Intervention implementation and data collection
TB, scabies, Mohéli, vomiting, leprosy, loss of sensation, eczema, Vomiting
SCABIES, ADVERSE EVENTS, EVENT, MYCOSES, LEPROSY, SKIN DISEASES, ECZEMA
Before the study begins, village elders will be informed about study objectives and procedures, followed by community sensitization. Annual door-to-door screening for leprosy will be conducted from 2023 to 2026, by teams that consist of experienced health services staff and community volunteers. Data to be collected include geographic coordinates of all households visited as well as individual data, in particular demographic data and for those present during the visit, health, and medical data, results of examinations for leprosy and/or TB, eligibility for PEP, acceptance/refusal of PEP, and occurrence of adverse events. Data entry will be performed directly in the field, making use of an Android app in REDCap (Research Electronic Data Capture). REDCap is widely used in research and is compliant with standards and applicable regulations of good clinical practice (GCP). Data can be entered in REDCap offline, to be uploaded to a secure server whenever internet connection is available. We will also make use of a paper form, one form per household, to record name, age, and gender of each individual enrolled. These forms have a pre-printed unique barcode for each individual recorded as well as a unique household ID. They will be entered in an MS Access database, from which new forms with household ID, names, ages, and barcodes can be printed each time a new survey round starts. The field staff will use these forms to find back households previously visited. When entering data in the REDCap forms, they will use these barcodes and household IDs, no other personal identifiers will be recorded.TB patients diagnosed nationwide will be asked to sign an informed consent and will have sputum, nasal and tongue swabs, tongue scraping, and face mask sampling for genotyping of The diagnosis of leprosy will be following WHO guidelines, based on three cardinal signs: patch with loss of sensation, enlarged peripheral nerves, and/or slit-skin smear (SSS) positive for acid-fast bacilli. All leprosy cases diagnosed will be confirmed by experienced national leprosy control program health staff. All new leprosy cases detected will be treated according to the national guidelines. Other skin diseases such as mycoses, scabies, or eczema will also be treated free of charge. Subject to informed consent, all incident leprosy patients in Anjouan and Mohéli will be enrolled in a sub-study in which slit skin smears, nasal and tongue swabs, tongue scraping, facial mask sampling, and skin biopsies from non-facial lesions will be sampled to be tested with quantitative polymerase chain reaction (qPCR). If sufficient DNA is available, we will conduct further molecular tests for During the first round of annual door-to-door screening for leprosy, residents will be informed about objectives and study procedures, and requested to provide written informed consent. They will then be individually assessed for PEP eligibility. Upon completion of screening in a village, a PEP eligibility zone will be determined based on presence of leprosy index cases within 100 m. If more than 50% of the population lives within a 100-meter radius of an index case, the entire village will be eligible. Then, provision of PEP will be organized according to the study arms in another visit. All new leprosy cases diagnosed in between annual screening rounds will also be taken into account in the study. Eligible contacts of these patients will receive PEP during the next round of PEP administration.All participants who received PEP will be re-visited the next day for assessing vomiting and (serious) adverse events ([S]AE). Vomiting will be recorded but the dose will not be repeated. In case of SAE, the health worker will record the event and report it within 24 h to the sponsor, refer the patient for appropriate care, and follow up until resolution. Household contacts provided BE-PEP will be offered a second dose four weeks later, as preliminary data from the PEOPLE trial documented that their residual risk is still up to three times higher compared to the rest of the population. SDR-PEP will be offered only once. In addition, there will be passive reporting of adverse events over the period of up to 30 days post-PEP administration, afterwards only adverse events that are linked to the PEP intake will be documented. Pregnancy is an exclusion criterion but in case an existing pregnancy at the time of PEP administration only becomes apparent afterwards, the participant will be followed up until the time of delivery.