PEP4LEP 2.0

The challenge

Despite much progress in disease control, leprosy remains a common problem in certain sub-Saharan African countries. Although rarely lethal, it can have a major impact on quality of life, leading to injuries that can be highly disabling and stigmatising, and prevent people from earning a living. 

Leprosy develops over a long period of time, and stigmatisation often leads people not to reveal their infection status. These factors lead to delays in care seeking and provide opportunities for infections to be transmitted to family members and social contacts. 

The risk of leprosy transmission can be significantly reduced by post-exposure prophylaxis (PEP), which involves providing antibiotics after exposure to contacts of patients to prevent infection. This approach has been shown to be highly effective, but it is not clear how it can best be implemented within health systems in sub-Saharan Africa.

In addition, leprosy is one of more than a thousand diseases that affect the skin, including several neglected tropical diseases, such as leishmaniasis, Buruli ulcer and lymphatic filariasis. Globally, almost a third of the world’s population is affected by skin diseases, and in parts of sub-Saharan Africa, skin conditions make up more than 10% of primary healthcare consultations. Since most countries have very few specialist dermatologists, there is interest in developing primary care systems that cover multiple skin conditions, an integrated approach to skin condition management that is recommended by the WHO.

The project

Funded through the EDCTP2 programme, the PEP4LEP project was set up to compare two ways to identify people who might benefit from PEP for leprosy. The first was based on ‘skin camps’ – temporary community-based clinics where community members coming into contact with patients could be assessed for leprosy and other skin conditions, receiving PEP when necessary. The second approach was similar but involved community members attending existing health facilities. A cluster randomised trial was organised in Ethiopia, Mozambique and Tanzania, with areas in the three countries randomised to one of the two models.

The project was badly affected by the COVID-19 pandemic, which disrupted the organisation of skin camps. In addition, a core outcome being assessed in the project was the delay in diagnosis of leprosy cases, which was itself affected by the disruption of health services during the pandemic.

Global Health EDCTP3 funding is enabling the PEP4LEP 2.0 project to complete its study and also to recruit additional cases so that the specific effects of the pandemic can be assessed. In addition, the project is now capturing data on the longer-term impacts of the two models through extended follow-up and is carrying out a cost-effectiveness analysis. The project is also consulting with healthcare workers and community members to assess the acceptability of the two models and to gather insights into the practicalities of implementation.

Impact

The PEP4LEP 2.0 project will provide key data on possible ways to implement post-exposure prophylaxis (PEP) for leprosy prevention and management of skin diseases. It will:

• Generate high-quality data on the impact of PEP on the leprosy disease burden in real-world, high-burden settings.
• Provide an indication of the effectiveness and cost-effectiveness of the two models of PEP delivery.
• Identify key factors associated with the effective implementation of each model.
• Strengthen skills in diagnosis and integrated management of skin diseases at the community level.

Identification of an effective model for community-based management of skin conditions could have a major impact on the quality of life of millions of people in sub-Saharan Africa affected by leprosy and a host of other neglected tropical diseases affecting the skin.