Placebo Intravaginal Rings for Acceptability and Safety
(MATRIX-003 Trial)
Trial Summary
Do I need to stop taking my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use antibiotics, steroids, or antifungal therapies within 14 days of enrollment. It's best to discuss your specific medications with the study team.
What data supports the idea that Placebo Intravaginal Rings for Acceptability and Safety is an effective treatment?
The available research shows that Placebo Intravaginal Rings are generally well-accepted by users, with most women finding them easy to use and comfortable. However, there is no specific data provided that supports their effectiveness as a treatment for any condition. The studies focus more on the acceptability and potential of intravaginal rings for delivering other drugs, rather than proving the effectiveness of the placebo rings themselves. Therefore, there is no evidence from the provided information that Placebo Intravaginal Rings are an effective treatment.12345
What safety data exists for placebo intravaginal rings?
A study involving 166 women using a placebo intravaginal ring (IVR-2) found no clinically significant lesions in the vaginal and cervical epithelium over 6 months. Minor changes like erythema and petechiae were noted, mostly resolving with continued use. The study suggested a link between tampon use and these changes, but not with smoking or intercourse frequency. Overall, the placebo IVR-2 was deemed safe without significant epithelial changes.13467
Is the treatment in the trial 'Placebo Intravaginal Rings for Acceptability and Safety' a promising treatment?
What is the purpose of this trial?
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.
Research Team
Catherine A Chappell, MD
Principal Investigator
University of Pittsburgh
Eligibility Criteria
This trial is for HIV-negative women aged 18-45, who are not pregnant or planning to become so, and are either not sexually active or in a monogamous relationship. They must be willing to avoid other vaginal products and abstain from sex for the first two weeks of each ring use period.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase 1
Participants use the first assigned placebo intravaginal ring for 4 weeks
Rest Period
Participants have a rest period with no ring use for 1-3 weeks
Treatment Phase 2
Participants use the second assigned placebo intravaginal ring for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo Intravaginal Ring A
- Placebo Intravaginal Ring B
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
Oak Crest Institute of Science
Collaborator
United States Agency for International Development (USAID)
Collaborator