Improving outcomes for children with malaria, diarrhoea and pneumonia in Mozambique through the inSCALE technology innovation: A cluster randomised controlled trial

Background The majority of post-neonatal deaths in children under 5 are due to malaria, diarrhoea and pneumonia (MDP). The WHO recommends integrated community case management (iCCM) of these conditions using community-based health workers. However iCCM programmes have suffered from poor implementation and mixed outcomes. We designed and evaluated a technology-based intervention ‘inSCALE’ (Innovations At Scale For Lasting Effects) to support iCCM programmes and increase appropriate treatment and other outcomes for children with MDP. Methods This superiority cluster randomised controlled trial allocated all 12 districts in Inhambane Province in Mozambique to receive iCCM only (control) or iCCM plus the inSCALE technology intervention. The key components of the intervention consisted of a digital application on smartphones and tablets providing clinical decision support algorithms, stock tracking, automatic personalised messaging, free calls, and solar chargers for iCCM-trained community health workers and primary care facility supervising staff in intervention districts. Population surveys were conducted at baseline and after 18 months in all districts to assess the impact of the intervention on the coverage of appropriate treatment for malaria, diarrhoea and pneumonia in children 2-59months of age, on prevalence of cases of these conditions, and on a range of secondary household and health worker level outcomes. All statistical models accounted for the clustered study design and variables used to constrain the randomisation. A meta-analysis of the estimated pooled impact of the technology intervention was conducted including results from a sister trial (inSCALE-Uganda). Findings The study included 2740 eligible children in control arm districts and 2863 children in intervention districts. The prevalence of cases of MDP decreased from 53.5% (1467) to 43.7% (1251) in the control and intervention arms respectively (risk ratio 0.82, 95% CI 0.78-0.87, p<0.001). The rate of care seeking to the iCCM-trained community health worker increased in the intervention arm (14.4% vs 15.9% in control and intervention arms respectively) but fell short of the significance threshold (adjusted RR 1.63, 95% CI 0.93-2.85, p=0.085). Coverage of the appropriate treatment of cases of MDP increased by 26% in the intervention arm (RR 1.26 95% CI 1.12-1.42, p<0.001) after accounting for the randomisation and design effects. Across two country trials, the estimated pooled effect of the inSCALE intervention on coverage of appropriate treatment for MDP was RR 1.15 (95% CI 1.08-1.24, p <0.001). Interpretation The inSCALE intervention led to a reduction in prevalence of MDP and an improvement in appropriate treatment when delivered at scale in Mozambique. The programme will be rolled out by the ministry of health to the entire national CHW and primary care network in 2022. This study highlights the potential value of a technology intervention aimed at strengthening iCCM systems to address the largest causes of childhood morbidity and mortality in sub-Saharan Africa. Author Summary The inSCALE cluster-randomised trial in Mozambique was part of a $10million project funded by the Bill and Melinda Gates Foundation to design and test innovative primary care interventions to improve health outcomes for children with malaria, diarrhoea and pneumonia (MDP), which together are the largest killers of children aged <5yrs. The study aimed to strengthen the primary health care system with a focus on community health workers, representing the most accessible level of care for many underserved populations. We designed a technology-based intervention delivered using cheap smartphones. This intervention was based on mHealth principles and included basic AI to guide correct diagnosis and treatment of MDP, provided personalised feedback to health workers, and alerts to supervising health facilities on stock outs and data tracking. The study was implemented within the entire province of Inhambane, and districts were randomly assigned to the intervention or to continue with standard care (control). Compared to control districts, we observed significant reductions in the prevalences of MDP in children under 5 years (reductions of 20% for malaria, 34% for pneumonia, and 45% for diarrhoea) and an increase in appropriate treatment of any cases of MDP by 26% (of all cases MDP) and 40% (of all children) in the intervention districts. As a result of this trial, the government of Mozambique incorporated the inSCALE intervention into its policy for child health services, and is in the process of scaling up the programme to all 8000+ community health workers across the country (2022). ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT01972321 ### Funding Statement The inSCALE study was supported by The Bill and Melinda Gates Foundation, grant number OPP1002407. The BMGF played no role in the design, analysis, decision to publish or preparation of this manuscript. ### 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: Ethical approval for the study was obtained from the Mozambique National Bioethics Committee for Health (reference 345-CNBS-10) and the London School of Hygiene & Tropical Medicine Ethics Committee in the UK (reference 5762). This includes for storage of anonymised data in public repositories. 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 and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Data will be available after publication at this address: https://doi.org/10.17037/DATA.00002559