Screening and Enrollment flow
Analysis Flow
Reporting Tables
Table 1. Expected and Actual Enrollment by month during the enrollment period
Month, Dates
Expected
Enrollment, N (%)
Actual,
N (%)
Month 1, Feb 9 - 28
67
41
Month 2, March 1 – 27
67
51
Month 3, April 3 - 28
67
18
Background
This single-arm trial seeks to evaluate the preliminary efficacy of menstrual cups on non-optimal vaginal microbiome (VMB), BV, and STIs of economically vulnerable women at high risk for STIs and HIV, and to understand safety, acceptability, and implementation needs. The goal of this study is to generate preliminary efficacy