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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 : Unknown
Verified July 2019 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2001
Last Update Posted : July 18, 2019
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
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.

Condition or disease
HIV Infections

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 4982 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Women's Interagency HIV Study (WIHS)
Study Start Date : October 1994
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Biospecimen Retention:   Samples With DNA
Blood, bodily fluid, and hair collection

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
HIV-infected women and HIV-uninfected women who are at risk of HIV infection

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000797

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United States, California
University of California - San Francisco
San Francisco, California, United States, 94122
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
United States, Illinois
Chicago Consortium
Chicago, Illinois, United States, 60612
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 11203
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Additional Information:
Publications of Results:

Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00000797    
Other Study ID Numbers: WIHS
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases