Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

408

Participants

Timeline

Start Date

February 13, 2023

Primary Completion Date

December 1, 2025

Study Completion Date

July 31, 2027

Conditions
Bacterial VaginosisVaginal MicrobiomeChlamydia Trachomatis InfectionNeisseria Gonorrheae InfectionTrichomonas Vaginitis
Interventions
DEVICE

Menstrual Cup

Menstrual cups are inserted vaginally to collect menstrual flow, with some designed especially for use during intercourse, which will be used in this study. Medical devices registered with the U.S. FDA, a reusable silicon cup can last up to 10 years, is cost-effective, and has reduced environmental impact.

Trial Locations (2)

60612

Rush University Medical Center, Chicago

Unknown

Nyanza Reproductive Health Society, Kisumu

Sponsors
All Listed Sponsors
collaborator

Nyanza Reproductive Health Society

OTHER

collaborator

Liverpool School of Tropical Medicine

OTHER

collaborator

University of Illinois at Chicago

OTHER

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Rush University Medical Center

OTHER