Efficacy analysis
malaria, fever
MALARIA, REGRESSION, HAND INFECTION
The primary analysis will be the differential malaria incidence after the 6-month follow-up period between the intervention and control groups. Incidence will be based on monthly RDT results from the active cohort. Each RDT performed will be taken to represent one visit, which is equivalent to one child-month at risk. In the per-protocol correction, 14 days of time at risk for each treatment received (based on the post treatment prophylaxis provided by AL).Differential incidence between intervention and control clusters will be assessed using a count data regression model accounting for the cluster design effect. Primary analysis will be assessed using generalized estimating equations.Analysis in the multivariate model will be adjusted for potential confounders identified in the univariate analysis. Based on previous vector-control trials, the variables to be considered can be classified in the following categories: demographics (age and gender), socio-economics (head of household formal education, head of household occupied as a subsistence farmer, electricity in the household, livestock-human ratio, number of nets owned and distance to the nearest health facility), clinical (having experienced fever in the previous 48h, having slept under a bed net the previous night and infection of a sibling in the same household). A step-wise approach will be applied for building the final multivariate model, considering those variables with p-values lower than 0.20 in the univariate analysis.To assess the bias due to LTFU, sensitivity analyses limited to participants who receive all treatments may be performed. Additional support will be obtained from a comparison of the baseline characteristics of individuals who remain vs. those that are LTFU.Assessment of the direct benefit to the population that receives treatment will be done through passive surveillance at health facilities and cross-sectional studies to allow for a better risk-benefit analysis in this population.