Implementation of a Mental Health Literacy e-Curriculum (MHLeC) in Malawi Universities: a feasibility cluster randomised trial protocol

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Abstract
Background Mental health literacy (MHL) in Malawi is low. Mental illness is often attributed to substance abuse or spirit possession, resulting in stigma, maltreatment, and discrimination towards people with mental health problems. Inadequacies in Malawi's mental health services and workforce increase limited treatment access, knowledge, and negative attitudes, causing an epidemic of substance use and suicides. MHL is foundational for mental health promotion, prevention of mental illness, and stigma reduction. Educational settings are ideal for implementing mental health promotion activities. We want to deliver a MHL e-curriculum (MHLeC) to first year university students in Malawi to improve their MHL. The project aims to assess the feasibility of implementing MHLeC in four Malawian universities within a cluster randomised trial. Methods In this pragmatic, cluster randomised feasibility trial, we will approach four to eight public and private tertiary institutions about study participation. Clusters will be participating universities allocated to the mandatory MHLeC or the voluntary MHLeC group using stratified randomisation on a 1:1 ratio. University characteristics (e.g., public or private, number of first-year students enrolled, and information technology (IT) infrastructure) will be used to stratify randomisation. Specific feasibility objectives include 1) estimating likely participation rates of universities and students 2) establishing potential attendance /retention rates during MHLeC delivery 3) assessing acceptability of the MHLeC through qualitative feedback after intervention delivery 4) assessing appropriateness of chosen questionnaires for measuring student outcomes. Data will be analysed descriptively. Outcomes from data collected will inform feasibility of a future main trial including main trial design and recruitment strategies, sample size and power calculations for a full-scale cluster randomised trial. Discussion This trial will give us insights on how best to conduct the definitive trial. The intervention can be rolled out nationally within a full-scale trial in Malawi and tested in similar cohorts across Africa if positive results are obtained. More broadly, this research has the potential to significantly increase mental health awareness among young people in Malawi. Trial registration: This study is registered on the Pan African Clinical Trials Registry (PACTR) website https://pactr.samrc.ac.za/ (PACTR202308849574524). Registered 31st August 2023.

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