Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Aug 26;11(8):e046125.
doi: 10.1136/bmjopen-2020-046125.

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 #  1 , Thomas Hambridge #  2 , Robin van Wijk  1 , Christa Kasang  3 , Jan Hendrik Richardus  4 , Kidist Bobosha  5 , Fernando Mitano  6   7 , Stephen E Mshana  8 , Ephrem Mamo  5 , Abdoulaye Marega  6 , Nelly Mwageni  8 , Taye Letta  9 , Artur Manuel Muloliwa  6   7 , Deus Vedastus Kamara  10 , Ahmed Mohammed Eman  11 , Litos Raimundo  12 , Blasdus Njako  13 , Liesbeth Mieras  1
Affiliations

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 et al. BMJ Open. .

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).

Keywords: infectious diseases & infestations; public health; tropical medicine.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
PEP4LEP project organisation chart.
Figure 2
Figure 2
PEP4LEP countries’ leprosy incidence in 2019 according to the WHO (2020).
Figure 3
Figure 3
Flow of participants through the PEP4LEP study.
See this image and copyright information in PMC

References

    1. World Health Organization . Promoting an integrated approach to enhance detection of neglected tropical diseases of the skin, 2019. Available: https://www.who.int/neglected_diseases/news/Promoting-453integrated-appr... [Accessed 19 Jun 2019].
    1. World Health Organization . Weekly epidemiological record / relevé épidémiologique hebdomadaire. In: Wkly Epidemiol rec. 95, 2020: 417–40. https://apps.who.int/iris/handle/10665/334140
    1. Smith CS, Noordeen SK, Richardus JH, et al. A strategy to halt leprosy transmission. Lancet Infect Dis 2014;14:96–8. 10.1016/S1473-3099(13)70365-7 - DOI - PubMed
    1. World Health Organization . Guidelines for the diagnosis, treatment and prevention of leprosy. New Delhi: World Health Organization, 2018.
    1. van Beers SM, Hatta M, Klatser PR. Patient contact is the major determinant in incident leprosy: implications for future control. Int J Lepr Other Mycobact Dis 1999;67:119–28. - PubMed

Publication types

Associated data