NIAID
Resources for Studying HIV/AIDS in Women
NIAID supports clinical
trials networks through the NIAID Division of
AIDS to identify effective therapies for men,
women and children with HIV infection.
The Adult AIDS Clinical
Trials Group (ACTG) is a network of 30 sites
based at major academic institutions with the
ability to carry out sophisticated large-scale
research studies.
The Pediatric AIDS
Clinical Trials Group (PACTG) is a network of
21 sites funded by NIAID and 25 NICHD-funded
sites, all based at major academic institutions
across the United States. PACTG investigators
conduct studies addressing the safety and
toxicity of antiretroviral drugs and
immunotherapy used during pregnancy, as well as
larger trials aimed at reducing perinatal HIV
transmission. The PACTG also supports a follow-up
study for HIV-infected women who were enrolled in
ACTG 076.
The Terry Beirn
Community Programs for Clinical Research on AIDS
(CPCRA) complements the ACTG by building on
the expertise of primary care providers,
involving them in the design and conduct of
scientifically sound, community-based clinical
trials.
In addition, through the NIAID
Division of Intramural Research, the
Institute conducts basic and clinical research
toward the development of treatments and vaccines
for men, women and children with HIV infection.
The NIAID-supported HIVNET,
established in 1993, conducts large-scale trials
in the United States and abroad to evaluate the
efficacy of vaccines and other strategies to
prevent transmission of HIV.
NIAID's clinical trials
programs are committed to ensuring the inclusion
of HIV-infected women, conducting research on
conditions that affect both non-pregnant and
pregnant women, and identifying real or potential
barriers that prevent the recruitment and
retention of women into research studies. Funds
are available to clinical trials sites for
ancillary services to do gynecologic assessments
and to help provide child care, transportation
and linkage to social services when needed.
The Women's Health
Committee of the Adult ACTG provides advice and
ensures that the network's scientific agenda
reflects women's issues. As part of their
mandate, the committee reviews the eligibility
requirements for ACTG studies to determine
whether certain criteria, such as weight or blood
iron, contribute to the difficulties in enrolling
women in studies.
The Patient Care Committee
of the Adult ACTG has evaluated other possible
barriers that may prevent women from
participating in clinical trials. They found many
women with HIV lack access to health care,
HIV-related information, and have few options to
support themselves and their children. The Women,
Children and People of Color Interest Group of
the CPCRA also has explored this issue.
Researchers in both networks work closely with Community
Constituency Groups (CCGs), church
groups, social workers and others at the
grassroots level to find solutions to these
problems.
In addition, the Adult ACTG
has established two working groups, the HPV
Working Group and the Wasting Pathogen Study
Group, which have made women-specific research
issues priorities of their scientific agendas.
Community involvement is an
important part of the clinical trials networks.
The CPCRA and the Adult and Pediatric ACTGs each
receive advice from members of HIV-affected
communities through CCGs. In the case of the
Pediatric and Adult ACTGs, CCG members are
selected from Community Advisory Boards (CABs)
that provide direction to, and oversight of,
clinical trials at the local level. CCG members
serve as full and active members on all
committees of the ACTG and CPCRA to ensure
community input into NIAID's scientific agenda.
Increased Representation
of Women in Clinical Trials. The ACTG and
CPCRA have included women in their trials since
the networks were established. The overall
enrollment of women in NIAID trials has climbed
steadily and now approaches the rate of female
U.S. AIDS cases. As of April 1997, women
accounted for 19 percent of the adults in the
CPCRA, and 15 percent of those in the ACTG. In
1996, women accounted for 20 percent of adult
U.S. AIDS cases.
Epidemiologic Studies
NIAID supports large
cohort studies that are providing important
information on HIV and AIDS in women.
The Women's
Interagency HIV Study (WIHS), a
multicenter, prospective cohort study, was
established in August 1993 to explore the
natural history of HIV infection in U.S.
women. WIHS researchers are comprehensively
investigating the impact of HIV among women
aged 13 and older, who are seen at clinic
sites every six months. Primary research
areas that are currently being studied or
developed in the WIHS, with the help of the
WIHS Community Advisory Board, include:
- The spectrum of
HIV-related conditions in women.
- Aspects of HIV
infection that are specific to women,
such as genital infections and
conditions (e.g., HPV infection) that
lead to cervical cancer.
- HIV disease
progression and related viral,
immunologic and hormonal factors.
- Substance abuse
and sexual behavior, and their
relationship to risk reduction
interventions and healthcare
utilization.
- Treatment
compliance and its role in disease
episodes.
WIHS accrual was
completed in October 1995 at six U.S. sites,
with 2,080 HIV-infected women and 575
HIV-uninfected women at risk for HIV
infection. To enroll women representative of
the national HIV/AIDS epidemic, including
"hard-to-reach" women such as
injection drug users, study investigators
have used multifaceted strategies such as
providing childcare, food vouchers and
transportation; soliciting community advice
in designing protocols; and employing
culturally competent and bilingual staff.
Recent data from the WIHS provide important
information on the risk factors for HIV
infection in women.
The WIHS is
co-sponsored by NIAID and other NIH
institutes: National Institute of Child
Health and Human Development, National
Institute on Drug Abuse, National Cancer
Institute, and National Institute of Dental
Research.
The WIHS is
collaborating with a companion multicenter,
prospective cohort study of HIV in women, The
HIV Epidemiology Research Study (HERS),
which is sponsored by the CDC and NIAID. HERS
has enrolled 920 HIV-infected and 460
HIV-uninfected women in four U.S. sites. The
HERS clinical sites are funded in part by
NIAID.
A large amount of
information has been collected on
HIV-infected individuals since September 1990
through the NIAID-supported Observational
Database (ODB), a component of the CPCRA.
The CPCRA researchers are attempting to
characterize the full spectrum of HIV
infection and to provide an epidemiologic
profile of the infection in both men and
women. Information is collected on
transmission, symptoms, current treatments
and factors associated with disease
progression. Because participating women
receive care from community physicians, the
ODB also offers a snapshot of routine
clinical practice. Women enrolled in the ODB
who meet eligibility requirements have the
opportunity to participate in CPCRA treatment
protocols.
Other NIAID initiatives
include the Heterosexual AIDS Transmission
Study (HATS), a collaborative project
with the CDC, which began in December 1988
and ended in 1994. A subsequent study is
tracking the acquisition of STDs in women
with HIV infection and following the natural
course of their HIV disease. This study,
called the Women's AIDS Cohort Study
(WACS), has enrolled 450
HIV-infected and high-risk uninfected women.
NIAID merged WACS with WIHS in June 1994.
WACS investigators have
found that women diagnosed with HIV reduce
their number of sex partners, increase condom
use and show a trend towards stopping use of
illegal drugs.
Questions regarding
women who have HIV and are pregnant include
the effects of anti-HIV drugs on both the
mother and the fetus, the influence of HIV on
pregnancy and the effects of pregnancy on the
course of HIV infection. Current NIAID
studies such as the Women and Infants
Transmission Study (WITS) will answer
many of these questions. NIAID established
WITS in 1988 in collaboration with NICHD. The
study addresses specific questions relating
to the natural history of HIV in pregnant and
non-pregnant women, including gynecologic
complications, changes in the immune system
and progression of disease. WITS emphasizes
the long-term follow-up of HIV-infected women
after they have given birth. The study has
successfully recruited a population of more
than 1,500 women enrollees from diverse
racial/ethnic backgrounds who are
representative of the HIV epidemic among
women in the United States.
For More Information
About Treatment and Clinical Trials
NIAID provides major
support for the AIDS Clinical Trials
Information Service, at 1-800-TRIALS-A, to
advise callers of the status of HIV clinical
trials being conducted throughout the United
States. The AIDS Treatment Information
Service at 1-800-HIV-0440 provides
information about federally approved
treatment guidelines. Both services operate
from 9 a.m. to 7 p.m. Eastern Time, Monday
through Friday. English- and Spanish-speaking
specialists are available.
The NIAID HIV/AIDS
Research Agenda and fact sheets on NIAID
HIV/AIDS vaccine research, clinical trials
for AIDS therapies and vaccines, and on
AIDS-related opportunistic infections are
available from the NIAID Office of
Communications. To receive free copies, call
(301) 496-5717, Monday through Friday, 8:30
a.m. to 5:00 p.m. Eastern Time.
NIAID, a
component of the National Institutes of
Health, supports research on AIDS,
tuberculosis and other infectious diseases as
well as allergies and immunology.
Prepared by:
Office of Communications
National Institute of Allergy and Infectious
Diseases
National Institutes of Health
Bethesda, MD 20892
Public Health
Service
U.S. Department of Health and Human Services
April 1997
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