Digital communication between mothers and community health workers to support neonatal health (CHV-NEO): study protocol for a randomized controlled trial.

Background: Provision of essential newborn care at home, rapid identification of illness, and care-seeking by caregivers can prevent neonatal mortality. Mobile technology can connect caregivers with information and healthcare worker advice more rapidly and frequently than healthcare visits. Community health workers (CHWs) are well-suited to deliver such interventions. We developed an interactive short message service (SMS) intervention for neonatal health in Kenya, named CHV-NEO. CHV-NEO sends automated, theory-based, actionable, messages throughout the peripartum period that guide mothers to evaluate maternal and neonatal danger signs and facilitate real-time dialogue with a CHW via SMS. We integrated this intervention into Kenya's national electronic community health information system (eCHIS), which is currently used at scale to support CHW workflow. Methods: The effect of CHV-NEO on clinical and implementation outcomes will be evaluated through a non-blinded cluster randomized controlled trial. Twenty sites across Kisumu County in Western Kenya were randomized 1:1 to provide either the national eCHIS with integrated CHV-NEO messaging (intervention) or standard of care using eCHIS without CHV-NEO (control). We will compare neonatal mortality between arms based on abstracted eCHIS data from 7200 pregnant women. Secondary outcomes include self-reported provision of essential newborn care (appropriate cord care, thermal care, and timely initiation of breastfeeding), knowledge of neonatal danger signs, and care-seeking for neonatal illness, compared between arms based on questionnaires with a subgroup of 2000 women attending study visits at enrollment in pregnancy and 6 weeks postpartum. We will also determine CHV-NEO's effect on CHW workflows and evaluate determinants of intervention acceptability, adoption, and fidelity of use through questionnaires, individual interviews, and messaging data. Discussion: We hypothesize that the CHV-NEO direct-to-client communication strategy can be successfully integrated within existing CHW workflows and infrastructure, improve the provision of at-home essential newborn care, increase timely referral of neonatal illness to facilities, and reduce neonatal mortality. The intervention's integration into the national eCHIS tool will facilitate rapid scale-up if it is clinically effective and successfully implemented. Trial registration: ClinicalTrials.gov, NCT05187897. The CHV-NEO study was registered on January 12, 2022. [ABSTRACT FROM AUTHOR]