Post-Exposure Prophylaxis (PEP++) project
This project is also known as the “Stop the Transmission of Leprosy! project” (or “stop leprabesmetting” in Dutch).
The number of new leprosy patients fell in the first five years of this millennium but has since levelled off to between 210,000 and 250,000 globally detected per year in the last 10 years. It is clear from the data on the proportion of children among new patients that the chain of transmission has still not been interrupted in many countries and areas. There is strong evidence that close and frequent contact with an infected person (like family members and neighbours) leads to a higher risk of becoming infected with the leprosy bacteria than those with less or no contact.
The PEP++ project seeks to interrupt leprosy transmission in two high-endemic districts of India, Brazil and Indonesia, the three countries with the highest global burden of leprosy. The project targets close contacts (household members, family members, neighbours and social contacts) of people affected by leprosy, given that they have the highest risk of developing the disease. The project uses a cluster-randomised controlled trial design to test the efficacy of an enhanced chemoprophylaxis regimen against leprosy. In addition, an enhanced package of leprosy control measures, that includes chemoprophylaxis, will be implemented in both intervention and control areas. Clusters of persons affected by leprosy will be identified by GIS mapping to target blanket campaigns where chemoprophylaxis will be provided to around 100 close contacts per leprosy patient. In the intervention areas, twenty close contacts of leprosy patients will receive enhanced chemoprophylaxis (i.e. PEP++ regimen) and an additional eighty contacts will receive SDR-PEP. In the control areas, all contacts will receive SDR-PEP. Outside the cluster areas, twenty close contacts will receive the PEP++ regimen in the intervention areas and SDR-PEP in control areas. Through this project, we expect that over 700,000 contacts will be treated preventively with chemoprophylaxis.
The project will use a number of innovative approaches to interrupt the transmission of leprosy:
- More effective prevention of leprosy among contacts of new patients. The current regimen for post-exposure prophylaxis (PEP) of leprosy, single-dose rifampicin (SDR) reduces the risk of leprosy among contacts of new patients by 57%. We expect that three doses of the new PEP++ regimen, a combination of rifampicin/clarithromycin for adults and children, will be 80-90% effective;
- Improved strategies for early case detection of leprosy, including context-specific community education materials to improve the perception and knowledge of leprosy and reduce stigma;
- Training of health care professionals at primary and referral level to improve their skills on leprosy diagnosis;
- Identification of high-endemic clusters of leprosy through GIS-based mapping of current and recent cases; and
- Blanket preventive chemotherapy in all villages and neighbourhoods where a cluster of people affected by leprosy has been identified.
Scientific title: “A cluster-randomised controlled trial on post-exposure chemoprophylaxis in contacts of persons affected by leprosy in six districts of India, Indonesia and Brazil.”
The main objective is:
- To interrupt the transmission of M. leprae in the project interventions areas, which eventually will lead to zero new cases of leprosy in these areas.
The specific objectives are:
- To stop the transmission of M. leprae in a previously endemic community, as evidenced by a reduction of the number of new cases of leprosy by 50% in 2024.
- To demonstrate the increased efficacy and acceptability of the enhanced post-exposure prophylaxis regimen (PEP++) compared to SDR-PEP.
- To demonstrate the benefit of identifying the cluster of known (former) leprosy patients using GIS mapping methods in targeting the allocation of SDR-PEP in blanket chemoprophylactic campaigns;
- To investigate the knowledge, attitudes and beliefs regarding leprosy and persons affected to develop community education and behaviour change interventions that will reduce stigma, improve strategies for early case detection and increase acceptance of programme interventions;
- To provide additional building blocks for making an investment case for leprosy elimination through a cost-benefit analysis.
Project start: 2017; chemoprophylaxis intervention in early 2020.
Project duration: 60 months, with a possible extension of 18 to 24 months.
Netherlands Trial Register (NTR) number: Trial NL7022 (NTR 7221)
This project is funded by the Dutch Postcode Lottery through its Dream Fund. Read about the project on the Dutch Postcode Lottery’s website here: https://www.postcodeloterij.nl/goede-doelen/bijzondere-projecten/leprastichting-stop-leprabesmetting