Women's Interagency HIV Study (WIHS)
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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. |
ClinicalTrials.gov Identifier: NCT00000797 |
Recruitment Status
:
Active, not recruiting
First Posted
: August 31, 2001
Last Update Posted
: April 11, 2017
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Condition or disease |
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HIV Infections |
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.
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 : | April 2019 |


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.
Ages Eligible for Study: | 30 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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

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 ClinicalTrials.gov identifier (NCT number): NCT00000797
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 |
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000797 History of Changes |
Other Study ID Numbers: |
WIHS |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | April 11, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |