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Clinical trialNCT06163274TerminatedEarly phase 1Interventional

Trial to Assess Acceptability and Safety of Two Placebo Intravaginal Rings

SponsorUniversity of PittsburghEnrollment93AcceptabilitySafety
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

South Africa
  • Wits Reproductive Health and Hiv Institute

    Hillbrow, Johannesburg, South Africa

  • Centre for the Aids Programme of Research in South Africa - Vululindlela

    Pietermaritzburg, KwaZulu-Natal, South Africa

  • the Aurum Institue - Tembisa #4

    Tembisa, South Africa

United States
  • Magee-Womens Hospital of Upmc

    Pittsburgh, Pennsylvania, United States

Zimbabwe
  • Harare Health and Research Consortium

    Chitungwiza, Zimbabwe

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study — it may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
28 Feb 2024
Primary completion
24 Jan 2025
Completion
24 Jan 2025
Last update posted
3 Mar 2025
Registered enrollment
93
Registry id
NCT06163274

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.