Community-based participatory learning and action groups to improve healthcare access for people with disabilities in Luuka district, Uganda: Study protocol for a cluster-randomized controlled trial with economic and process evaluations

<ns3:p>Background Globally, 1.3 billion people live with disabilities, many of whom face substantial barriers to healthcare access, contributing to poorer health and reduced life expectancy. Participatory community approaches have improved healthcare access and outcomes for other marginalized groups, but have not been trialed for people with disabilities. This study evaluates whether Participatory Learning and Action for Disability (PLA-D) can reduce mortality and unplanned hospitalization among people with disabilities in Uganda. Methods A pragmatic, cluster-randomized, two-arm superiority trial with integrated process and economic evaluations will be conducted in Luuka district, Uganda (May 2024–July 2026). One hundred villages (clusters) were purposively selected and randomized 1:1 to intervention or control. The intervention comprises a 12-month PLA-D cycle designed to improve access to healthcare for people with disabilities. Disability-focused health system strengthening activities, including healthcare worker training and health facility accessibility audits, were implemented across the district covering participants in both arms. A baseline survey (May–September 2024) anticipated identifying 5,000 people with disabilities using age-appropriate Washington Group tools alongside locally recognised disability categories. Caregiver report was used, where required. The primary outcome is a composite measure of death or unplanned hospitalization during the 24-month follow-up period, assessed at endline (May–July 2026). Secondary outcomes (quality of life, health expenditure, morbidity, healthcare access and quality, attitudes and participation) will be evaluated via in-depth questionnaires with a random sample of approximately 2,000 individuals at baseline and follow-up. Analyses will follow an intention-to-treat approach. Process and economic evaluations will explore implementation, mechanisms, contextual factors, and incremental cost-effectiveness. Ethics and dissemination Ethical approval was obtained from the Uganda Virus Research Institute (Ref:GC/127/904), the Ugandan National Council of Science and Technology (Ref:SS1348ES), and the London School of Hygiene &amp; Tropical Medicine (Ref: 29927). Findings will be disseminated through meetings, publications, and conferences. Trial registration ISRCTN 66594817. Trial Sponsor London School of Hygiene &amp; Tropical Medicine. Keppel Street, London WC1E 7HT, United Kingdom. Tel: +44 (0)20 7636 8636. Email: [email protected] As Trial Sponsor LSHTM leads study design, analysis and interpretation of data, and publication writing and submission, as well as having overall oversight of data collection and management. The funder will have no input into the management and outputs from the trial.</ns3:p>