The SToP Trial: See Treat Prevent skin sores and scabies A healthy skin programme in communities in the Kimberley.

The overall duration of the trial is four years and it will be conducted in four Kimberley community clusters using a stepped-wedge design. The stepped-wedge design allows the scientific rigour of a randomized trial, whilst acknowledging the pragmatic need to gradually roll out an intervention over several communities in a remote region. The trial comprises of four phases: 1. Baseline 2. Intervention (implementation of the "SToP activities", where clusters are randomly "stepped" onto the SToP activities, following the stepped wedge design; two clusters randomised to the SToP activities known as "step 1" and two clusters randomised to the SToP activities one year later known as "step 2"). 3. Follow up. 4 Maintenance. Intervention: The "SToP Activities" There are three intervention components, collectively known as the “SToP activities”. As per the stepped-wedge design, all community clusters will have transitioned ("stepped" onto) to the SToP activities upon completion of the trial. In Step 1, two randomly selected community clusters will receive the SToP activities. In Step 2, the remaining 2 community clusters will transition to receive the SToP activities. The SToP activities have three main components - (a)"See"ing, (b)"Treat"ing, and (c) "Prevent"ing skin infections: a) “See”ing skin infections by providing health care worker training on the diagnosis and treatment of skin infections, and by conducting school-based surveillance for skin infections. Health care worker training will be provided by trial staff and include face-to-face training sessions to up-skill health care workers with the latest evidence based recommendations for identifying and treating skin infections. Health care workers will be invited to attend this training session prior to each school based surveillance/screening visit (described below). The training session duration will range from 1-2hours up to a full day (depending on availability of health care workers). Health care workers will also be provided with online and paper resources of this training information, such as a training flipchart, self-assessment quiz for feedback on their learning, and training videos. Where possible, trial staff will provide further 'hands on' training and demonstrate identifying skin infections by partnering with health care worker staff to complete the school-based surveillance/screening. The school-based surveillance/screening (and early childhood where feasible) will involve trial staff (and where possible, health care worker staff) screening children at school to assess their skin for infections. If skin infections are identified, the child will be referred to the local clinic for treatment. Their parent/caregiver will also be notified and recommended to take them to the clinic for treatment. School surveillance/screening visits will occur in all 4 communities three times per year for 3 years (total of 9 visits). b) “Treat”ing skin infections according to the latest evidence and utilising ‘Structured Administration and Supply Arrangements’ (previously known as “standing orders”) for streamlined treatment, namely co-trimoxazole twice daily for 3 days for impetigo, ivermectin on days 0 and 8 for scabies cases and their contacts and holistic care including treatment of those identified with crusted scabies (ivermectin on days 0, 1 and 8 for grade 1 crusted scabies). Treatment will occur at the local community clinic and occur as individuals present to the clinic and are assessed as requiring this treatment. Mode, dose and duration for cotrimoxazole (for treatment of impetigo): 4mg/kg/dose twice daily for 3 days according to weight band based dosing of the trimethoprim component of trimethoprim/ sulphamethoxazole. Either syrup or tablets will be recommended depending on age and preference. Adherence to the treatment will not be monitored. The investigational medicinal product (IMP) for this trial is ivermectin (for treatment of scabies/crusted scabies). This trial will use ivermectin off label as first line treatment for cases of scabies, preventative treatment of asymptomatic household contacts of the diagnosed cases, and be administered to patients more than 15kg but irrespective of age. Mode, dose and duration for ivermectin: 200 µg/kg (weight band dosing) single dose oral tablet (once daily), taken on day 0 and day 8. Ivermectin dosing will predominantly occur at the clinic as it will be a single dose on day 0 (and day 8) if indicated. Adherence to the treatment will not be monitored but adverse events will be recorded. Patients presenting with both scabies and impetigo will be treated for both conditions simultaneously as described above. c) “Prevent”ing skin infections through embedded, culturally informed and developed health promotion and environmental health activities. These activities will occur throughout the trial at a community level and as determined by local health promotion and environmental health services. Health promotion and environmental health activities are part of routine care in the Kimberley. As such, the service partners in the research will continue to deliver health promotion/environmental health as per usual activities. The duration and frequency will vary depending on need and prioritisation from the service providers. The trial team will collect data on how frequently this occurs for the overall evaluation of the trial. The overall duration of the study is four years.