Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05666778 |
| Other study ID # |
22040505 |
| Secondary ID |
R01AI170564 |
| Status |
Active, not recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
February 13, 2023 |
| Est. completion date |
July 31, 2027 |
Study information
| Verified date |
June 2024 |
| Source |
Rush University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| 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.
