Clinical Research Directory

Impact Evaluation of Accelerating Climate-Resilient Water, Sanitation and Hygiene Services for Schools and Healthcare Facilities in Karamoja

Karamoja, in north-eastern Uganda, is among the most water-insecure regions in sub-Saharan Africa. Only 24 per cent of households can access the WHO-recommended 20 litres of water per person per day. Only 11.7 per cent have access to improved sanitation. A rapid vulnerability assessment covered all 182 operational primary schools in the sub-region between October and November 2025. It identified 53 schools as severely water insecure and a further 37 as moderately water insecure. Together, these schools serve an estimated 196,000 learners. The assessment also found that 89 schools lacked enough latrines to meet the national pupil-to-latrine ratio. Seventy-eight schools had no functional menstrual health management facilities. This study is a three-arm, phase-in cluster-randomised controlled trial. It evaluates the causal effects of a climate-resilient school WASH package on children's health and school attendance. It also examines adolescent girls' menstrual health self-efficacy. The study covers 60 primary schools that were found to be water-insecure across Karamoja's nine districts. The schools were stratified into three geographic zones. The researchers then used covariate-constrained randomisation to assign schools to three study arms. Phase 1 includes 30 schools receiving the intervention early. Phase 2 includes 20 schools receiving it later. The remaining 10 schools form the pure control group. The intervention combines climate-resilient WASH infrastructure with capacity-building and social and behaviour change activities. The infrastructure includes motorised boreholes, sex-disaggregated latrines and handwashing stations built to national standards. A subset of the boreholes will have data loggers for remote monitoring. The package also provides dedicated menstrual health facilities. These include enclosed changing areas and hygienic waste-disposal systems. Community water access points will be installed next to each school. Capacity-building activities will involve School Management Committees, Parent-Teacher Associations, teachers, District Water Officers and School Health Clubs. Data will be collected through three repeated cross-sectional rounds. The baseline will take place in the fourth quarter of 2026. The midline will take place in the first quarter of 2028, and the endline in the first quarter of 2030. Seven instruments will be used. These include pupil and matched caregiver surveys, school WASH facility and classroom roll-call observations, and head teacher and teacher surveys. The study will also digitise school enrolment, attendance and examination records. Community leaders will be interviewed separately. In each round, the sample will include 20 post-menarche girls and 20 general pupils per school. The study will interview one caregiver for each sampled pupil. The study will also interview six teachers, the head teacher and four community leaders in each school catchment. The study has three co-primary outcomes. The first is the pupil absence rate, measured using digitised attendance registers. The second is the seven-day prevalence of diarrhoea among pupils. The third is menstrual health self-efficacy among post-menarche girls. We will measure this using the 26-item Self-Efficacy in Addressing Menstrual Needs Scale (SAMNS-26). The primary analysis will estimate the intent-to-treat effect of assignment to Phase 1. At midline, Phase 1 schools will be compared with Phase 2 and pure control schools. We will conduct two comparisons at endline. First, we will compare all treated schools with the pure control group. Second, Phase 1 schools will be compared with Phase 2 schools to test whether effects differ by exposure duration.

Effect of Hygiene and Menstrual Hygiene Interventions on Learning and Psychosocial Wellbeing in Madagascar

A previous study in schools in rural Madagascar found that a bundle of hygiene-focused interventions substantially improved girls' learning outcomes. This study disentangles the effects of physical infrastructure (latrines, handwashing basins) from other intervention components (peer sensitization and free sanitary pad distribution) in a cluster-randomized trial across 140 secondary schools in the Amoron'i Mania region. The trial originally measured learning and psychosocial wellbeing outcomes and was prospectively registered with the AEA RCT Registry (AEARCTR-0014423). The study team is now also collecting secondary health biomarker outcomes (e.g., salivary cortisol and blood-based C-reactive protein) and is registering those health biomarker endpoints with ClinicalTrials.gov.

The Effect of Education Provided to Adolescents Living in a Container Settlement on Their Genital Hygiene Behaviours and Menstrual Experiences

The aim of this study was to determine the effect of education provided to adolescents living in a container city, tailored to their needs regarding genital and menstrual hygiene, on their genital hygiene behaviours and menstrual experiences. The training is planned to consist of a total of two sessions (four hours), with each session lasting two hours, held twice a week (Saturdays and Sundays), with a maximum of 15 adolescent girls in each group. The training schedule will be determined based on the days and times suitable for the adolescents. In addition, a copy of the educational material prepared for the training will be provided to each adolescent girl. Appropriate interactive educational techniques (demonstration, role-play, question-and-answer, brainstorming, games, etc.) relevant to the topic will be used in each session of the educational program. Prior to the education, the adolescent girls will be asked to complete the Demographic Characteristics Form, the Genital Hygiene Behaviour Scale (GHDÖ) and the Menstrual Experiences Scale (MDÖ) based on self-reports. Following the final session of the education programme, these adolescent girls will be asked to complete these forms again. Finally, following the collection of the final test data, follow-up data will be collected from the adolescents at the end of the third month.