Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202305912778108 Date of Approval: 26/05/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Periods: Optimizing Working Women’s Reproductive Health
Official scientific title Single arm trial of menstrual cups among economically vulnerable women to reduce Bacterial vaginosis and STIs through reduced harmful sexual and menstrual practices
Brief summary describing the background and objectives of the trial 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. 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. 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 Kisumu, Kenya. Each woman will be engaged in study protocol for 2 years. 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.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Menstrual Health Hygiene
Anticipated trial start date 01/02/2024
Actual trial start date 07/02/2024
Anticipated date of last follow up 01/12/2025
Actual Last follow-up date 31/07/2027
Anticipated target sample size (number of participants) 402
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Menstrual Cups 1 cup to be used monthly for 1 year 1 year after start of intervention At the intervention training session, we will provide women with one reusable menstrual cup each that can be worn safely during vaginal sexual intercourse, and replace them if damaged (a tracked data point). Following our previous studies implementing and supporting menstrual cup use, our comprehensive and standardized curriculum will be adapted to women engaged in sex for livelihood. Results from meta-analysis show that menstrual cup uptake takes 2-5 months to optimize, depending on the population and characteristics of the intervention setting. For example, menstrual cup use increases for those reporting having friends who successfully use cups. In our previous and current interventional menstrual cup studies, we trained adolescent girls in groups of 12 to 15 to foster this support, and will do so again in this study. Training sessions are interactive, and focus on active participation, demonstration, and ultimately, women trying it for themselves. Trainings will be led by a female Peer Research Assistant. The training will begin with a discussion and introduction to basic facts about menses and the female reproductive health system, followed by discussion and training on hand washing and basic hygiene. This is followed by training on menstrual cup use: how it works, material, safety, leakage, comfort, freedom of movement, length of time it can be worn, cost-effectiveness. As an example of interactive nature, participants are asked to draw picture/diagram of where the cup sits in the female reproductive system, and to brainstorm activities that can be done while wearing it. This is followed by details of how to insert and remove the cup. Using actual menstrual cups, each woman will practice methods for cup folding, insertion, managing discomfort, preventing leakage, and learning when, how, and where to empty the cup. We will also instruct on hygiene when removing the cup, what to do if the cup is dropped, and how to properly clean and store the cup between uses. 402
Control Group Standard Menstual Health Practices Monthly 1 year prior to intervention onset In the first year of the study, all women will use their standard menstrual hygiene practices in an observational cohort that will set baselines for our primary and secondary outcomes. 402 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adolescent girls and women aged 15 to 35 years who report: 1. Menstruation in the past 2 months 2. Having exchanged sex for money or items of value within the past 2 months 3. Living and/or working in Kisumu area 4. Consent to participate 1. Outside of eligible age range (<15 years or >35 years) 2. Last menstrual period more than 2 months ago 3. Current pregnancy (as determined by urine HCG) 4. Pregnancy within the past 6 months 5. Presently having an IUD 6. Not living or working in study area 7. Refused consent Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 Year(s) 35 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/12/2022 Jaramogi Oginga Odinga Teaching and Referral Hospital Institutional Scientific and Ethical Review Committee JOOTRH ISERC
Ethics Committee Address
Street address City Postal code Country
Jaramogi Oginga Odinga Teaching and Referral Hospital, Kakamega road Kisumu 40100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome occurrence of BV Baseline, 6-, 12-, 18- and 24-Months
Secondary Outcome Occurrence of STI (binary composite of infection with CT, NG, or TV) Baseline, 6-, 12-, 18- and 24-Months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UNIM Research and Training Centre UNIM Research and Training Centre Lumumba sub County Hospital Compound off Ondiek Highway Kisumu 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institutes of Health National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland 20892 Bethesda Maryland United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rush University RUSH University 600 S. Paulina St. Chicago 60612 United States of America University
COLLABORATORS
Name Street address City Postal code Country
Supriya D. Mehta Rush University School of Medicine 1750 W. Harrison Street Chicago Jelke 112 United States of America
Penelope Phillips Howard Liverpool School of Tropical Medicine, Pembroke Place Liverpool L3 5QA United Kingdom
Stefan Green Rush University School of Medicine 1750 W. Harrison Street Chicago Jelke 11 United States of America
Runa Bhaumik University of Illinois at Chicago School of Public Health 1603 W. Taylor Street Chicago MC 923 United States of America
Linda Mason Liverpool School of Tropical Medicine, Pembroke Place Liverpool L3 5QA United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fredrick Otieno fotieno@nrhskenya.org +254721759867 UNIM Research and Training Centre Lumumba sub County Hospital Compound off Ondiek Highway
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Director Nyanza Reproductive Health Society
Role Name Email Phone Street address
Scientific Enquiries Supriya Mehta Supriya_Mehta@rush.edu +13129960064 Rush University School of Medicine 1750 W. Harrison Street
City Postal code Country Position/Affiliation
Chicago Jelke 112 United States of America Professor
Role Name Email Phone Street address
Public Enquiries Fredrick Otieno fotieno@nrhskenya.org +254721759867 UNIM Research and Training Centre Lumumba sub County Hospital Compound off Ondiek Highway
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified data will be stored indefinitely on Rush University and NRHS servers; data is never destroyed due to processes of accountability, reproducibility, and for sharing. Additionally, in keeping with NIH (sponsor) requirements, a de-identified minimal dataset allowing replication of primary analyses will be deposited with NIH. However, procedures are in place that written request must be made to the PI and approved by the Co-Investigators prior to sharing. Informed Consent Form,Study Protocol Within a year of study completion (2026) Controlled access with deidentified data available on request with justification of the same
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information