MTN 020 (ASPIRE)

Status:Completed
Phase:III
Principal Investigator(s):Jared Baeten, Thesla Palanee
Objective:To assess the safety and effectiveness of a silicone elastomer vaginal matrix ring containing dapivirine worn for a month at a time. Results released in February 2016: found the dapivirine ring reduced the risk of HIV infection by 27% overall. Additional analysis released in July 2016 found that, among women who appeared to use the ring most regularly, HIV risk was cut by more than 50% across all analyses, and for those who benefitted the most, by 75% or more. Last updated October 20, 2022
Prevention Option(s):Microbicides
Study Design:Controlled, Placebo, Randomized
Arms and Assigned Interventions
Description4-week vaginal dapivirine (25 mg) ring
Mode of DeliveryRing
ARMsExperimental
Results: Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women
Official Code: NCT01617096
Related Publications:
Patterns of Adherence to a Dapivirine Vaginal Ring for HIV-1 Prevention Among South African Women in a Phase III Randomized Controlled Trial
Experiences with simultaneous use of contraception and the vaginal ring for HIV prevention in sub-Saharan Africa
Acceptability of the Dapivirine Vaginal Ring for HIV-1 Prevention and Association with Adherence in a Phase III Trial
Risk of HIV-1 acquisition among South African women using a variety of contraceptive methods in a prospective study
Acquisition of Sexually Transmitted Infections among Women Using a Variety of Contraceptive Options: A prospective Study among High-risk African Women
Clinical and Virologic Outcomes Following Initiation of Antiretroviral Therapy Among Seroconverters in the Microbicide Trials Network-020 Phase III Trial of the Dapivirine Vaginal Ring
Vaginal Ring Use in a Phase 3 Microbicide Trial: A Comparison of Objective Measures and Self-reports of Non-adherence in ASPIRE
Trial Sponsors: MTN, NIAID, NICHD, NIMH
Start Date
End Date
July 24, 2012
December 31, 2015
Enrollment:3,540
Age range: 18 Years ↔ 45 Years
Population:Cisgender Women