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

Abstract

IntroductionLeprosy, 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 analysisPEP4LEP 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 disseminationEthical 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 numberNL7294 (NTR7503).

Prolonged delays in leprosy case detection in a leprosy hot spot setting in Eastern Ethiopia

“…A structured questionnaire was adopted from our previous work conducted in East Hararghe Zone, Ethiopia [ 33 ]. This questionnaire was designed as part of the PEP4LEP project, a research project in which integrated skin screening interventions for leprosy are tested, together with the administration of chemoprophylaxis (single-dose rifampicin post-exposure prophylaxis, SDR-PEP) to contacts of leprosy patients [ 36 ]. The questionnaire comprised: (1) patient socio-demographic characteristics; (2) questions to determine the delay in case detection; (3) questions to identify the reasons for delay in case detection; (4) an annex with a picture set to recognize leprosy symptoms and; (5) an annex with a local calendar to translate the patient’s indication of time to a number of months [ 33 ].…”

Leprosy epidemiological trends and diagnosis delay in three districts of Tanzania: A baseline study

“…The study activities are a component of the baseline survey for the PEP4LEP study. 8 The PEP4LEP project in Tanzania was approved on 17 June 2019 by the National Institute for Medical Research (NIMR) of Tanzania (reference number: NIMR/HQ/R.8c/Vol.1/1530). The PEP4LEP project is registered at The Netherlands Trial Register, registration date 10 September 2018, NL7294 (NTR7503).…”

Epidemiological trends of leprosy and case detection delay in East Hararghe Zone, Ethiopia: A baseline survey

“…Data collection on case detection delay was paper-based during a series of interviews with 50 recently diagnosed leprosy patients by a trained health worker using a semi-structured questionnaire which was designed for the PEP4LEP project. 22,27 The questionnaire consists of 10 questions and aims to collect information on the diagnosis delay, the reasons of delay, the signs and symptoms described and steps taken during the course of illness up until the time of diagnosis by a health professional. It also contains annexes as supplementary material: a set of clinical photos of leprosy signs and a local calendar listing important dates, such as festivities and religious celebrations to help the patient to recall the time of onset of first signs.…”

“…22 25 The PEP4LEP study is a cluster-randomised implementation trial in Ethiopia, Mozambique and Tanzania comparing two interventions of integrated skin-screening of contacts of leprosy patients combined with SDR-PEP distribution. 22 Before implementing the PEP4LEP study in Ethiopia, it is necessary to describe the trends in leprosy indicators and assess the baseline case detection delay in the study districts. This baseline survey is an integral part of the PEP4LEP project and aims: (1) to describe the epidemiological trends of leprosy in East Hararghe Zone between 2010 and 2019; and (2) to estimate the case detection delay in the PEP4LEP study districts before the start of the study intervention.…”