The SToP (See, Treat, Prevent) Skin Sores and Scabies Trial - a stepped wedge cluster randomised trial for skin disease control in remote Western Australia: Statistical analysis plan

The SToP trial is an (open-cohort) stepped-wedge cluster randomised trial (SWCRT) that aims to evaluate a skin health programme comprising three intervention components (1) seeing skin infections; (2) treating skin infections; and (3) preventing skin infections. Four community clusters in the remote Kimberley region of Western Australia will participate in the study. The primary outcome is the diagnosis of impetigo in children (5-9 years) observed during school-based surveillance visits. We provide a detailed, prospective statistical analysis plan (SAP). The plan was written by the trial statistician and details the study design as well as the statistical methods and reporting to be used. The SAP was produced prior to any of the authors viewing any of the trial data. Application of this SAP will minimise bias and supports transparent and reproducible research. SToP is registered under the Australian and New Zealand Clinical Trials Registry, ACTRN12618000520235.