statistics about African American MSM are based on estimates. African
American women have the largest percentage of heterosexually transmitted
AIDS of all women, and it is unknown how much of this is attributable to
DL men. In studies, up to 57 percent of African American MSM say they
also have sex with women.

Sexual identity and behavior are not simple or clear-cut. Sexual
orientation is based on which gender a person is attracted to. Sexual
identity is how people self-describe, to others or to themselves. Sexual
behavior is based on with whom people have sex. There are many
combinations, including African American men who identify themselves as
heterosexual and have sex with both men and women. Most studies are
conducted of men who identify themselves as gay or bisexual. In one
study, nearly one-third of HIV-positive men who identified themselves as
heterosexual also reported having anal sex with men. Condom use with
other men was 100 percent inconsistent; with women, 95 percent
inconsistent; and 46 percent reported having anal sex with women.

Theories related to Down Low behavior in the face of HIV risk include:

-   Homophobia in the African American community, which can lead to
    compartmentalization. A post on the New York Times Web forum
    charged: "The 'reporter' or anthropological tour guide provided no
    basis for his assertion that blacks are generally more homophobic
    than whites. Some studies have found similar attitudes in whites and
    African Americans about people with AIDS and homosexuals, and that
    African Americans and whites both have negative associations with
    gay sex and HIV."

-   Dual minority status. An integrated sexual and racial identity is
    associated with higher self-efficacy to prevent HIV.

-   Nondisclosure of sexuality. Compared to African American MSM who
    disclosed their sexuality, nondisclosers were less likely to believe
    they could become infected with HIV. They were less likely to report
    three or more lifetime HIV tests, but also less likely to be
    HIV-positive. The nondisclosers were more likely to have had three
    or more female partners and to report unprotected vaginal or anal
    sex with women. They were less likely to have had more than five
    male partners or report unprotected sex with men.

-   Incarceration. Few studies have documented homosexual activity among
    incarcerated African American men. A study of African American MSM
    in Los Angeles (LA) County found no association between
    incarceration and HIV status and higher rates of anal sex outside of
    prison for men of all sexual orientations.

-   Drug use, and the presumption that men who use drugs are more likely
    than non-drug-using men to engage in risky sexual behavior. A study
    found that HIV-positive men who identified themselves as
    heterosexual were more likely than controls to use heroin,
    methamphetamine, and nitrites, and less likely to report condom use
    when trading sex for drugs.

In summary, sexual orientation, identity, and behavior are not always
congruent; most previous research on African American MSM is not
applicable to DL men; and theories about HIV risk among DL men must be
studied with DL populations. Several research gaps exist, and Mr. Millet
suggested how to meet some of them. Additional qualitative and
quantitative studies are needed, and the precise meaning of the Down Low
needs to be specified. Probability-based methods should be integrated
into sampling procedures,

and the sexual risk of DL men needs to be determined and compared with
other African American men. Researchers need to investigate contextual
factors of HIV risk for DL men, including the effect of the Internet,
where DL men congregate. There is a dearth of interventions for African
American MSM.

#### ***Discussion***

Mr. Minor commended Mr. Millet on the very informative presentation.

Dr. Green asked about the generalizability of prison studies. Mr. Millet
said that is a conundrum, with African American men more likely to be
incarcerated, and higher rates of HIV in incarcerated men. The LA County
study is not that generalizable, and the finding that more anal sex is
taking place outside prison than within was unexpected and may need
further verification.

Ms. Shoemaker noted that her common sense tells her that the language of
discussion around HIV/AIDS will have to change. Everyone is at risk at
one time or another, although most people don't believe they are. She
educates high school and college students about HIV/AIDS and when she
says everyone could be at risk, she is reprimanded. But information like
that in Mr. Millet's presentation confirms for her that everyone is at
risk. She asked if Mr. Millet agrees that language has to change. Mr.
Millet agreed that it does. He added that the fear-based methods of HIV
prevention that were developed in the early years of the epidemic are
not that relevant to today's world, where effective treatment exists.
Also, messages about treatment are not getting out. This disconnect
between sexual identification and behavior is a double-edged sword, he
said. Some of these men may not believe they are at higher risk---and,
indeed, when you look at the data, they are not at high risk; men who
are not identified as gay don't have that many risky sexual encounters
and unprotected anal sex.

Rev. Sanders addressed the mythology around this issue and asked about
the relationship of incarceration. He said there could be a tremendous
impact on curbing the spread of HIV/AIDS by working in jails and prisons
because of the vulnerability of the incarcerated population. Mr. Millet
responded that just because data are presented doesn't mean something is
true---it's just what researchers have at the moment. Studies of white
MSM have found outbreaks of STDs in incarcerated men, but that has not
been documented in African American MSM.

Dr. Sullivan asked for clarification of the definition of DL and if it
is thought to be a transient phenomenon or more permanent. Mr. Millet
said that one of the problems is that there is no definition, and care
must be taken that definitions of sexual identity and behavior not be
overly constrictive. The popular definition in the media is men who have
relationships with women, and also have casual sexual relations with men
and don't tell the women. But there is a range of behaviors of people
who identify with the Down Low, and the term remains malleable and
elastic. Transience is unknown, and may differ for individuals; for some
men this is part of a journey, while others may be comfortable with

their sexuality on the DL and want to stay that way. Of greatest concern
is men transmitting diseases to unsuspecting women. About 20 studies
have shown fairly definitively that African American men are more likely
not only to identify as bisexual, but to be bisexually active, and
currently bisexually active, than men from other communities.

Dr. Primm asked if the term Down Low has become so popularized in the
media and gay community as to have a negative connotation that would
further drive people underground, and if there should be an attempt to
change it and use a less negative expression. Mr. Millet responded that
the term was created within the community and was almost empowering, but
now it has been filtered through the media and become negative. These
men were already hard to identify, he added, and it is hard to get HIV
messages to them. What is needed is HIV messages that get to all African
American men, and a more holistic approach to men's health in programs
for African Americans.

Dr. Primm asked if so-called "metrosexuals" are people on the Down Low,
or just people doing what comes naturally for them, by choice. Mr.
Millet said metrosexual is another term used to refer to straight men
who flirt with bisexuality and have stereotypic gay characteristics, but
the word represents a different phenomenon.

Mr. Sneed said that now that he is 51, he has had 46 years of experience
with the types of individuals covered by this presentation, both inside
and outside prison. Meanwhile, scientists study and research while
people die. Prison for too many African American men is a continuum, and
they spend lifetimes in the criminal justice system, involved in drug
use and abuse from alcohol to amphetamines, and as commercial sex
workers who lack reasonable employment. He does not believe that
messages alone will solve this problem. The problem he sees is not lack
of information; it is the mood of apathy. Apathy is a more serious
situation than lack of information.

Concerning African American women, Mr. Sneed continued, their problem
goes beyond HIV/AIDS to the fact that there is a serious shortage of
African American men for African American women in this country. This
may allow them to let their guard down and engage in less safe sex. Mr.
Sneed encouraged the exercise of more common sense in the Council's
deliberations. The problem can be solved, but it takes a great deal of
effort---it takes science and common sense and love and compassion. He
asked that the June 27, 2004, New York Times article about homeless gay
men be circulated to the panel, with the understanding that the article
is true but underestimates and sugarcoats the problem. Mr. Millet agreed
with all of Mr. Sneed's points, and added that people have gone far past
science in labeling and stigmatizing, and science is needed to figure
out the extent of the problem. It is known that African American women
are infected by bisexually active men; what is unknown is the extent of
the problem and the actual HIV sexual risk.

Debbie Rock said that her concern is the way all this affects women, no
matter what terminology is used. The women and their children are the
ones who are suffering, and they never had a choice about any of it. Mr.
Millet said that it is known that women are

becoming infected with HIV through bisexual men, but what is not known
is if this is a huge bridge like the Golden Gate Bridge or a small
footbridge. He clarified that the epidemic seems to be MSM-driven, not
bisexually driven.

Dr. Joe McIlhaney said that the issue in Africa has also been
HIV-infected men passing the infection to their wives, and the behavior
changes in Uganda have resulted in a decrease in HIV. The job of this
Council, he said, is to figure out the solutions for this country. Mr.
Millet added that the job of the Council is not to demonize DLs, and
that sexuality is far more complex than that. A woman may know her
partner is sleeping with other men or women, and still choose to be with
that partner.

# HIV Treatment Barriers for African Americans

Presenter: Dr. David Malebranche, Emory University School of Medicine

Dr. Malebranche thanked the Council for inviting him to speak, after a
previous presentation to the Treatment and Care Subcommittee. He
introduced himself as a clinician at an AIDS clinic in midtown Atlanta,
and he also supervises residents, medical students, nurse practitioners,
and physician assistants in internal medicine and does research on the
social context underlying the epidemiology statistics. This is to ensure
that researchers remember that the numbers represent people. His
research focus is on different levels of treatment barriers.

This presentation examines two issues: first, health disparities and HIV
treatment for African Americans and why African Americans are dying at
such disproportionate rates; and second, barriers to treatment, with
voices from a marginalized community to explain some of the barriers.
One of three African American men who have sex with men is\
HIV-positive.

Recent reports have highlighted the unequal treatment for a broad range
of health problems for African Americans and whites. More than 100
studies have found that minorities are less likely to receive needed
services. Reductions in AIDS mortality among African Americans have not
equaled those in white Americans, despite the introduction of HAART.
Moreover, African Americans with HIV/AIDS use less outpatient and more
inpatient care than their white counterparts, even when controlling for
insurance and socioeconomic status. Heavy reliance on inpatient and
emergency room (ER) facilities leads to fragmented care and worse HIV
health outcomes, while increased outpatient support and ancillary
services lead to improved adherence, increased clinical retention rates,
and decreased hospital admission rates.

Interpersonal aspects of care, particularly the patient-provider
relationship, are important to minority patients and women. However,
some researchers have observed physician bias, specifically, physician
perceptions of African Americans as less educated, less intelligent, and
less pleasant. These perceptions influence physician expectations of
their African American patients to engage in risk behaviors and follow
medical advice, and it influences their treatment decisions. Meanwhile,
patient perceptions of negative expectations from health care providers
may influence their adherence to HAART.

Dr. Malebranche wanted to examine these communication gaps from both
physician and patient points of view. In preliminary investigations, he
spoke with a group of HIV-positive African American men. One stated that
he thought his doctor was just trying to make money for pharmaceutical
companies. Dr. Malebranche established a protocol of qualitative
research measures that included eight focus groups of 81 self-identified
African American MSM, in Atlanta, New York City, and upstate New York.
He had support from the AIDS Education Training Center, and his work was
published in the January 2004 Journal of the National Medical
Association. His study objectives were to:

-   Explore the perceived barriers to health care among African American
    MSM

-   Describe the health care experiences of African American MSM

-   Describe the factors affecting adherence and health care utilization
    among this population.

Dr. Malebranche identified four types of barriers: external,
internal(ized), institutional, and pharmacological. External barriers
include finances, insurance, access to clinics, transportation, and
education and literacy. Some people cannot afford to take time off of
work to sit in a doctor's office. They may be faced with a battle
whether to give priority to their work or their health care. He quoted a
participant from a Manhattan focus group: "What I've realized is you
have to have money. That's been my goal, to get a job with insurance.
Because if you don't have insurance, it's like you don't exist."

Internalized barriers include racism (racial stress and stereotypes),
sexual prejudice, fear, distrust, mental health problems, and substance
and alcohol abuse. Dr. Malebranche used quotes from his focus groups to
illustrate some of these barriers:

-   Racial stress: "Being a black man is a hard struggle. Not just being
    gay, being straight---being a general black man is an everyday
    struggle. I don't care how you put it, white America either wants
    you in a cell or a grave." And: "We \[black men\] have to wake up in
    the morning and put on armor every day." And: "Because we're black,
    we all have the same face. So when you approach someone, they think
    that you're going to automatically cross them in a very aggressive,
    intimidating way. You're black first."

-   Sexual prejudice: "In school you got peer pressure. Everything, a
    lot of it revolves around sexuality. 'Oh, he dress gay! Oh, he talk
    gay! Oh, he look gay!' You know, so when you go to the doctor and he
    asks you, 'Okay, have you had\
    sexual ...' --- 'No!' I mean, that's just how you look at it,
    because that's just it, this big ol' thing about gayness, it's just
    no. Just no, no, no."

-   Fear: "You know HIV is prevalent in your group, you catch a cold and
    you're scared to go to the doctor."

-   Stereotypes: "As being a young black male, if I would come and say
    something's wrong with me, they \[medical providers\] would say,
    'Oh, look at this, you know they probably just hip-hoppin' and
    screwin' down and you know, smokin' the blunts, and then he gonna
    come here, talkin' about how he sick.' So it's like I'm stereotyped
    already. And now if you say you're gay, everybody can get the
    picture of the feminine, gay brother. So I guess it can come to the
    sexuality, because they feel, 'Oh, you must have been loose in the
    booty already.' "

-   Distrust: "I see doctors as opportunists. They're like legal
    hustlers. Just legal drug dealers." And: "The same way you look at
    your shoes \[right with left\] is how they \[doctors\] look at gays.
    Gays is AIDS. AIDS is a monkey. In the dark understanding of the
    virus itself, that's where it came from, monkeys. And the monkeys
    represent what? Blacks."

-   Mental health and substance abuse: This is another elephant in the
    room, rarely discussed.

Institutional barriers are another type of impediment. These include
clinic stigma---some patients won't enter a clinic if it is identified
as an HIV clinic. Waiting times can be another barrier; patients may
have to wait weeks for a visit to be scheduled, then hours once they
arrive, and then get rushed through. They often see multiple personnel,
another barrier. They are concerned about confidentiality and who will
see their records, and are bothered by impersonal health care workers.

Quotes from the focus groups illustrated some principles relating to
institutional barriers:

-   Choice of access: "I would rather go to the emergency room than go
    to my doctor's office, because I know there \[the ER\], I'm seeing
    the receptionist, the nurse, the doctor, and that's all."

-   Judgments: "I was talking to her \[the doctor\] about the symptoms I
    was having. And she's like, she asked me when was the last time I
    had anal sex. And I told her, like whenever it was. And she's like,
    'Well, you know ... the anus really isn't made for that.' And this
    really surprised me. And I was like, 'Yeah, I know, but it's a
    little too late.' You know?"

-   Interpersonal relationship and adherence: "My doctor now, I wouldn't
    say she's uncaring, but she's not that caring either. She's like, 'I
    wanna put you on medication.' And I'm like, 'Why?' My viral load is
    undetectable and my T-cell count is in the 700s. And I'm like, 'No!'
    She says, 'Well, if that's the way you wanna go, fine. But it's your
    life and if you die quicker because of it, then don't come crying to
    me.' And she filled out a medical form for me and said, 'Refuses to
    take medications!' in big letters! That pissed me off!"

-   Communication: "I think a lot of times it's just a culture. And a
    lot of these people \[medical care providers\] might be
    knowledgeable, but they're not knowledgeable of the people they're
    dealing with. So they're generally mechanical. They know how to do
    this, they know how to do that, but they don't know how to deal with
    you. They don't know."

Pharmacological barriers include access, cost, pill burden (which is
improving), pill timing, side effects (sometimes seen as trading one
disease for another), resistance, and few long-term efficacy studies.
Results of studies are just beginning to come in.

In conclusion, the barriers to HIV treatment are multidimensional for
African Americans, and not just for MSM, although Western medicine is
seen as more detrimental to African American MSM. The culture of
medicine as a barrier was a theme that was repeated in all the focus
groups, as well as the importance of the doctor-patient relationship.

To have the greatest impact on access and adherence and improve HIV
outcomes, the approach must be at all four levels: external, internal,
institutional, and pharmacological. An effective HIV vaccine is not
expected until 2009 or 2010 or even later, and as African Americans
carry a disproportionate burden, it is necessary to look at the whole
picture. The weakest link is at the institutional level.

Dr. Malebranche said that the focus groups explained the statistics for
him. He listed program and policy implications of these treatment
barriers for African Americans in the four categories:

-   External

    -   Establish a national health care system. This is another
        elephant in the room, but it should be acknowledged; health care
        is not a privilege but the right of the American people. Dr.
        Sullivan noted that 44 million people at any point in time and
        60-some million through the course of a year do not have health
        insurance coverage.

    -   Increase Ryan White and ADAP funding.

-   Internal(ized)

    -   Look at HIV in a more holistic context; focus more on the social
        context of HIV and its impact on health care utilization and
        treatment.

    -   Fund social empowerment health initiatives (gender- and
        culture-specific).

    -   Hire and retain more mental health providers at HIV
        community-based organizations and medical facilities. A
        one-stop-shopping approach is one way to accomplish this.

-   Institutional

    -   Support partnerships between academic centers and community-
        and\
        faith-based organizations.

    -   Fund innovative health and community programs. A good example is
        Project Brotherhood in Chicago.

    -   Fund cultural competency programs for ALL medical staff, not
        just doctors, but also nurses, receptionists, phlebotomists, and
        anyone who interacts with patients.

-   Pharmacological

    -   Develop more tolerable, simple medication regimens.

    -   Develop programs targeting patient facilitators of adherence.

    -   Support microbicide development.

#### ***Discussion***

Ms. Rock commented that without good, quality support services, what
researchers do means nothing. One example is child care---without it,
parents simply cannot get to their appointments. Peer mentoring is
another essential; without assistance in understanding medical language
(or the English language), medicine can't help much. Dr. Malebranche
agreed that social services must catch up with technology. HIV is a
social disease---it's not West Nile, and it's not the flu, and it forces
the medical profession to look at issues of sexuality and disparities in
care. It focuses on the whole individual.

Mr. Sneed noted that when it comes to African Americans, the biggest
problem has been the abject failure of African American
same-gender-loving men and women to mount a response comparable to that
of their white counterparts. Until that is done, the community will
remain in hell. Some \$600 billion goes through the hands of African
Americans, and if just 10 percent of that could be applied to HIV/AIDS,
it could mean huge improvements in prevention and care. Mr. Sneed
suggested that pharmaceutical companies could play a motivating role,
and government would never provide enough funding to solve this.

Ms. Clements said that the presentation mentioned many issues not
usually spoken of. She has asked many people, why don't you make your
appointments?---not realizing how threatening and intimidating that can
be. The doctor may say, "I'm going to cure you of HIV but you're going
to die of cancer if you don't stop smoking," and that person won't
return for subsequent care. People going to appointments need an excuse
to miss work for 5 hours every month, or to find a babysitter, and may
be trying to hide that they have HIV. Regarding the Down Low discussion,
women must take action and be more responsible and not be victims, she
added, because women can control their own behaviors, even if they can't
control others' behaviors.

Dr. Sweeney noted that people who identify themselves as transgenders
present special issues and have high prevalence, and should be
identified in a breakout category. She asked if any of the cases in
13-year-olds were vertical transmissions, infected at birth. She also
asked if medical students are taught interviewing skills in this area.
Smoking cessation models have demonstrated that information carries more
weight when it is initiated by a physician. In response to the comments
about national health care, she said that the National Community Health
Center system is the closest thing this country has to a national health
care system.

Dr. Malebranche answered that there is even less research about
transgendered individuals than African American MSMs, although there are
spot programs around the country, including some work in San Francisco.
Mr. Millet added that the CDC has a project in New York City looking at
transgender populations and HIV prevalence. In the past, they were
combined with MSM or simply overlooked, but an outbreak of tuberculosis
in transgenders got some attention. Dr. Malebranche said that he didn't
think that any of the cases of HIV infection in 13-year-olds were
vertical transmission cases. He added that he has found some medical
students very interested in learning about human sexuality.

Ms. Shoemaker expressed concern about HIV vaccines or medication
regimens, which may give people a false sense of security. She said
prescribing information needs to be more detailed for physicians. Dr.
Malebranche said that physicians are generally trained in cultural
competency, but there are glaring omissions about sexual cultural
competence. The general rule for physicians is to listen first and try
to hear what patients are saying, and integrating this into general
cultural competence would be very helpful.

# African American Women and HIV/AIDS

Presenter: Jean R. Anderson, M.D., Johns Hopkins HIV Women's Health
Program

Mr. Minor introduced this presentation as another elephant in the
room---African American women and HIV/AIDS. Since the Down Low
discussion brought to attention the epidemic in women and the
disproportionate numbers of African American women with HIV/AIDS, the
Council wanted to include this presentation, with information about the
level of treatment of African American women. Dr. Anderson was referred
to the Council by Debbie Rock.

Dr. Anderson, an obstetrician/gynecologist who began the women's HIV
clinic at Johns Hopkins Medical Institutions in 1987, has been caring
for women infected with HIV for 17 years. In considering HIV/AIDS
prevention and treatment, it is important to realize that African
American women also have to deal with the combined factors of gender and
race, with unique strengths and challenges associated with each. And
differences with other groups of women are a matter of degree more than
substance, with similarities more striking than differences.

Dr. Anderson focused her presentation on sociocultural and psychosocial
issues because they are the issues that make the difference in
prevention and treatment, and the ones that she spends most of her time
dealing with. A review of the epidemiology of women and HIV/AIDS shows
that women account for approximately 27 percent of all AIDS cases, with
the percentage varying by age. Almost half of AIDS cases and more than
half of HIV infections are in 13- to 19-year-olds. African American
women account for 63 percent of women with AIDS, a rate 23 times higher
than for white women. In the South, this rate shoots up to almost 80
percent. Heterosexual contact accounts for more than

60 percent of new AIDS cases in African American women, and more than 75
percent of AIDS cases in younger women.

Issues in prevention and treatment for African American women can be
biologic; these include vulnerability to infection, gynecologic
problems, pregnancy, and possible gender- and race-specific differences
in toxicity or effectiveness of treatment. Issues can also be
sociocultural and psychosocial. A body of psychological work examines
the way men and women look at themselves---for example, women more
frequently define themselves in the context of relationships and when
ill they worry about those who are dependent on them, while men worry
about who will take care of them. Other sociocultural issues include low
status in society, poverty, importance of childbearing, domestic
violence, depression, substance abuse, and stigma.

Barriers to HIV prevention include lack of perception of risk. African
American women are most often infected sexually and may not be aware of
their partners' HIV risk (for example, multiple partners, men on the
Down Low, substance abuse). They may not have access to adequate
information. Poverty is endemic and brings with it lack of health
insurance, limited access to care, child care and transportation
problems, responsibility for other family members, and, in some cases,
economic dependence on sex work.

Other barriers can be psychiatric morbidity, including depression,
posttraumatic stress disorder, and anxiety disorders; substance abuse;
low self-esteem; and youth with its implications of peer norms, older
partners, inadequate communication and negotiation skills, and myths and
misunderstandings.

African American women have less power than their partners in sexual
relations. This is often a component of economic dependence, as well as
lack of totally woman-controlled prevention methods and fears of
abandonment and sexual and emotional violence. In addition, the value of
childbearing and pressure to have children may decrease the likelihood
of safer sexual practices---condom use also prevents pregnancy, which
women may want.

A triad of comorbidities---domestic violence, depression, and substance
abuse---are common in HIV-positive and high-risk women. They often
coexist, and they increase the risk for HIV, poor access to care, and
poor adherence to care and treatment.

#### Domestic violence. The Women\'s Interagency HIV Study (WIHS) found that two-thirds of women with HIV had a lifetime history of domestic violence and one-quarter to one-third a history of childhood sexual abuse. No significant differences were observed based on HIV status or race. The HIV Cost and Service Utilization Study (HCSUS) found that 25 percent of women reported physical harm after their HIV diagnosis, and half of these said the HIV status was the cause of the violence. And domestic violence is associated with increased risk for HIV. Risk factors for domestic violence include:

-   Low Socio-Economic Status (SES) and educational level

-   Unmarried status

-   Youth

-   Depression or substance abuse

-   Partner's substance abuse

-   Social norms reinforcing male power over women

-   Pregnancy.

#### Depression. Across cultures, women have lifetime incidence rates of major depression twice that of men. In women of all races who are HIV-positive, depression rates are more than twice those of men with HIV and the general population. Increased risk behaviors are seen in women with HIV and depression, including inadequate adherence to medical followup and HAART regimens. Untreated depression is associated with more rapid CD4 decline and increased mortality. More positively, treatment of depression is associated with increased likelihood of HAART treatment. However, African American women are less likely than others to use mental health services. 

#### Substance abuse. Women are almost 50 percent less likely to use illicit drugs than men, and African Americans have lower rates of alcohol use than whites. Rates of illicit drug use are similar. Substance abuse plays a key role, however, among African American women in HIV transmission, even if it is not the women's own substance abuse. Non-IDU is responsible for a substantial proportion of unsafe sexual behavior and is a major risk for HIV infection. It is a huge barrier to both prevention and treatment.

Biologic vulnerability compounds the psychosocial risks. Women are more
vulnerable to STDs including HIV for anatomic and possibly hormonal
reasons. Rates of STDs are highest in young African American women, and
other STDs increase the rate of HIV transmission.

Women do not have control in barrier prevention methods, but female
condoms are being used increasingly by the female African American
population that Dr. Anderson treats. While the female condom is
female-controlled, it cannot be used without the knowledge of the male
sexual partner. The critical need is for an effective microbicide, which
can be controlled by a woman and used in secret.

Important barriers to care are late diagnosis and disclosure issues.
African American women are more likely than African American men to be
diagnosed late in the course of HIV/AIDS, and 56 percent of individuals
diagnosed with AIDS within a year of HIV diagnosis were African
Americans. This is because of the lack of perception of risk, and a
general care pattern that is sporadic and crisis-oriented because of
competing demands of life. It is incumbent upon health care providers to
talk to African American women about HIV and offer testing. Disclosure
issues also loom large. Dr. Anderson knows of many women who have been
beaten or abandoned after disclosure of HIV infection to their partner.
And stigma has decreased dramatically, but it is still a huge issue.

Other barriers are lack of access to care, often because of lack of
insurance, transportation and child care issues, and lack of trust in
the health care system; and competing concerns, including food, shelter,
drugs for substance abusers, and tending to the needs of children and
other family members. Depression is another barrier to care, as are
adverse reactions to medications. Many women experience fat
redistribution from drugs, for example, which leads to body image
changes.

Poverty is a huge issue. The majority of U.S. women with AIDS are
unemployed; of those with jobs, 83 percent earn less than \$10,000 a
year. Half have at least one child under the age of 15. Women are 1.6
times more likely than men to delay medical care, and having a child
increases the likelihood of delay. A HCSUS finding was that women and
African Americans had less desirable patterns of care and were less
likely to receive HIV-appropriate medications; insurance was a major
mediating factor, and care improved with time.

More than one-third of HIV-positive adults in care went without or
postponed care at least once in 6 months because of competing
subsistence needs such as money for food, clothing, and housing; lack of
transportation; inability to get out of work; or feeling too sick. A
study found that having at least one competing need was associated with
never having received antiretroviral drugs.

Dr. Anderson has seen her HIV-related practice grow from one-half a
clinic day per week to a current one-third of the entire clinic
population. From the start of the epidemic, she observed frequent
gynecologic (GYN) problems in these patients that may or may not have
been related to HIV. Dr. Anderson advises all gynecologists to think
about HIV when they see women with GYN problems. Of 262 HIV-positive
women in one study, 46.9 percent also had at least one continuing GYN
condition; and in an inpatient AIDS service, 83 percent of the women had
coexisting GYN problems, although only 9 percent were admitted with a
primary GYN problem. There is no evidence that these problems vary by
race. Commonly observed conditions include:

-   Menstrual disorders

-   Genital ulcer disease

-   Abnormal vaginal discharge

-   Pelvic inflammatory disease

-   Human papillomavirus (HPV), cervical dysplasia, and neoplasia. HPV
    is particularly persistent in HIV-positive women, and is viewed as
    an opportunistic infection.

HPV is associated with cervical cancer, and in 1993 invasive cervical
cancer became an AIDS-indicator condition. Women with HIV and cervical
cancer tend to be younger and less immunosuppressed compared to
HIV-positive women with other indicator conditions. Also, women with HIV
and cervical cancer are generally younger than HIV-negative women with
cervical cancer.

Pregnancy is an important aspect of being female, and studies have
looked at pregnancy after HIV diagnosis. Dr. Anderson observed that many
of her African American patients were driven from the health care system
by health care providers who were judgmental about childbearing. Some 18
percent to 40 percent of U.S. women become pregnant after a diagnosis of
HIV. In the WIHS cohort, 7 percent of women reported conception
annually, from 1994 to 2002, and more than three-quarters occurred
*with* the use of contraception.

Of U.S. women in general, 36 percent say they want children in the
future; that number decreased to 29 percent in a HCSUS study of
HIV-positive women. More than half of the HIV-positive women had CD4
counts under 200 and slightly more than one-quarter had partners who
were also HIV-positive. As many as 50 percent of all pregnancies are
shown to be unintended, and that number has been found to be as high as
80 percent in HIV-positive populations. Dr. Anderson suggested a number
of possible reasons:

-   Lack of power in sex relationship

-   Pressure from partner or family to have children

-   Unawareness of contraception options

-   Belief that a woman cannot become pregnant if she is HIV-positive

-   Disorganized lifestyle

-   Taking chances

-   Cognitive impairment.

Much of Dr. Anderson's current practice involves preconception care and
counseling, mostly with HIV-positive African American women, and
sometimes with their partners. She discusses with them how to get
pregnant safely and using antiretroviral therapy before conception. She
advises other practitioners to discuss pregnancy with their HIV-positive
patients at intervals during routine care with emphasis on these
situations:

-   Interest in conceiving

-   Nonuse or inadequate use of contraception

-   Change in relationship

-   Medications with potential for reproductive toxicity

-   Important new developments in pregnancy and HIV

-   Risks for unintended pregnancy

-   Enrollment in clinical trials.

Treatment goals for these women include choosing drugs effective in
reducing perinatal transmission; attaining a stable, maximally
suppressed viral load; evaluating and treating antiretroviral side
effects that could affect maternal or fetal outcomes (for example,
hyperglycemia, hepatic toxicity, anemia); evaluating OIs and the need
for prophylaxis; and administering appropriate immunizations.

One of the barriers to adherence is refilling medications, and
appropriate social supports can make a difference. Unfortunately, there
is a dearth of information about safety and toxicity of antiretrovirals
in women, and some indications that severe side effects are increased in
women. These include lactic acidosis, pancreatitis, and liver toxicity.

Nevirapine is an anti-HIV drug often used in women, including pregnant
women. Recently the Food and Drug Administration (FDA) required a black
box warning for women with CD4 counts above 250, warning of a
rash-associated hepatotoxicity that is 10 times more likely in women
with higher CD4 counts. Hepatic failure and death have been reported
among women, including pregnant patients, and this usually occurs early
in therapy with little warning. This drug should be used with caution in
pregnant women with higher CD4 counts, and generally only when other
options are not available or acceptable.

A growing number of studies are beginning to show what works to prevent
HIV in women. Skills-building techniques focus on condom use, cognitive
coping skills, and communication skills. Project RESPECT was one program
that was effective in reducing

unsafe behaviors; it employed interactive counseling interventions
focused on self-efficacy, attitudes, and perceived norms. The CDC's
Women and Infants Demonstration Projects found that media outreach and
community mobilization increased condom use.

As a clinician, Dr. Anderson has had an opportunity to observe certain
strengths in African American women with HIV. These include solidarity
and sisterhood, religious faith, and multigenerational networks. These
are not unique to HIV but play a positive role for HIV-infected women.

There is ample information from published literature that supports the
need to better identify and use social support networks for women. Use
of peer counselors as case managers and outreach workers has been
responsible for the success of her program, Dr. Anderson said. Journal
clubs are also a good way to identify barriers and supports, and
journaling itself can become a tool to enhance adherence and help
support.

Knowledge is important, she added, but it is not everything. Women must
be engaged "where they are," they must change attitudes and norms, and
they must develop communication and negotiation skills. Religious faith
is a real weapon against HIV, with the ability to promote prevention and
adherence to treatment and provide needed support. Religious beliefs are
also associated with safer sex behaviors, attitudes toward sex, and the
ability to negotiate safe sex in African American adolescent females.

Dr. Anderson concluded with inspirational and instructive quotes from
some of her patients:

-   "I thank God for opening the gates of hell and letting me out," said
    one woman who saw HIV as her second chance in life.

-   "I think God placed me here in this situation to help other people,
    because cocaine will kill you quicker than anything else. Having HIV
    was a turning point in my life. God got mad at me. So I made a
    choice: did I want to live with this disease, or did I want to kill
    myself? God pulled me through this and I don't have to die in
    secrecy."

-   "HIV is not my worst problem." This statement illustrates the need
    for other services along with HIV treatment to be provided as
    conveniently as possible, and to address the proximal societal
    causes of HIV infection such as stigma and discrimination, mental
    illness, substance abuse, and status of women. Until these are
    addressed, Dr. Anderson said, the fight against HIV will be a losing
    battle.

#### ***Discussion***

Dr. Jane Hu said she learned a great deal from the afternoon
presentations, and the three speakers shed light on cultural and social
issues related to HIV/AIDS in African American communities. She
emphasized that not only health care providers but also the whole of
American society should know about these issues. She asked if the
Treatment and Care and Prevention Subcommittees could write resolutions
to recommend more appropriate social and cultural approaches in the
African American community, using information presented by today's
speakers. She emphasized the importance of the

President and Congress understanding social and cultural issues of the
African American community, because that is what could cause change. Mr.
Minor answered that the current motion, contained in the briefing book,
asks for more research dollars for prevention and targets the African
American community. That will be discussed tomorrow. Dr. Hu added that
the African American community, male and female, needs HIV clinics to
understand their social and cultural problems.

Dr. Primm asked about the impact of the black box warning for
nevirapine. Also, he said he was struck by the information that 77
percent of conceptions occur with the use of some sort of contraception,
and knows of condoms that come off during intercourse. Dr. Anderson said
that nevirapine is a huge issue of concern. A single dose to prevent
vertical transmission has been shown to be safe, and the WHO
recommendation for use of HAART includes nevirapine-based regimens for
women. There is concern about the implications of these therapies, and
no answers yet. Regarding condom failure, she said that condoms are the
most common contraceptive device used, and they provide dual protection
against pregnancy and disease. She added that she hasn't had complaints
from her patients about condoms coming off, but breakage is the most
common complaint.

Dr. Green noted a 1995 study from Johns Hopkins that looked at condom
use over time in an African American population and found no difference
in STD rates between users and nonusers. He also asked how age fits into
the concept of biological vulnerability. One of the reasons Uganda has
focused on trying to get young people, especially females, to delay
sexual debut is because they believe younger females are more vulnerable
than older women, with more delicate sexual organs, vulnerable to
tearing. Dr. Anderson said there is some evidence of a more vulnerable
epithelial covering in younger women, which may be associated with the
hormonal factors she mentioned. This also might explain high rates of
STDs among adolescent women, although it is not clear if STDs are
mediated through trauma. Dr. Green added that maybe a culturally
competent message to the African American community should be to delay
sexual debut.

Mr. Grogan said that the HCSUS data, although recently published, is
about 8 years old, and asked if more recent data are available. Dr.
Anderson said she has not seen any recent updates from HCSUS.

Ms. Rock emphasized the importance of the one-stop-shopping approach for
treatment and social services. In a dream world, she said, women with
children could get treatment alongside their children, as well as
support services. She asked if such an approach is doable. It is, Dr.
Anderson responded, and a Hopkins study several years ago found that
women did better in adhering to recommended care for their children than
they did for themselves. She added that perinatal transmission can be
reduced to a very low rate (less than 1 percent) with current methods,
but won't be wiped out entirely because of women who do not perceive
their risk.

Dr. Malebranche spoke of gender role conflict and stress, and what is
expected of men and women, and how that pressure affects behavior.
One-stop shopping, he said, must be focused on both culture and gender.
Concerning biological vulnerability, he pointed to a

body of literature about behaviors that put women at increased risk for
HIV, such as overuse of vaginal douches, and the fact that African
American women have been found to be more likely to use douches. It is
behaviors and practices that transmit HIV---not who is doing something,
but what he or she is doing.

Dr. Prem Sharma said that the disproportionate incidence of HIV in
African Americans is very striking and asked if there are any data
available on the progression from HIV to AIDS based on race, or any
biological evidence that it progresses at a different rate dependent on
race. Mr. Millet said that two large multisite studies in men and women
have looked at natural progression of HIV/AIDS, with African Americans
being a large subset of the study. Dr. Anderson said that several
studies have shown that women tend to have viral loads about half that
of men in early infection, and then the loads start increasing until
there is ultimately no difference. Mr. Millet said that one study
reported in the MMWR comparing men of different ethnicities after HAART
treatment found that African American MSM were less likely to be on
HAART, less likely to be in care, and more likely to die than white,
Asian/Pacific Islaner, or Latino MSM.

Dr. Sharma asked for information about vulnerability to infection
according to race or other factors. Mr. Millet said some studies have
looked at this, including circumcision studies that have found that men
who are circumcised are less likely to contract HIV than those who are
not. Studies that look at genetic vulnerability can be controversial, he
noted. Worldwide, black populations are less likely to be homozygous, or
even heterozygous, for CCR5. Mr. Millet added that
psychoneuroimmunological studies have found that disease in men who
rated higher on stress and mental health scales progressed more rapidly,
and that further genetic and immunological studies need to be done.

Dr. Sullivan, returning to a comment from Mr. Sneed, asked what are
strategies to use with people who know they are HIV-positive but still
engage in risk behavior, and how they can be more responsible,
particularly men who may be engaged in sexual activities to support
themselves financially. Dr. Malebranche said that recent studies have
found a resurgence of irresponsible sexual behavior, including a
behavior called "bug chasing," which is looking for HIV-positive men to
have sex with. White men and African American men may have different
reasons for their behaviors, he added, and strategies must meet the
person where he or she is and deal with substance abuse, mental health,
self-esteem, or whatever other issues predominate in a person's life. A
problem with HIV prevention is that it began with sexuality and a
disease-based approach. But HIV is an opportunist, he emphasized, taking
advantage of marginalized settings and people. If HIV is eliminated
tomorrow, another disease will take its place, if underlying issues are
not addressed. A new study examines African American MSM who did not
have male role models, looking at definitions of masculinity and how
they were raised. Those early issues set the landscape for HIV, and if
social context is ignored, the underlying foundation will always be
crumbling, and the battle lost.

Ms. Clements reiterated the point that many at-risk women do not
consider themselves at risk or think of HIV as a possibility. If they
have tested HIV-negative, they often assume that their partner is
negative, or else he would have transmitted the virus to them. Dr.

Anderson agreed, noting that more effort must be focused on high-risk
HIV-negative women, and that a common myth is that if they are negative,
they can continue doing what they are doing. These women present an
important avenue of prevention and are shortchanged if it is not taken
advantage of. She said that in her program, all counselors are certified
in HIV counseling and all pregnant women are offered HIV testing. If
they are HIV-positive, counselors follow them. Dr. Anderson also
emphasized the importance of normalizing testing and making it part of a
regular GYN examination, which is the position of the American College
of Obstetrics and Gynecology. She added that women should be counseled
along with testing, whether the test comes out positive or negative.

Ms. Ivantic-Doucette said that the discussion of contraception struck
home with her, as she herself has experienced four unintended
pregnancies. Contraceptive failure is common. She is troubled by the
heavy emphasis on biomedical services and medical providers as
gatekeepers, even though they have limited education about health
outside the biomedical domain. Both Dr. Malebranche and Dr. Anderson
said that solutions that work often had little to do with the medical
domain. Ms. Ivantic-Doucette suggested broadening the language to talk
about primary health care, moving beyond biomedical and expanding
interventions---for example, using food vouchers as a health
intervention. Not only language, but also the power structure of
providing care, needs further examination.

Ms. Ivantic-Doucette also asked about training for health care
providers, to move from biomedical and cognitive training to focus on
other health interventions. Ms. Cleveland said that programs and
policies are driven by research, and most research has been biomedically
focused. Most of the social research that has been done has used
Caucasian gay male populations, and there is a dearth of information
regarding women and communities of color. Programs must be based on the
science, she said, and CDC allocates resources along disease-specific
lines. It is not easy to put out a program announcement (PA) for
integrated approaches, but the CDC is examining housing and other social
issues related to HIV.

Dr. Malebranche added that researchers are questioning the
\[biomedical\] institution itself as a viable tool for addressing
HIV/AIDS. But alternatives are also difficult. Using churches is one
option, but in some churches ideas relevant to HIV prevention cannot be
addressed because the church takes a strong stand against any sex
outside marriage. His response is that each church is different, and
some are very progressive in discussing sexuality. That is also true of
different pockets of the Western biomedical culture. He agreed with the
need to change some of the language, but also recommended speaking to
the larger issue of viability of institutions. Not every church, every
medical school, and every medical clinic is the same, and those with
viable approaches need to be identified.

Dr. Anderson said that with the explosion of biomedical information and
de-emphasis of the art of medicine, the problem is getting worse, not
better. Practitioners are busier, patients are more complicated, and
complex training needs should be emphasized not just in medical schools
but also in nursing, social work, and other related disciplines.

Dr. Yogev said he was surprised that none of the speakers suggested
broader solutions, and suggested a number of issues for consideration:

-   HIV is the only STD in which partner notification is not required,
    and perhaps the Council should consider recommending it.

-   The CDC's patient information page has removed information about
    contraceptives for women, and he questioned this.

-   He recommended caution about nevirapine, and that clinicians might
    be blaming it prematurely. International colleagues, particularly,
    are using it and marveling how easy it is to administer. It seems to
    be an important drug---40 percent of women resisting with one dose,
    shows how effective it is---and we have to be careful not to throw
    out the baby with the bathwater, but more study is needed.

-   He questioned comments about perinatal transmission being conquered
    and warned that the less than 1 percent transmission rate cited was
    achieved in controlled academic environments. This is an area that
    needs continued investment.

Dr. Anderson said she did not intend to imply that perinatal
transmission is over and agreed that it is still a problem, particularly
with many women not knowing their status. Recently in Baltimore, four
HIV-positive babies were born to women who tested negative early in
pregnancy and became infected later in pregnancy.

Ms. Biaggi commented that the Down Low phenomenon is also common in
Latino communities, and occurs across ethnic lines. But she has not
heard anything about programs or intervention strategies that have
proved effective. She suggested that with all the underlying issues, it
would need a very specific intervention that addresses societal issues.
Mr. Millet said that is one of the problems; there are few interventions
for MSM specifically, very few that are effective, and even fewer for
minorities. He knows of eight effective MSM interventions, two of them
for minorities---one for African Americans and one for Asian/Pacific
Islanders, but none for Latinos. There are many interventions for IDUs
and women, but it is glaring that in the third decade of the epidemic,
there are so few interventions that target the population at risk. He
reiterated that a holistic approach to health is needed for men who have
sex with men, with HIV testing as a component. Providers must make sure
they are asking the right questions and not making assumptions.
Evidence-based information about these populations is needed.

Dr. McIlhaney asked Dr. Anderson if she thinks HIV testing of pregnant
women should be required. She said yes, but it should be an opt-out
approach, so they should be able to say no if they want to. He asked at
what age young women are typically infected, and Dr. Anderson said that
she sees perinatally infected girls of 16 or 17, including some who are
in the pregnancy program. The adolescent clinic is unfortunately growing
by leaps and bounds as well.

Rev. Sanders returned to the issue of expanding the language, which he
thinks is important. Discussion of holistic approaches occasionally
includes a reference to religion, but spirituality has been largely
overlooked. People are religious by choice, but spiritual by nature, and
a lack of attention to this area accounts for much of what drives low
self-

esteem and translates to negative behaviors. People are caught up in
dysfunctional belief systems, and spirituality must be addressed---the
core, the universal principles at the heart of our belief systems, and
how they come to bear in our response to HIV/AIDS. This must be
addressed in a way that debunks the religious issue. Some models funded
by SAMHSA and the CDC have developed around the issue of spirituality,
including one that targets women.

Dr. Malebranche agreed with the need to address spirituality in
research. He said that in a study currently being conducted in Atlanta,
30 African American men were asked to rank six qualities that contribute
to their concepts of themselves as men, and 67 percent ranked
spirituality as most important. However, that still begs the questions
of what spirituality is, how it evolves over time, and how it can be
factored into health issues such as HIV/AIDS.

Mr. Minor thanked all the presenters. Rev. Sanders thanked the Chair for
his accurate reading of the spirit of the discussion and letting the
meeting flow. Dr. Sullivan adjourned the meeting at 5:32 p.m.

# Presidential Advisory Council on HIV/AIDS (PACHA)

# 24th Meeting

**Hubert Humphrey Building**

**200 Independence Avenue, S.W.**

**Room 705A**

**Washington, DC 20201**

**Monday, June 28, 2004, and Tuesday, June 29, 2004**

# *DAY 2*

**MORNING SESSION**

Dr. Louis Sullivan convened the meeting at 8:40 a.m.

Lisa Mai Shoemaker called attention to a handout she had distributed,
with articles from a Family Circle Magazine in 1986 about fears about
HIV transmission and another about green tea as a treatment for HIV. The
purpose of distributing the Family Circle article was to make the point
that the conversation about HIV transmission hasn't changed much in
nearly 20 years. She also included some material about Magic Johnson; it
had appeared that young people believed he was "cured," which is
disconcerting, but this material referred to his saying he is not cured.

## Agenda

The morning's agenda was organized by the Treatment and Care
Subcommittee, introduced by Brent Tucker Minor, and by the International
Subcommittee, introduced by Abner Mason.

# TREATMENT AND CARE PRESENTATION

-   Ryan White Reauthorization Process. Marty McGeein, Department of
    Health and Human Services, presenter.

# INTERNATIONAL PRESENTATIONS

-   HHS HIV/AIDS-Related Activities in India. Dr. Amar Bhat, Office of
    Global Health Affairs, DHHS, presenter.

-   Epidemic in India. Dr. Robert Bollinger, Johns Hopkins University,
    presenter.

# India at the Crossroads. Teresita Schaffer, Center for Strategic and International Studies, presenter. 

-   President's Emergency Plan for AIDS Relief. Dr. Joseph O'Neill,
    Department of State, presenter.

# TREATMENT AND CARE

# 

# Ryan White Reauthorization Process

Presenter: Marty McGeein, Senior Advisor, Assistant Secretary for
Planning and Evaluation (ASPE), DHHS

Mr. Minor introduced the speaker, noting that the President has
supported reauthorization of Ryan White CARE funding, and that it is
important to acknowledge that the needs of people with AIDS have changed
in recent years, and care and treatment need to be considered in light
of that. Now is a crossroads time for the treatment of people with AIDS.

Ms. McGeein said that she is reporting on DHHS activities regarding the
Ryan White CARE Act reauthorization, and she is the person in charge of
pulling this together. Last week in a major address, in addition to
announcing that he was making \$20 million available for ADAP, President
Bush enunciated the three major principles of AIDS funding:

-   Care and treatment: Clinical services must take precedence over all
    others, taking advantage of the astounding advances in AIDS
    treatment in the past 15 to 20 years.

-   Flexibility: DHHS wants some flexibility in disbursement of Ryan
    White funds. Current regulations make it impossible to respond to
    crises.

-   Accountability: The Department must have the authority and the
    ability to assess States' activities and ensure that the funds are
    being used for their intended purpose.

Achieving these principles will require a fair amount of work, Ms.
McGeein acknowledged. She and her staff are in the process of developing
and analyzing options, and she coordinates a working group that meets
biweekly. They are designing policy options and the Health Resources and
Services Administration (HRSA) has been invaluable in providing an
overview and making sure key personnel are well versed. The group has
been soliciting input from stakeholders. There are many roads in this
particular map, she added.

Ms. McGeein recommended the two Institute of Medicine (IOM) reports,
"Measuring What Matters" and "Public Financing and the Delivery of
Health Care in HIV/AIDS," as good information sources about AIDS. She
said that she anticipates more interaction and discussion with
HIV/AIDS-related groups, and warned that this is not a fast process, but
the end result will be a fully developed understanding of where the Ryan
White CARE Act should be going and how to make it responsive and
responsible.

### **Discussion**

Mr. Minor asked who is on the working group, and Ms. McGeein said it is
composed of members of the Office of the Secretary's staff, including
the general counsel, representatives from the Office of HIV/AIDS Policy
(OHAP), the Assistant Secretary for Legislation (ASL), and the budget
people. Joseph Grogan is also a member of the group.

Dr. Henry McKinnell said that he doesn't think reauthorization is what
is wanted, but rather reform, and that perhaps the language of the
discussion should be changed to talk about modernization or reform along
with reauthorization. Ms. McGeein said that is understood, but changing
the language might impede progress. She added that the Ryan White CARE
Act has done a "mountain of good," but HIV/AIDS care and treatment have
changed, and what was good in 1990 and even 2000 might not be good in
2005. She emphasized again the principles: care and treatment take
precedence, accountability, and flexibility.

Debbie Rock asked what the PACHA role is. Ms. McGeein responded that she
wants to hear from Council members; they should funnel their ideas,
concepts, and questions to her, and she hopes that conversation and
dialogue develop. She walks away from the conversations both enlightened
and burdened, she said---enlightened because they have described
something she hadn\'t recognized, and burdened because she now feels
compelled to fix it. Mr. Grogan is the point of contact.

Dr. Ram Yogev asked if the Council will get feedback from Ms. McGeein
from time to time, and Ms. McGeein said that this type of dialogue can
continue, and she is willing to come to Council meetings and provide
updates on the work her Office is doing.

Anita Smith asked if there are milestones in this long process. Ms.
McGeein said that the reauthorization process is a full year's worth of
work, and she knows of no particular point where the group will say, "We
wish we'd known this 3 months ago." She added that the door is open for
input. There are no milestones per se, and the final deadline is
September 30, 2005.

Mr. Minor noted that with the emphasis on clinical services, and people
living longer and needing those services for longer periods of time, if
the amount of funding doesn't expand to meet these needs, something will
need to be cut. People in the community are nervous about this, he said,
and as yesterday's presentations made clear, HIV is not the only problem
for most people who are infected. How will that be incorporated into
decisions? he asked. On one hand, people have major needs such as
transportation, childcare, good nutrition, oral health, and housing. How
will that be balanced against the challenge of limited funding? It will
require a careful balancing act, Ms. McGeein answered, and like
everything else in health care, issues must be prioritized. DHHS does
not control the dollars, Congress controls the dollars. Control of
funds, competing priorities, and diverse considerations are the crux of
why the process will take so long. She did not have a specific answer as
to how the multiple challenges will be balanced.

Jacqueline Clements said that while the Ryan White Act provides a
variety of services, in some States there is an abundance of services,
but in others services are very limited. She asked how to ensure that
everyone living with HIV gets at least core services. Ms. McGeein said
that this is a formula distribution problem, and some States have more
generous formulas, including Medicaid, and she is not sure how this can
be addressed. She noted that the IOM report recommending HIV reporting
rather than AIDS reporting conceded that changing the reporting would
not completely address this.

Karen Ivantic-Doucette asked about consideration of IOM recommendations
about expanding use of Medicaid. When people with AIDS stay healthy and
do not qualify for disability, Ryan White funds will not be enough for
care and treatment. She asked if Medicare could function in a capacity
different from its usual role, as it does for dialysis. Ms. McGeein said
that the IOM study on public funding is still being reviewed, but she
does not think this Administration is in a position to increase Medicaid
benefits. She would be concerned about expanding the range of Medicare
benefits because of the size of the population involved.

Dr. Monica Sweeney said that one of yesterday's presentations discussed
the difficulty in collecting surveillance data, including the facts that
reports are coming from only 25 or 30 States, and some by name
reporting, some by code. She asked if, in terms of accountability and
flexibility and modernization, there is something that could be done to
make reporting more user-friendly for States, have it tied to the Ryan
White Act, and give States time to get their information technology
together and establish a somewhat uniform system. Ms. McGeein responded
that the ties between surveillance and the Ryan White Act are exact, and
money is disbursed on the basis of AIDS reporting. IOM has suggested
reverting to HIV reporting; in the 2000 reauthorization, States were
given until 2007 to report in this mode, and 36 States are currently
reporting in a mode that is acceptable to the Centers for Disease
Control and Prevention (CDC). So the timeline is already in place, but
IOM also said that even with clean, accurate reporting, there are still
problems, and it will take a huge amount of negotiation to have the
money completely follow the disease. In response to another question
from Dr. Sweeney, Ms. McGeein said that HIV name-based reporting is what
the CDC wants.

Rev. Edwin Sanders made a formal request that Ms. McGeein be in
attendance at all Council meetings until the reauthorization process is
completed.

Dr. David Reznik said that oral health care is one of the top three
unmet needs of people with HIV. As a care provider in a primary care
setting, he also understands that patients have many comorbidity
factors---for example, substance abuse, poverty---and care and treatment
need to be prioritized, but it is also essential to not undersell the
importance of some of these support services that allow people to take
medications. If someone is homeless, he or she is not likely to take
medications. Ms. McGeein answered that she understands that in providing
care and treatment, services that allow someone to access care and
treatment should not be eliminated.

Dr. Sullivan asked for more information about members of the working
group. The members are from the internal Office of the Secretary, Ms.
McGeein said. The next phase of the process, beginning in late summer or
early fall, will involve conversations with stakeholders, the service
providers and other patient advocates. Early in the process, she added,
these representatives said they were not ready for meetings, and they
have been allowed to complete their work but they will be an important
part of the process.

Mr. Minor asked what further accountability is sought and what seems to
be missing. The reports required are very comprehensive and time
consuming to complete, he said, and present a burden for some agencies,
particularly small ones. Ms. McGeein said that an agency may say at the
beginning of the year it is going to do something, but when its report
comes in at the end of the year, it did something else. HRSA would like
to have an explanation of these discrepancies, and the long interim of
silence worries some people. However, some States and cities are superb
in their accountability, she added. In response to a comment from Ms.
Rock about the large number of reports about program progress that are
written and filed, Ms. McGeein said there is a need for a feedback loop,
which does not currently exist.

Cheryl-Anne Hall asked if, with the burden of HIV/AIDS shifting to the
African American community, funds will be shifted to the African
American community, where there is a need. Ms. McGeein said that part of
the answer is related to the formula. The goal is for the money to
follow the disease, and the hope is that by changing the structuring so
that care and treatment come first, artificial barriers will be removed
and that will be the result.

## Remarks

Mr. Minor thanked Ms. McGeein for her presentation. Dr. Sullivan
announced that Dr. McKinnell had some comments to share with the
Council.

Dr. McKinnell said he shares the President\'s concern that too many
people do not have access to lifesaving medicines, and concluded that
the pharmaceutical industry needs to be part of the solution to that
problem. In 2002 Pfizer froze its prices on drugs for the ADAP program.
Even though the \$20 million designated for ADAP will clear the waiting
lists, they will grow again. Pfizer is announcing that it is continuing
the price freeze on HIV drugs through September 2005, he said. There is
still concern that people do not have access to drugs, however. Pfizer
is also finalizing a program that gives the uninsured access to the
lowest drug prices; low-income uninsured will be able to get Pfizer
drugs for free for a \$15 monthly access charge. Ms. Hall asked how
patients will know about this. Dr. McKinnell said a press release would
be issued on July 7, 2004. Dr. Sweeney said that a program called Share
the Care helps make Pfizer drugs available to many patients in community
health centers and she is glad to hear that Pfizer is making the savings
more broadly available.

Dr. Sullivan said that at yesterday's session the transition underway
for staff at the President's Office was noted, and he asked Dr.
Elizabeth Onjoro from that Office to tell the Council about her new
responsibilities.

Dr. Onjoro is with the Office of the Global AIDS Coordinator, which is
now focusing on 15 countries, since Vietnam was recently added to the
list. The Office handles oversight in these countries, to ensure that
the emergency plan is implemented, and that the program is integrated
with the countries' own 5-year plans. The goal is to make sure those two
purposes are blended, and that tax dollars are spent appropriately and
accounted for. All HIV activities in the 15 countries are being
coordinated with the goal to provide care in the most effective and
efficient manner possible. The countries have not yet been divided, as
staff determines the best rationale for teaming countries. She requested
support and encouragement from the Council.

# INTERNATIONAL 

Mr. Abner Mason said that the International Subcommittee has had a busy
and productive period since the last Council meeting. The Subcommittee
has two resolutions it is proposing. One is to select a 15th country for
the President's Emergency Plan for AIDS Relief (PEPFAR), but since that
has already been done, that resolution will be modified. The other is to
improve the prevention of mother-to-child transmission while still
providing treatment options for mothers. To increase understanding of
what is happening in Asia, and particularly in India, the Subcommittee
has invited speakers knowledgeable about that part of the world to share
their experiences and views.

# Overview of HHS Activities in India

Presenter: Dr. Amar Bhat, Director, Office of Asia and the Pacific,
Office of Global Health Affairs, DHHS

This Office is fairly new, Dr. Bhat said, but global health has been of
interest to the Secretary for some time. The Office combined the Offices
of International Activities and International Refugee Health about 2
years ago and formulates policy and provides advice to the Secretary and
Deputy Secretary and DHHS agencies about their international activities.
All of the HHS agencies listed in the Department's organizational chart
have important activities in HIV/AIDS. Dr. Bhat's presentation focused
primarily on India, but also covered some activities in Vietnam, and the
Global Fund to Fight AIDS, Tuberculosis and Malaria, which is meeting
this week in Geneva, Switzerland.

The United States has a long history of cooperation in India and has
been involved in the country since the 1960s. The Health Office in the
U.S. embassy represents DHHS in India. The original intent of the Office
was to manage U.S.-controlled rupees (received from India for grain
purchases) to fund cooperative health projects, as well as education and
cultural projects. Over the past 35 years, the Health Office has
directed more than \$200 million in U.S.-owned rupees to fund
cooperative health projects in high-priority areas such as HIV/AIDS,
tuberculosis, malaria, polio, leprosy, and cancers of various sorts.
Some of the projects, for example, in oral cancer, have led to benefits
not only for India but also for global populations.

Today the shift is from rupees to NIH dollar grants and CDC technical
assistance. The Office's annual budget is about \$40 million, with about
half of that designated for HIV/AIDS activities, 1 of 10 Indo-U.S.
bilateral programs. NIH grants are increasing rapidly, and the quality
of scientists in India has gone up dramatically, partly because of the
rupee reinvestment program. The NIH is authorized to make competitive
grants to foreign investigators, and most of the awards are to teams of
U.S. and Indian scientists. The NIH has a long history of training and
capacity building; the NIH Visiting Program funds more than 150 Indian
scientists on the NIH campus, and the Fogarty International Center
sponsors 30 to 50 Indian trainees in the United States and hundreds in
India each year.

Dr. Bollinger will speak in greater detail about NIH-supported research
in India in the next presentation. Some of the projects include the
National Institute of Allergy and Infectious Diseases (NIAID)
Comprehensive International Program on AIDS, the NIH International AIDS
Project, and NIAID's HIV Vaccine and Prevention Trial Networks. The CDC
also has a number of programs in India, and they are increasing rapidly,
covering health problems such as polio, AIDS, tuberculosis, and malaria.

The CDC's Global AIDS Program (GAP) was established in 2001 with offices
in New Delhi and Chennai, in southeast India. Headed by Dr. Dora Warren,
GAP has had notable activities, including work with the Government
Hospital of Thoracic Medicine in Chennai, which has been nearly
overwhelmed by a large number of AIDS cases. GAP had been working to
help the hospital improve its lab services, information technology,
patient management, and care and treatment, particularly using
antiretrovirals (ARVs). The hospital is very crowded, and the CDC
recently funded construction of a new ward.

India has 4.5 million people living with HIV/AIDS, almost 11 percent of
the global AIDS burden and 68 percent of the disease burden for South
and Southeast Asia. It faces the threat of being overwhelmed. Efforts
must be sustained and prevention closely linked to care. India possesses
significant assets that are not present in the rest of the developing
world, including a wealth of skills in health and science, medical
institutions and infrastructure, biotechnology, and a drug development
industry that can help support its capacity to respond to the epidemic.
India recently joined the Global Fund as a board member. The country
also started its own ARV therapy program, with the admirable goal of
reaching 100,000 people in a year.

Dr. Bhat then spoke about the HIV/AIDS situation in Vietnam, which the
President just announced will be the 15th focus country to receive
assistance from the President's Emergency Plan for AIDS Relief. Except
for India, Vietnam is the largest country in Southeast Asia. In a
population of 82 million, the HIV/AIDS prevalence is about 0.66 percent,
with HIV cases in all 64 provinces and 93 percent of all districts.
Vietnam is predicted to have an increase in persons infected with HIV
from 130,000 in 2002 to 1 million by 2010. The epidemic is found
primarily in injecting drug users (IDUs) in the north and commercial sex
workers in the south, but it is spreading to the general population.

DHHS has had activities in Vietnam since 1999, and GAP representatives
have been there since 2001. Two CDC staff members plus an attaché from
Dr. Bhat's Office are in the country. GAP funding in Vietnam is about
\$2.9 million per year, there are a few NIH grants in place, and the
U.S. Agency for International Development (USAID) also has some
substantial activity. Activities include voluntary counseling and
testing, care and treatment, establishment of AIDS clinics, technical
assistance (TA), and quality assurance in lab testing for HIV and other
sexually transmitted diseases (STDs). A new GAP office is opening in Ho
Chi Minh City.

Secretary Thompson is chairing the board meeting of the Global Fund
today and yesterday in Geneva. The Fund is considering about \$1 billion
of grant proposals, which generally have been 50 percent HIV/AIDS, 25
percent TB, and 25 percent malaria. They will also revisit the issue of
continuation of grants after a 2-year limit and how to manage the
process of renewing grants. So far the Fund has awarded \$2.1 billion
worldwide, but only about \$300 million has been disbursed so far, with
the rest pending paperwork.

### **Discussion**

Dr. Sullivan asked for further detail about existing cases of polio in
India and elsewhere. Dr. Bhat said that there are six remaining
countries with natural pockets of polio---Nigeria, Ethiopia, Sudan,
Afghanistan, Pakistan, and India. In India, these are mainly in the
north, in Uttar Pradesh and Bihar, and scattered in the south from
migration. Technically, the polio eradication program is scheduled to
end this year, but mop-up activities will continue. Dr. Sullivan
expressed concern that polio has still not been completely eradicated.
Dr. Bhat said that until it is, continuing activities will be funded,
such as multiple national immunization days. Deadlines are needed for
motivation. Most of the problems are at local levels and involve local
bureaucracies. In Nigeria, Afghanistan, and Pakistan, health workers
encounter misinformation, i.e., that the polio vaccine is unsafe, but
that is much less a problem in India. Strong efforts using religious and
community leaders and others are underway to counteract the
misinformation.

Dr. Sullivan also questioned the selection of Vietnam as the 15th
country for PEPFAR. He noted that outside sub-Saharan Africa, more
people in India are infected with HIV than in any other country. Other
arguments for India are that the country already has NIH scientists, as
well as a middle class and a growing economy. Dr. Bhat deferred these
questions to Dr. O'Neill of the Global AIDS Coordinator's Office, who
will address the Council later in the morning. But he assured Dr.
Sullivan that \$20 million for HIV/AIDS assistance has already been
committed to India, and funds to India will not decrease because it was
not chosen as a focus country. The PEPFAR decision was based on where
the United States can have the most impact, and the policymakers feel
they can bring Vietnam from the brink of an epidemic. Dr. Sullivan
remained unconvinced, commenting that he would like to hear more about
the choice of a country of 80 million over a country of 1.1 billion.

Dr. Sullivan also asked about the NIH Fogarty program. Dr. Bhat said it
is a university-based program across the country, and the NIH visiting
program, which supports 150 scientists per year, is focused on the NIH
campus, the University of North Carolina, and other sites.

Dr. Prem Sharma said that Dr. Sullivan's question about PEPFAR is on the
minds of many, and asked if the \$40 million designated by DHHS for
India is inclusive of \$20 million for HIV/AIDS. Yes, it is, Dr. Bhat
responded, although the \$20 million figure actually includes funds from
DHHS and USAID. Dr. Sharma also asked the status of leprosy in India,
which is not mentioned in the CDC budget. Leprosy activities have wound
down through the years, Dr. Bhat said, although some contracts are still
outstanding. Given the biology of the bacillus, much of the TB work has
relevance to leprosy.

Dr. Sharma also asked the extent of private sector work related to
polio, mentioning efforts of U.S. Rotary Clubs. Dr. Bhat replied that
other organizations have also worked on this, but the Rotary stands out,
and the international chairman accompanied Secretary Thompson on a
recent trip through India. Also, people in India have been instrumental
in organizing vaccine efforts.

Dr. Yogev commented that \$20 million to fight HIV/AIDS is not much for
a country the size of India. Also, he did not see any mention of work to
prevent mother-to-child transmission. Dr. Bhat said that Dr. Bollinger
is concluding some studies in that area and asked him to comment on this
work when he presents his report.

Dr. Beny Primm said he is concerned about the lack of focus on IDU as a
driving force for HIV infection in India, when it has increased by 40
percent in some areas. It seems there would be harm reduction programs
supported by the Government, he said, such as use of buprenorphine and
needle exchange programs. Dr. Bhat said that GAP programs have not
focused on IDU, although there have been some small National Institute
on Drug Abuse grants in northern areas. He added that India is not the
easiest place to work, there is stigma associated, and lack of interest
in the population in attacking this problem, but some NGOs are doing
good work focusing on methadone treatment and harm reduction. Dr. Primm
suggested that the Council recommend supporting drug treatment programs
in India.

Dr. McKinnell challenged Dr. Bhat's assessment, citing Richard Feecham,
executive director of the Global Fund, that there is a huge growing HIV
epidemic in India. Dr. Bhat called the efforts of the Indian Government
admirable, but Dr. McKinnell contended that they are embarrassing. He
knows of no drug discovery in India, although there are 22,000 drug
companies in India. Many drugs are substandard because there are no
patent laws and inadequate regulation. There are more drug companies in
India than there are people on ARV, he charged. Dr. Bhat disagreed that
there is no drug discovery activity, and said India has increased its
own private sector research funding, and more original research is going
on. Changes are also underway in patent law, and researchers who began
training with U.S. scientists 15 years ago are now moving to leadership
positions. However, he agreed that the Indian Government has not played
a strong role, but cautioned that in India quiet collaboration works
better than negativity and aggression.

Ms. Rock noted that culture can create barriers, and in speaking to
people from India, she has learned that physicians may not adhere to
confidentiality guidelines, leading to discrimination. She asked if that
is being addressed in any way. Dr. Bhat said it is difficult, because it
is a cultural issue, and DHHS is not doing much in this area. There is a
learning curve for physicians about HIV/AIDS, he added, and training
seminars and continuing education programs may be addressing
confidentiality issues, but he did not know that for certain.

Ms. Ivantic-Doucette returned the discussion to polio eradication. She
asked if vaccination efforts were coming up against pockets of
immunosuppressed people (such as with HIV) who cannot mount a response
to the vaccine. Dr. Bhat said he could not comment on medical aspects,
but the polio vaccination is primarily focused on children, and they are
not where HIV is seen in India.

# HIV and AIDS in India: Challenges and Opportunities

Presenter: Dr. Robert Bollinger, Professor of Infectious Diseases and
International Health, Johns Hopkins Schools of Medicine and Public
Health

Mr. Mason introduced Dr. Bollinger, noting that he has been named
director of the newly established Johns Hopkins Center for Clinical
Global Health Education, which will develop and implement clinical
training programs for health care providers in resource-limited settings
such as India.

Dr. Bollinger thanked the Council for the opportunity to talk about the
HIV epidemic in India. He first worked in India 25 years ago treating
leprosy. For the past 12 years he has directed a large Indo-U.S.
collaborative HIV research program with a broad menu of activities in
Pune, India. The focus of that program includes clinical research in ARV
therapy, microbicide studies, vaccine development, and maternal-infant
transmission studies.

India is huge and complex, Dr. Bollinger said, as is its HIV epidemic.
Between 60 and\
65 percent of HIV cases in Asia are in India, with two new infections
each minute. The first case of HIV in India was described in 1987. From
1996 to 2002, there was a 60 percent increase in HIV in India. There are
different estimates for the total number of cases. The National AIDS
Control Organization (NACO) says 4.6 million, the Joint United Nations
Programme on HIV/AIDS (UNAIDS) estimates 5.4 million, and the National
Intelligence Council estimates 8 million. Whichever number is true, they
all describe too many HIV infections and a public health crisis.

Like India itself, the HIV epidemic is geographically diverse. In size
and complexity, India is essentially a continent of its own. The
distribution of HIV is not uniform. Dr. Bollinger hypothesized that
distribution patterns reflect migration patterns in India.

Who is infected with HIV in India? The 61,201 AIDS cases reported to
NACO by December 31, 2003, grossly underestimate the number, but the
data are informative in that 85 percent of cases are attributed to
sexual transmission, with heterosexual contact as the risk factor. The
largest risk groups are men who visit commercial sex workers, the
commercial sex workers themselves, the wives of those men, and the
children of those subsequently infected mothers. Other risk groups are
not as large but are also important: IDUs, men who have sex with men
(MSM), transfusion recipients, and urban youth. It is unclear what
impact HIV has on health care personnel and medical personnel.

Increasing HIV prevalence over time is seen in men who attend STD
clinics. This is a sentinel risk group, at higher risk for the epidemic
anywhere in the world. About 20 percent of people who come to the clinic
are already infected with HIV. The pattern of HIV in this matches what
has been seen in other countries, particularly South Africa, only a few
years later. The infection rate in sex workers is about 30 percent in
most urban areas in India, and about 50 percent in Pune, the location of
Dr. Bollinger's clinic. Increase in HIV prevalence is seen in wives of
STD patients---married monogamous women whose only risk factors are
their husbands.

In trying to determine how generalized the epidemic is in India, a
random survey of adults aged 18 to 40 in the community and in wine shops
in 24 urban slums around Chennai found a relatively low HIV prevalence
in the community (1 percent of men, 0.2 percent of women) but higher
rates in the wine shops, which are associated with female sex workers
(2.3 percent of men, 8.1 percent of women).

Comparing risk data in India to two African countries, Kenya and Zambia,
the overall HIV infection rates in India are much lower---0.7 percent in
India, 19.8 percent in Kenya, and 23.2 percent in Zambia. A higher
percentage of Indians in this age group are married, and 12 percent of
men and 2 percent of women report extramarital sexual contact. The
reports of extramarital sex in Africa are much higher---48 percent for
Kenyan men, 21 percent for Zambian men, 21 percent for Kenyan women, 15
percent for Zambian women. There is also a higher percentage of condom
use with nonspousal partners in India. But the key transmission group in
India is men who have sex with female sex workers, Dr. Bollinger
reiterated, and then transmit the virus to their wives, who then
transmit it to their infants. Most of the epidemic is being driven by
these high-risk men.

The goal is to protect wives and their subsequent children. Condoms have
been shown to be very effective. In a study of 200 discordant couples,
where the man was infected and the woman was not, intensive intervention
and couples counseling brought about a very low transmission rate of 1.4
percent, demonstrating the effectiveness of counseling. None of the
HIV-negative wives were infected if their husbands used condoms.

Looking at other risk groups, a tremendous increase in HIV rates in IDUs
has been seen in India. In a study of male IDUs in Manipur, India, 80
percent became infected, less than 15 percent used condoms regularly,
and more than 50 percent of their wives are now infected, which is not
surprising. In another risk group, about 6.6 percent of men who come to
the STD clinics in Pune reported some MSM activity, usually at an early
age, and usually do not consider themselves homosexual. The prevalence
of HIV in that population is about 19 percent, which is similar to men
in this group who do not report MSM.

HIV prevalence in pregnancy has been fairly flat for the past 10 years
in studies in India, Pune, and Thailand. This is in contrast to rising
rates in pregnant women in South Africa and in earlier years of the
epidemic in Uganda. However, in India even low prevalence translates to
large numbers.

How bad will the epidemic be in India? With at least 4 million infected
persons, India already faces a public health crisis. India has the
second largest HIV burden in the world---at least 12 percent of global
infections and more than twice the infection rate as in Vietnam. Every
fourth newly infected person in the world is an Indian, and just a 1
percent increase in adult HIV prevalence in India would mean at least 5
million more infections.

The large total population of India puts the problems of HIV on a
different scale than faced by smaller countries. There have already been
at least 500,000 HIV-associated deaths in India, most in the past 5
years. India is at the beginning of the HIV epidemic, but there is
already a significant public health challenge that is reflected in the
lower life expectancy in India and will now be compounded by the HIV
epidemic.

The public health system in India is already overburdened with
infectious disease, and limited resources are available for HIV care.
Even some of the best-equipped hospitals have overflowing wards with
patients in the hallways. HIV is going to stress an already stressed
system. HIV patients present very late to the health care system in
India, with 56 percent in one study also infected with TB, a respiratory
disease easily spread from patient to patient. The late presentation of
HIV also raises questions about the access point to deliver
HAART---intervention is needed at an earlier point. In a study of 655
hospitalized HIV patients, the in-hospital mortality rate was 25
percent.

Cervical cancer is another increasingly important problem. It is already
the third leading cause of death in Indian women, and HIV significantly
increases risk of human papillomavirus (HPV) infection and cervical
cancer. This raises great concerns about the impact of HIV on the health
of women, which is already challenged by cervical cancer.

Stigma is an important issue related to HIV---and one that is familiar
to Dr. Bollinger after his years of work in leprosy control. The
community has become more accepting of HIV, he has found, but in urban
areas, women have been pushed out of their homes and beaten by their
in-laws and lost everything after diagnosis with HIV. But support from
husbands for their wives is also seen after counseling. It takes effort
and targeted approaches.

For Council members interested in further information, Dr. Bollinger
recommended an article in the April 24, 2004, issue of Science by Jon
Cohen and Malcolm Linton, which he made available to the Council.

HIV treatment is just now becoming available in India. Guidelines for
ARV therapy were published in February 2004, and in March 2004, NACO
rolled out a pilot ARV treatment program. However, only 1 to 3 percent
of people in the country actually have access to ARV. So there is a
great need and a great underserved population that needs antiretroviral
care in India.

Another challenge is the drugs that are available. A number of companies
are producing generic ARV drugs, with only a few companies putting out
the great majority of drugs. The quality of these drugs needs to be
investigated, but some studies have found comparable biological
responses to the nongenerics. Combinations that require fewer pills per
day offer a much better chance for adherence in India and other
settings.

The NACO plan initiated in March has a limited and uncertain supply of
HAART. It is focused on the already overburdened public health system,
even though more than 70 percent of health care in India is from the
private sector. To get free care, some patients must now leave their
private doctors and move to public health programs. NACO needs to figure
out how to bridge this public/private partnership if it wants to have an
impact. Like many programs, it prioritizes women and children, but if
the whole family, including the husband, is not treated, no one
benefits. Only a few urban pilot sites have actually been able to
deliver drugs so far, with only a handful of patients. Sustainability
and scale-up of this program are uncertain. Initial programs focused on
urban areas, but a large percentage of India's population lives in rural
India, where one of the challenges would be simply to get a clean glass
of water to swallow pills with every day.

Strengths in India are the large number of doctors and nurses and the
educated populace. But they don't have trained health care workers who
know how to deliver antiretroviral care. They need resources and
training.

Dr. Bollinger listed five ways the United States can help India with its
HIV epidemic:

-   Increase support for HIV clinical care

-   Foster public-private partnerships for HIV care and prevention

-   Increase support for Indo-U.S. collaborative HIV research

-   Increase support for public health research training

-   Provide support for HAART, clinical monitoring, opportunistic
    infection (OI) diagnosis, and treatment.

With more resources, he emphasized, India can overcome the HIV epidemic
challenges. With the human capital of India, U.S. dollars can go a long
way if spent efficiently and properly.

Dr. Bollinger also described why the battle against HIV/AIDS in India is
important to the United States. India, a critical strategic, economic,
and political partner, is vulnerable to this expanding epidemic.
Increased HIV and TB drug resistance in India will have a global impact.
India has a unique infrastructure and many talented people. India's
success or failure will have an impact on the HIV epidemic throughout
Asia, containing half the world's population. And India has a window of
opportunity, but must act decisively, and now.

### **Discussion**

Dr. McKinnell thanked Dr. Bollinger for his presentation, and for his
many years of work in India. He asked if the low HIV rates compared to
the high cervical cancer rates in India cause him to question the data,
and if he is seeing the resistance to nevirapine that is being seen in
Africa. Dr. Bollinger said that he is concerned that cervical cancer,
already a major problem before HIV, will get worse. HPV infection is
exacerbated by HIV.

Resistance to nevirapine is a major concern, Dr. Bollinger said. One of
the limitations of HAART therapy in India is that there is relatively
little access to protease inhibitors. Most of the combinations available
in India include a non-nucleoside reverse transcriptase inhibitor
(NNRTI), in most cases nevirapine. So the HAART fixed-dose combinations
that are available in India almost exclusively rely upon nevirapine as
part of that combination, and there are not many other alternatives.

India also has the world's largest nevirapine program for women to
prevent mother-to-child transmission. That is likely to have an impact
on the efficacy of the current combinations for those mothers should
they subsequently need care. Another challenge is the reliance on
zidovudine (AZT). A very high prevalence of anemia is seen in women on
this drug, limiting its usefulness. Dr. McKinnell added that if there
are problems with nevirapine, there are most likely also problems with
other NNRTIs, and options are limited. Dr. Bollinger said that liver
toxicity is also associated with nevirapine, particularly in women with
higher CD4 counts.

Ms. Shoemaker asked if IDUs are presenting with more OIs because of
already compromised immune systems. Dr. Bollinger answered that
susceptibility to OIs depends on CD4 counts, and that many people die of
TB undiagnosed (but infected) with HIV. Without TB prevention, HAART may
turn out to have limited effectiveness in the epidemic in India.

Dr. Green noted the low rates of extramarital sex by women, and asked if
there are any strategies to achieve consistent condom use. Dr. Bollinger
said his experience is limited to the research setting, but the Pune
study demonstrated that it is possible, with 60 percent of couples
continuing to use condoms. Whether that can be scaled up in a
generalized way for women at risk throughout India is difficult to say.

Dr. Sweeney asked if a model used in New York City for TB therapy, with
directly observed therapy (DOT) for patients to take medications 6 days
per week, might be of use. Researchers in New York found it could
significantly affect outcome. She also asked how to prevent
mother-to-child transmission from breastfeeding, and if condoms are
available from health departments in India. Dr. Bollinger said that DOT
makes a lot of sense for ARV therapy; there are limited drug options in
India, but this is not insurmountable. Regarding mother-to-child
transmission, a clinical trial in Pune is looking at extended use of
nevirapine for infants who are breastfeeding. Earlier HIV-infected
mothers were advised not to breastfeed, but hospitalization and deaths
of these infants was extremely high because safe formula is not readily
available, so the risk of death from not breastfeeding exceeded the risk
of death from HIV. Finally, condoms are widely available in India.

# India at the Crossroads

# Presenter: Teresita Schaffer, Director of South Asia Program, Center for Strategic and International Studies

Mr. Mason introduced Ms. Schaffer, former ambassador to Sri Lanka and
current director of the South Asia Program at the Center for Strategic
and International Studies (CSIS). Ms. Schaffer said that two other items
in her resume might be of interest to the Council: she was science
attaché in New Delhi in the late 1970s in an HHS-funded slot, and she
also organized the recent trip to India (January 3--10, 2004) that Dr.
Sullivan led.

Ms. Schaffer presented findings from the trip to Council members and
distributed a report from the weeklong visit to three Indian cities
("India at the Crossroads, Confronting the HIV/AIDS Challenge"). She
also made available a short briefing paper on the Indian election. The
purpose of the mission to India derived from the intent of CSIS's
HIV/AIDS task force to look at second-wave countries in the HIV
pandemic, and to gain a better understanding of India's current status
in combating HIV/AIDS and what that situation means for the worldwide
pandemic and, ultimately, for the United States.

The trip provided insights and prompted recommendations. The main
finding was that this is a moment of strategic opportunity in India, as
it deals with the second largest number of people with HIV in the world.
A revolution has taken place in India-U.S. relations over the past
decade, with security the most dynamic area. India is a nuclear power,
with the fourth largest army in the world and a nuclear neighbor with
which it has an unresolved dispute. It lives in a dangerous
neighborhood. It has become an increasingly important security presence
in that area, and a country that has compatible security relations with
the United States.

The future of HIV/AIDS is one of the major wild cards hanging over
India's future. The projections for burden of infection 10 years from
now have been presented at this meeting. However, no one has a good
estimate of what the economic impact might be. Failure to bring the
epidemic under control will sap the nation's economy and cause terrible
social upheaval, as it has in southern Africa.

This is also a moment of strategic opportunity for India in its policy
toward HIV/AIDS. As other speakers have suggested, India is more like a
continent than a country, with 10 states with more than 50 million
people and a relatively decentralized federal system. But there is an
important national overlay to HIV/AIDS policy. NACO was established
about 12 years ago. Until this year, national policy focused almost
entirely on prevention, although the Indian Government was relatively
slow to put resources into prevention. The recent trip to India
highlighted a dramatic increase in awareness of the epidemic, although
it remains spotty in some areas.

What is new is that the Government has decided to become involved in
providing antiretroviral drugs. There had been approximately 15,000
patients on ARV, mostly through private sources. Bringing patients who
need ARV into the public health system will be a huge burden, requiring
new skills and taxing already overcrowded facilities. The next 6 to 12
months are a critical time for India's HIV/AIDS policy and its public
health system. It is important that prevention be considered in the
context of care, without the availability of care leading people to
ignore prevention.

In India since January, ARV drugs have been made available and a new
Government has been elected and installed at national and local levels.
The new leaders have a greater commitment to addressing the epidemic.
The CSIS delegation spent an hour with the new prime minister, Manmohan
Singh, who spoke eloquently on the need to combat HIV/AIDS and the need
for a social change movement, as India experienced in the 19th century.
The new health minister is a 36-year-old medical doctor from a political
family, although without much personal political experience. He has not
had sufficient time to get involved with HIV/AIDS, but Ms. Schaffer was
confident he will join and support the efforts to fight it.

The impact on state leaders is less clear. One state leader who showed
remarkable leadership against the epidemic at the state level was not
reelected, and it is uncertain what approach his successors will take.
The largest high-prevalence states are relatively well governed. Part of
their risk factor is the fact that they are economically stable, thus
attracting job-seeking migrants. HIV is a difficult subject for
politicians to talk about, but there are tentative signs in India that
it is becoming good politics to have an AIDS program as part of state
policy. Democracy may be an asset, as is a strong NGO community, and a
business community that is beginning to show interest. The largest and
most dynamic of India's business organizations, the Confederation of
Indian Industry, has sponsored the development of workplace guidelines.

India also has important problems. The cost of providing ARVs on the
large scale needed for this huge country must be viewed in the context
of a Government managing a fiscal deficit that is more than 10 percent
of the gross domestic product. However badly needed, resources for the
program are simply not there. A second problem is stigma and
discrimination. Recently introduced antidiscrimination legislation did
not pass, but it is likely it will be reintroduced. Third, while India
has a substantial research establishment, needed linkages between social
and biological research are weak.

There are several lessons to be learned from the Indian experience. The
United States and the international community have not yet determined
how to deal with megacountries, and the HIV/AIDS second wave is
occurring in the two megacountries of India and China. The
decentralization that is necessary in such large countries almost
guarantees an uneven program. Second, how is the epidemic measured in a
megacountry? Surveillance resources have been allocated to areas known
to have greater prevalence, but it may be that counts are very
inaccurate in areas with enormous populations and badly run
infrastructures. It is important to determine how to provide the
appropriate tools to get to the right populations. This may need to be
done at local rather than state levels.

The problem of scale in the programs themselves is related to both of
these issues. The Indian Government program and the Bill and Melinda
Gates Foundation program are trying to develop scaleable projects that
can be adapted from district to district. But in a country where food,
language, and social customs vary from community to community, one size
will not fit all. NGOs can help address this, and small focused
approaches may lead to making large-scale approaches more acceptable in
specific communities.

The major conclusion from these observations, Ms. Schaffer said, is that
it is time for the United States to step up its involvement. In general,
large countries get much less aid per capita than small countries, and
India will always have much less assistance on any per capita basis. It
is regretful that the Administration decided not to put India on the
PEPFAR list, she said, because this is bound to have some impact on
resource allocation and available funds are not infinite. India will
have a hard time making its own increased investment in the epidemic
because of its general fiscal situation.

Established collaborative mechanisms need strengthening, and we may not
have heard the last of PEPFAR related to India. Professional engagements
through the NIH and the Fogarty International Center are prized in India
and need to be expanded. The United States needs to learn from India's
experience, not only to be an effective partner with India in combating
the epidemic there, but also to better understand the dynamics of this
increasingly diverse epidemic worldwide, and so that India can
contribute its resources to the broader fight against this terrible
scourge.

# President's Emergency Plan for AIDS Relief

Presenter: Dr. Joseph O'Neill, Medical Director and Deputy Coordinator,
Office of the U.S. Global AIDS Coordinator, U.S. Department of State

Mr. Mason said that questions for Ms. Schaffer and Dr. Bollinger would
be deferred until after Dr. O'Neill's presentation, to accommodate his
schedule. He introduced Dr. O'Neill as "an extraordinary public
servant," who has had a great deal to do with PEPFAR, which has brought
enormous hope and optimism around the world. President Bush described
Dr. O'Neill as "the architect of the global AIDS initiative ... a
pioneer in many ways, a deeply compassionate person."

Dr. O'Neill opened with the comment that he expects a lot of questions
about India and PEPFAR, and there is a tremendous amount of
misunderstanding about PEPFAR---how it was designed and why certain
decisions were made. He wants to provide the Council with an overview
perspective and understanding of the thinking behind the decisions, so
the Council can best provide its best advice.

When developing the PEPFAR plan, Dr. O'Neill said, President Bush was
willing to find and invest money for a significant effort, but *not* to
put money into business as usual. Focus was important, as was the issue
of the United States taking leadership fighting HIV/AIDS in the world.

The most important reason the Administration established PEPFAR was as
an act of compassion, an understanding that an enormous problem exists
and the world is not doing enough about it. Dr. O'Neill quoted writer
Elie Weisel: "We are responsible for one another. ... If not, we are
condemned by our solitude forever ... ." That quote, he said, sums up
why the United States is taking action---to help the rest of the world
but also to help ourselves as a country. In proposing PEPFAR and
requesting \$15 billion over 5 years, the President described it as a
"work of mercy beyond all current international efforts ... to turn the
tide against AIDS in the most affected nations of Africa and the
Caribbean."

Budget figures show a significant increase over the years in the U.S.
commitment to combat HIV/AIDS globally:

> FY 2001 \$ 840 million
>
> FY 2003 1,581 million
>
> FY 2004 2,443 million\*
>
> FY 2005 2,821 million\*
>
> (\* \$15 billion over 5 years, not \$3 billion/year)

This is the largest global health effort directed against a single
disease in history. With a \$15 billion commitment, it is important to
be intelligent about how it is spent, Dr. O'Neill cautioned. It was
decided that the smartest way was to ramp up spending over time because
of infrastructure issues, a desire to focus on treatment, and the
necessity to train personnel. The U.S. investment is more than the total
from all other countries worldwide to fight global HIV/AIDS. It is not
true, as sometimes charged, that the United States is lagging behind the
world; the rest of the world is lagging behind the United States.

HIV/AIDS is a complex disease involving complex approaches. The
President's initiative focused on treatment, and this represents the
most complicated global effort ever to deliver complex medical treatment
and prevention strategies to millions of people. The task demands a
comprehensive strategy. This includes the Global Fund (to which the
United States is the largest donor), which has bilateral activities in
more than 80 countries, including India. India, in fact, will receive
more money than some of the PEPFAR countries. The 15 focus countries
have also received funding from the Preventing Mother-to-Child
Transmission (PMTCT) initiative.

The intent of choosing focus countries was to concentrate on regions of
the world that need help the most. The 14 countries originally targeted
had more than 50 percent of the world's AIDS cases with the most
intractable problems, the least resources, and host governments with the
least ability to respond. The goal was to show that American initiative
can turn this problem around, and convince other wealthy countries in
the world to add their contributions. The Office of the U.S. Global AIDS
Coordinator did not want to add a 15th country, but this was mandated by
Congress.

Regarding the U.S. role in the Global Fund, the United States made a
founding contribution of \$200 million and currently provides almost 40
percent of all pledges to the Global Fund through 2008 and 31 percent of
the cash on hand. There are statutory limits on contributions; the
United States is prohibited from exceeding 33 percent of total
contributions.

PEPFAR recognizes that AIDS is not only complex, it is also an
emergency. Years of planning are an unavailable luxury. The strategy
must be focused and aggressive, as illustrated by this timeline of U.S.
global HIV/AIDS efforts:

-   January 20, 2001: President Bush inaugurated.

-   May 11, 2001: President makes founding contribution to the Global
    Fund and provides technical assistance to implement activities.

-   June 19, 2002: President announces \$500 million PMTCT program.

-   January 29, 2003: President announces \$15 billion PEPFAR
    commitment.

-   May 27, 2003: President signs authorizing bill.

-   January 23, 2004: Congress passes appropriations.

-   February 23, 2004: First round of grants (\$350 million) in hands of
    partners in Africa and Caribbean.

-   June 23, 2004: Second round (\$500 million) released.

The rapidity of the response has been remarkable, Dr. O'Neill said,
particularly in contrast to the more cautious approach of the Global
Fund. In about 6 months, the United States has moved about twice as much
money into the countries than any other large international organization
has done in 2 years. This was not doing business as usual, but involved
overturning an enormous number of apple carts in Washington and around
the world to do business differently, to create Dr. O'Neill's Office to
consolidate the funding, to develop a strategy. It is an extraordinary
accomplishment.

His Office fought hard to control the money, Dr. O'Neill added, and does
have that control, which allows coordination and the ability to operate
on the basis of a single unified policy. One thing this coordination has
yielded is a common dataset between DHHS and USAID that cuts across
countries, which allows uniform evaluation strategies. Dr. O'Neill
contrasted this to the beginning of the PMTCT initiative, which had
input from 28 different units with 28 different evaluation strategies.

The pharmaceutical issue has received a bit of media attention recently.
The U.S. Government expects to spend more than \$4 billion on
pharmaceuticals and distribution systems in the 15 PEPFAR countries.
This has stimulated a market for pharmaceuticals and greatly increased
interest in most target countries to develop their own capacity for
manufacture of HIV/AIDS drugs. This is worrisome because of the issue of
quality of generic drugs. The United States has a unique responsibility
to ensure the quality of the drugs it is purchasing.

The issue of drug resistance is a real one that may not be taken
seriously enough. It involves large numbers of people and the potential
to harm millions, in the context of weak clinical systems in the
countries where PEPFAR operates, compared to the United States, where
early warning systems give indications of developing resistance. That is
not available in PEPFAR countries, and there is a huge potential for
significant impact.

The United States is committed to purchasing high-quality drugs at the
lowest possible cost, and is working on mechanisms that will allow for
cost reductions by large-scale purchasing. This means regulatory review,
as is done in this country. The drugs will be reviewed on a fast track.
Some of the PEPFAR countries are countries where inferior drugs have
been "dumped" for years. The intent now is to provide the same level of
consumer protection to the poorest person in Africa as to the richest
person in New York City. The United States will not compromise on drug
quality, Dr. O'Neill said, and he is proud of this ethically sound
position. FDA tentative approval is expected to be very quick, with good
manufacturing practices already being implemented.

Dr. O'Neill quoted President Bill Clinton on the necessity for "a
Government that demands responsibility from industry and producers, but
also provides clearer, stricter standards of safety and the means to
enforce them." The current initiatives mark the first time this is being
done in a serious way internationally.

The PMTCT initiative is on track to achieve its goals of reaching 1
million women and providing ARV prophylaxis to 80 percent of
HIV-positive women delivering children in target countries. After 18
months, it has trained 14,700 health workers, 900 facilities have
established PMTCT capacity, PMTCT services have been provided to 378,000
women, and 34,000 women have been provided ARV prophylaxis with the
bottom line an estimated 4,800 cases of HIV prevented. This real
progress is the result of good work by many people, including Council
members. The PMTCT initiative has now been folded into the PEPFAR
initiative.

Current projections are to have more than 200,000 people on treatment by
the end of PEPFAR's first year and expose millions to information that
will prevent HIV infection. Dr. O'Neill expressed confidence that the
first-year projection will be met, putting the project on track to
provide treatment for 2 million people by 2008 and achieve its noble and
substantial goals.

### **Discussion**

Dr. Sullivan commended the strategy and reiterated the need to get in
front of the epidemic in second-wave countries such as India and China,
which contain one-third of the world's population. He asked why the
United States is not more involved with those countries, warning that in
10 years it will be too late and they will look like sub-Saharan Africa.
Dr. O'Neill responded that this needs to be put in context, and before
the 14 PEPFAR countries were even announced, the United States had
doubled its global assistance for HIV/AIDS. The 14 countries selected
were picked because they have the least amount of resources to dedicate
to the battle, and it is necessary to ask if other donor countries are
doing all they can, and if India and China are doing all they can for
their own people.

Dr. O'Neill emphasized that the United States is not turning a blind eye
to the rest of the world, but can't solve the HIV/AIDS problem on its
own. One important purpose of PEPFAR is to provide leadership to the
rest of the world and dispel the feeling that this work is hopeless,
with no possibility of impact. India is getting \$20 million in U.S.
assistance without being a PEPFAR country; Vietnam is getting \$16
million. India also gets money from other donors; there is little of
this going on in Vietnam. The projected rate of infection from 2000 to
2010 will increase eightfold in Vietnam, compared to fivefold in India.

Dr. Hu agreed with Dr. O'Neill that the U.S. Government is doing what it
should and doing it well, and commended the choice of Vietnam as the
15th PEPFAR country. She emphasized the importance for awareness of the
HIV/AIDS epidemic in Asia, so what has happened in Africa can be
prevented. While India and China have more resources than African
countries, on a per capita basis, they are still very poor countries.
But there are many things the United States can do to encourage other
countries to take more responsibility for their own people, including
stipulations in trade negotiations and requirements for matching funds.

Ms. Ivantic-Doucette asked for guidance on PMTCT issues and
recommendations during lactation. A motion on this will be presented to
the Council, based on preliminary data that are compelling but limited
about single-dose nevirapine resistance. However, it appears that
projects in PEPFAR countries are using single-dose nevirapine therapy to
prevent mother-to-child transmission. Dr. O'Neill said that sufficient
data are not available to definitively answer the question. PEPFAR works
in sovereign nations, and its job is primarily to work with policy and
clinical recommendations and standards of care developed by health
ministries and provide them with technical assistance. When data do not
lead in a clear direction, he said, he would be reluctant to countermand
what a sovereign nation wants to do. The United States should tread
lightly regarding this issue.

Dr. McIlhaney said that drugs are not available to treat everyone, but
he is concerned that the availability of medication might produce
disinhibition and decreased behavior change. He emphasized the
importance of behavior change to produce dramatic decreases in HIV, and
cautioned against losing that focus. Dr. O'Neill said that what is
needed is good behavioral science research in this area. However,
provision of treatment is a key element in the prevention strategy. This
may mean perturbing the system, but it's a world that needs change---but
it is important to be cautious about unintended consequences. The system
needs to be set up to figure out unintended impacts and intervene
quickly.

### **Discussion---Part 2**

(related to presentations by Dr. Bollinger and Ms. Schaffer)

Dr. Yogev referred to data introduced by Dr. Bollinger that childhood
mortality in India is higher than in South Africa. He fears that the
enormity of the HIV/AIDS problem for children is being ignored. He
described an "unfavorable experience" in Thailand, where a combination
drug not authorized for pediatric use was being broken into smaller
doses for children but still proving to be toxic. The drug was withdrawn
by the World Health Organization. Dr. Bollinger said this reinforces his
point that health indicators are already difficult, and bringing HIV
into the situation translates to a major problem with limited treatment
options. He said he shares Dr. Yogev's concern.

Dr. Yogev asked if any liquid formulation of drugs is available. Dr.
Bollinger said it is, but the quality is unclear. In the absence of an
alternative, people are using them and children seem to respond
favorably. Dr. Yogev also asked why the number of infected women in Pune
almost doubled in the past 5 years, and Dr. Bollinger said that refers
only to a specific subset of women whose husbands are at high risk and
is not representative of the whole population. Any epidemic reaches a
threshold, and that threshold can have a different inflection point for
different populations and different diseases. A concern is whether that
threshold is being reached in India, and that the inflection will be
seen. Ms. Shaffer added that it is also important to recognize
geographic differences. Dr. Yogev emphasized the narrow window of
opportunity for intervention, before the threshold is reached.

Dr. Yogev also commented that nevirapine resistance is an *in vitro*
phenomenon with unknown clinical effects, and caution should be
exercised in suggesting that it has exhausted its usefulness and
promoting substitution of a more expensive, more complicated therapy.
Dr. Bollinger argued that concern is warranted about the issue of
resistance and limited ability to treat a mother with nevirapine
resistance. It is also not clear if her child could benefit from
treatment with nevirapine. Resistance is a bigger issue in India than
elsewhere, because of the potential for distributing highly resistant
virus worldwide and in the region on a scale that couldn't happen, for
example, in Vietnam. He is very concerned about the potential regional
and global impact, and if India's ARV program is not properly managed,
it could have worldwide implications.

Dr. Primm suggested a push to establish drug treatment programs to
thwart the escalation of IDUs. Dr. Bollinger said he and his team have
looked at the population in Pune and talked to others in other parts of
country and determined that IV drug use is an important problem in some
areas, but the majority of patients seen in urban India do not have IV
drug use as a risk factor. The reason is simple---drugs are expensive,
and the people are poor, and there is not much of a market except in
certain areas such as Manipur, where drugs flow freely. But IV drug use
at this point is not a generalized problem in India, and not a driving
force outside of Manipur. Alcohol use and other risk behaviors have more
of an effect on behavior than IV drugs do. Ms. Schaffer added that one
of the programs she visited in New Delhi had started as a treatment
clinic for IV drug users and then had branched out.

Dr. Sullivan concluded the session with the comment that while his task
force was in India, they ran into a congressional delegation that
expressed strong interest in what was going on. The CSIS task force has
two honorary chairs, Senators Bill Frist and Russ Feingold, so there is
strong congressional interest. He wants to see other nations around the
world do their share, but there is no question that as the wealthiest
nation on earth, the United States can do more---not only because it is
compassionate and humane, but it is in our country's own self-interest.
The United States must provide leadership; without the resolve to try to
change the reality we confront, these meetings are a waste of everyone's
time.

The full Council adjourned at 1:05 p.m., with members moving into a
working lunch and Subcommittee breakout meetings to consider motions and
other business. Mr. Grogan announced the room numbers and staff for
each.

### **AFTERNOON SESSION**

The full Council reconvened at 2:40 p.m.

## Treatment and Care Subcommittee

Mr. Minor brought up two issues he has discussed with Ms. Smith and Mr.
Mason, the other Subcommittee Chairs. First, there was some confusion
about the meeting schedule for the Subcommittees and he asked that it be
clarified. Mr. Grogan said that the next full Council meeting will be
early in October 2004, and the PACHA budget will be discussed this week,
and then the Subcommittee meetings will be planned. Mr. Minor thanked
him and noted that with interim Subcommittee meetings, Council members
can be better prepared.

Mr. Minor then said he would like to request a meeting with the
President, to sit down and discuss these many issues that Council
members know are close to his heart. He emphasized the importance of the
work that the Council does, and that it be communicated at the highest
levels. Mr. Grogan said he would pass the request along.

Before getting to the motions, Mr. Minor brought up a letter to
Secretary Thompson that was included in members' packets. The letter had
three purposes:

-   To recognize the appointment of Carol Thompson as director of the
    White House Office of National AIDS Policy, which represents a
    strong commitment of the Administration to the work of ONAP.

-   To recognize the President and Secretary Thompson for their support
    on reauthorization of the Ryan White CARE Act.

-   To recognize the extraordinary work of Josephine Robinson as
    executive director of the Council, and to recognize Mr. Grogan as
    her successor.

Mr. Minor moved that the Council adopt this letter and send it forward.
The motion was seconded and passed unanimously.

Next, Mr. Minor followed up on a motion to request a White House Summit
on the domestic HIV/AIDS agenda, unanimously passed at the last Council
meeting. He has received considerable feedback on the idea of a Summit,
and based on that, suggested the meeting for next summer, to coincide
with the reauthorization of the CARE Act, as an opportunity to showcase
new ways that the CARE Act will propel care and services and highlight
the domestic HIV/AIDS agenda. The Summit would include the President and
be inclusive and nonpartisan. With a national election coming, Mr. Minor
acknowledged that planning for 2005 could be uncertain but he wants to
be prepared, with the Summit as a placeholder and on the radar screen.
He asked if any other Council members had thoughts about the Summit.

Rev. Sanders suggested that late spring or early summer would be a good
time for an HIV/AIDS Summit, because the CDC National Prevention
Conference is held in late July or early August, and it would be good to
have the Summit in advance of that conference. Dr. Yogev asked if he
could get a copy of the motion regarding the Summit, and Mr. Minor said
he would provide a copy of the motion and the comments he has received
about it.

Mr. Sneed apologized for missing the morning session and assured Council
members that he was "attending to the people's business." He expressed
support of a Summit and emphasized the importance of the details in
planning such an event. He said that he believes that as the country
moves through reauthorization and addresses disparities in health
outcomes, a Summit will help people refocus and become reenergized.
Also, a new generation of people is being affected by HIV/AIDS, and this
would help bring them on board.

# First motion: ADAP

Mr. Minor noted that with the President's announcement last week of \$20
million for ADAP, the motion in the briefing book had to be redrafted to
reflect the President's leadership on this issue. ADAP continues to be
of critical importance for people living with HIV and AIDS, and the
justification for the motion now deals with why ADAP is important, what
its role is in helping people with AIDS, and how the current crisis is
currently affecting communities.

The modified motion now reads as follows:

**PRESIDENTIAL ADVISORY COUNCIL ON HIV/AIDS**

**TREATMENT AND CARE SUBCOMMITTEE**

##### DRAFT MOTION

WHEREAS, the AIDS Drug Assistance Program (ADAP) is the primary source
of Public Health Service (PHS) recommended antiretroviral therapies for
136,000+ uninsured or under-insured Americans living with HIV/AIDS each
year^1^, and

WHEREAS, highly active antiretroviral therapy for HIV infection has
reduced the death rate from AIDS by 72 percent since 1995 and are cost
effective overall, and

WHEREAS, recent scientific studies have found that people living with
HIV/AIDS receiving highly active antiretroviral therapy have a 60
percent reduction in infectivity to partners, making treatment an
important tool for prevention, and

WHEREAS, in May of 2004, 11 ADAPs had waiting lists representing 1,629
people, and 8 ADAPs have put cost containment measures in place, and 10
ADAPs are anticipating instituting cost-containment measures including
closed enrollment to new clients and reduced formularies^1^, and

WHEREAS, any long-term solution to the ADAP crisis cannot be instituted
until the Ryan White CARE Act is reauthorized in 2005, a short term
resolution to the problem facing Americans awaiting access to
life-sustaining drugs must be addressed immediately, and

WHEREAS, any changes to the present formula distribution of Federal
earmark ADAP funds will not go into effect until FY07,

WHEREAS, the President has recognized the importance of eliminating the
ADAP waiting list and recently authorized the expenditure of \$20
million to address this issue,

BE IT RESOLVED that PACHA thank President Bush for his leadership to
address the ongoing ADAP crisis and for making the elimination of
waiting lists a top priority in his AIDS agenda, and

BE IT FURTHER RESOLVED that these funds are targeted to those areas
demonstrating the greatest need and are spent expeditiously to maximize
their benefit to the community, and

BE IT FURTHER RESOLVED that the President and Secretary continue to
ensure the availability of funds for HIV/AIDS medications until a
long-term solution is enacted.

Citation

1\. *The* *ADAP Watch*, June 2004; National Association of State and
Territorial AIDS Directors (NASTAD)

#### ***Discussion***

The intent of the motion, Mr. Minor said, is to thank the President for
his leadership and highlight the need for eliminating the waiting list,
to target funds to places with waiting lists, and to direct that money
be spent quickly since this is an ongoing crisis.

Mr. Minor moved that the ADAP motion be adopted. The motion was
seconded.

Ms. Ivantic-Doucette noted that the motion has no provisions about
formularies, and just covers allocation of resources and not monitoring.
Mr. Minor responded that the Subcommittee did not want to fix
formularies or add drugs, just simply recognize the current status for
people who are eligible. Dr. Reznik added that formularies cannot change
until the money is allocated. Ms. Ivantic-Doucette said that perhaps the
Council could consider standardizing formularies and establishing
clinical guidelines at a later meeting. Mr. Sneed suggested a
grammatical revision changing "thank" in the first *be it resolved* to
"thanks."

### **Motion carries**

The motion was passed unanimously as amended. Dr. McKinnell said that he
supported the motion but abstained, given the absence of a general
waiver.

***Prevention and Treatment and Care Subcommittees***

**Second motion: African American Resolution**

Mr. Minor asked that Rev. Sanders introduce the motion. Rev. Sanders
noted that the motion came out of a joint meeting between the Prevention
Subcommittee and the Treatment and Care Subcommittee. Considering the
available data, he said, the whereas clauses, the justification for the
resolution, could have continued for pages. The whereas that follows the
first statement is driven by the epidemiological data that were
presented to the Council yesterday and presented to the Subcommittees
last month. This topic was the byproduct of cumulative information
presented at Council meetings over the past couple of years describing
the disproportionate and devastating impact of HIV/AIDS on the African
American community.

The motion was introduced as follows:

**PRESIDENTIAL ADVISORY COUNCIL ON HIV/AIDS**

**PREVENTION AND TREATMENT AND CARE SUBCOMMITTEES**

**DRAFT MOTION**

The Treatment and Care AND Prevention Subcommittees have met jointly to
consider the state of HIV/AIDS among African Americans;

WHEREAS, in 2002, the AIDS annual rate for African Americans was 10
times greater than the rate for white Americans (78.5/100,000 versus
7.8/100,000);

WHEREAS, in 2002, African Americans accounted for 50 percent of the more
than 42,000 estimated AIDS cases diagnosed in the United States;

WHEREAS, HIV/AIDS is among the top three leading causes of death for
African American men ages 25--54 and African American women ages 35--44;

WHEREAS, the leading cause of HIV infection among African American women
is heterosexual contact;

WHEREAS, the leading cause of HIV infection among African American men
is sexual contact with other men, followed by injecting drug use;

WHEREAS in 2002, 62 percent of children born to HIV-infected mothers
were African American;

WHEREAS African Americans represented approximately 64 percent of all
AIDS cases among women in 2001;

WHEREAS it is estimated that approximately 1 in 160 African American
women is infected with HIV, as compared to 1 in 400 Latina women, and 1
in 3,000 white women;

BE IT RESOLVED that PACHA recommends to the President and the Secretary
of Health and Human Services that all programmatic initiatives and
resource allocations follow the epidemic and in particular address the
devastating and disproportionate impact HIV disease currently has among
African Americans.

BE IT FURTHER RESOLVED that PACHA advises the President and Secretary to
encourage African American leaders from the political, faith-based,
corporate, education, health care, and support services arenas to speak
out more forcefully about HIV disease to stimulate discussion about both
its consequences and means of prevention.

BE IT FURTHER RESOLVED that PACHA recommends expedited funding of
additional and targeted behavioral research to identify cultural,
institutional, and societal issues that can inform future prevention,
care and treatment initiatives to effectively alleviate the impact of
HIV in the African American community.

### **Discussion**

Rev. Sanders moved that the motion be accepted. It was seconded.

Mr. Sneed proposed that the motion be amended to add a definitive focus
on young people aged 16-25. Dr. Sullivan suggested adding "youth
leaders" on line 2 of the second "be it (further) resolved," and Mr.
Sneed asked that it read "community youth leaders."

Dr. Sharma said that the role of media is not discussed and needs to be
addressed. Mr. Minor said that could be implied under the "corporate"
heading, to avoid an extensive "laundry list" of subjects. Dr. Yogev
said emphasis on adolescents is needed because the age when youth become
sexually active is ignored, and research should be encouraged in
children as young as age 8. Mr. Minor said that could either be amended
now, or the Subcommittee could simply be asked to include language that
would address this, since it doesn't affect the goals of the resolution.
Dr. Sullivan said he would accept the latter.

Ms. Ivantic-Doucette suggested that the second "be it resolved"
specifically reference African American leaders "from all sectors." Dr.
Primm agreed that media should be specifically mentioned, and Mr. Minor
agreed it could be included. Dr. Sweeney endorsed the inclusion of
media. Dr. McKinnell added that the Council might want to consider the
broader role of media. Ms. Smith said that the Prevention Subcommittee
has discussed this extensively and will be introducing a motion about
media.

The second "be it resolved" was amended to read:

BE IT FURTHER RESOLVED that PACHA advises that the President and
Secretary encourage African American leaders from [all
sectors]{.underline}, including the political, faith-based, corporate,
[all media]{.underline}, education, [community youth
leaders]{.underline}, health care, and support services arenas to speak
out more forcefully about HIV disease to stimulate discussion about both
its consequences and means of prevention.

### **Motion carries**

The motion was passed unanimously.

***International Subcommittee***

Mr. Mason announced that the motion concerning preventing
mother-to-child transmission would be tabled pending more information
about the nevirapine issue, and the Subcommittee will bring it forward
at the next Council meeting.

## Third motion: Asian AIDS epidemic

Several small changes were suggested for the Asian motion and
incorporated. The amended motion was introduced as follows:

**PRESIDENTIAL ADVISORY COUNCIL ON HIV/AIDS**

**INTERNATIONAL SUBCOMMITTEE**

**DRAFT MOTION**

WHEREAS, the Asian AIDS epidemic, with more than 10 million cases, is
second only to the Sub-Saharan epidemic, is expanding faster, and is
expected to overtake the Sub-Saharan epidemic by 2010.

WHEREAS, the XV International AIDS Conference in Bangkok this July will
focus international attention on the hitherto neglected Asian epidemic.

WHEREAS, in Asia, as in Africa, the AIDS epidemic, if unchecked,
threatens to destabilize whole countries and is currently a factor
in destabilizing Myanmar, and whereas the AIDS destabilization threat to
Asia is as real as it is to Africa, the major difference being the
timeframe.

WHEREAS, the worldwide economic and geopolitical consequences of
destabilization in China, India, and Southeast Asia would be grave.

WHEREAS, Asia, while undergoing rapid economic advances, is politically
less stable and its health care infrastructure is less well developed
than in Europe and North America.

 

WHEREAS, many Asian countries are recognizing the implications and
extent of their AIDS epidemics and want to act. 

 

WHEREAS, these countries often have the basic economic resources to
provide ARV treatment but lack the expertise to quickly implement AIDS
treatment and prevention programs.

 

WHEREAS, the United States has wide experience and expertise in
implementing AIDS treatment and prevention programs.

 

WHEREAS, there is a window of opportunity in both India and China to
block the bridging of HIV infections from high-risk groups to the
general population.

WHEREAS, appropriate preventive interventions can have significant
impact on national HIV prevalence prior to such bridging.

 

BE IT THEREFORE RESOLVED that PACHA recommends to the President that
HIV/AIDS prevention and treatment be on the agenda at all appropriate
bilateral discussions with these two countries, and that discussions be
initiated in the near future with India and China on establishing
cost-sharing programs to facilitate access to American expertise in
implementing AIDS prevention and treatment.

### **Discussion**

Mr. Mason moved to approve the motion, and it was seconded.

### **Motion carries**

The motion was approved unanimously.

## Housekeeping Chores and Adjournment 

Mr. Minor said that the meeting went very smoothly and he commended the
good work of Joseph Grogan and Dana Ceasar.

Mr. Sneed said that there is a new television program from the youth
leadership development program in the heart of the inner-city urban
ghetto in south Dallas featuring same-gender-loving males, and if anyone
wants a DVD copy, he can supply it.

Mr. Mason said that it is important that all Council members know what
Subcommittees are working on in the future, and suggested that
Subcommittee Chairs give what is on their agendas for the next few
months to Mr. Grogan, to help the Council work together more
cooperatively.

Rev. Sanders asked about the status of the guiding principles that were
discussed at the last meeting. Mr. Minor said it was very interesting
that the President's recent comments on HIV/AIDS spoke of three guiding
principles, a significant reference that reaffirms the need for context
for the Council's decisions. He suggested this be discussed in
September, in relation to the Summit. Rev. Sanders asked that the record
reflect that the motions from the International Subcommittee and the one
that dealt with the African American community were clearly a reflection
of points that were made in the guiding principles.

Dr. Sullivan adjourned the meeting at 3:28 p.m.