A Phase 3B Open-Label Follow-on Trial to Assess the Continued Safety and Adherence to a Vaginal Ring Containing Dapivirine in Women (HOPE)
Division of AIDS (DAIDS)
Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD)
National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)
MTN-025, the HIV Open-label Prevention Extension (HOPE) trial, is a multi-site, open-label, randomized, Phase 3B trial that has been implemented since the dapivirine vaginal ring (VR) was found to be a safe and effective HIV prevention method in the MTN-020 (ASPIRE) trial. Eligible HIV-uninfected ASPIRE participants will receive a silicone elastomer VR containing 25 mg of dapivirine, to be replaced monthly, for a total period of 12 months of use. Study follow-up visits will occur monthly for the first 3 months, and quarterly thereafter, reflecting a transition to a more real-world type of follow-up (versus a clinical trial approach). The study will compare the safety of and participant adherence to dapivirine (25 mg) in a silicone elastomer VR. Should a woman choose not to take part in MTN-025, she will have the option of completing a brief survey and may be selected for qualitative evaluation assessing reasons for non-interest in enrolling. The HOPE sample size will be contingent upon how many former ASPIRE participants are interested in enrolling, are HIV-negative and otherwise eligible to enroll.
Years: 2016 – present
Nyaradzo Mgodi, MSc, MBChB, MMed
Z.M. Chirenje, MD, FRCOG
Felix Muhlanga, MBChB, MMed
Locations: Spilhaus, Seke South, and Zengeza CRSs
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