NCT06163274

Trial to Assess Acceptability and Safety of Two Placebo Intravaginal Rings

MATRIX-003: Trial to Assess Acceptability and Safety of Two Placebo Intravaginal Ring Designs

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This research study is being conducted to find out how easy, comfortable, and safe intravaginal rings are for women to use. The two rings used in this study do not dispense any medications, are the same size, but differ in their flexibility and hardness. This study will enroll approximately 100 HIV-negative persons, aged18-45 years, and assigned female sex at birth from sites in the United States, South Africa, and Zimbabwe. Participants will be randomly assigned to use (self-insert) Ring A for 4 weeks and then Ring B for 4 weeks or Ring B first followed by Ring A. There will be a 1-3-week rest period between using the two different rings. The study involves answering questions, undergoing pelvic examinations, and collecting blood and vaginal fluid samples over a total of 7 in-person visits and 2 telephone calls over approximately 9-11 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 ring use to gauge interest in the future use of intravaginal rings as a HIV prevention option.

Detailed description

The goal of this randomized, clinical trial is to compare two placebo intravaginal rings in HIV seronegative persons, aged 18-45 years, assigned female sex at birth who are at low risk of acquiring HIV infection. Participants will be recruited from five sites, one in the US and four in sub-Saharan Africa. Approximately 100 participants will be randomized (1:1), stratified by site, to the sequence of using the two intravaginal rings (A followed by B or B followed by A). The two rings differ only by mechanical attributes, such as flexibility and hardness. Each ring will be self-inserted and left in place for 4-weeks. After 4 weeks, the first assigned ring will be removed by the participant at the clinic. Then there will be a 7-21-day period of no ring use. The participant will then return to the clinic and self-insert the second assigned ring and leave it in place for 4 weeks, after which the participant will return to the clinic for self-removal of the ring. Differences in safety, acceptability, social harms and benefits, and composition of the vaginal microbiome between the two rings will be assessed. 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 ring use to gauge interest in the future use of intravaginal rings as a HIV prevention option.

Conditions

• Safety
• Acceptability

Interventions

Type	Name	Description
DEVICE	Placebo Intravaginal Ring A	Placebo Intravaginal Ring A consists of a flexible lavender silicone scaffold, with an outer diameter of 55 mm and a durometer value of 40A (Shore A hardness scale). The ring holds two blank grey cassettes.
DEVICE	Placebo Intravaginal Ring B	Placebo Intravaginal Ring B consists of a flexible lavender silicone scaffold, with an outer diameter of 55 mm and a durometer value of 50A (Shore A hardness scale). The ring holds two blank grey cassettes.

Timeline

• Start date: 2024-02-28
• Primary completion: 2025-01-24
• Completion: 2025-01-24
• First posted: 2023-12-08
• Last updated: 2025-03-03

Locations

5 sites across 3 countries: United States, South Africa, Zimbabwe