Women's Interagency HIV Study (WIHS)

This study is ongoing, but not recruiting participants.

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: April 7, 2017

Last verified: April 2017

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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

Biospecimen Retention: Samples With DNA

Blood, bodily fluid, and hair collection


Estimated Enrollment:	4982
Study Start Date:	October 1994
Estimated Primary Completion Date:	April 2019 (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 (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

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
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)

More Information

Additional Information:

Click here for the WIHS homepage. This link exits the ClinicalTrials.gov site

Publications:

Massad LS, Riester KA, Anastos KM, Fruchter RG, Palefsky JM, Burk RD, Burns D, Greenblatt RM, Muderspach LI, Miotti P. Prevalence and predictors of squamous cell abnormalities in Papanicolaou smears from women infected with HIV-1. Women's Interagency HIV Study Group. J Acquir Immune Defic Syndr. 1999 May 1;21(1):33-41.

Anastos K, Kalish LA, Hessol N, Weiser B, Melnick S, Burns D, Delapenha R, DeHovitz J, Cohen M, Meyer W, Bremer J, Kovacs A. The relative value of CD4 cell count and quantitative HIV-1 RNA in predicting survival in HIV-1-infected women: results of the women's interagency HIV study. AIDS. 1999 Sep 10;13(13):1717-26. Erratum in: AIDS 2000 May 5;14(7):891.

Feldman JG, Burns DN, Gange SJ, Bacchetti P, Cohen M, Anastos K, Nowicki M, Delapena R, Miotti P. Serum albumin as a predictor of survival in HIV-infected women in the Women's Interagency HIV study. AIDS. 2000 May 5;14(7):863-70.

DeHovitz JA, Kovacs A, Feldman JG, Anastos K, Young M, Cohen M, Gange SJ, Melnick S, Greenblatt RM. The relationship between virus load response to highly active antiretroviral therapy and change in CD4 cell counts: A report from the Women's interagency HIV study. J Infect Dis. 2000 Nov;182(5):1527-30. Epub 2000 Sep 27.

Levine AM, Berhane K, Masri-Lavine L, Sanchez M, Young M, Augenbraun M, Cohen M, Anastos K, Newman M, Gange SJ, Watts H. Prevalence and correlates of anemia in a large cohort of HIV-infected women: Women's Interagency HIV Study. J Acquir Immune Defic Syndr. 2001 Jan 1;26(1):28-35.

Minkoff H, Ahdieh L, Watts H, Greenblatt RM, Schmidt J, Schneider M, Stek A. The relationship of pregnancy to the use of highly active antiretroviral therapy. Am J Obstet Gynecol. 2001 May;184(6):1221-7.

French AL, Kirstein LM, Massad LS, Semba RD, Minkoff H, Landesman S, Palefsky J, Young M, Anastos K, Cohen MH. Association of vitamin A deficiency with cervical squamous intraepithelial lesions in human immunodeficiency virus-infected women. J Infect Dis. 2000 Oct;182(4):1084-9. Epub 2000 Sep 1.

Greenspan D, Komaroff E, Redford M, Phelan JA, Navazesh M, Alves ME, Kamrath H, Mulligan R, Barr CE, Greenspan JS. Oral mucosal lesions and HIV viral load in the Women's Interagency HIV Study (WIHS). J Acquir Immune Defic Syndr. 2000 Sep 1;25(1):44-50.

Mirmirani P, Hessol NA, Maurer TA, Berger TG, Nguyen P, Khalsa A, Gurtman A, Micci S, Young M, Holman S, Gange SJ, Greenblatt RM. Prevalence and predictors of skin disease in the Women's Interagency HIV Study (WIHS). J Am Acad Dermatol. 2001 May;44(5):785-8.

Stancliff S, Abel S, Agins B. Oral mucosal lesions and HIV viral load in the Women's Interagency HIV Study (WIHS). J Acquir Immune Defic Syndr. 2001 May 1;27(1):96-7.

Justman JE, Benning L, Danoff A, Minkoff H, Levine A, Greenblatt RM, Weber K, Piessens E, Robison E, Anastos K. Protease inhibitor use and the incidence of diabetes mellitus in a large cohort of HIV-infected women. J Acquir Immune Defic Syndr. 2003 Mar 1;32(3):298-302.

Kirstein LM, Greenblatt RM, Anastos K, Levine A, French AL, Minkoff H, Silver S, Gange SJ; Women's Interagency HIV Study Collaborative Research Group. Prevalence and correlates of highly active antiretroviral therapy switching in the Women's Interagency HIV Study. J Acquir Immune Defic Syndr. 2002 Apr 15;29(5):495-503.

Preston-Martin S, Kirstein LM, Pogoda JM, Rimer B, Melnick S, Masri-Lavine L, Silver S, Hessol N, French AL, Feldman J, Sacks HS, Deely M, Levine AM. Use of mammographic screening by HIV-infected women in the Women's Interagency HIV Study (WIHS). Prev Med. 2002 Mar;34(3):386-92.

Mulligan R, Phelan JA, Brunelle J, Redford M, Pogoda JM, Nelson E, Seirawan H, Greenspan JS, Navazesh M, Greenspan D, Alves ME. Baseline characteristics of participants in the oral health component of the Women's Interagency HIV Study. Community Dent Oral Epidemiol. 2004 Apr;32(2):86-98.

Strickler HD, Palefsky JM, Shah KV, Anastos K, Klein RS, Minkoff H, Duerr A, Massad LS, Celentano DD, Hall C, Fazzari M, Cu-Uvin S, Bacon M, Schuman P, Levine AM, Durante AJ, Gange S, Melnick S, Burk RD. Human papillomavirus type 16 and immune status in human immunodeficiency virus-seropositive women. J Natl Cancer Inst. 2003 Jul 16;95(14):1062-71.

Silverberg MJ, Ahdieh L, Munoz A, Anastos K, Burk RD, Cu-Uvin S, Duerr A, Greenblatt RM, Klein RS, Massad S, Minkoff H, Muderspach L, Palefsky J, Piessens E, Schuman P, Watts H, Shah KV. The impact of HIV infection and immunodeficiency on human papillomavirus type 6 or 11 infection and on genital warts. Sex Transm Dis. 2002 Aug;29(8):427-35.

Richardson JL, Martin EM, Jimenez N, Danley K, Cohen M, Carson VL, Sinclair B, Racenstein JM, Reed RA, Levine AM. Neuropsychological functioning in a cohort of HIV infected women: importance of antiretroviral therapy. J Int Neuropsychol Soc. 2002 Sep;8(6):781-93. Erratum in: J Int Neuropsychol Soc. 2005 Jan;11(1):120.

Szczech LA, Gange SJ, van der Horst C, Bartlett JA, Young M, Cohen MH, Anastos K, Klassen PS, Svetkey LP. Predictors of proteinuria and renal failure among women with HIV infection. Kidney Int. 2002 Jan;61(1):195-202.

Minkoff H, Ahdieh L, Massad LS, Anastos K, Watts DH, Melnick S, Muderspach L, Burk R, Palefsky J. The effect of highly active antiretroviral therapy on cervical cytologic changes associated with oncogenic HPV among HIV-infected women. AIDS. 2001 Nov 9;15(16):2157-64.

Augenbraun M, Tarwater P, Greenblatt R, Cohen M, French A, Gore ME, Watts H, Preston-Martin S, Anastos K; Women's Interagency HIV Study (WIHS). Opportunistic infection prophylaxis in the women's interagency HIV study (WIHS). J Acquir Immune Defic Syndr. 2001 Oct 1;28(2):195-6.

Hessol NA, Anastos K, Levine AM, Ameli N, Cohen M, Young M, Augenbraun M, Miotti P, Gange SJ. Factors associated with incident self-reported AIDS among women enrolled in the women's interagency HIV study (WIHS). WIHS Collaboratorive Study Group. AIDS Res Hum Retroviruses. 2000 Aug 10;16(12):1105-11.

Hessol NA, Seaberg EC, Preston-Martin S, Massad LS, Sacks HS, Silver S, Melnick S, Abulafia O, Levine AM; WIHS Collaborative Study Group. Cancer risk among participants in the women's interagency HIV study. J Acquir Immune Defic Syndr. 2004 Aug 1;36(4):978-85.

Palacio H, Li X, Wilson TE, Sacks H, Cohen MH, Richardson J, Young M, Muñoz A; Women's Interagency HIV Study (WIHS). Healthcare use by varied highly active antiretroviral therapy (HAART) strata: HAART use, discontinuation, and naivety. AIDS. 2004 Mar 5;18(4):621-30.

Szczech LA, Hoover DR, Feldman JG, Cohen MH, Gange SJ, Goozé L, Rubin NR, Young MA, Cai X, Shi Q, Gao W, Anastos K. Association between renal disease and outcomes among HIV-infected women receiving or not receiving antiretroviral therapy. Clin Infect Dis. 2004 Oct 15;39(8):1199-206. Epub 2004 Sep 27.

Berhane K, Karim R, Cohen MH, Masri-Lavine L, Young M, Anastos K, Augenbraun M, Watts DH, Levine AM. Impact of highly active antiretroviral therapy on anemia and relationship between anemia and survival in a large cohort of HIV-infected women: Women's Interagency HIV Study. J Acquir Immune Defic Syndr. 2004 Oct 1;37(2):1245-52.

Silverberg MJ, Gore ME, French AL, Gandhi M, Glesby MJ, Kovacs A, Wilson TE, Young MA, Gange SJ. Prevalence of clinical symptoms associated with highly active antiretroviral therapy in the Women's Interagency HIV Study. Clin Infect Dis. 2004 Sep 1;39(5):717-24. Epub 2004 Aug 16.

Tien PC, Cole SR, Williams CM, Li R, Justman JE, Cohen MH, Young M, Rubin N, Augenbraun M, Grunfeld C. Incidence of lipoatrophy and lipohypertrophy in the women's interagency HIV study. J Acquir Immune Defic Syndr. 2003 Dec 15;34(5):461-6.

Viscidi RP, Ahdieh-Grant L, Schneider MF, Clayman B, Massad LS, Anastos KM, Burk RD, Minkoff H, Palefsky J, Levine A, Strickler H. Serum immunoglobulin A response to human papillomavirus type 16 virus-like particles in human immunodeficiency virus (HIV)-positive and high-risk HIV-negative women. J Infect Dis. 2003 Dec 15;188(12):1834-44. Epub 2003 Dec 5.

Wilson TE, Barrón Y, Cohen M, Richardson J, Greenblatt R, Sacks HS, Young M; Women's Interagency HIV Study. Adherence to antiretroviral therapy and its association with sexual behavior in a national sample of women with human immunodeficiency virus. Clin Infect Dis. 2002 Feb 15;34(4):529-34. Epub 2002 Jan 9.

Wilson TE, Gore ME, Greenblatt R, Cohen M, Minkoff H, Silver S, Robison E, Levine A, Gange SJ. Changes in sexual behavior among HIV-infected women after initiation of HAART. Am J Public Health. 2004 Jul;94(7):1141-6.

Ahdieh-Grant L, Li R, Levine AM, Massad LS, Strickler HD, Minkoff H, Moxley M, Palefsky J, Sacks H, Burk RD, Gange SJ. Highly active antiretroviral therapy and cervical squamous intraepithelial lesions in human immunodeficiency virus-positive women. J Natl Cancer Inst. 2004 Jul 21;96(14):1070-6.

Anastos K, Barrón Y, Cohen MH, Greenblatt RM, Minkoff H, Levine A, Young M, Gange SJ. The prognostic importance of changes in CD4+ cell count and HIV-1 RNA level in women after initiating highly active antiretroviral therapy. Ann Intern Med. 2004 Feb 17;140(4):256-64.

Augenbraun M, Goedert JJ, Thomas D, Feldman J, Seaberg EC, French AL, Robison E, Nowicki M, Terrault N. Incident hepatitis C virus in women with human immunodeficiency virus infection. Clin Infect Dis. 2003 Nov 15;37(10):1357-64. Epub 2003 Oct 14.

Barrón Y, Cole SR, Greenblatt RM, Cohen MH, Anastos K, DeHovitz JA, Delapenha R, Gange SJ. Effect of discontinuing antiretroviral therapy on survival of women initiated on highly active antiretroviral therapy. AIDS. 2004 Jul 23;18(11):1579-84.

Cejtin HE, Jacobson L, Springer G, Watts DH, Levine A, Greenblatt R, Anastos K, Minkoff HL, Massad LS, Schmidt JB. Effect of hormonal contraceptive use on plasma HIV-1-RNA levels among HIV-infected women. AIDS. 2003 Jul 25;17(11):1702-4.

Cole SR, Hernán MA, Robins JM, Anastos K, Chmiel J, Detels R, Ervin C, Feldman J, Greenblatt R, Kingsley L, Lai S, Young M, Cohen M, Muñoz A. Effect of highly active antiretroviral therapy on time to acquired immunodeficiency syndrome or death using marginal structural models. Am J Epidemiol. 2003 Oct 1;158(7):687-94.

Falusi O, French AL, Seaberg EC, Tien PC, Watts DH, Minkoff H, Piessens E, Kovacs A, Anastos K, Cohen MH. Prevalence and predictors of Toxoplasma seropositivity in women with and at risk for human immunodeficiency virus infection. Clin Infect Dis. 2002 Dec 1;35(11):1414-7. Epub 2002 Nov 11.

Feldman JG, Gange SJ, Bacchetti P, Cohen M, Young M, Squires KE, Williams C, Goldwasser P, Anastos K. Serum albumin is a powerful predictor of survival among HIV-1-infected women. J Acquir Immune Defic Syndr. 2003 May 1;33(1):66-73.

French AL, Benning L, Anastos K, Augenbraun M, Nowicki M, Sathasivam K, Terrault NA. Longitudinal effect of antiretroviral therapy on markers of hepatic toxicity: impact of hepatitis C coinfection. Clin Infect Dis. 2004 Aug 1;39(3):402-10. Epub 2004 Jul 12.

Greenspan D, Gange SJ, Phelan JA, Navazesh M, Alves ME, MacPhail LA, Mulligan R, Greenspan JS. Incidence of oral lesions in HIV-1-infected women: reduction with HAART. J Dent Res. 2004 Feb;83(2):145-50.

Landay A, Benning L, Bremer J, Weiser B, Burger H, Nowicki M, Kovacs A. Correlates of immune activation marker changes in human immunodeficiency virus (HIV)-seropositive and high-risk HIV-seronegative women who use illicit drugs. J Infect Dis. 2003 Jul 15;188(2):209-18. Epub 2003 Jul 1.

Massad LS, Springer G, Jacobson L, Watts H, Anastos K, Korn A, Cejtin H, Stek A, Young M, Schmidt J, Minkoff H. Pregnancy rates and predictors of conception, miscarriage and abortion in US women with HIV. AIDS. 2004 Jan 23;18(2):281-6.

Massad LS, Seaberg EC, Watts DH, Hessol NA, Melnick S, Bitterman P, Anastos K, Silver S, Levine AM, Minkoff H. Low incidence of invasive cervical cancer among HIV-infected US women in a prevention program. AIDS. 2004 Jan 2;18(1):109-13.

Navazesh M, Mulligan R, Barrón Y, Redford M, Greenspan D, Alves M, Phelan J; Women's Interagency HIV Study participants. A 4-year longitudinal evaluation of xerostomia and salivary gland hypofunction in the Women's Interagency HIV Study participants. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Jun;95(6):693-8.

Philpott S, Weiser B, Tarwater P, Vermund SH, Kleeberger CA, Gange SJ, Anastos K, Cohen M, Greenblatt RM, Kovacs A, Minkoff H, Young MA, Miotti P, Dupuis M, Chen CH, Burger H. CC chemokine receptor 5 genotype and susceptibility to transmission of human immunodeficiency virus type 1 in women. J Infect Dis. 2003 Feb 15;187(4):569-75. Epub 2003 Jan 29.

Gandhi M, Ameli N, Bacchetti P, Sharp GB, French AL, Young M, Gange SJ, Anastos K, Holman S, Levine A, Greenblatt RM. Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols. AIDS. 2005 Nov 4;19(16):1885-96.

Kovacs A, Wasserman SS, Burns D, Wright DJ, Cohn J, Landay A, Weber K, Cohen M, Levine A, Minkoff H, Miotti P, Palefsky J, Young M, Reichelderfer P; DATRI Study Group; WIHS Study Group. Determinants of HIV-1 shedding in the genital tract of women. Lancet. 2001 Nov 10;358(9293):1593-601. Erratum in: Lancet 2002 Feb 16;359(9306):630.

Schneider MF, Gange SJ, Williams CM, Anastos K, Greenblatt RM, Kingsley L, Detels R, Muñoz A. Patterns of the hazard of death after AIDS through the evolution of antiretroviral therapy: 1984-2004. AIDS. 2005 Nov 18;19(17):2009-18.

Chu H, Gange SJ, Yamashita TE, Hoover DR, Chmiel JS, Margolick JB, Jacobson LP. Individual variation in CD4 cell count trajectory among human immunodeficiency virus-infected men and women on long-term highly active antiretroviral therapy: an application using a Bayesian random change-point model. Am J Epidemiol. 2005 Oct 15;162(8):787-97. Epub 2005 Aug 31.

Ameli N, Bacchetti P, Morrow RA, Hessol NA, Wilkin T, Young M, Cohen M, Minkoff H, Gange SJ, Greenblatt RM. Herpes simplex virus infection in women in the WIHS: epidemiology and effect of antiretroviral therapy on clinical manifestations. AIDS. 2006 Apr 24;20(7):1051-8.

Navazesh M, Mulligan R, Pogoda J, Greenspan D, Alves M, Phelan J, Greenspan J, Slots J. The effect of HAART on salivary microbiota in the Women's Interagency HIV Study (WIHS). Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Dec;100(6):701-8. Epub 2005 Jan 25.

Liu C, Weber K, Robison E, Hu Z, Jacobson LP, Gange SJ. Assessing the effect of HAART on change in quality of life among HIV-infected women. AIDS Res Ther. 2006 Mar 20;3:6.

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

Massad LS, Xie X, Darragh T, Minkoff H, Levine AM, Watts DH, Wright RL, D'Souza G, Colie C, Strickler HD; Women's Interagency HIV Study Collaborative Study Group. Genital warts and vulvar intraepithelial neoplasia: natural history and effects of treatment and human immunodeficiency virus infection. Obstet Gynecol. 2011 Oct;118(4):831-9. doi: 10.1097/AOG.0b013e31821a0f4d.


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:	April 7, 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

ClinicalTrials.gov processed this record on August 22, 2017

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