Sample size
For sample size calculations we used the methodology described by Hayes and Bennet for cluster randomized trials [To assess the effect of BE-PEP at the village level, the entire population examined will be considered in the analysis. If incidence at the village level is 1.1 per 1,000 per year, as observed in the PEOPLE trial, and a 50% reduction is achieved with BE-PEP, the available sample size would provide a power of approximately 90% over a three-year follow-up period.