Implementation approaches for leprosy prevention with single-dose rifampicin: A support tool for decision making

Background: In the past 15 years, the decline in annually detected leprosy patients has stagnated. To reduce the transmission of Mycobacterium leprae, the World Health Organization recommends single-dose rifampicin (SDR) as post-exposure prophylaxis (PEP) for contacts of leprosy patients. Various approaches to administer SDR-PEP have been piloted. However, requirements and criteria to select the most suitable approach were missing. The aims of this study were to develop an evidence-informed decision tool to support leprosy programme managers in selecting an SDR-PEP implementation approach, and to assess its user-friendliness among stakeholders without SDR-PEP experience. Methodology: The development process comprised two phases. First, a draft tool was developed based on a literature review and semi-structured interviews with experts from various countries, organisations and institutes. This led to: an overview of existing SDR-PEP approaches and their characteristics; understanding the requirements and best circumstances for these approaches; and, identification of relevant criteria to select an approach. In the second phase the tool’s usability and applicability was assessed, through interviews and a focus group discussion with intended, inexperienced users; leprosy programme managers and non-governmental organization (NGO) staff. Principal findings: Five SDR-PEP implementation approaches were identified. The levels of endemicity and stigma, and the accessibility of an area were identified as most relevant criteria to select an approach. There was an information gap on cost-effectiveness, while successful implementation depends on availability of resources. Five basic requirements, irrespective of the approach, were identified: stakeholder support; availability of medication; compliant health system; trained health staff; and health education. Two added benefits of the tool were identified: its potential value for advocacy and for training. Conclusion: An evidence-informed SDR-PEP decision tool to support the selection of implementation approaches for leprosy prevention was developed. While the tool was evaluated by potential users, more research is needed to further improve the tool, especially health-economic studies, to ensure efficient and cost-effective implementation of SDR-PEP. Author summary: The chance of contacts of leprosy patients developing leprosy can be reduced by providing a single dose of rifampicin. The implementation of this type of post-exposure prophylaxis can be done in various ways. This study led to the development of the SDR-PEP decision support tool to select the most suitable approach. It was developed in two phases; first, a tool was drafted based on a literature review and expert interviews, this was followed by phase 2 in which interviews and a focus group discussion with intended users of the tool were held. Five SDR-PEP implementation approaches that have been developed so far were identified. Apart from the characteristics of these approaches, the tool lists five basic requirements for the successful implementation of any approach, and criteria that help to select the best approach in a given context. A flowchart supports the selection process. The study found that the tool can also be used for lobby and advocacy, to clarify SDR-PEP implementation and the choice for an approach, and in training on SDR-PEP implementation. Information about costs and cost-effectiveness of the approaches is limited. Further research will help to continue to improve the tool.