Background: A stepped-wedge, community randomised trial was implemented in Australia’s Northern Territory to test whether a clinic-level intervention could improve prophylaxis delivery for Aboriginal people with ARF/RHD. Ten clinics received a multifaceted intervention which supported them to develop and implement strategies to improve penicillin delivery and RHD care, aligned with themes of the Chronic Care Model. The proportion of patients receiving ≥80% of scheduled injections in the intensive phase (126/304 [41.5%]) did not improve compared with baseline (141/304 [46.4%]), odds ratio 0.78 (95% CI 0.54 to 1.11). An overarching theory-driven evaluation framework guided the analysis of qualitative data to explain the reasons for the study not achieving its primary outcome.
Methods: The intervention’s effectiveness, efficiency, process, fidelity, performance and context was evaluated. Pre and post interviews with participants (n=166), quarterly project officer observational reports (n=50), and detailed tracking of action plans (n=10) and implemented action items (n=252) provided primary qualitative data.
Findings: Low level of intervention uptake and exposure was documented affecting causal processes, thus attainment of outcomes. Acceptability and completeness of the intervention and its components, barriers to implementation and organizational change strongly contributed to intervention effectiveness. All sites highlight the significance of context in assessing why an intervention may be implementable and effective in one setting but not another.
Conclusion: Despite implementing a comprehensive health system strengthening strategy, we did not find a significant improvement in adherence to ARF secondary prophylaxis. Other strategies for improved ARF prevention, including Group A Streptococcal prevention and treatment are required.