SToP (See, Treat, Prevent) skin sores and scabies trial: study protocol for a cluster randomised, stepped-wedge trial for skin disease control in remote Western Australia

Abstract

IntroductionSkin is important in Australian Aboriginal culture informing kinship and identity. In many remote Aboriginal communities, scabies and impetigo are very common. Untreated skin infections are painful, itchy and frequently go untreated due to under-recognition and lack of awareness of their potential serious complications. We hypothesise that the skin infection burden in remote Aboriginal communities can be reduced by implementing streamlined training and treatment pathways integrated with environmental health and health promotion activities, tested in the See, Treat, Prevent (SToP skin sores and scabies) trial.Methods and analysisSToP will evaluate a skin control programme using a stepped-wedge, cluster randomised trial design with three intervention components (the ‘SToP activities’): (1) seeing skin infections (development of training resources implemented within a community dermatology model); (2) treating skin infections (employing the latest evidence for impetigo, and scabies treatment); and (3) preventing skin infections (embedded, culturally informed health promotion and environmental health activities). Four community clusters in the remote Kimberley region of Western Australia will participate. Following baseline data collection, two clusters will be randomly allocated to the SToP activities. At 12 months, the remaining two clusters will transition to the SToP activities. The primary outcome is the diagnosis of impetigo in children (5–9 years) at school-based surveillance. Secondary outcome measures include scabies diagnosis, other child health indicators, resistance to cotrimoxazole in circulating pathogenic bacteria, determining the economic burden of skin disease and evaluating the cost effectiveness of SToP activities.Ethics and disseminationThis study protocol was approved by the health ethics review committees at the Child and Adolescent Health Service (Approval number RGS0000000584), the Western Australian Aboriginal Health Ethics Committee (Reference number: 819) and the University of Western Australia (Reference RA/4/20/4123). Study findings will be shared with community members, academic and medical communities via publications and presentations, and in reports to funders. Authorship for all publications based on this study will be determined in line with the Uniform Requirements for Manuscripts Submitted to Biomedical Journals published by the International Committee of Medical Journal Editors. Sharing results with organisations and communities who contributed to the study is paramount. The results of the SToP trial will be shared with participants in a suitable format, such as a single summary page provided to participants or presentations to communities, the Kimberly Aboriginal Health Planning Forum Research Subcommittee and other stakeholders as appropriate and as requested. Communication and dissemination will require ongoing consultation with Aboriginal communities to determine appropriate formats.Trial registration numberACTRN12618000520235.

Strengths-Based Nursing to Combat Common Infectious Diseases in Indigenous Australians

“…The See Treat Prevent (SToP) protocol uses three intervention steps to manage skin infections, sores, and scabies infestations [ 18 ]. The three steps are seeing and identifying skin infections and/or scabies (after community dermatology model training), treating using evidence-based approaches, and preventing via local health education promotion to hand-picked community members (SBN) and adjustments to the local environment ( Figure 1 ) [ 18 ]. Clinical examination is the main diagnostic approach for scabies whilst dermoscopy scraping microscopy can also be performed [ 19 ].…”

Complicated skin and soft tissue infections in remote indigenous communities

“…Health promotion activities, training of healthcare workers in early recognition and treatment of skin infections and ultimately attention to the social determinants of health are all needed to reduce this burden. The SToP trial currently underway in the Kimberley seeks to address comprehensively these to reduce skin infections and subsequent complications …”

Molecular diagnosis of scabies using a novel probe-based polymerase chain reaction assay targeting high-copy number repetitive sequences in the Sarcoptes scabiei genome

“…Patients, or parent or caregiver, recruited in the study provided written informed consent. The second clinical study conducted in Kimberley, Western Australia [ 28 ] was approved by the Child and Adolescent Health Research Ethics Committee (approval number RGS0000000584) and the Western Australian Aboriginal Health Ethics Committee (approval number 819). Parents or caregivers of children recruited in the study provided written informed consent.…”

“…The school-surveillance was part of the SToP (See, Treat, Prevent) skin sores and scabies trial conducted in Kimberley, Western Australia. The study design and selection criteria of this study has been described elsewhere [ 28 ]. Inclusion criteria were children with suspected scabies according to the 2018 IACS diagnostic criteria for scabies [ 29 ].…”