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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.
Schoenmakers, Anne; Hambridge, Thomas; van Wijk, Robin; Kasang, Christa; Richardus, Jan Hendrik; Bobosha, Kidist; Mitano, Fernando; Mshana, Stephen E; Mamo, Ephrem; Marega, Abdoulaye; Mwageni, Nelly; Letta, Taye; Muloliwa, Artur Manuel; Kamara, Deus Vedastus; Eman, Ahmed Mohammed; Raimundo, Litos; Njako, Blasdus; Mieras, Liesbeth.
  • Schoenmakers A; Medical Technical Department, NLR, Amsterdam, The Netherlands.
  • Hambridge T; Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands t.hambridge@erasmusmc.nl.
  • van Wijk R; Medical Technical Department, NLR, Amsterdam, The Netherlands.
  • Kasang C; Deutsche Lepra- und Tuberkulosehilfe e.V, Wuerzburg, Germany.
  • Richardus JH; Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.
  • Bobosha K; Armauer Hansen Research Institute, Addis Ababa, Ethiopia.
  • Mitano F; Lúrio University, Nampula, Mozambique.
  • Mshana SE; Nampula Provincial Health Directorate, Ministry of Health Mozambique, Maputo, Mozambique.
  • Mamo E; Department of Microbiology and Immunology, Catholic University of Health and Allied Sciences, Mwanza, United Republic of Tanzania.
  • Marega A; Armauer Hansen Research Institute, Addis Ababa, Ethiopia.
  • Mwageni N; Lúrio University, Nampula, Mozambique.
  • Letta T; Department of Microbiology and Immunology, Catholic University of Health and Allied Sciences, Mwanza, United Republic of Tanzania.
  • Muloliwa AM; Ministry of Health Ethiopia, Addis Ababa, Ethiopia.
  • Kamara DV; Lúrio University, Nampula, Mozambique.
  • Eman AM; Nampula Provincial Health Directorate, Ministry of Health Mozambique, Maputo, Mozambique.
  • Raimundo L; Ministry of Health Tanzania, Dodoma, United Republic of Tanzania.
  • Njako B; Deutsche Lepra- und Tuberkulosehilfe e.V. Ethiopia, Addis Ababa, Ethiopia.
  • Mieras L; NLR Mozambique, Nampula, Mozambique.
BMJ Open ; 11(8): e046125, 2021 08 26.
Article in English | MEDLINE | ID: covidwho-1376488
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).
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Leprosy Type of study: Controlled clinical trial / Diagnostic study / Clinical Practice Guide / Randomized controlled trials / Screening study Topics: Vaccines Limits: Humans Country/Region as subject: Africa Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2020-046125

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Leprosy Type of study: Controlled clinical trial / Diagnostic study / Clinical Practice Guide / Randomized controlled trials / Screening study Topics: Vaccines Limits: Humans Country/Region as subject: Africa Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2020-046125