This is a “cluster randomized” trial on effectiveness of different modalities of Single Double Dose of Rifampicin Post-Exposure Prophylaxis (SDDR-PEP) for leprosy in the Comoros (Anjouan and Mohéli) and Madagascar.
PEOPLE: Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar
Project coordination
Project summary
This is a “cluster randomized” trial on effectiveness of different modalities of Single Double Dose of Rifampicin Post-Exposure Prophylaxis (SDDR-PEP) for leprosy in the Comoros (Anjouan and Mohéli) and Madagascar. Cluster randomized refers to the random allocation of clusters (villages) rather than individuals to study arms.
The study aims to identify which approach to the selection of contacts for post exposure prophylaxis is most effective to reduce incident leprosy, and to Interrupt ongoing transmission from asymptomatic persons in the process of developing multibacillary leprosy.
For the purpose of the study, villages on the Comoros and Madagascar will be randomly assigned to one of the study arms. For a period of 4 years, each village will be screened once every year. Depending on the study arm, Post-Exposure Prophylaxis (PEP) using rifampicin will be given to contacts of a newly diagnosed leprosy patient.
Three different ways of selecting contacts will be compared with a control arm in which no PEP is given: 1. No Post-Exposure Prophylaxis (PEP) is given to anyone 2. PEP is given to all household contacts of incident leprosy cases 3. PEP is given to all people who live in a 100m radius of incident leprosy cases 4. PEP is given to all household contacts of incident leprosy cases as well as to all others who live within a 100m radius of an incident leprosy case and test positive to a serological screening test (anti-PGL-1).
The main outcome is to compare the leprosy incidence between the arms after 45 months.
Main funder
European & Developing Countries Clinical Trials Partnership
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Supported by the European Union
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