Single arm trial of menstrual cups among economically vulnerable women to reduce Bacterial vaginosis and STIs through reduced harmful sexual and menstrual practices - Bacterial vaginosis (BV) is a priority clinical and public health concern because of its negative impact on fertility and birth outcomes. In the U.S. National Health and Nutrition Survey, a representative sample of reproductive aged American women, 29% experienced BV. At the same time, 25% of American women experience period poverty, which is the inability to purchase menstrual products or products of choice. This increases to 33-42% of economically vulnerable American women, who may resort to using unsafe materials like cloth, or wearing pads too long, and these can increase BV risk. Safe menstrual management is a pervasive problem across low- and middle-income countries. Among 3,400 women in Kenya, two-thirds in impoverished settings reported depending on sexual partners to provide branded products. Economically vulnerable women many continue to have sex during menses, and engage in unsafe menstrual practices, such as vaginal insertion of sponges or cotton balls. In a cluster randomized controlled trial among 436 Kenyan secondary schoolgirls aged 14-21, we observed that over 30 months, menstrual cups led to 37% increased odds of optimal vaginal microbiome (VMB) community state type (aOR=1.37; 95% CI: 1.06–1.75) and 24% reduced odds of BV (aOR=0.76; 95% CI: 0.59–0.98), and among 4,137 girls menstrual cups led to 33% (RR=0.67; 95% CI: 0.47-0.95) reduction in genital herpes. Menstrual cups designed for use during intercourse may help women prevent BV and sexually transmitted infections (STIs) through hygienic menstrual practices and avoidance of harmful practices. Objective: This single-arm trial seeks to evaluate the preliminary efficacy of menstrual cups on non-optimal VMB, BV, and STIs of economically vulnerable women at high risk for STIs and HIV. In Aim 1, we will evaluate the impact of menstrual cups on VMB, BV, and STIs among 402 economically vulnerable women in semiurban Kenya. In Aim 2, we will conduct integrated surveillance for enhanced detection of safety endpoints, risk of cup contamination, and mitigating or facilitating water, sanitation, hygiene factors. In Aim 3, we will identify constructs for successful menstrual programs using an implementation science framework. U.S. Impact: This study is being conducted in Kenya because it represents a “challenge case” scenario that cost-efficiently reduces the sample size and study duration needed to evaluate the intervention impact on health, saving money overall. Moreover, by testing the intervention in a higher risk context, this provides empiric data that covers the wide conditions faced by American women. If menstrual cups lead to improved VMB and reduced risk of BV for economically vulnerable women, this can lead to substantially improved health for American women. As a specific example, in published analysis of nearly 3,000 U.S. women, BV accounted for up to 40% of attributable risk for preterm birth occurring before 32 weeks. If BV can be reduced by 25% with menstrual cups, similar to our prior trial findings, this will lead to thousands of saved babies annually.
