Title: Trial to Assess Acceptability and Safety of Two Placebo Intravaginal Rings (IVR)
Brief Description: This clinical placebo study will enroll approximately 100 healthy, non-pregnant, HIV-uninfected persons assigned female sex at birth aged 18-45 years who are not at risk for pregnancy and are at low risk for sexually transmitted infections at one clinical site in the US and four clinical sites in Africa (Aurum-Tembisa, CAPRISA-Vulindlela, HHRC-Zengeza, and Wits RHI). The study will examine the acceptability and safety of two vaginal placebo ring products differing by material mechanical properties such as flexibility or hardness. Enrolled participants will be randomized to one of the two placebo rings, which they will administer vaginally once a month for 2 months, switching to the second placebo ring for the second month. Participants will remain sexually abstinent for the first 14 days of product use for each month. Please refer to the attached protocol concept for further details about this study.
Protocol Co-Chairs: Krishnaveni Reddy, MMedSci and Kathryn Mngadi, MBChB, Mphil Pall Med
Study Sites: University of Pittsburgh/Magee Womens Research Institute and Foundation (Pitt/MWRIF) CRS; The Aurum Institute Tembisa #4 CRS; Harare Health and Research Consortium (HHRC) Zengeza CRS; Wits Reproductive Health and HIV Institute (Wits RHI) CRS; and Centre for the AIDS Programme of Research in South Africa (CAPRISA) Vulindlela CRS
Email Groups: MATRIX-003 Protocol Development Team