Feasibility of integrating thermotherapy (TT) for the treatment of Cutaneous Leishmaniasis into the primary healthcare facilities in east gurage zone, ethiopia: a protocol for an implementation research study

Cutaneous Leishmaniasis (CL) represents a severe, neglected public health crisis in Ethiopia, causing an estimated 30,000 new cases annually. This epidemiological burden is exacerbated by a highly centralized care model that restricts diagnostic and therapeutic services to distant referral centers, thereby triggering protracted delays in patient care. Although radiofrequency thermotherapy (TT) has demonstrated efficacy and safety, empirical evidence regarding its operational integration into routine primary healthcare (PHC) infrastructures via task-sharing is lacking. This implementation research evaluates the feasibility, scalability, and systemic impact of decentralizing TT delivery to PHC facilities in Ethiopia. Anchored in the Medical Research Council (MRC) framework for complex interventions, this mixed-methods implementation research will be conducted across routine PHC facilities in the Sodo and South Sodo districts of Central Ethiopia. The core intervention comprises a multi-tiered task-sharing strategy designed to enable PHC staff and Health Extension Workers (HEWs) in syndromic screening, diagnostic referral, TT administration, and patient monitoring. Execution follows a three-phase sequential design: (I) co-design and contextual adaptation of the implementation package, (II) pilot testing and iterative optimization, and (III) operational scale-up alongside comprehensive evaluation. Qualitative evaluation relies on focus group discussions and semi-structured in-depth interviews with patients, frontline providers, HEWs, and health administrators to map implementation barriers, facilitators, and contextual determinants through thematic framework analysis. Quantitative components utilize a quasi-experimental design to evaluate clinical and safety outcomes among 103 patients presenting with uncomplicated CL. Primary implementation outcomes include feasibility, acceptability, appropriateness, and fidelity, alongside secondary clinical endpoints of treatment success rates, and health economic implications. The clinical endpoint is complete cure evaluated at Day 90 with extended follow-up through Day 180 to monitor lesion relapse. Quantitative data will be analyzed using descriptive and inferential statistical modalities. This study will provide evidence on the feasibility of delivering TT through Ethiopia’s PHC system and identify factors that influence successful implementation. The findings are expected to inform national efforts to decentralize CL services and improve access to safe and effective treatment for underserved populations in endemic areas. The study may also provide broader lessons for integration of neglected tropical disease services into PHC systems in low-resource settings. NCT06746350 first registered on 24 December 2024.