Menstrual health interventions to improve education and health outcomes among Ugandan students
| ISRCTN | ISRCTN45461276 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45461276 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | MR/V005634/1 |
| Sponsor | London School of Hygiene & Tropical Medicine |
| Funders | Medical Research Council, Wellcome Trust, National Institute for Health Research, Foreign, Commonwealth and Development Office |
- Submission date
- 02/09/2021
- Registration date
- 16/09/2021
- Last edited
- 28/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Many girls lack basic knowledge, facilities and/or materials for managing menstruation safely and with dignity. Improving menstrual health can lead to sustained long-term benefits to education, health and development. Many governmental and non-governmental organisations are interested in introducing interventions to improve menstrual health, including the UK Government Period Poverty Taskforce. However, there is a lack of evidence to guide policies and ensure interventions are effective.
Researchers have completed formative studies showing that poor menstrual health is a key factor associated with anxiety among girls and with missing secondary school or class in Wakiso District, Uganda. An effective intervention needs to address lack of knowledge of puberty and menstruation and the social environment (to reduce stigma), as well as practical methods to enable girls to better manage her periods (i.e. pad provision, education about effective pain management, and improvements to school toilet facilities). Studies suggest that an intervention addressing these elements can potentially improve education and mental health outcomes, but a randomised controlled trial is needed for definitive results to drive forward policy changes. The aim of this study is to assess whether the intervention (MENISCUS) improves educational attainment, mental health symptoms, menstrual management and quality of life outcomes among girls in secondary school in Uganda.
Who can participate?
Secondary 1 students (mean age 15 years) in about 60 eligible secondary schools in Wakiso and Kalungu Districts in Uganda.
What does the study involve?
About 60 schools will be randomly allocated so that half receive the MENISCUS intervention in 2022 and the other half receive optimised usual care (provision of Government Menstrual Health guidelines and other relevant printed materials). The outcomes will be compared in secondary students between the two groups after 1 year, adjusting for baseline measures.
The primary outcomes are examination performance based on the curriculum taught during the intervention year; and mental health symptoms including emotional symptoms, attention and peer relationship problems. The researchers will also assess the impact of the intervention on other outcomes including (in both girls and boys) menstrual knowledge and attitudes; and (in girls only) adequate menstrual practices (correct use of pads and/or menstrual cups), management of pain outcomes, self-efficacy (stigma and embarrassment around menstruation), quality of life, the prevalence of symptomatic urinary tract infections, school and class attendance during menses and overall, and confidence in maths and science. The main outcomes will be assessed in all students present in S3 at an endline survey. School and class attendance will be assessed in a sub-group of about 1500 girls.
The intervention has been designed to be culturally appropriate, aligned with Government guidelines, cost-effective, environmentally friendly and practically sustainable within the schools. The researchers will assess these elements through a process evaluation, health economics component and policy analysis.
At the end of the study, the schools in the control group will be offered the intervention package.
What are the possible benefits and risks of participating?
The benefits include improved self-efficacy to manage menstrual health. Risks include possible embarrassment in answering questions about genital symptoms or being asked to collect a urine sample. Participants will have an option to use a menstrual cup and may feel discomfort when inserting and removing the cup, and wrong placement may cause soreness until the participant becomes proficient in use.
Where is the study run from?
The London School of Hygiene & Tropical Medicine (UK), MRC/UVRI and LSHTM Uganda Unit, with implementing partner WoMena Uganda
When is the study starting and how long is it expected to run for?
November 2020 to August 2024
Who is funding the study?
The Department of Health and Social Care (DHSC) through the National Institute for Health Research (NIHR), Foreign, Commonwealth and Development Office (FCDO), the Medical Research Council (MRC), and the Wellcome Trust through the Joint Global Health Trials scheme
Who is the main contact?
Prof. Helen Weiss
helen.weiss@lshtm.ac.uk
Contact information
Scientific
LSHTM
Keppel Street
London
WC1E 7HT
United Kingdom
 ORCID ID |
0000-0003-3547-7936 |
|---|---|
| Phone | +44 (0)207927 2087 |
| helen.weiss@lshtm.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre interventional single-blinded cluster randomized controlled trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Menstrual health interventions, schooling and mental health symptoms among Ugandan students (MENISCUS): a school-based cluster-randomised trial |
| Study acronym | MENISCUS |
| Study objectives | The hypothesis is that the MENISCUS intervention will lead to improved educational performance, mental health outcomes and related health- and well-being outcomes among Ugandan secondary school girls. It is hypothesized that this will be achieved by improving self-efficacy for effective menstrual health (MH) in schools, through improving the MH social and physical environment, behavioural capability and observational learning. |
| Ethics approval(s) | 1. Approved 26/05/2021, Uganda Virus Research Institute Research Ethics Committee (UVRI-REC, Uganda Virus Research Institute, Plot 51-59 Nakiwogo Road, Entebbe, PO Box 49, Entebbe, Uganda; +256 414 320 385; directoruvri@uvri.go.ug), ref: GC/127/21/05/819 2. Approved 14/07/2021, Uganda National Committee for Science and Technology (UNCST, Plot 6, Kimera Road, Ntinda, PO Box 6884, Kampala, Uganda; +256 414 705500; info@uncst.go.ug), ref: HS1525ES 3. Approved 03/08/2021, London School of Hygiene and Tropical Medicine (Keppel Street, London, WC1E 7HT, UK; +44 207 636 8636; ethics@lshtm.ac.uk), ref: 22952 |
| Health condition(s) or problem(s) studied | Menstrual health and education, health and well-being outcomes |
| Intervention | This study will be an open-cohort cluster randomised control trial with 60 schools (clusters) randomised 1:1 to two arms, with a mixed-methods process evaluation, and economic and policy analyses to evaluate the effectiveness and cost-effectiveness of a school-based MH intervention to improve education, health and wellbeing outcomes. The use of an open-cohort design allows students entering schools after baseline to participate in the endline survey. The intervention will be implemented over the duration of 1 year in all intervention schools. At endline (2023), outcomes in all students in the class cohort who were present at baseline or joined during the intervention year will be assessed in a repeat of the cross-sectional survey. Selected secondary outcomes will be assessed in a randomly selected sample of approximately 1500 girls identified ahead of the endline survey to participate in a diary sub-study to assess associations of menstrual cycles and school attendance. Control condition: Control arm schools will receive the MoES Guidelines on Menstrual Hygiene Management (MHM) in Schools (circular No. 1/2015) and the 2018 National Sexuality Education Framework (NSEF). Students will receive the Government Menstruation Management Reader. Control schools (n=30) will be offered the intervention after the endline evaluation is completed. Intervention condition: Intervention arm schools will receive the control condition plus the MENISCUS intervention which comprises five components as follows: 1. Puberty Education Workshop: Train teachers of the participating students on how to deliver the puberty session to girls and boys. Teachers to develop an action plan, delivery of which will be overseen by a MH Leadership Group and the District Inspector of School. 2. Drama skit: MH drama skit developed by female and male students and performed at parents’ day or another suitable occasion. 3. Provision of an MH kit: Distribution of a MH kit (reusable sanitary pads provided in a bag with underwear, a water bottle, soap and a towel) with the option to receive a medical-grade silicone, re-usable menstrual cup and a container for disinfection and storage. Teachers and prefects to train students to use the products. Training includes an education session on menstruation for girls and boys, and a gender-specific participatory session. 4. Pain relief: Information on effective period pain management, addressing common myths included in MH Training. Vouchers for analgesics will be included in the MH kit, each to be redeemed for six paracetamol or ibuprofen tablets per month from the school nurse or specified teacher. 5. Improving school WASH facilities: Improvements to school WASH facilities (fixing doors, providing locks, sanitary bins, toilet paper cages, water carriers, liquid soap (5L), and water (20L) containers) over seen by The MH Action Group, monitored by the District Inspector of Schools during routine termly school inspection visits. Schools will be randomised 1:1 to intervention or control conditions in 3 batches, stratified by District (Kalungu) or sub-District (Wakiso). Restricted randomisation will be used to ensure good balance on key variables (i.e. school examination results, school type, mean SDQ score, current WASH facilities, and geographic area). |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Among all girls included in the endline survey: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 18/12/2023: |
| Completion date | 31/08/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 21 Years |
| Sex | All |
| Target sample size at registration | 3600 |
| Total final enrolment | 5066 |
| Key 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 |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 21/03/2022 |
| Date of final enrolment | 31/03/2023 |
Locations
Countries of recruitment
- Uganda
Study participating centre
Entebbe
-
Uganda
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository, Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository. The London School of Hygiene and Tropical Medicne (LSHTM Data Compass). Website: https://datacompass.lshtm.ac.uk/). Data will be available after a 2 year embargo period from the end of the trial, and then available for 10 years. We proposed to offer controlled access to data, to ensure data is used in compliance with ethical conditions. Researchers will be invited to provide information on their aims and proposed analyses. The PI and Co-Is will evaluate each request and decide whether to grant data access. In line with the MRC/UVRI & LSHTM RDM policy, requests will only be turned down for justifiable reasons. Requests will be considered within 4 weeks. Participants will be asked consent for data sharing. Data will be anonymised. Data on very small focus group discussions where deductive disclosure can be performed will not be shared. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 14/10/2024 | 17/10/2024 | Yes | No | |
| Results article | 01/05/2025 | 28/04/2025 | Yes | No | |
| Protocol article | 07/09/2022 | 08/09/2022 | Yes | No | |
| Other publications | Baseline data were used to assess factors associated with declining consent to receive a menstrual cup by parents and female students | 05/12/2024 | 11/12/2024 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Statistical Analysis Plan | version 1.2 | 16/01/2024 | 22/01/2024 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN45461276_SAP_v1.2_16Jan2024.pdf
- Statistical Analysis Plan
Editorial Notes
28/04/2025: Publication reference added.
11/12/2024: Publication reference added.
14/10/2024: Publication reference added.
22/01/2024: The statistical analysis plan was uploaded as an additional file.
18/12/2023: The following changes were made to the trial record:
1. The secondary outcome measures and inclusion criteria were updated.
2. Age limits added.
3. The target number of participants was changed from '60 clusters (schools) with approximately 60 participants per cluster' to '60 clusters (schools) with a harmonic mean of 60 female participants per cluster and 10 male participants per cluster at endline'.
4. Total final enrolment added.
5. The recruitment start date was changed from 01/03/2022 to 21/03/2022.
28/11/2023: The following changes were made to the trial record:
1. The overall end date was changed from 31/10/2023 to 31/08/2024.
2. The intention to publish date was changed from 01/12/2023 to 31/08/2024.
3. The plain English summary was updated to reflect these changes.
08/09/2022: Publication reference added.
08/08/2022: The secondary outcome measures have been updated.
17/05/2022: Trial website and link to participant information sheet added.
06/01/2022: The recruitment start date was changed from 01/01/2022 to 01/03/2022.
16/09/2021: Trial's existence confirmed by London School of Hygiene and Tropical Medicine.
