MATRIX-002

Title: Trial to Assess Acceptability and Safety of Two Placebo Prototype Vaginal Films

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 five clinical sites in the US (Pittsburgh), South Africa (Aurum and Wits RHI), Kenya (KEMRI), and Zimbabwe (HHRC). The study will examine the acceptability, usability, and safety of two placebo prototype vaginal films differing in the shape (square vs. rounded edges) when used with and without sex. User and partner experiences with the vaginal film will also be explored. Enrolled participants will be randomized (1;1) to one of the two placebo films, which they will administer vaginally once a month for 2 months, and will remain sexually abstinent for the first month of study participation.

Study Sites: University of Pittsburgh/Magee Womens Research Institute and Foundation (Pitt/MWRIF) CRS; The Aurum Institute Klerksdorp CRS; Wits Reproductive Health and HIV Institute (Wits RHI) CRS; Harare Health and Research Consortium (HHRC) Zengeza CRS; and Kenyan Medical Research Institute (KEMRI) Thika CRS

Protocol Co-Chairs: Nyaradzo M. Mgodi, MBChB, MMed and Alexandra Minnis, PhD, MPH 

Email Groups: MATRIX-002 Clinical Management Team; MATRIX-002 Management Team; MATRIX-002 Protocol Safety Review Team; MATRIX-002 Protocol Team; MATRIX-002 Safety Physician; MATRIX-002 South Africa Regulatory