NCT06046053

MATRIX-002: Trial to Assess Acceptability and Safety of Two Placebo Vaginal Films

MATRIX-002: Trial to Assess Acceptability and Safety of Two Placebo Prototype Vaginal Films

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Rohan, Lisa, PhD · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will enroll approximately 100 HIV-negative persons, aged18-45 years, and assigned female sex at birth from sites in the United States, Kenya, South Africa, and Zimbabwe. The study will assess the acceptability and safety of two placebo vaginal films. The placebo films do not contain any active medication, are the same size, but differ by shape (square versus rounded corners). Participants will be randomly assigned to one of the two films and asked to use (self-insert) the assigned film two times (approximately one month apart). Participants will be asked to refrain from sexual activity during the first month of use and may resume usual sexual activity during the second month of use. The study involves answering questions, undergoing pelvic examinations, and collecting blood and vaginal fluid samples. The study involves a total of 10 visits/contacts, including in person visits and telephone calls over approximately 9 weeks. In addition, both participants and approximately 30 of their sexual partners will be asked to take part in in depth interviews to further assess acceptability, attitudes, and experiences with film use to gauge interest in the future use of vaginal films as a HIV prevention option.

Detailed description

The goal of this randomized, clinical trial is to compare two placebo vaginal films in HIV seronegative adult (18-45 years old) persons assigned female sex at birth who are at low risk of acquiring HIV infection, and sexual partners of evaluable participants. Participants will be recruited from five sites, one in the US and four is sub-Saharan Africa. Approximately 100 participants will be randomized (1:1), stratified by site, to insert either placebo vaginal film A or placebo vaginal film B, which differ only by shape, once monthly for two months. Participants will be asked to refrain from sexual activity during the first month of use and may resume usual sexual activity during the second month of use after insertion of the second film which will be the same film they were assigned to use during the first month. Differences in safety, acceptability, usability, social harms and benefits, and vaginal microenvironment between the two films and the two study phases (i.e., with and without sexual abstinence requirement) will be assessed. In addition, both participants and approximately 30 sexual partners of evaluable participants will be asked to take part in in depth interviews to further assess acceptability, attitudes, and experiences with film use to gauge interest in the future use of vaginal films as a HIV prevention option.

Conditions

• Safety
• Acceptability
• Usability

Interventions

Type	Name	Description
DRUG	Placebo Vaginal Film with Square Corners	2" x 2" placebo vaginal film with square corners
DRUG	Placebo Vaginal Film with Rounded Corners	2" x 2" placebo vaginal film with rounded corners

Timeline

• Start date: 2023-10-18
• Primary completion: 2024-12-10
• Completion: 2024-12-10
• First posted: 2023-09-21
• Last updated: 2024-12-19

Locations

5 sites across 4 countries: United States, Kenya, South Africa, Zimbabwe

Regulatory

• FDA-regulated drug study