Assessing Per-Sex-Act HIV-1 Risk Reduction Among Women Using the Dapivirine Vaginal Ring

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; MTN-020/ASPIRE Study Team

doi:10.1093/infdis/jiad550

Assessing Per-Sex-Act HIV-1 Risk Reduction Among Women Using the Dapivirine Vaginal Ring

J Infect Dis. 2024 Apr 12;229(4):1158-1165. doi: 10.1093/infdis/jiad550.

Authors

Randy M Stalter¹, Tracy Q Dong², Craig W Hendrix³, Thesla Palanee-Phillips^{1

4}, Ariane van der Straten^{5

6}, Sharon L Hillier^{7

8}, Flavia M Kiweewa⁹, Nyaradzo M Mgodi¹⁰, Mark A Marzinke³, Linda-Gail Bekker¹¹, Lydia Soto-Torres¹², Jared M Baeten^{1

13}, Elizabeth R Brown^{2

14}; MTN-020/ASPIRE Study Team

Collaborators

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

Affiliations

¹ Department of Epidemiology, University of Washington, Seattle, WA, USA.
² Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
³ Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.
⁴ Wits Reproductive Health and HIV Research Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
⁵ Center for AIDS Prevention Studies, Department of Medicine, University of California San Francisco, San Francisco, CA, USA.
⁶ ASTRA consulting, Kensington, CA, USA.
⁷ Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
⁸ Magee-Womens Research Institute, Pittsburgh, PA, USA.
⁹ Research Department, Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.
¹⁰ Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.
¹¹ The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
¹² Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
¹³ Departments of Medicine and Global Health, University of Washington, Seattle, WA, USA.
¹⁴ Department of Biostatistics, University of Washington, Seattle, WA, USA.

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.

Keywords: HIV-1; dapivirine; per sex act; preexposure prophylaxis; vaginal ring.

Publication types

Randomized Controlled Trial
Clinical Trial, Phase III

MeSH terms

Adolescent
Adult
Anti-HIV Agents* / therapeutic use
Contraceptive Devices, Female*
Female
HIV Infections* / epidemiology
HIV Infections* / prevention & control
HIV Seropositivity*
HIV-1*
Humans
Middle Aged
Pyrimidines*
Risk Reduction Behavior
Young Adult

Assessing Per-Sex-Act HIV-1 Risk Reduction Among Women Using the Dapivirine Vaginal Ring

Authors

Collaborators

Affiliations

Abstract

Publication types

MeSH terms

Substances

Associated data

Grants and funding