Menstrual Cups for Vaginal Infections

(POWWERHealth Trial)

Recruiting at 1 trial location

Overseen By Fredrick Otieno, DCMA, PhD

Age: < 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Rush University Medical Center

Disqualifiers: Pregnancy, Post-natal, IUD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

408 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Menstrual Cup for vaginal infections?

Research suggests that menstrual cups may help reduce bacterial vaginosis (BV) and improve vaginal health, as they are more hygienic compared to other menstrual products. This could potentially lower the risk of vaginal infections. ^{1 2 3 4 5}

Is the menstrual cup safe for use?

Research shows that menstrual cups are generally safe for use. Studies have assessed their safety and acceptability, indicating they can be a safe option for menstrual management. ^{1 2 4 6 7}

How does the treatment of menstrual cups differ from other treatments for vaginal infections?

Menstrual cups are unique because they offer a non-drug approach to managing vaginal health by potentially reducing bacterial vaginosis and other infections through improved menstrual hygiene, unlike traditional treatments that often involve medications. ^{1 2 4 7 8}

What is the purpose of this trial?

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 Criteria

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.

Inclusion Criteria

My job does not depend on my gender.

Residing in Kisumu County

Able to provide informed consent

Exclusion Criteria

IUD in situ

Pregnancy

I have gone through menopause.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Participants are observed for 12 months using their usual menstrual hygiene management practices

12 months

Monthly phone calls for assessment and troubleshooting

Intervention

Participants receive reusable menstrual cups and are trained on their use, with assessments at baseline, 6 months, and 12 months

12 months

3 visits (in-person) for assessments at baseline, 6 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention period

6 months

Treatment Details

Interventions

• Menstrual Cup

Trial Overview 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.

Participant Groups

Group I: Intervention Arm Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Nyanza Reproductive Health Society

Collaborator

Trials

5

Recruited

4,600+

Liverpool School of Tropical Medicine

Collaborator

Trials

96

Recruited

804,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Analysis of bacterial vaginosis, the vaginal microbiome, and sexually transmitted infections following the provision of menstrual cups in Kenyan schools: Results of a nested study within a cluster randomized controlled trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Impact of imparting knowledge and awareness on the usage of menstrual cups: A study based on project 'Thinkal' at Alappuzha Municipality in Kerala. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of the menstrual cup for non-surgical management of vesicovaginal fistula among women at a health facility in Ghana. [2023]

4. Colombia pubmed.ncbi.nlm.nih.gov

Acceptability and safety of the menstrual cup: A systematic review of the literature [2023]

5. England pubmed.ncbi.nlm.nih.gov

Use of menstrual cups among school girls: longitudinal observations nested in a randomised controlled feasibility study in rural western Kenya. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Safety assessment scheme for menstrual cups and application for the evaluation of a menstrual cup comprised of medical grade silicone. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Acceptability and safety of the menstrual cups among Iranian women: a cross-sectional study. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Menses cup evaluation study. [2017]