Women's Interagency HIV Study (WIHS)

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Nctid: NCT00000797

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The relationship of pregnancy to the use of highly active antiretroviral therapy. Am J Obstet Gynecol. 2001 May;184(6):1221-7. doi: 10.1067/mob.2001.113871."}, {"pmid"=>"10979903", "type"=>"RESULT", "citation"=>"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. doi: 10.1086/315816. Epub 2000 Sep 1."}, {"pmid"=>"11064503", "type"=>"RESULT", "citation"=>"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. doi: 10.1097/00042560-200009010-00006."}, {"pmid"=>"11312425", "type"=>"RESULT", "citation"=>"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. doi: 10.1067/mjd.2001.112350."}, {"pmid"=>"11404529", "type"=>"RESULT", "citation"=>"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. doi: 10.1097/00126334-200105010-00019. No abstract available."}, {"pmid"=>"12626890", "type"=>"RESULT", "citation"=>"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. doi: 10.1097/00126334-200303010-00009."}, {"pmid"=>"11981366", "type"=>"RESULT", "citation"=>"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. doi: 10.1097/00126334-200204150-00010."}, {"pmid"=>"11902857", "type"=>"RESULT", "citation"=>"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. doi: 10.1006/pmed.2001.1003."}, {"pmid"=>"15061857", "type"=>"RESULT", "citation"=>"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. doi: 10.1111/j.0301-5661.2004.00128.x."}, {"pmid"=>"12865452", "type"=>"RESULT", "citation"=>"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. doi: 10.1093/jnci/95.14.1062."}, {"pmid"=>"12172526", "type"=>"RESULT", "citation"=>"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. doi: 10.1097/00007435-200208000-00001."}, {"pmid"=>"12240742", "type"=>"RESULT", "citation"=>"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. doi: 10.1017/s1355617702860064. 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Opportunistic infection prophylaxis in the women's interagency HIV study (WIHS). J Acquir Immune Defic Syndr. 2001 Oct 1;28(2):195-6. doi: 10.1097/00126334-200110010-00014. No abstract available."}, {"pmid"=>"10954885", "type"=>"RESULT", "citation"=>"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. doi: 10.1089/088922200414947."}, {"pmid"=>"15220706", "type"=>"RESULT", "citation"=>"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. 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Epub 2002 Jan 9."}, {"pmid"=>"15226134", "type"=>"RESULT", "citation"=>"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. doi: 10.2105/ajph.94.7.1141."}, {"pmid"=>"15265968", "type"=>"RESULT", "citation"=>"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. doi: 10.1093/jnci/djh192."}, {"pmid"=>"14970148", "type"=>"RESULT", "citation"=>"Anastos K, Barron 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. 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Effect of hormonal contraceptive use on plasma HIV-1-RNA levels among HIV-infected women. AIDS. 2003 Jul 25;17(11):1702-4. doi: 10.1097/00002030-200307250-00019."}, {"pmid"=>"14507605", "type"=>"RESULT", "citation"=>"Cole SR, Hernan MA, Robins JM, Anastos K, Chmiel J, Detels R, Ervin C, Feldman J, Greenblatt R, Kingsley L, Lai S, Young M, Cohen M, Munoz 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. doi: 10.1093/aje/kwg206."}, {"pmid"=>"12439806", "type"=>"RESULT", "citation"=>"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. doi: 10.1086/344462. Epub 2002 Nov 11."}, {"pmid"=>"12792357", "type"=>"RESULT", "citation"=>"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. doi: 10.1097/00126334-200305010-00010."}, {"pmid"=>"15307009", "type"=>"RESULT", "citation"=>"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. doi: 10.1086/422142. Epub 2004 Jul 12."}, {"pmid"=>"14742653", "type"=>"RESULT", "citation"=>"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. 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Low incidence of invasive cervical cancer among HIV-infected US women in a prevention program. AIDS. 2004 Jan 2;18(1):109-13. doi: 10.1097/00002030-200401020-00013."}, {"pmid"=>"12789150", "type"=>"RESULT", "citation"=>"Navazesh M, Mulligan R, Barron 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. doi: 10.1067/moe.2003.230."}, {"pmid"=>"12599073", "type"=>"RESULT", "citation"=>"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. doi: 10.1086/367995. 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Patterns of the hazard of death after AIDS through the evolution of antiretroviral therapy: 1984-2004. AIDS. 2005 Nov 18;19(17):2009-18. doi: 10.1097/01.aids.0000189864.90053.22."}, {"pmid"=>"16135508", "type"=>"RESULT", "citation"=>"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. doi: 10.1093/aje/kwi268. Epub 2005 Aug 31."}, {"pmid"=>"16603858", "type"=>"RESULT", "citation"=>"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. doi: 10.1097/01.aids.0000222078.75867.77."}, {"pmid"=>"16301151", "type"=>"RESULT", "citation"=>"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. doi: 10.1016/j.tripleo.2004.10.011. Epub 2005 Jan 25."}, {"pmid"=>"16549012", "type"=>"RESULT", "citation"=>"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. doi: 10.1186/1742-6405-3-6."}, {"pmid"=>"35230165", "type"=>"DERIVED", "citation"=>"Cohen MH, Benning L, Weber KM, Sharma A, Plankey M, Kempf MC, Wilson TE, Aouizerat B, Milam J, Adimora AA, Wingood G, Carrico AW. Predictors and Consequences of Prescription Opioid Use in Women Living With and Without HIV: 20-Year Follow-Up. J Womens Health (Larchmt). 2022 Aug;31(8):1188-1196. doi: 10.1089/jwh.2021.0231. Epub 2022 Feb 28."}, {"pmid"=>"34449258", "type"=>"DERIVED", "citation"=>"Massad LS, Daubert EM, Evans CT, Minkoff H, Kassaye S, Dionne-Odom J, Seidman D, Murphy K, Alcaide ML, Adimora AA, Sheth AN, Golub ET, French AL, Weber KM. Trends in Bacterial Vaginosis Prevalence in a Cohort of U.S. Women with and at Risk for HIV. J Womens Health (Larchmt). 2022 May;31(5):726-732. doi: 10.1089/jwh.2021.0102. Epub 2021 Aug 27."}, {"pmid"=>"34315432", "type"=>"DERIVED", "citation"=>"Kato Y, Kizer JR, Ostovaneh MR, Lazar J, Peng Q, van der Geest RJ, Lima JAC, Ambale-Venkatesh B. Extracellular volume-guided late gadolinium enhancement analysis for non-ischemic cardiomyopathy: The Women's Interagency HIV Study. BMC Med Imaging. 2021 Jul 27;21(1):116. doi: 10.1186/s12880-021-00649-6."}, {"pmid"=>"33141170", "type"=>"DERIVED", "citation"=>"Haley DF, Edmonds A, Ramirez C, French AL, Tien P, Thio CL, Witt MD, Seaberg EC, Plankey MW, Cohen MH, Adimora AA. Direct-Acting Antiviral Hepatitis C Treatment Cascade and Barriers to Treatment Initiation Among US Men and Women With and Without HIV. J Infect Dis. 2021 Jun 15;223(12):2136-2144. doi: 10.1093/infdis/jiaa686."}, {"pmid"=>"28270536", "type"=>"DERIVED", "citation"=>"Haley DF, Kramer MR, Adimora AA, Haardorfer R, Wingood GM, Ludema C, Rubtsova A, Hickson DA, Ross Z, Golub E, Bolivar H, Cooper HL. Relationships between neighbourhood characteristics and current STI status among HIV-infected and HIV-uninfected women living in the Southern USA: a cross-sectional multilevel analysis. Sex Transm Infect. 2017 Dec;93(8):583-589. doi: 10.1136/sextrans-2016-052889. Epub 2017 Mar 7."}, {"pmid"=>"21934446", "type"=>"DERIVED", "citation"=>"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."}], "seeAlsoLinks"=>[{"url"=>"http://statepiaps.jhsph.edu/wihs/", "label"=>"Click here for the WIHS homepage."}]}, "descriptionModule"=>{"briefSummary"=>"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.", "detailedDescription"=>"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.\n\nStudies 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.\n\nParticipants 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."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT"], "maximumAge"=>"55 years", "minimumAge"=>"30 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"HIV-infected women and HIV-uninfected women who are at risk of HIV infection", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* HIV infection\n* 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\n* Either have never taken HIV antiretroviral medications or have a documented start date of highly active antiretroviral therapy (HAART) after January 1, 2008\n* If have taken HAART, have documentation of pre-HAART CD4 counts and HIV RNA quantification\n* Willing and able to have blood drawn\n* Give consent to have their specimens stored in the WIHS national repository\n* Able to complete study visit interviews in English or Spanish every 6 months\n* Able to travel to and from site clinic and participate in study visits as an outpatient\n\nExclusion Criteria:\n\n* Perinatally acquired HIV\n* Enrolled in the WIHS through another site\n* HAART started before January 1, 2008, except during pregnancy\n* Participant plans to move out of the area within 12 months"}, "identificationModule"=>{"nctId"=>"NCT00000797", "briefTitle"=>"Women's Interagency HIV Study (WIHS)", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Women's Interagency HIV Study (WIHS)", "orgStudyIdInfo"=>{"id"=>"WIHS"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"94122", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"University of California - San Francisco", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"20007", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Georgetown Univ Med Ctr", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Chicago Consortium", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"10467", "city"=>"Bronx", "state"=>"New York", "country"=>"United States", "facility"=>"Montefiore Medical Center", "geoPoint"=>{"lat"=>40.84985, "lon"=>-73.86641}}, {"zip"=>"11203", "city"=>"Brooklyn", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY / Health Sciences Ctr at Brooklyn", "geoPoint"=>{"lat"=>40.6501, "lon"=>-73.94958}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}