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HHS Public Access Author Manuscript HHS Public Access Author manuscript Author Manuscript Author ManuscriptAIDS. Author Author Manuscript manuscript; Author Manuscript available in PMC 2016 November 01. Published in final edited form as: AIDS. 2015 November ; 29(17): 2353–2359. doi:10.1097/QAD.0000000000000827. Effectiveness of Hormonal Contraception in HIV-Infected Women using Antiretroviral Therapy: A Prospective Study Maria Pyraa,b, Renee Heffrona,b, Nelly R. Mugob,d,e, Kavita Nandaf, Katherine K. Thomasa, Connie Celuma,b,c, Athena P. Kourtisg, Edwin Wereh, Helen Reesi, Elizabeth Bukusij, Jared M. Baetena,b,c, and for the Partners in Prevention HSV/HIV Transmission Study and Partners PrEP Study Teams* aDepartment of Epidemiology, University of Washington, Seattle, Washington, USA bDepartment of Global Health, University of Washington, Seattle, Washington, USA cDepartment of Medicine, University of Washington, Seattle, Washington, USA dDepartment of Obstetrics & Gynaecology, University of Nairobi, Nairobi, Kenya Corresponding author: Jared M. Baeten, University of Washington Department of Global Health, 325 Ninth Avenue Box 359927, Seattle, WA 98104, Phone: +1-206-520-3808, Fax: +1-206-520-3831, [email protected]. *Members of the study team listed after the Acknowledgements Data were presented at the 8th IAS Conference on HIV Pathogenesis, Treatment & Prevention in Vancouver, Canada. Authors' Contributions: JMB and RH conceived of the research question; MP conducted the data analysis. MP & JMB drafted the paper. NRM, KN, KKT, CC and APK assisted in refining the research question and analysis. EW, HR, and EB assisted in data collection. All authors contributed to editing the text and approved the final version. Partners in Prevention HSV/HIV Transmission Study Team: University of Washington Coordinating Center and Central Laboratories, Seattle, USA: Connie Celum (principal investigator), Anna Wald (protocol co-chair), Jairam Lingappa (medical director), Jared M. Baeten, Mary Campbell, Lawrence Corey, Robert W. Coombs, James P. Hughes, Amalia Magaret, M. Juliana McElrath, Rhoda Morrow, James I. Mullins Study sites and site principal investigators: Cape Town, South Africa (University of Cape Town): David Coetzee; Eldoret, Kenya (Moi University, Indiana University): Kenneth Fife, Edwin Were; Gaborone, Botswana (Botswana Harvard Partnership): Max Essex, Joseph Makhema; Kampala, Uganda (Infectious Disease Institute, Makerere University): Elly Katabira, Allan Ronald; Kigali, Rwanda (Rwanda Zambia HIV Research Group, and Emory University): Susan Allen, Kayitesi Kayitenkore, Etienne Karita; Kisumu, Kenya (Kenya Medical Research Institute, University of California San Francisco): Elizabeth Bukusi, Craig Cohen; Kitwe, Zambia (Rwanda Zambia HIV Research Group, and Emory University): Susan Allen, William Kanweka; Lusaka, Zambia (Rwanda Zambia HIV Research Group, and Emory University): Susan Allen, Bellington Vwalika; Moshi, Tanzania (Kilimanjaro Christian Medical College, Harvard University): Saidi Kapiga, Rachel Manongi; Nairobi, Kenya (University of Nairobi, University of Washington): Carey Farquhar, Grace John-Stewart, James Kiarie; Ndola, Zambia (Rwanda Zambia HIV Research Group, and Emory University): Susan Allen, Mubiana Inambao; Orange Farm, South Africa (Reproductive Health Research Unit, University of the Witwatersrand): Sinead Delany-Moretlwe, Helen Rees; Soweto, South Africa (Perinatal HIV Research Unit, University of the Witwatersrand): Guy de Bruyn, Glenda Gray, James McIntyre; Thika, Kenya (University of Nairobi, University of Washington): Nelly Rwamba Mugo Partners PrEP Study Team: University of Washington Coordinating Center and Central Laboratories, Seattle, USA: Connie Celum (principal investigator, protocol co-chair), Jared M. Baeten (medical director, protocol co-chair), Deborah Donnell (protocol statistician), Robert W. Coombs, Jairam R. Lingappa, M. Juliana McElrath. Study sites and site principal investigators: Eldoret, Kenya (Moi University, Indiana University): Kenneth H. Fife, Edwin Were; Kabwohe, Uganda (Kabwohe Clinical Research Center): Elioda Tumwesigye; Jinja, Uganda (Makerere University, University of Washington): Patrick Ndase, Elly Katabira; Kampala, Uganda (Makerere University): Elly Katabira, Allan Ronald; Kisumu, Kenya (Kenya Medical Research Institute, University of California San Francisco): Elizabeth Bukusi, Craig R. Cohen; Mbale, Uganda (The AIDS Support Organization, CDC-Uganda): Jonathan Wangisi, James D. Campbell, Jordan W. Tappero; Nairobi, Kenya (University of Nairobi, University of Washington): James Kiarie, Carey Farquhar, Grace John-Stewart; Thika, Kenya (University of Nairobi, University of Washington): Nelly R. Mugo; Tororo, Uganda (CDC-Uganda, The AIDS Support Organization): James D. Campbell, Jordan W. Tappero, Jonathan Wangisi. Data management was provided by DF/Net Research, Inc. (Seattle, USA) and site laboratory oversight was provided by Contract Lab Services (University of the Witwatersrand, Johannesburg, South Africa). Pyra et al. Page 2 eSexual, Reproductive, Adolescent and Child Health Research Program, Kenya Medical Author Manuscript Author Manuscript Author Manuscript Author Manuscript Research Institute, Nairobi, Kenya fFHI 360, Contraceptive Technology Innovation Department, Durham, North Carolina, USA gDivision of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia, USA hDepartment of Reproductive Health, Moi University, Eldoret, Kenya iWits Reproductive Health and HIV Institute (WRHI), University of the Witswatersrand, Johannesburg, South Africa jCenter for Microbiology Research, Kenya Medical Research Institute Abstract Objective—To assess whether antiretroviral therapy (ART) may diminish the effectiveness of hormonal contraceptive methods. Methods—Using data from 5,153 HIV-infected women followed prospectively one to three years in three HIV prevention studies in Africa, we compared incident pregnancy rates by contraceptive method (implant, injectable, oral, or none) and ART use. Multivariable Cox regression models were used to determine adjusted hazard ratios (aHR) and test interactions between each method and ART use. Results—During follow-up, 9% of women ever used implants, 40% used injectables, and 14% used oral contraceptives; 31% of women ever used ART, mostly nevirapine (75% of ART users) or efavirenz-based (15%). Among women not using contraception, pregnancy rates were 13.2 and 22.5 per 100 women-years for those on and not on ART, respectively. Implants greatly reduced the incidence of pregnancy among both women on ART (aHR 0.06, 95% CI 0.01-0.45) and not on ART (aHR 0.05, 95% CI 0.02-0.11). Injectables (aHR 0.18 on ART and aHR 0.20 not on ART) and oral contraceptives (aHR 0.37 on ART and aHR 0.36 not on ART) also reduced pregnancy risk, though by lesser degrees. ART use did not significantly diminish contraceptive effectiveness, although all methods showed non-statistically significant reduced effectiveness when concurrently using efavirenz. Conclusion—Hormonal contraceptive methods are highly effective in reducing pregnancy risk in HIV-infected women, including those concurrently using ART. Studies of potential interactions between ART and contraceptives should evaluate real-world effectiveness of contraceptive methods; in this study, implants were the most effective method to prevent pregnancy, even during ART use. Keywords hormonal contraception; women; antiretroviral agents Introduction Worldwide, a substantial unmet need for safe, effective contraception remains, particularly in areas with a high HIV prevalence [1]. For HIV-infected women, contraception is AIDS. Author manuscript; available in PMC 2016 November 01. Pyra et al. Page 3 important for their own health, for preventing mother-to-child HIV transmission, and to Author Manuscript Author Manuscript Author Manuscript Author Manuscript control their fertility. For women using antiretroviral therapy (ART), concerns have been raised that some progestin-based contraceptive methods may be less effective when used with certain ART agents. Specifically, it has been suggested that the non-nucleoside reverse- transcriptase inhibitors (NNRTIs), nevirapine (NVP) and efavirenz (EFV), may accelerate the progestin metabolism through the cytochrome p450 pathway [2]. Studies of interactions between ART and contraceptive methods have been limited by short follow-up times, HIV- uninfected populations, and/or surrogate endpoints [3]. We sought to understand the effect of ART on contraceptive effectiveness, measured by the clinical endpoint of pregnancy, using prospectively collected data from over 5,000 women with chronic HIV infection from East and Southern Africa. Methods Study Population Data contributed by women in three prospective studies (Partners in Prevention HSV/HIV Transmission Study, Couples Observation Study, and Partners PrEP Study) were combined for this analysis. Enrollment for these studies has previously been described [4–6]. In brief, 8,640 HIV serodiscordant heterosexual couples from seven African countries (Botswana, Kenya, Rwanda, South Africa, Tanzania, Uganda, Zambia) were enrolled and followed between 2004 and 2013; overall, in 63% of couples the seropositive partner was female. At enrollment, HIV-infected partners were not using ART; clinical and immunologic status was monitored during follow-up and ART was recommended according to national guidelines. Demographic information was collected at enrollment; data on sexual behavior,
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