Year: 2023
Type: article
Abstract: BACKGROUND: Confounding introduced by individuals' sexual risk behavior is potentially a significant source of bias in HIV-1 prevention intervention studies. To more completely account for sexual behaviors when assessing the efficacy of the monthly dapivirine ring, a new longer-acting HIV-1 prevention option for women, we estimated per-sex-act risk reduction associated with product use. METHODS: We conducted a secondary analysis of data from MTN-020/ASPIRE, a phase 3, randomized, placebo-controlled efficacy trial of the dapivirine ring that recruited HIV-uninfected, African women aged 18-45 years. With cumulative sex acts as the time scale, we used multivariable Cox regression with inverse probability of censoring weights to estimate HIV-1 risk reduction associated with a rate of dapivirine release indicative of consistent product use. RESULTS: Women in the dapivirine ring group (n = 1187) had an estimated incidence rate of 2.3 (95% confidence interval [CI], 1.8-3.1) HIV-1 acquisition events per 10 000 sex acts versus 3.6 (95% CI, 2.9-4.4) per 10 000 acts in the placebo group (n = 1187). Dapivirine release indicative of consistent ring use was associated with a 63% (95% CI, 33%-80%) per-sex-act HIV-1 risk reduction. CONCLUSIONS: These results support the efficacy of the dapivirine vaginal ring for HIV-1 prevention and help to inform decision-making for women, providers, and policymakers regarding product use. CLINICAL TRIALS REGISTRATION: NCT01617096.
Authors: Randy M Stalter, Tracy Q Dong, Craig W Hendrix, Thesla Palanee-Phillips, Ariane van der Straten, Sharon L Hillier, Flavia M Kiweewa, Nyaradzo M Mgodi, Mark A Marzinke, Linda-Gail Bekker, Lydia Soto-Torres, Jared M Baeten, Elizabeth R Brown, for the MTN-020/ASPIRE Study Team, Jared Baeten, Thesla Palanee-Phillips, Elizabeth Brown, Lydia Soto-Torres, Katie Schwartz, Bonus Makanani, Francis Martinson, Linda-Gail Bekker, Vaneshree Govender, Samantha Siva, Zakir Gaffoor, Logashvari Naidoo, Arendevi Pather, Nitesha Jeenarain, Gonasagrie Nair, Thesla Palanee-Phillips, Flavia Matovu Kiweewa, Nyaradzo Mgodi, Felix Mhlanga
Institutions: University of Washington, Fred Hutch Cancer Center, Johns Hopkins University, University of the Witwatersrand, University of California, San Francisco, Atmospheric and Space Technology Research Associates (United States), University of Pittsburgh, Magee-Womens Research Institute, MUJHU Research Collaboration, University of Zimbabwe, University of Cape Town, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Gilead Sciences (United States)
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funders: Gilead Sciences, University of Washington, Johns Hopkins University, ViiV Healthcare, FHI 360, Adolescent Medicine Trials Network for HIV/AIDS Interventions, South African Medical Research Council, University of Cape Town, National Institutes of Health, University of North Carolina at Chapel Hill, Medical Research Council, National Institute of Mental Health, National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development, Eunice Kennedy Shriver National Institute of Child Health and Human Development
Awards: Microbicide Trials Network, Statistical and Data Management Center (SDMC): Microbicide Trials Network, Leadership and Operations Center (LOC): Microbicide Trials Network, Units for HIV/AIDS Clinical Trials Networks, UZ-UCSF Clinical Trials Unit, Laboratory Center (LC): Microbicide Trials Network, UZ-UCSF CTU, STD and AIDS Research Training Grant, Rustbelt Center for AIDS Research (Case/UHC-Pitt CFAR), The Johns Hopkins University-Blantyre Clinical Trials Unit, Host Defense Training in Allergy and Infectious Diseases, SDMC: HIV Prevention Trials Network, Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplication
OpenAlex ID: W4389794616