Menstrual health interventions, schooling, and mental health problems among Ugandan students (MENISCUS): study protocol for a school-based cluster-randomised trial
Authors: Kansiime Catherine , Hytti Laura , Nelson Kate Andrews , Torondel Belen , Francis Suzanna C. , Tanton Clare , Greco Giulia , Belfield Sophie , Nakalema Shamirah , Matovu Fred , Ssemata Andrew Sentoogo , Alezuyo Connie , Neema Stella , Jerrim John , Bonell Chris , Seeley Janet , Weiss Helen A. ,   MENISCUS Group, Tumuhimbise Aggrey , Baleke Christopher , Ndekezi Denis , Ssenyondwa Denis , Nakuya Kevin , Mugenyi Levicatus , Namirembe Prossy , Batuusa Ratifah , Bakanoma Robert , Lagony Stephen , Ssesanga Titus Kisa 
Published: September 2022

Abstract
Background
Menstrual health is an increasingly recognised public health issue, defined as complete physical, mental, and social well-being in relation to the menstrual cycle. The MENISCUS trial aims to assess whether a multi-component intervention addressing physical and emotional aspects of menstrual health improves educational attainment, mental health problems, menstrual management, self-efficacy, and quality of life among girls in secondary school in Uganda.

Methods
The study is a parallel-arm cluster-randomised controlled trial with 60 schools (clusters) in Wakiso and Kalungu districts, with a mixed-methods process evaluation to assess intervention fidelity and acceptability and economic and policy analyses. The schools will be randomised 1:1 to immediate intervention or to optimised usual care with delayed intervention delivery. The intervention includes creation of a Menstrual Health Action Group at schools and NGO-led training of trainers on puberty education, development of a drama skit, delivery of a menstrual health kit including reusable pads and menstrual cups, access to pain management strategies including analgesics, and basic improvements to school water, sanitation, and hygiene facilities. Baseline data will be collected from secondary 2 students in 2022 (median age ~15.5 years), with endline after 1 year of intervention delivery (~3600 females and a random sample of ~900 males).
The primary outcomes assessed in girls are (i) examination performance based on the Mathematics, English, and Biology curriculum taught during the intervention delivery (independently assessed by the Uganda National Examinations Board) and (ii) mental health problems using the Total Difficulties Scale of the Strengths and Difficulties 25-item questionnaire. Secondary outcomes are menstrual knowledge and attitudes in girls and boys and, in girls only, menstrual practices, self-efficacy in managing menstruation, quality of life and happiness, prevalence of urogenital infections, school and class attendance using a self-completed menstrual daily diary, and confidence in maths and science.

Discussion
The trial is innovative in evaluating a multi-component school-based menstrual health intervention addressing both physical and emotional aspects of menstrual health and using a “training of trainers” model designed to be sustainable within schools. If found to be cost-effective and acceptable, the intervention will have the potential for national and regional scale-up.

Trial registration
ISRCTN 45461276. Registered on 16 September 2021