A Phase 3B Open-Label Follow-on Trial to Assess the Continued Safety and Adherence to a Vaginal Ring Containing Dapivirine in Women (HOPE)
Sponsors:
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)
Protocol Summary:
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
Investigators:
Nyaradzo Mgodi, MSc, MBChB, MMed
Z.M. Chirenje, MD, FRCOG
Felix Muhlanga, MBChB, MMed
Locations: Spilhaus, Seke South, and Zengeza CRSs
MTN
Current Study
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