Master statistical analysis plan: attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia.

ABSTRACT: This manuscript is a master statistical analysis plan for each of three-cluster randomized controlled trials to evaluate the efficacy of attractive targeted sugar baits (ATSB) described in an already published protocol. The master SAP contains an overarching plan for all three trials, which can be adapted to trial-specific circumstances. The primary objective of the trials is to evaluate the efficacy of ATSB in the presence of universal vector control coverage with insecticide-treated nets (ITN) or indoor residual spraying (IRS) after two transmission seasons on clinical malaria incidence as compared with universal vector control coverage with ITN or IRS alone. The primary outcome measure is the incidence rate of clinical malaria, assessed in cohorts aged 12 months to less than 15 years (≥

SUBMITTER: Yukich J 

PROVIDER: S-EPMC10685482 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature