The Women's Interagency HIV Study was established in August 1993 to investigate the impact and progression of HIV disease in women. The WIHS enrolls both HIV-positive and HIV-negative women. The core portion of the study includes a detailed and structured interview, physical and gynecologic examination, and laboratory testing. The WIHS participants are also asked to enroll in various sub-studies, such as cardiovascular, metabolic, musculoskeletal, and neurocognition. New proposals for WIHS sub-studies are submitted for approval by various scientific investigators from around the world.
In addition, the WIHS Data Management and Analysis Center is located in Baltimore, MD. Each consortium is affiliated with local research institutes to see study participants. Each also has its own Community Advisory Board.
Initial enrollment into the WIHS occurred between October 1994 and November 1995. The total initial enrollment for the WIHS was 2,056 HIV-positive women and 569 HIV-negative women. Since WIHS recruited its initial population, several new trends developed as the HIV epidemic evolved, all of which argued for an expansion of the WIHS cohort. First, despite careful follow-up of the cohort, the inevitable course of illness and time had led to and death. Additionally, increased sample sizes were needed because the effectiveness and consequences of Highly Active Antiretroviral Therapy added new strata to many key analyses, and decreased the incidence of clinical outcomes. And finally, as the original cohort continued to age, it became less able to support studies of risk behaviors, sexually transmitted diseases, and reproductive function. Thus, WIHS funding was augmented in 2001 to empower the study to efficiently and precisely meet the study’s specific aims through the recruitment of additional women. Total enrollment in 2001-02 was 738 HIV-positive and 403 HIV-negative participants. Beginning in January 2011, the WIHS opened enrollment again, in order to replace those women who had died during WIHS III and WIHS IV. Total enrollment in 2011-12 was 276 HIV-positive and 95 HIV-negative participants. In the summer of 2013, the WIHS will begin enrolling approximately 800 women from the WIHS Southern sites. All potential study participants undergo an initial screening to determine study eligibility. If the woman is willing to take part in the study and gives informed consent, she will participate in an in-depth interview, physical exam, and specimen collection.
