Project: Chemoprophylaxis for leprosy: comparing the effectiveness and feasibility of a skin camp intervention to a health centre based intervention. An implementation trial in Mozambique, Ethiopia and Tanzania.

Acronym PEP4LEP (Reference Number: RIA2017NIM-1839)
Duration 01/10/2018 - 31/01/2023
Project Topic Context & objectives PEP4LEP aims to identify the most effective and feasible method for screening people at risk of developing leprosy and administering chemoprophylaxis. A single dose of rifampicin has been proven to reduce the risk of developing leprosy by 60% when administered to contacts of leprosy patients. Although the WHO incorporated this post-exposure prophylaxis treatment in the latest guidelines (2018), little is known about the most feasible implementation method. PEP4LEP is a research project (cluster-randomized implementation trial) which compares the effectiveness and feasibility of a skin camp intervention to a health centre-based intervention in Mozambique, Ethiopia, and Tanzania. To avoid stigma and increase health benefits, participants in the PEP4LEP study are not only screened for leprosy, but also for other skin diseases. This integrated dermatological screening process is an evidence based and WHO supported method to detect leprosy. In PEP4LEP, two study interventions are tested: One PEP4LEP study intervention will be community based, organizing skin camps to screen around 100 contacts (household members and neighbours / community members) of a person affected by leprosy and provide them with a single dose of rifampicin when eligible. The other intervention will be health centre based, inviting the household contacts of a person affected by leprosy to be screened in a health centre, and also to be given a single dose of rifampicin when eligible. The comparison of two study interventions is made by looking at patient detection rates, delays in case detection, (cost-)effectiveness, and acceptability by stakeholders. In both cases, the SkinApp is used and tested for acceptability by health workers and contacts of persons affected by leprosy. NLR developed the SkinApp as mobile health tool to support health workers, as there is a dermatologist shortage in low resource settings in general and sub-Saharan Africa more specifically. SkinApp aims to assist in the recognition of early signs and symptoms of leprosy, so that treatment can start as soon as possible. In this project, approximately 30,000 contacts of people affected by leprosy will be screened and when eligible, they will receive a single dose of rifampicin as chemoprophylaxis to reduce their risk of developing leprosy and spreading the disease. The results of the PEP4LEP study may help implementing skin screening and SDR-PEP into national and international leprosy control guidelines. Description of the work performed The first project year of the PEP4LEP project was the preparation and piloting project phase. The research protocol was written and translated where needed. The required staff was hired to execute the project. The involved universities all contracted a PhD researcher that specializes in a different PEP4LEP study objective. An extensive interactive training programme for health workers was developed and adapted to the contexts in the three countries. Field visits were organized to visit study locations, assess patient numbers, and to inform communities and health workers. Furthermore, ethical approval was obtained in Mozambique and Tanzania and Ethiopia is expected to receive ethical approval in Q1 of 2020. To measure the case detection delay, a draft questionnaire was composed, tested and validated for the included counties. The final version of the questionnaire is included with the index patient collection forms and will be administered with every new leprosy patient identified throughout the PEP4LEP project. Simultaneously, the country versions of the SkinApp version 3 were tested in all countries, in which the Tanzanian PhD-student played a major role. The PEP4LEP project was presented on several occasions. In March, the third version of the SkinApp has won the Apps Award of the ISNTD Festival 2019, “in recognition for the outstanding contribution by the SkinApp to the diagnosis and management of skin diseases including Neglected Tropical Diseases”. In April PEP4LEP was presented at the LRI Springmeeting and in September 2019, presentations on PEP4LEP were given during the 20th International Leprosy Congress in Manilla, Philipines. Research articles have been drafted in the first year, and the first scientific publications are expected in 2020. More information can be found on the project website:
Network EDCTP2
Call Targeting control and elimination of NIDs through product-focused implementation research

Project partner

Number Name Role Country
1 Nederlandse Stichting voor Leprabestrijding Coordinator Netherlands
3 Armauer Hansen Research Institute Partner Ethiopia
5 Catholic University of Health and Allied Sciences-Bugando Partner Tanzania
6 DAHW Deutsche Lepra- und Tuberkulosehilfe e.V. Partner Germany
8 Erasmus Universitair Medisch Centrum Rotterdam Partner Netherlands
9 Federal Democratic Republic of Ethiopia Ministry of Health Partner Ethiopia
11 Ministério da Saúde Partner Mozambique
13 Ministry of Health, Community Development, Gender, Elderly and Children Partner Tanzania
15 Universidade Lúrio Partner Mozambique