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

Primary Purpose

Bacterial Vaginosis, Vaginal Microbiome, Chlamydia Trachomatis Infection

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Menstrual Cup
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacterial Vaginosis focused on measuring Menstrual Cup, Menstrual Health, Menstrual Hygiene, Bacterial vaginosis, Vaginal microbiome, Sexually transmitted infections, Kenya

Eligibility Criteria

15 Years - 35 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Rush University Medical Center
  • Nyanza Reproductive Health SocietyRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 19, 2022
Last Updated
April 28, 2023
Sponsor
Rush University Medical Center
Collaborators
Nyanza Reproductive Health Society, Liverpool School of Tropical Medicine, University of Illinois at Chicago, National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT05666778
Brief Title
Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
July 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
Nyanza Reproductive Health Society, Liverpool School of Tropical Medicine, University of Illinois at Chicago, National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
402 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Menstrual Cup
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the impact of menstrual cups on BV
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Evaluate the impact of menstrual cups on STI
Description
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.
Time Frame
2 years
Title
Evaluate the impact of menstrual cups on vaginal microbiome (VMB)
Description
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.
Time Frame
2 years

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
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.
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Supriya Mehta, MHS, PhD
Phone
312-942-5248
Email
Supriya_Mehta@rush.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Fredrick Otieno, DCMA, PhD
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Supriya Mehta, PHD
Phone
312-942-5428
Email
Supriya_Mehta@rush.edu
Facility Name
Nyanza Reproductive Health Society
City
Kisumu
State/Province
Nyanza
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fredrick Otieno, DCMS, PHD
Phone
+254 072 175 9867
Email
fotieno@nrhskenya.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Minimum IPD for main analysis replication will be made available at the time of publication. After completion of the study, data will be deposited in a registry for clinical trials data within 15 months.
IPD Sharing Time Frame
ICFs and analytic code, will be included as supplementary material with published with manuscripts.

Learn more about this trial

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

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