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

Bacterial Vaginosis Clinical Trial

— POWWERHealth  

Official title:

Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs Through Reduced Harmful Sexual and Menstrual Practices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05666778
• Other study ID #: 22040505
• Secondary ID: R01AI170564
• Status: Recruiting
• Phase: Phase 2
• Start date: February 13, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: April 2023
• Source: Rush University Medical Center
• Contact: Supriya Mehta, MHS, PhD
• Phone: 312-942-5248
• Email: Supriya_Mehta[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In western Kenya, HIV prevalence is 16% among women in the general population, and 29% among the most economically constrained women. The HIV/STI epidemic overlaps with broader reproductive health concerns. Menstrual hygiene management (MHM) is a pervasive problem across low- and middle-income countries. In Phillips-Howards' survey of over 3,400 women in rural Kenya, two-thirds of women in impoverished settings state they depend on their sexual partners to provide branded products. Economically vulnerable women at high risk for HIV and STI are uniquely challenged because many continue to have sex during menses, and engage in harmful MHM practices, such as vaginal insertion of sponges and cotton to maintain dryness. Led by co-investigator Phillips-Howard, a cluster-randomized study of 644 girls aged 14-16 years old in western Kenya compared reusable menstrual cups to usual menstrual practice and counseling; after 9 months, menstrual cup use resulted in 35% reduction (p=0.034) in Bacterial vaginosis (BV) prevalence and 56% reduction (p=0.001) in STI prevalence compared to other materials. Among 431 Kenyan secondary schoolgirls aged 14-21, we observed cloth use for menses was associated with a 1.72-fold increased odds of non-optimal vaginal microbiome (CST-IV vs. CST-I: aOR=1.90; 95% CI: 1.03-2.86). Over 18 months of observation prior to COVID-19, girls using menstrual cups to manage menses had 20% higher occurrence of Lactobacillus crispatus dominated CST-I (aRR=1.29; 95% CI: 1.08-1.53, controlling for age, and baseline STI and sexual activity). Menstrual cups designed for use during intercourse may help women prevent BV and STIs through hygienic menstrual practices and avoidance of harmful practices to maintain vaginal dryness during menses. Objective: This single-arm interventional 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, assess safety profile, and understand implementation needs. In Aim 1, we will evaluate the impact of menstrual cups on VMB, BV, and STIs among 402 economically vulnerable women in semi-urban 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 (WASH) factors. In Aim 3, we will identify constructs for successful MHM program implementation using an implementation science framework. Future Directions: The biological protection suggested in a randomized setting, and our findings that unhygienic cloth use is associated with non-optimal VMB, while menstrual cup use increases optimal VMB composition, together provide rational justification for this trial, of relevance to economically challenged women globally. Assessing preliminary efficacy signal in conjunction with implementation characteristics and adverse events, will generate a comprehensive and necessary foundation for definitive assessment of effectiveness of menstrual cups as a multipurpose intervention for MHM, and to reduce BV and STIs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 402
• Est. completion date: July 31, 2027
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Chlamydia Trachomatis Infection
• Communicable Diseases
• Gonorrhea
• Infections
• Neisseria Gonorrheae Infection
• Trichomonas Vaginitis
• Vaginal Diseases
• Vaginal Microbiome
• Vaginitis
• Vaginosis, Bacterial

Intervention

Device:
• Menstrual Cup
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.

Locations

Country	Name	City	State
Kenya	Nyanza Reproductive Health Society	Kisumu	Nyanza
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (5)

Lead Sponsor	Collaborator
Rush University Medical Center	Liverpool School of Tropical Medicine, National Institute of Allergy and Infectious Diseases (NIAID), Nyanza Reproductive Health Society, University of Illinois at Chicago

Countries where clinical trial is conducted

United States,  Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, with fixed effect for intervention period, to analyze a vector of pre- and post- measurements as the outcome.	2 years
Secondary	Evaluate the impact of menstrual cups on STI	We employ similar approach for analysis of secondary outcome of STI (binary composite of infection with Chlamydia trachomatis [CT], Neisseria gonorrhoeae [NG], or Trichomonas vaginalis [TV]), as for Outcome 1.	2 years
Secondary	Evaluate the impact of menstrual cups on vaginal microbiome (VMB)	Vaginal microbiome will be dichotomized as Community State Type I (CST-I; Lactobacillus crispatus dominated; optimal) vs. other CST. We will employ similar approach for analysis of secondary outcome of VMB (binary) as for Outcome 1.	2 years