Feasibility of Integrating Thermotherapy (TT) for Treatment of Cutaneous Leishmaniasis Into the Primary Healthcare Facilities in East Gurage Zone, Ethiopia

This study aims to improve access to effective treatment for cutaneous leishmaniasis (CL), specifically focusing on treatment with thermotherapy (TT) in selected districts in Sodo and south Sodo districts in Ethiopia. The study is structured into three phases, aligned with the different phases of the MRC framework for complex interventions. It follows an iterative approach, where the following phases depend on the findings from the preceding phases.

• Phase 1 of the project works on developing the training packages for the PHC staff and Health Extension Workers (HEWs) to diagnose/manage patients with CL and to refer suspected CL patients to the health centers respectively. The investigators will develop the training packages in consultation with a dermatologist with experience in TT for CL, the research team, the health department officials, the primary healthcare (PHC) staff, and HEWs.
• Phase 2- involves piloting the intervention approach in two of the health centers and TT will be administered by the PHC staff for 20 CL patients. In this phase, the investigators will do a feasibility, acceptability, and appropriateness assessment. The feasibility assessments encompass technical and allocative. Technical feasibility assesses the match between the technical complexity of the intervention and the capacity to implement it while allocative feasibility assesses whether the right approach is being followed in terms of resource allocation within the healthcare system. The PHC staff who have experience implementing TT and the health officials will be in a better position to give this critical information in a focus group discussion. The investigators will also assess fidelity to assess whether the training package has been well received by the PHC staff.

Phase 3- involves implementing the intervention in other health centers and on larger CL patients and assessing the feasibility, acceptability, appropriateness, as well as cost-effectiveness. In this phase, TT treatment will be administered to an additional 145 people making the total number of CL patients treated in this study 165. While implementing the study activities, the investigators will abide by the Good Clinical Practice (GCP) principles. Serious and Unexpected Serious Adverse Reactions (SUSARs) will also be reported to the Ethiopian Food and Drug Authority (EFDA) according to the pharmacovigilance requirement of the Authority.

In this study, the following research designs will be followed:

1. Qualitative study designs; The researchers will use Focus Group Discussions (FGDs) to assess the feasibility, acceptability, and appropriateness of integrating TT from the PHC staff, the health officials, and HEWs. Additionally, to assess the same parameters from patients and the community in-depth interviews will employed. To further augment data collected through FGD and in-depth interviews to assess feasibility, acceptability, and appropriateness using a validated tool by Weiner et al. The investigators will assess fidelity to evaluate to what extent the trained PHC staff has adhered to the training package which could also tell us the technical feasibility of the intervention. The feasibility assessment includes allocative and technical feasibility.
2. A cross-sectional study to assess the diagnostic accuracy of primary health care staff in correctly identifying CL patients using PCR as a gold standard. This design will assist in further assessing the fidelity of the PHC staff in adhering to the training package delivered in the first phase of the training. Additionally, the investigators will have information on the technical feasibility of the intervention by looking at the percentage of CL cases and non-CL cases correctly identified.
3. Quasi-experimental design to assess the treatment success rate of TT in treating CL. An independent dermatologist will assess the response to the TT. In this study, there is neither a control group nor randomized patients The catchment areas of health centers that are not providing TT will serve as a control group. Patients with CL within these control catchment areas will be followed for a maximum of 3 months before they are referred to TT-providing centers for treatment. Eligible CL patients are offered TT treatment by the PHC staff and only if interested, the CL Patients will undergo TT treatment. TT will be administered up to two times to the Cutaneous Leishmaniasis (CL) patients in the intervention group: