PEP4LEP study protocol: Integrated skin screening and SDR-PEP administration for leprosy prevention: Comparing the effectiveness and feasibility of a community-based intervention to a health centre-based intervention in Ethiopia, Mozambique and Tanzania

Anne Schoenmakers, Thomas Hambridge*, Robin Van Wijk, Christa Kasang, Jan Hendrik Richardus, Kidist Bobosha, Fernando Mitano, Stephen E. Mshana, Ephrem Mamo, Abdoulaye Marega, Nelly Mwageni, Taye Letta, Artur Manuel Muloliwa, Deus Vedastus Kamara, Ahmed Mohammed Eman, Litos Raimundo, Blasdus Njako, Liesbeth Mieras

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Introduction Leprosy, or Hansen's disease, remains a cause of preventable disability. Early detection, treatment and prevention are key to reducing transmission. Post-exposure prophylaxis with single-dose rifampicin (SDR-PEP) reduces the risk of developing leprosy when administered to screened contacts of patients. This has been adopted in the WHO leprosy guidelines. The PEP4LEP study aims to determine the most effective and feasible method of screening people at risk of developing leprosy and administering chemoprophylaxis to contribute to interrupting transmission. Methods and analysis PEP4LEP is a cluster-randomised implementation trial comparing two interventions of integrated skin screening combined with SDR-PEP distribution to contacts of patients with leprosy in Ethiopia, Mozambique and Tanzania. One intervention is community-based, using skin camps to screen approximately 100 community contacts per leprosy patient, and to administer SDR-PEP when eligible. The other intervention is health centre-based, inviting household contacts of leprosy patients to be screened in a local health centre and subsequently receive SDR-PEP when eligible. The mobile health (mHealth) tool SkinApp will support health workers' capacity in integrated skin screening. The effectiveness of both interventions will be compared by assessing the rate of patients with leprosy detected and case detection delay in months, as well as feasibility in terms of cost-effectiveness and acceptability. Ethics and dissemination Ethical approval was obtained from the national ethical committees of Ethiopia (MoSHE), Mozambique (CNBS) and Tanzania (NIMR/MoHCDEC). Study results will be published open access in peer-reviewed journals, providing evidence for the implementation of innovative leprosy screening methods and chemoprophylaxis to policymakers. Trial registration number NL7294 (NTR7503).

Original languageEnglish
Article numbere046125
JournalBMJ Open
Volume11
Issue number8
DOIs
Publication statusPublished - 26 Aug 2021

Bibliographical note

Funding Information:
Funding This project was supported by the EDCTP2 programme under Horizon 2020 (grant number RIA2017NIM-1839-PEP4LEP). The project also received funding from the Leprosy Research Initiative (LRI; www.leprosyresearch.org) under LRI grant number 707.19.58. Both funding bodies reviewed and approved the study proposal.

Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

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