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

Status: Active_not_recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 15
Maximum Age: 35
Healthy Volunteers: t
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• 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.

Locations
United States
Illinois
Rush University Medical Center
Chicago
Other Locations
Kenya
Nyanza Reproductive Health Society
Kisumu
Time Frame
Start Date: 2023-02-13
Completion Date: 2027-07-31
Participants
Target number of participants: 408
Treatments
Other: Intervention Arm
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), University of Illinois at Chicago, Liverpool School of Tropical Medicine, Nyanza Reproductive Health Society
Leads: Rush University Medical Center

This content was sourced from clinicaltrials.gov