ISRCTN45461276Active, not recruiting未知
Menstrual health interventions, schooling and mental health symptoms among Ugandan students (MENISCUS): a school-based cluster-randomised trial
ondon School of Hygiene & Tropical Medicine0 sites5,066 target enrollmentStarted: September 16, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 5,066
Study Overview
Brief Summary
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36071530/ (added 08/09/2022)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Current inclusion criteria as of 18/12/2023:
- •School-level inclusion criteria:
- •1. Mixed-sex secondary schools with S1–S4 classes
- •2. Day or mixed day/boarding schools.
- •3. At least minimal WASH facilities (including an improved water source and sex-specific sanitation facilities that are functional, usable, and accessible to female students at the time of the rapid assessment eligibility survey)
- •4. Estimated enrolment of 50–125 female S1 students in Wakiso and 40–125 female students in S1 in Kalungu, based on the 2019 report on the Master List of Education Institutions in Uganda
- •School-level exclusion criteria:
- •1. Schools that are currently participating in a menstrual health-related programme
- •2. Boarding schools with no day students
- •3. Single-sex schools
- •4. Schools exclusively for students with disabilities
- •5. Schools where more than approximately ~10% of students or parents of students do not understand Luganda or English
- •Participant-level inclusion criteria:
- •1. Female students in the class cohort of S2 in 2022 who were enrolled in a trial school at the time of the baseline and/or endline survey
- •2. Male students in the class cohort of S2 in 2022 who were enrolled in a trial school at the time of the baseline survey
- •3. For the diary sub-study, female trial participants were eligible if they reported having started menstruation at the time of the baseline survey
- •Previous inclusion criteria:
- •1. All female students starting Secondary 2 during 2021/2022 who are present and whose parents have given consent will be eligible for the baseline survey and to receive the intervention.
- •2. A simple random sample of ~15 male students (starting S2 during 2021) per school (900 total) who are present during Q4 2021 will be selected to participate in the baseline survey and asked to provide assent for data collection. The sampling will be done by the trial statistician using the random-number generator in Stata
- •3. The endline survey and assessment will be in Q1-2 2023, and all female students present and who have given consent/assent for the research will be eligible, as will the male students with baseline data
Exclusion Criteria
- •Does not meet the inclusion criteria
Investigators
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