Women's Interagency HIV Study (WIHS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000797
First received: November 2, 1999
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Women's Interagency HIV Study (WIHS)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Biospecimen Retention:   Samples With DNA

Blood and bodily fluid collection


Estimated Enrollment: 4176
Study Start Date: August 2004
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

HIV-infected women and women at risk of HIV infection

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000797

Locations
United States, California
Univ of Southern California / LA County USC Med Ctr Recruiting
Los Angeles, California, United States, 900331079
Contact: Yvonne Barranday    323-343-8287      
University of California - San Francisco Recruiting
San Francisco, California, United States, 94122
Contact: Claudia Ponath    415-353-9797      
Contact    510-869-6972      
United States, District of Columbia
Georgetown Univ Med Ctr Recruiting
Washington, District of Columbia, United States, 20007
Contact: Emily Packard    202-784-6472      
United States, Illinois
Chicago Consortium Recruiting
Chicago, Illinois, United States, 60612
Contact: Angie Shansky    312-550-6192      
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Metta Cantlo    718-655-8769      
SUNY / Health Sciences Ctr at Brooklyn Recruiting
Brooklyn, New York, United States, 11203
Contact: Barbara Driscoll    718-270-3310      
Sponsors and Collaborators
  More Information

Additional Information:
Publications:

Additional 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
Study First Received: November 2, 1999
Last Updated: October 30, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014