Women's Interagency HIV Study (WIHS)

HIV in women is increasing worldwide, with women comprising approximately 14% of the total
adult and adolescent AIDS cases, the highest proportion yet reported. The impact of AIDS is
particularly severe in minority populations; among women, African Americans, and Hispanics
combined now represent the majority of AIDS cases (76%) in the United States. AIDS is now the
third leading cause of death for women aged 25 to 44 (after cancer and cardiovascular
disease) and is the leading cause of death of African American women in this age group.

Studies of HIV and AIDS in women can play a unique role in testing new biological or
socio-behavioral hypotheses at the population level and in linking basic science findings and
laboratory methods to well-defined populations and communities. Research areas that are
likely to draw more attention in the near future will include the study of pathogenicity and
transmissibility of different HIV subtypes or recombinant forms and their interaction with
variably susceptible individuals; the change in the scope of HIV natural history studies in
the era of combination antiretroviral therapy; and the contribution of such studies to the
design of a wide spectrum of prevention modalities (e.g., prevention of HIV and prevention of
opportunistic infections). In addition, studies of natural history of HIV-related
malignancies and active surveillance of malignancies in HIV infected and high-risk uninfected
women may lead to new screening and prevention modalities in high-risk populations of women.

Participants will have study visits every 6 months. Questionnaires regarding sexual behavior,
health care utilization, medical and obstetric/gynecological history, psychosocial factors,
and sociodemographics will be completed by participants. Physical, gynecological, and
lipodystrophy examinations will also be conducted at each visit, and current medication
regimen will be noted. Blood and other bodily fluid samples will be collected and registered
in both local and national repositories of the WIHS in conjunction with NIAID.

Inclusion Criteria:

- HIV infection

- Willing to be retested for HIV infection for this study unless hardcopy documentation
of a positive result (HIV ELISA test and a confirmatory Western blot) is available

- Either have never taken HIV antiretroviral medications or have a documented start date
of highly active antiretroviral therapy (HAART) after January 1, 2008

- If have taken HAART, have documentation of pre-HAART CD4 counts and HIV RNA
quantification

- Willing and able to have blood drawn

- Give consent to have their specimens stored in the WIHS national repository

- Able to complete study visit interviews in English or Spanish every 6 months

- Able to travel to and from site clinic and participate in study visits as an
outpatient

Exclusion Criteria:

- Perinatally acquired HIV

- Enrolled in the WIHS through another site

- HAART started before January 1, 2008, except during pregnancy

- Participant plans to move out of the area within 12 months