Renee Heffron1, Nelly Mugo, Edwin Were, James Kiarie, Elizabeth A Bukusi, Andrew Mujugira, Lisa M Frenkel, Deborah Donnell, Allan Ronald, Connie Celum, Jared M Baeten. 1. aDepartment of Global Health bDepartment of Medicine cDepartment of Epidemiology dPediatrics & Laboratory Medicine eDepartment of Obstetrics and Gynecology, University of Washington, Seattle, Washington, USA fCenter for Clinical Research, Kenya Medical Research Institute, Nairobi gDepartment of Reproductive Health, Moi University, Eldoret hDepartment of Obstetrics & Gynecology, University of Nairobi and Kenyatta National Hospital iCenter for Microbiology, Kenya Medical Research Institute, Nairobi, Kenya jVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA kDepartments of Medicine and Medical Microbiology, University of Manitoba, Winnipeg, Canada. *The Partners PrEP Study Team is listed in the Acknowledgements.
Abstract
OBJECTIVE: To evaluate preexposure prophylaxis (PrEP) efficacy for HIV-1 prevention among women using depotmedroxyprogesterone acetate (DMPA) for contraception and men whose HIV-1-infected partners use DMPA. DESIGN: Secondary analysis of data from a randomized placebo-controlled trial of daily oral tenofovir and emtricitabine/tenofovir PrEP among heterosexual Kenyan and Ugandan HIV-1 serodiscordant couples. METHODS:PrEP efficacy for HIV-1 prevention was compared among HIV-1-uninfected women usingDMPA versus no hormonal contraception and among HIV-1 uninfected men whose HIV-1-infected female partners used DMPA versus no hormonal contraception. RESULTS: Of 4747 HIV-1 serodiscordant couples, 901 HIV-1-uninfected women used DMPA at some point during follow-up, 1422 HIV-1-uninfected women used no hormonal contraception, 1568 HIV-1-uninfected men had female partners who used DMPA, and 2626 men had female partners who used no hormonal contraception. PrEP efficacy estimates for HIV-1 prevention, compared with placebo, were similar among women using DMPA and those using no hormonal contraception (64.7 and 75.5%, adjusted interaction P = 0.65). Similarly, for men whose female partners used DMPA, PrEP efficacy did not differ from men whose partners used no hormonal contraception (90.0 versus 81.7%, adjusted interaction P = 0.52). CONCLUSION:PrEP is efficacious for HIV-1 prevention among women using DMPA and men whose partners use DMPA, suggesting PrEP could mitigate the potential increased HIV-1 acquisition and transmission risks that have been associated with DMPA use. Women at risk for HIV-1 choosing DMPA could maintain this contraceptive method and add PrEP to achieve prevention of unintended pregnancy and HIV-1.
RCT Entities:
OBJECTIVE: To evaluate preexposure prophylaxis (PrEP) efficacy for HIV-1 prevention among women using depot medroxyprogesterone acetate (DMPA) for contraception and men whose HIV-1-infected partners use DMPA. DESIGN: Secondary analysis of data from a randomized placebo-controlled trial of daily oral tenofovir and emtricitabine/tenofovir PrEP among heterosexual Kenyan and Ugandan HIV-1 serodiscordant couples. METHODS: PrEP efficacy for HIV-1 prevention was compared among HIV-1-uninfectedwomen using DMPA versus no hormonal contraception and among HIV-1 uninfected men whose HIV-1-infected female partners used DMPA versus no hormonal contraception. RESULTS: Of 4747 HIV-1 serodiscordant couples, 901 HIV-1-uninfectedwomen used DMPA at some point during follow-up, 1422 HIV-1-uninfectedwomen used no hormonal contraception, 1568 HIV-1-uninfectedmen had female partners who used DMPA, and 2626 men had female partners who used no hormonal contraception. PrEP efficacy estimates for HIV-1 prevention, compared with placebo, were similar among women using DMPA and those using no hormonal contraception (64.7 and 75.5%, adjusted interaction P = 0.65). Similarly, for men whose female partners used DMPA, PrEP efficacy did not differ from men whose partners used no hormonal contraception (90.0 versus 81.7%, adjusted interaction P = 0.52). CONCLUSION: PrEP is efficacious for HIV-1 prevention among women using DMPA and men whose partners use DMPA, suggesting PrEP could mitigate the potential increased HIV-1 acquisition and transmission risks that have been associated with DMPA use. Women at risk for HIV-1 choosing DMPA could maintain this contraceptive method and add PrEP to achieve prevention of unintended pregnancy and HIV-1.
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