NCT05666778: POWWERHealth

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

Active, enrolled Phase 2 Last updated 31 December 2025

What this trial tests

Phase 2 trial testing Menstrual Cup in Bacterial Vaginosis in 408 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 February 2023

Primary endpoint
30 June 2026

31 July 2027

Quick facts

Lead sponsor	Rush University Medical Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	408
Start date	13 February 2023
Primary completion	30 June 2026
Estimated completion	31 July 2027
Sites	2 locations across Kenya, United States

Drugs / interventions tested

• Menstrual Cup

Conditions studied

• Bacterial Vaginosis — all drugs for Bacterial Vaginosis →
• Vaginal Microbiome — all drugs for Vaginal Microbiome →
• Chlamydia Trachomatis Infection — all drugs for Chlamydia Trachomatis Infection →
• Neisseria Gonorrheae Infection — all drugs for Neisseria Gonorrheae Infection →

Sponsor

Rush University Medical Center

Who can join

Adults 15 to 35, female only, with Bacterial Vaginosis or Vaginal Microbiome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

HIV remains a global pandemic with 37 million infected. In western Kenya, 16% of women in the general population and 29% of the poorest women have HIV. The HIV and sexually transmitted infection (STI) epidemics overlap with broader reproductive health concerns. Menstrual hygiene management is a big problem in low- and middle-income countries and a lack of menstrual products negatively impacts women's work-life. This comes from cultural taboos, stigma, and discrimination, promoting secrecy around menstruation, high cost of menstrual products, use of traditional materials (e.g. rags, cotton wool, etc.) causing leakage and odor, and lack of water and safe hygiene facilities. Menstrual cups designed for use during sex may help women prevent Bacterial vaginosis (BV) and STIs through hygienic period practices, and may help them avoid bad practices in an attempt to maintain vaginal dryness. The goal of this interventional trial is to test the impact of menstrual cups on vaginal microbiome, BV, and STIs of poor women at high risk for STIs and HIV. We predict to see 25% less BV, our primary outcome, over one year. This trial aims to learn more about the safety of the intervention, and understand what is needed to fully implement the program.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Water, sanitation and hygiene at sex work venues to support menstrual needs.
   Phillips-Howard PA, Osire E, Akinyi C, Zulaika G, et al · · 2024 · cited 6× · PMID 38481834 · DOI 10.3389/fpubh.2024.1305601
2. Menstrual cups to reduce bacterial vaginosis and STIs through reduced harmful sexual and menstrual practices among economically vulnerable women: protocol of a single arm trial in western Kenya.
   Zulaika G, Otieno FO, Mason L, van Eijk AM, et al · · 2024 · cited 4× · PMID 39516733 · DOI 10.1186/s12889-024-20491-z
3. 'once they see blood then the mood for sex is spoiled' A qualitative exploration of female sex worker's male client views of menstruation, sex during menses and the menstrual disc.
   Osire E, Young S, Awiti E, Akinyi C, et al · · 2024 · cited 1× · PMID 39724197 · DOI 10.1371/journal.pone.0315383
4. Sub-optimal menstrual materials and vaginal microbiome disruption in women relying on sex for livelihood.
   Mehta SD, Zulaika G, Osire E, Agingu W, et al · · 2025 · PMID 41602108 · DOI 10.3389/fcimb.2025.1662237