Puberty health intervention to improve menstrual health and school attendance among adolescent girls in The Gambia: study methodology of a cluster-randomised controlled trial in rural Gambia (MEGAMBO TRIAL).

BACKGROUND: Menstrual health (MH) is a recognised global public health challenge. Poor MH may lead to absence from school and work, and adverse health outcomes. However, reviews suggest a lack of rigorous evidence for the effectiveness of MH interventions on health and education outcomes. The objective of this paper is to describe the methods used in a cluster-randomised controlled trial to estimate the effect of a multi-component intervention to improve MH and school attendance in The Gambia. METHODS: The design ensured half the schools (25) were randomised to receive the intervention which comprised of the following components: (i) Peer education camps and menstrual hygiene laboratories in schools, (ii) Mother's outreach sessions, (iii) Community meetings, and (iv) minor improvements of school Water Sanitation and Hygiene (WASH) facilities and maintenance. The intervention was run over a three-month period, and the evaluation was conducted at least three months after the last intervention activity was completed in the school or community. The other 25 schools acted as controls. Of these 25 control schools one Arabic school dropped out due to COVID-19. The primary outcome was the prevalence of girls missing at least one day of school during their last period. Secondary outcomes included: Urinary Tract Infection (UTI) symptoms, biochemical markers of UTI in urine, Reproductive Tract Infection symptoms, self-reported menstruation related wellbeing, social support and knowledge, perceptions and practices towards menstruation and MH in target school girls. In addition, a process evaluation using observations, routine monitoring data, survey data and interviews was undertaken to assess dose and reach (quantitative data) and assess acceptability, fidelity, context and possible mechanisms of impact (qualitative data). Cost and cost-effectiveness of the intervention package will also be assessed. CONCLUSION: Results will add to scarce resources available on effectiveness of MH interventions on school attendance. A positive result may encourage policy makers to increase their commitment to improve operation and maintenance of school WASH facilities and include more information on menstruation into the curriculum and help in the reporting and management of infections related to adolescent menstruation. Trial Registration PACTR, PACTR201809769868245, Registered 14th August 2018, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3539.