Multi-methods process evaluation of the SToP (See, Treat, Prevent) trial: a cluster randomised, stepped wedge trial to support healthy skin.

Background: Healthy skin is important for maintaining overall physical and cultural health and wellbeing. However, remote-living Australian Aboriginal children contend with disproportionally high rates of (Strep A) infected impetigo. The SToP Trial was a large stepped-wedge cluster randomised trial of See, Treat, and Prevent (SToP) skin health activities implemented between 2019 and 2022 in the Kimberley region of Western Australia, during which a decrease in impetigo was observed. We aim to evaluate the implementation of the SToP Trial activities and understand the relationship between the trial methodologies and outcomes observed.

Methods: A trial evaluation framework was developed, with the aim to assess whether the SToP activities were implemented as intended, and to gain insights into the implementation and practice necessary to translate this project more broadly. The evaluation employed a multi-methods approach, drawing on both quantitative (metadata relating to type and frequency of project activities, survey results) and qualitative (interview and yarning) data. The evaluation aimed to assess the delivery of the program in terms of implementation, degree of impact, and context.

Findings: Nine Kimberley communities participated in the SToP Trial between September 2018 and November 2022. During visits at the end of Steps 1 and 2 (October 2021 and October 2022, respectively), 152 people including 46 community members, 69 school staff members, 29 clinic staff members and 8 other service providers participated in a combination of individual and group interviews/yarns. Findings indicate the SToP Trial and associated activities existed and were completed within a culturally complex context with competing health and socioeconomic priorities while retaining specificity to each involved community. Acceptance and uptake of community activities was high, reflected in a marked decrease in skin infection during the Trial period. Trial activities including increased skin surveillance, staff training, availability of study treatment, environmental health initiatives and health promotion could not individually be linked to this improvement in skin health.

Interpretation: The leadership and guidance of community leaders, families, and regional Kimberley partners contributed to the Trial succeeding in its intended delivery of activities. Similar projects should prioritise a co-designed community-wide, holistic approach to health issues.

Funding: This trial was funded by the WA Department of Health, Australian National Health and Medical Research Council (NHMRC), and Healthway.