# Menstrual cups, maturation of the adolescent vaginal microbiome, and STI/HIV risk

> **NIH NIH R01** · UNIVERSITY OF ILLINOIS AT CHICAGO · 2020 · $435,221

## Abstract

A disproportionate number of new HIV infections occur in adolescent girls in sub-Saharan Africa (SSA). In
parts of western Kenya, HIV prevalence rises from 1.3% in 13-14 year-olds to 12.8% by age 18 years.
Bacterial vaginosis (BV), which doubles the risk of HIV acquisition and transmission, affects 20-50% of general
population women in SSA and Kenya. For adolescent girls, the HIV/STI epidemic overlaps with broader
reproductive health concerns. Menstrual hygiene management (MHM) is a pervasive problem across low- and
middle-income countries and a lack of MHM materials negatively impacts girls' health and schooling. To attend
school and obtain necessities such as sanitary products, soap and underwear, girls consequently often engage
in exchange sex. To tackle these challenges, Co-Investigator Phillips-Howard conducted a cluster randomized
controlled feasibility study following 644 girls aged 14-16 years old: after one year, menstrual cup use resulted
in 35% lower (p=0.034) BV prevalence and 52% lower (p=0.039) STI prevalence compared to control condition
of menstrual hygiene counseling. Based on our and others' research, we hypothesize menstrual cups protect
against STIs by preserving or promoting a Lactobacillus-dominant vaginal microbiome (VMB). Numerous
studies associated a Lactobacillus-dominant VMB with reduced risk of STI and HIV acquisition. We propose to
study this proposed microbiome-related mechanism to understand how menstrual cup use leads to reduced
BV and STIs, and the effect of menstrual cup use on evolution of the adolescent VMB. We will: Aim 1:
Determine the influence of menstrual cup use on the VMB and how this is related to risk of BV and STIs; Aim
2: Identify the change in VMB as girls initiate sexual activity, and whether this is modified by menstrual cup
use, and Aim 3: Augment trial pharmacovigilance through detection of E. coli on cups and correlation with
VMB. The proposed study will be a longitudinal sub-study of 440 girls aged 14-16 years nested within a
recently funded cluster randomized controlled trial to examine menstrual cup use versus cash transfer or
control condition among 3,864 secondary school girls in Siaya County, Kenya (DfID/MRC/Wellcome Trust; PI:
Phillips-Howard). To achieve our aims, we will characterize the VMB using high throughput amplicon
sequencing of portions of the bacterial 16S rRNA gene. Participants (220 cup users, 220 controls) will be
asked to provide a self-collected vaginal swab at baseline prior to allocation and at each semi-annual visit, for
a maximum of 6 samples per subject (BL, 6-, 12-, 18-, 24-, 30-months). BV will be assessed at baseline at
each semi-annual visit, and STIs (C. trachomatis, T. vaginalis, N. gonorrhoeae) at baseline and annually. HIV
and HSV-2 are assessed at baseline and annually by the larger trial. Results from this study will provide
understanding of whether microbiome modulating interventions being tested for adult women are applicable for
adolescent girls. Menstru...

## Key facts

- **NIH application ID:** 9829110
- **Project number:** 5R01HD093780-03
- **Recipient organization:** UNIVERSITY OF ILLINOIS AT CHICAGO
- **Principal Investigator:** Supriya Dinesh Mehta
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $435,221
- **Award type:** 5
- **Project period:** 2017-12-27 → 2021-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9829110

## Citation

> US National Institutes of Health, RePORTER application 9829110, Menstrual cups, maturation of the adolescent vaginal microbiome, and STI/HIV risk (5R01HD093780-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9829110. Licensed CC0.

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