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Trial to Assess Acceptability and Safety of Two Placebo Intravaginal Rings

NCT06163274 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2025-03-03

No results posted yet for this study

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.

Conditions

  • Safety
  • Acceptability

Interventions

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.

Sponsors & Collaborators

  • United States Agency for International Development (USAID)

    collaborator FED

  • Oak Crest Institute of Science

    collaborator OTHER

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Catherine A Chappell, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-28
Primary Completion
2025-01-24
Completion
2025-01-24

Countries

  • United States
  • South Africa
  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06163274 on ClinicalTrials.gov