Study design
TB, Leprosy, leprosy, Mohéli
ADVERSE EVENTS, LEPROSY, LEPROSY
The BE-PEOPLE trial is a cluster randomized trial in which 44 clusters from the islands of Anjouan and Mohéli (Comoros) will be randomized to two study arms. These include 34 out of 48 villages that were also part of the PEOPLE trial as well as nine new villages of which one has been divided into two. For randomization, clusters will be listed in order of decreasing baseline leprosy prevalence by island and by former PEOPLE trial study arm. They will then be randomized to arm 1 (BE-PEP), intervention, or arm 2 (SDR-PEP), comparator arm, of BE-PEOPLE. Participants residing in villages arm 1 who are between two and five years of age and with a weight of 10–20 kg are not eligible for BE-PEP but will be offered SDR-PEP instead.A first round of PEP will be provided in 2023, within one month following the screening in each village. This will be considered the start of follow-up. Screening will take place on an annual basis until the fourth and final round in 2026, which will be the end of follow-up. Leprosy incidence will be measured at the individual level among those that received either SDR-PEP or BE-PEP, excluding those below five years of age or weighing less than 20 kg because they are not eligible for BE-PEP. We will also compare incidence at village level between arm 1 and arm 2 villages, irrespective of whether or not an individual received PEP and of the kind of PEP received.Each individual provided PEP will be revisited the day after PEP intake to document any adverse events.Throughout the study skin biopsies will be collected of all consenting leprosy patients and slit skin smears of multibacillary patients, as well as sputum samples of all consenting TB patients. In addition nasal and tongue swabs, tongue scraping, and face mask samples will be collected from both TB and leprosy patients. Those that are PCR-positive for Cost data will be collected alongside the trial.Immediately following the final survey round in 2026, a serosurvey quantitatively assessing anti-PGL-I IgM antibodies will be conducted in BE-PEOPLE villages that were previously (since 2019) part of study arm 4 of the PEOPLE trial.