Menstrual Cups for Vaginal Infections (POWWERHealth Trial)

Phase 2

Waitlist Available

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to reduce bacterial vaginosis and STIs in Kenyan women at high risk of HIV with the use of menstrual cups. It will also measure the safety & impact of menstrual cups on vaginal microbiome.

Who is the study for?

This trial is for women aged 15-35 in Kisumu County, Kenya who are not pregnant, post-menopausal, or within six months postnatal. Participants must have had a menstrual period in the last two months and rely on sex for livelihood. They should be able to give informed consent and not currently use an IUD.

What is being tested?

The study tests if using menstrual cups can reduce bacterial vaginosis (BV) and sexually transmitted infections (STIs) among economically vulnerable women at high risk of STIs/HIV. The goal is to see a 25% reduction in BV over one year while assessing safety and implementation needs.

What are the potential side effects?

Potential side effects may include discomfort or irritation from the menstrual cup use. However, since this is a non-drug intervention, fewer side effects are expected compared to medicinal treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate the impact of menstrual cups on BV

Secondary study objectives

Evaluate the impact of menstrual cups on STI

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention ArmExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Menstrual Cup

2017

N/A

~4140

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