PEP4LEP 2.0 - Chemoprohylaxis for leprosy: comparing the effectiveness and feasibility of a community-based intervention to a health centre-based intervention in Ethiopia, Mozambique, and Tanzania.

Project Information

PEP4LEP 2.0

Grant agreement ID: 101145677

DOI

10.3030/101145677

Project closed

EC signature date 4 March 2024

Start date 1 April 2024

End date 31 March 2026

Funded under

• Health

Total cost

€ 1 780 303,75

EU contribution

€ 1 780 303,75

Coordinated by

NEDERLANDSE STICHTING VOOR LEPRABESTRIJDING
Netherlands

Periodic Reporting for period 1 - PEP4LEP 2.0 (PEP4LEP 2.0 - Chemoprohylaxis for leprosy: comparing the effectiveness and feasibility of a community-based intervention to a health centre-based intervention in Ethiopia, Mozambique, and Tanzania.)

Reporting period: 2024-04-01 to 2025-03-31

Summary of the context and overall objectives of the project

Leprosy remains a significant public health challenge in high-endemic regions of Africa. Early detection and preventive treatment are essential to reduce transmission and disability. In line with recommendations from the World Health Organization (WHO), PEP4LEP 2.0 builds on the EDCTP2-PEP4LEP project to identify effective, feasible methods for screening those at risk of leprosy, skin neglected tropical diseases (NTDs), and other skin conditions. It supports WHO guidance on administering single-dose rifampicin post-exposure prophylaxis (SDR-PEP). The project is implemented in Ethiopia, Mozambique, and Tanzania, where access to skin and leprosy care remains limited. PEP4LEP 2.0 is a two-arm, cluster-randomised trial comparing: (1) community-based skin camps screening around 100 contacts per index case and providing SDR-PEP, and (2) health-centre-based screening of household contacts. The sample size of EDCTP2-PEP4LEP was increased by 25% to account for COVID-19-related delays. The main objective is to compare the effectiveness of both interventions in detecting new cases and reducing case detection delay. Additional objectives include modelling long-term impact, assessing cost-effectiveness, analysing acceptability, documenting COVID-19 effects, evaluating prevalence of skin NTDs, studying organisational aspects and assessing health worker capacity. The project aims to inform scalable, evidence-based strategies for leprosy prevention in resource-limited settings. More: https://www.leprosyrelief.org/pep4lep2.0

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

In year one, both intervention arms included participants in all three countries. A total of 646 index patients (46 in PEP4LEP 2.0 from April 2024 – March 2025) and 22,563 contacts (2,550 in PEP4LEP 2.0) were screened. Among these, 282 new leprosy cases were detected (24 in PEP4LEP 2.0) and 10,436 individuals were diagnosed with skin conditions (1,188 in PEP4LEP 2.0). Diagnosed conditions include fungal infections, impetigo, atopic dermatitis, and NTDs like scabies, chromoblastomycosis, lymphatic filariasis, mycetoma, onchocerciasis, and podoconiosis.
As of March 2025, 74% of the target index patient sample and 61.1% of contacts have been included, reaching the milestone of 50% enrolment in both interventions. A total of 20,356 contacts (2,299 in PEP4LEP 2.0) received SDR-PEP. Data collection continues on cost-effectiveness, COVID-19 impact, skin disease prevalence, healthcare worker learning, and skin camp organisation, using REDCap and KoboCollect systems. Despite delays in Mozambique due to unrest and cyclones, activities resumed and intensified. Training for healthcare workers and junior researchers was conducted. Dissemination included submission of a literature review on dermatological assessments to a scientific journal and the preparation of a manuscript on healthcare worker learning. Preliminary findings were presented at the WHO Second Skin NTD Meeting, LRI Spring Meeting, InCORNTD, NNN, and ESCMID.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

PEP4LEP 2.0 goes beyond current practices by integrating leprosy prophylaxis with broad skin disease screening in community settings, significantly increasing reach and reducing barriers to health care access. It introduces innovative tools like the NLR SkinApp which has been adopted by WHO. The project’s qualitative components also contribute new insights into informal learning and service acceptability. These findings address key implementation gaps and help design patient-centred, scalable approaches to integrated dermatological and leprosy care. The PEP4LEP 2.0 project is strongly aligned with Sustainable Development Goal (SDG) 3 – Good Health and Well-being, but also contributes to SDGs 1, 4, 5, 10, and 17.

SDR-PEP for leprosy prevention handed out in a skin camp in Mozambique_PEP4LEP2.0

Health education in a skin camp in Mozambique_PEP4LEP2.0

Infant diagnosed with scabies in a skin camp in Mozambique_PEP4LEP2.0

Community gathering in a skin cmap in Mozambique_PEP4LEP2.0

Tinea capitis detected in a skin camp in Mozambique_PEP4LEP2.0

Healthcare workers performing skin screening in Mozambique_PEP4LEP2.0

Ibraimo conducting a focus group discussion in Mozambique_PEP4LEP2.0