Women's Interagency HIV Study (WIHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000797
Recruitment Status : Active, not recruiting
First Posted : August 31, 2001
Last Update Posted : May 2, 2018
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

November 2, 1999
August 31, 2001
May 2, 2018
October 1994
April 2019   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00000797 on Archive Site
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Women's Interagency HIV Study (WIHS)
Women's Interagency HIV Study (WIHS)
The Women's Interagency HIV Study (WIHS), a multicenter, prospective study, was established in August 1993 to carry out comprehensive investigations of the impact of HIV infection and its clinical, laboratory, and psychosocial effects in women. The purpose of this study is to collect and evaluate these data from HIV infected and at-risk women to better understand and provide support for women whom are currently HIV infected or who are at risk for HIV infection.

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.

Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Blood, bodily fluid, and hair collection
Probability Sample
HIV-infected women and HIV-uninfected women who are at risk of HIV infection
HIV Infections
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Not Provided
April 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
30 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
May 2018