Data analysis
TB, leprosy
LEPROSY
To assess the effectiveness of PEP at the individual level, we will fit a Poisson model adjusted for follow-up time as an offset term with the villages nested in islands as a random effect and type of PEP (BE-PEP or SDR-PEP) as an explanatory variable, with SDR-PEP as reference category. We will exclude participants below the age or weight limits for BE-PEP, even if they have received SDR-PEP. For each individual, follow-up time will start the day he or she was last examined before the first dose of PEP was administered and will end either at the time of their last survey visit or at the time the individual was diagnosed with leprosy. All incident leprosy cases diagnosed after the first door-to-door screening in 2023 until the final survey in 2026 will be considered. Participants lost to follow-up after their first intake of PEP will be excluded.Using a similar Poisson model, we will calculate the incidence rate ratio of leprosy at the village level between arms 1 and 2, including all participants, irrespective of whether they received PEP and the regimen received. Follow-up time will start on the median date of first PEP administration in each village and end on the median date of the final survey round. For incident leprosy cases follow-up time will end on the date of diagnosis. Although villages will be randomized, we will explore baseline prevalence of leprosy as a potential confounder.In the villages included in arm 4 of the PEOPLE trial, we will conduct an anti-PGL I survey in 2026 to compare the seroprevalence rates with those of 2019 in different age groups at the village and island level.We will calculate costs per person screened for leprosy and the cost per person provided either SDR-PEP or BE-PEP. If BE-PEP is found to be more effective, then the cost-effectiveness analysis will be performed with the average cost per case of leprosy averted per arm and island. Also, incremental costs per person treated will be calculated using SDR-PEP as a baseline.Finally, the prevalence of bedaquiline and/or rifampicin-resistant strains will be calculated per island. We will include in the numerator all leprosy or TB patients with resistance to rifampicin and/or bedaquiline, and all leprosy or TB patients tested in the denominator. Any apparent annual trends will be tested with chi-square for trend to assess statistical significance.