uvaRing Study

Phase 4

• Conditions: HIV/AIDS; Bacterial Vaginosis

• Registration Number: PACTR202006666229813
• Lead Sponsor: niversity of Washington

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

Female Eligibility Criteria:

=18-40-year-old BV+ by Amsel’s criteria
Not intending or wishing to become pregnant over the course of the study
Capable of providing written informed consent

Male Eligibility Criteria:

Main sex partner of the randomized female participant
Capable of providing written informed consent

Exclusion Criteria

Female Exclusion Criteria:

Current pregnancy
Desire/intent to become pregnant over the course of the study
Current cigarette smoking if age is older than 35 years
Unable to comprehend consent material because of the language barrier or psychological difficulty
Male Exclusion Criteria:

Unable to comprehend consent material because of the language barrier or psychological difficulty

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome 1: Quantity of L. crispatus determined by species-specific qPCR assay <br>Outcome 2: Local immune parameters, including cytokines, innate mediators, and functional antimicrobial activity in cervicovaginal secretions as assessed by anti-E. coli, anti-HSV, and anti-HIV activity <br><br>

Secondary Outcome Measures

Name	Time	Method
Quantity of genital HIV shedding among HIV-infected participants <br>