PEP4LEP
PEP4LEP aims to identify the most effective and feasible method for screening people at risk of developing leprosy and administering chemoprophylaxis.
Chemoprophylaxis for leprosy patients: comparing two intervention types
While some bacteria multiply every minute, the leprosy bacillus only divides once every two weeks. Thus, it may take as long as two to five years before a person affected by leprosy develops symptoms. As a result, an infected person may spread the bacilli for years without being aware. To stop transmission, an innovative, head-on approach is required.
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 (WHO 2018), little is known about the most feasible distribution 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, participants in the PEP4LEP study are not only screened for leprosy, but also for other skin diseases. This dermatological screening is an evidence based and WHO supported method to detect leprosy. The comparison is made by looking at patient detection rates, delays in case detection, cost-effectiveness, and acceptability by stakeholders.
- One PEP4LEP study intervention will be community based, using skin camps to screen around 100 contacts 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.
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 diagnostic tool for health workers, as there is a dermatologist shortage in sub-Saharan Africa. The SkinApp assists health workers in diagnosis and treatment plan decision making. Besides leprosy, other dermatological conditions that are more common are included in the app (e.g. fungal infections), but also skin diseases that may be life-threatening (e.g. blistering diseases) or which are associated with other neglected tropical diseases or HIV/AIDS.
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. The results of the PEP4LEP study may help adapting skin screening and SDR-PEP into routine care as well as in national and international guidelines.
Project details
Project start date: 1 October 2018
Project duration: 52 months
Project partners:
- NLR, the Netherlands (Coordinator)
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC), the Netherlands
- DAHW Deutsche Lepra- und Tuberkulosehilfe e. V., Germany
- Ministry of Health, Community Development, Gender, Elderly and Children – Tanzania, United Republic of Tanzania
- Catholic University of Health and Allied Sciences-Bugando (CUHAS), United Republic of Tanzania
- Ministerio da Saúde – Mozambique, Mozambique
- Universidade Lúrio, Mozambique
- Federal Democratic Republic of Ethiopia Ministry of Health (FMOH), Ethiopia
- Armauer Hansen Research Institute (AHRI), Ethiopia