Menstrual health interventions, schooling and mental health symptoms among Ugandan students (MENISCUS): a school-based cluster-randomised trial

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.

We have completed formative studies showing that i) poor menstrual health is a key factor associated with anxiety among girls, and with missing secondary school or class in Wakiso District, Uganda, and ii) 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 their periods i.e. pad provision, education about effective pain management, and improvements to school toilet facilities. Our 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 the trial 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. The intervention has been developed with teachers and schools, and was successfully piloted in two schools in 2017-2018. The trial will evaluate the impact of the intervention by randomising 48 secondary schools in two districts, so that 24 schools receive the MENISCUS intervention, and 24 receive optimised usual care (provision of Government Menstrual Health guidelines and other relevant printed materials). The outcomes will be compared in secondary students (mean age 15 years) between arms after one year, adjusting for baseline measures.

The primary outcomes are i) examination performance based on the curriculum taught during the intervention year; and ii) mental health symptoms including emotional symptoms, attention and peer relationship problems. We 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) menstrual practices (correct use of pads and/or menstrual cups), self-efficacy (stigma and embarrassment around menstruation), school and class attendance, and prevalence of urogenital infections. The main outcomes will be assessed in all students who were exposed to the intervention in Secondary 2. The latter two outcomes will be assessed in a sub-group of 1920 girls.

The intervention has been designed to be culturally appropriate, aligned with Government guidelines, cost-effective, environmentally-friendly and practically sustainable within the schools. We will assess these elements through a process evaluation, health economics analysis and policy analysis.

The intervention is novel in several ways. It will be the first to i) be truly multi-component (i.e. not focusing primarily on either education, provision of pads, or improvement of toilet facilities), ii) address pain management (a major reason for school absence in girls), iii) focus on boys as well as girls (enabling us to address stigma and improve the school environment), and iv) include secondary schools in rural and peri-urban areas (most previous studies have been in primary schools in rural areas).

At the end of the trial, the schools in the control arm will be offered the intervention package. We will share findings with local, national and international stakeholders through a workshop and meetings so that the intervention can be scaled-up as appropriate, and provide needed evidence to guide the rapidly growing community of implementing partners working to improve menstrual health globally.

There is little rigorous research on the effectiveness of menstrual health (MH) interventions to improve education and health outcomes. This evidence-gap precludes effective policy guidelines. Uganda is an ideal location for MH research leading to policy impact, given the Government's proven political will to improve menstrual health.

We propose a cluster-randomised trial, with 48 secondary schools randomised 1:1 to receive either i) Government MH guidelines (control arm) or ii) guidelines plus the MENISCUS package (intervention arm). MENISCUS is an innovative multi-component intervention, addressing both the psychosocial (knowledge, attitudes, anxiety, stigma and distress) and physical barriers (pain management, access to appropriate materials to manage menstruation, improvement of WASH facilities) to good MH.

The objective is to evaluate the effectiveness and cost-effectiveness of MENISCUS on educational attainment of material taught during the intervention year, and on mental health symptoms. Secondary outcomes include (in girls and boys) menstrual knowledge and attitudes, and (in girls) menstrual practices, self-efficacy in managing menstruation, school and class absenteeism, and prevalence of urogenital infections. To enhance buy-in and sustainability of the intervention, an MH Leadership group will be formed, including community gatekeepers and key influencers in the school community.

The intervention will focus on delivering the intervention to students in Standard 2 (~10000 participants).The results will provide the costs of setting up and running the intervention package, describe the distribution of costs across the intervention elements, the unit cost per student reached and the cost of delivering all activities in intervention schools. Primary and selected (policy-relevant) secondary outcome measures will be used for the cost-effectiveness analysis of the intervention relative to the optimised usual care (represented by the control schools).

ODA compliance: The trial will be conducted in Uganda which is in the "least developed" category of DAC-list of ODA recipients.

The specific problem is that many girls in Uganda lack basic knowledge, facilities and/or materials for managing menstruation with safety and dignity and without stigma, as in many low- and middle-income countries (LMICs). Improving the ability of girls to manage the MH addresses their rights to dignity, education, health, gender equality and water and sanitation, with impact on development, productivity and the environment.

Trial participants: The primary immediate impact of the trial will primarily be on secondary school girls in the trial schools, with secondary impacts on boys, teachers and parents in these schools and communities. Girls and boys in the trial schools will be exposed to increased education about puberty and menstruation, and improved WASH facilities. Girls will have access to menstrual products and pain relief strategies. Teachers and parents will benefit from increased information about MH and changes in the social environment. Schools in the control arm will be offered the intervention after the endline survey has been completed.

National impact: Secondary-school girls, boys, teachers and parents in Uganda will benefit from rigorously-conducted, fully-costed, policy-relevant research conducted in two Districts with diverse socio-economic settings. This will provide evidence on how to improve menstrual literacy and management in schools, reduce menstrual stigma, and improve mental health symptoms, educational attainment and quality of life in similar settings. Impact will come from our policy analysis, and established links with, and support from, relevant stakeholders, including the Ministry of Education and Sports (MoES) and Ministry of Health (MOH).

In Uganda, there is a high degree of awareness of the need to improve menstrual health. The MoES convenes the National Menstrual Hygiene Management (MHM) Steering Committee, which held the first international MHM conference in 2014, and a National Symposium on MHM in 2018. International MHM Day is marked every year in Uganda, and we will present our findings at this gathering to motivate improvement in MH. For example, results of the MENISCUS-2 study (presented in 2018) have been cited as a motivator to improve MH in Uganda (https://www.girlsglobe.org/2018/06/12/action-time-menstrual-hygiene-management-in-uganda/). We anticipate the proposed trial will be similarly influential nationally.

Regional and global impact: Our broader goal is to improve education, health and development outcomes among menstruators in LMICs and to reduce menstruation-related stigma. The intervention is aligned with Sustainable Development Goals (SDG) 1 (End poverty), 3 (Good Health and Wellbeing), 4 (Quality Education), 5 (Gender Equality), 6 (Clean water and sanitation) and 10 (Reduced Inequalities). We will facilitate translation to international policy through inclusion of WHO and other international stakeholders (e.g. the co-ordinator of the global "MHM in Ten" initiative to advance the MHM agenda in schools by 2024), on the Trial Steering Committee. WHO already support improvements to menstrual health, and in 2018 convened a global research collaborative meeting on menstrual health. We will also reach the MHM implementing community through the Virtual MHM Conference (https://www.mhmvirtualconference.com/mhm-in-ten/), the MH hub (https://mhhub.org/). Regionally, our impact will be through the African Coalition for MHM (https://twitter.com/africomhm), and the network of MH researchers from Tanzania, Kenya and Zimbabwe who will meet to exchange knowledge and evidence during our study.

We will register the trial on the ISRCTN registry, publish the project's findings in peer-reviewed academic journals with open access, and make our data publicly available within 12 months of trial completion.