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

NCT05666778 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: 22040505R01AI170564
• Study Type: interventional
• Target: 408
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Bacterial Vaginosis; Vaginal Microbiome; Chlamydia Trachomatis Infection; Neisseria Gonorrheae Infection; Trichomonas Vaginitis

Keywords

Menstrual Cup; Menstrual Health; Menstrual Hygiene; Bacterial vaginosis; Vaginal microbiome; Sexually transmitted infections; Kenya

Outcome Measures

Primary Outcomes (1)

• Evaluate the impact of menstrual cups on BV

  For primary outcome BV (binary, 7-10 vs. 0-6) the measures will be baseline to 12 month cumulative incidence control/pre-menstrual cup intervention and 12- to 24-month cumulative incidence in the intervention phase. We will employ a linear mixed model (LMM; observations nested in individual), with binomial distribution and log link function, examining cup use as a time-varying exposure among all participants who were given the cup within the intervention phase and reported using the cup. A supplemental analysis may examine BV from 12-36 months in the intervention phase.

  2 years

Secondary Outcomes (2)

• Evaluate the impact of menstrual cups on STI

  2 years

• Evaluate the impact of menstrual cups on vaginal microbiome (VMB)

  2 years

Study Arms (1)

Intervention Arm

OTHER

After completing 12 months observation of usual practices of menstrual hygiene management, all participants will be provided reusable menstrual cups that can be worn during sex. The menstrual cup training is comprised of a 2 hour group session that covers basic information on reproductive health, menstrual health, and menstrual hygiene, cup use (insertion/removal), storage, cleaning. In the first three months after intervention delivery, there are monthly phone calls to assess usage and for trouble shooting. There are 12 months of observation in the menstrual cup arm, with Bacterial vaginosis (BV) and vaginal microbiome (VMB) assessment at the beginning of the 12-month period, at 6 months, and at 12 months. Sexually transmitted infection (STI) is measured at the beginning of the 12- month intervention period, and then at 12 months. Dec 2025: As a supplemental analysis, observation of the menstrual cup arm is extended to 18-24 months, to more fully capture putative secular trends.

Device: Menstrual Cup

Interventions

Menstrual Cup DEVICE

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.

Intervention Arm

Eligibility Criteria

• Age: 15 Years - 35 Years
• Gender Eligibility Details: The interventional portion of this study includes only cis-gendered females, as outcomes related to the vaginal microbiome and menstruation are relevant only to biological females. To illustrate how menstrual hygiene management may biologically mediate the vaginal microbiome and subsequent related outcomes of BV and STIs, it is essential to enroll females.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age 15-35 years,
• able to provide informed consent,
• residing in Kisumu County,
• not currently pregnant,
• has experienced a menstrual period in the past 2 months, and
• dependent on sex for livelihood as defined above.

You may not qualify if:

• pregnancy,
• post-natal (within 6 months),
• post-menopausal,
• amenorrhea,
• IUD in situ.

Sponsors & Collaborators

• Rush University Medical Center: lead
• Nyanza Reproductive Health Society: collaborator
• Liverpool School of Tropical Medicine: collaborator
• University of Illinois at Chicago: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Nyanza Reproductive Health Society

Kisumu, Nyanza, Kenya

Location

Related Publications (1)

• Zulaika G, Otieno FO, Mason L, van Eijk AM, Bhaumik R, Green SJ, Phillips-Howard PA, Mehta SD. 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. BMC Public Health. 2024 Nov 8;24(1):3089. doi: 10.1186/s12889-024-20491-z.

  PMID: 39516733 DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial; Gonorrhea; Trichomonas Vaginitis; Sexually Transmitted Diseases

Interventions

Menstrual Hygiene Products

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Trichomonas Infections; Protozoan Infections; Parasitic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feminine Hygiene Products; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 28, 2022
• Study Start: February 13, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: ICFs and analytic code, will be included as supplementary material with published with manuscripts.

Locations

KE (1); US (1)