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

University of Pittsburgh5 sites in 3 countries93 target enrollmentFebruary 28, 2024

ConditionsSafety Acceptability

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Safety
Sponsor: University of Pittsburgh
Enrollment: 93
Locations: 5
Primary Endpoint: Number of Participants Preferring to Use Placebo Intravaginal Ring A versus Ring B
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 28, 2024

End Date

January 24, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

University of Pittsburgh

Responsible Party

Principal Investigator

Catherine Anne Chappell

Principal Investigator

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

•Assigned female sex at birth.
•Able and willing to provide written informed consent to be screened for and enrolled in MATRIX-003 in one of the study languages.
•Able and willing to provide adequate contact/locator information.
•Able and willing to comply with all protocol requirements, including:
•Abstaining from other intravaginal products or practices for the duration of the study.
•Abstaining from penetrative vaginal intercourse (i.e., oral-, digital-, penile-penetration) for the first 14 days of each product use period.
•Refraining from participation in other research studies involving drugs, medical devices, vaginal products, or vaccines starting 2 weeks before the Screening Visit and for the duration of the study, or in observational or qualitative studies for the duration of the study, unless approved by the Protocol Safety Review Team.
•Reliable access to a private phone for scheduled phone contacts.
•HIV-uninfected based on testing performed at Screening and Enrollment.
•Per participant report, must be either not currently sexually active or in a mutually monogamous relationship with only one partner who is not known to be HIV positive or to currently have a sexually transmitted infection.

Exclusion Criteria

•Per participant report at Screening and Enrollment, intends to do any of the following during the study participation period:
•Become pregnant.
•Breastfeed.
•Relocate away from the study site.
•Travel away from the study site for a time period that would interfere with product resupply and/or study participation.
•Positive HIV test at Screening or Enrollment.
•Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis, or Treponema pallidum (Syphilis) at Screening and (per participant report) treated for potential sexually transmitted infection within past 12 months.
•Diagnosed with urinary tract infection, pelvic inflammatory disease, or reproductive tract infection requiring treatment at Enrollment.
•Note: Otherwise eligible participants diagnosed during screening with a urinary tract infection, symptomatic yeast infection or symptomatic bacterial vaginosis infection are offered treatment. If treatment is completed and symptoms have resolved within 45 days of obtaining informed consent for screening, the participant may be enrolled.
•Clinically apparent Grade 2 or higher pelvic exam finding at Enrollment.