Abstract

Background: The inSCALE cluster randomised controlled trial evaluated two interventions, mHealth and Village Health Clubs (VHCs) which aimed to improve Community Health Worker (CHW) treatment for malaria, diarrhoea, and pneumonia within the Integrated Community Case Management programme. Methods: In a cluster randomised trial, 39 sub-counties in Midwest Uganda, covering 3167 CHWs, were randomly allocated to mHealth; VHC or usual care (control) arms. Household surveys captured parent-reported child illness, care seeking and treatment practices. Intention-to-treat analysis estimated the proportion of appropriately treated children with malaria, diarrhoea and pneumonia according to WHO informed national guidelines. Registration: ClinicalTrials.gov (NCT01972321). ResultsBetween April-June 2014, 7679 households were surveyed; 2806 children were found with malaria, diarrhoea or pneumonia symptoms in the last one month. Appropriate treatment was 11% higher in the mHealth compared to the control arm (risk ratio [RR] 1·11, 95% CI 1·02, 1·21; p=0·018). The largest effect was on appropriate treatment for diarrhoea (RR 1·39; 95% CI 0·90, 2·15; p=0·134). The VHC intervention increased appropriate treatment by 9% (RR 1·09; 95% CI 1·01, 1·18; p=0·059), again with largest effect on treatment of diarrhoea (RR 1·56, 95% CI 1·04, 2·34, p=0·030). CHWs provided the highest levels of appropriate treatment compared to other providers. However, differences in appropriate treatment were at health facilities and pharmacies, with CHW appropriate treatment the same across the arms. The rate of CHW attrition in both intervention arms was less than half that of the control arm; adjusted risk difference mHealth arm -4·42% (95% CI -8·54, -0·29, p=0·037) and VHC arm -4·75% (95% CI -8·74, -0·76, p=0·021). Interpretation: Appropriate treatment by CHWs was encouragingly high across arms. The inSCALE mHealth and VHC interventions have the potential to reduce CHW attrition and improve the treatment of sick children, but not through the hypothesised mechanisms of improved CHW utilization and treatment. Trial Registration: ClinicalTrials.gov (NCT01972321). Funding: Bill & Melinda Gates Foundation and UK DFID Declaration of Interest: We declare no competing interests Ethical Approval: The inSCALE trial, registered as NCT01972321, was approved by Makerere University Institutional Review Board, the Uganda National Council of Science and Technology (ref. HS 958), and London School of Hygiene & Tropical Medicine Ethics Committee in the UK (ref. 5762). Oral consent for the random allocation of districts to intervention or control groups was obtained from the sub-county leadership. Individual written informed consent was obtained from the caregiver for baseline and follow up data collection after explaining the purpose of the interview. Participants were free to decline the interview at any time.

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