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 to 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. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ACTRN12618000520235 ### Clinical Protocols ### Funding Statement This study this work pertains to was funded by the Western Australia Department of Health Future Health WA Third Year Initiative: Kimberley Healthy Skin Program (FHWAYR3-2015/16-KHS) and the National Health and Medical Research Council (NHMRC) Project Funding (GNT1128950). AB and SYCT are supported by NHMRC fellowships (1088735 and 1145033). TCB is supported by a Career Development Fellowship from the NHMRC-funded Improving Health Outcomes in the Tropical North: A multidisciplinary collaboration (Hot North; APP1131932). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The SToP trial protocol is approved by the local medical ethical review committees at the University of Western Australia (Reference RA/4/20/4123), the Child and Adolescent Health Service (Approval number RGS0000000584) at Perth Children's Hospital and by the Western Australian Aboriginal Health Ethics Committee (Reference number: 819). The study has also been reviewed and approved by the Catholic Education Office (Ref. no. RP2017/57) and Western Australian Department of Education (Ref. no. D18/0281633) for school-based surveillance. The study has also been reviewed and supported by the Kimberley Aboriginal Health Planning Forum Research Subcommittee (Ref. no. 2016-14). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors