PEP4LEP

Chemoprophylaxis for leprosy patients: comparing two intervention types

While some bacteria multiply every minute, the leprosy bacillus only doubles once every two weeks. Consequently, it may take as long as two to five years before a person affected by leprosy develops symptoms. Also, leprosy symptoms, like skin lesions with impaired sensation, are often not recognized or responded to in a timely manner by patients and health care workers. As a result, an infected person may spread the bacilli for years without knowing. 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%, or in some cases even 80%, 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 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, participants in the PEP4LEP study are not only screened for leprosy, but also for other skin diseases. This dermatological screening process is an evidence based and WHO supported method to detect leprosy. The comparison of two study interventions 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 (household members and neighbours) of a person affected by leprosy and provide them with a single dose of rifampicin.
• 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. SkinApp aims to support community health workers to recognize the early signs and symptoms of leprosy, so that treatment can start immediately. By enabling timely diagnosis and treatment, the SkinApp contributes to the prevention of disabilities as well as psychological and socio-economic problems like stigma. Besides leprosy, other dermatological conditions that are more common are included in the app (e.g. fungal infections), skin diseases that may be life-threatening (e.g. blistering diseases) and skin conditions that are associated with other neglected tropical diseases or HIV/AIDS.

Also, a capacity assessment will take place, testing the effect of skin screening capacity building initiatives, like the SkinApp, for community health workers.

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 hopefully prevent them from 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 routine care guidelines.

Project details

Project start date: 1 October 2018

Project duration: 52 months

Project partners:

• NLR, the Netherlands (Coordinator)
• DAHW Deutsche Lepra- und Tuberkulosehilfe e. V., Germany
• Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC), the Netherlands
• 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

Funding