Department of Global Health, University of Washington, Seattle, WA, USA.
Department of Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.
Trials. 2024 Oct 4;25(1):657. doi: 10.1186/s13063-024-08501-2.
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.
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.
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.
ClinicalTrials.gov, NCT05187897 . The CHV-NEO study was registered on January 12, 2022.
在家中提供基本新生儿护理、快速识别疾病以及护理人员寻求医疗帮助，可以预防新生儿死亡。移动技术可以比医疗访问更快速和频繁地将护理人员与信息和医疗保健工作者的建议联系起来。社区卫生工作者（CHW）非常适合提供此类干预措施。我们在肯尼亚开发了一种名为 CHV-NEO 的新生儿健康互动短信息服务（SMS）干预措施。CHV-NEO 在围产期会发送自动的、基于理论的、可操作的信息，指导母亲评估产妇和新生儿的危险信号，并通过 SMS 与 CHW 进行实时对话。我们将这种干预措施整合到肯尼亚现有的国家电子社区卫生信息系统（eCHIS）中，该系统目前正在大规模使用，以支持 CHW 的工作流程。
CHV-NEO 对临床和实施结果的影响将通过一项非盲、集群随机对照试验进行评估。在肯尼亚西部基苏木县的 20 个地点，按照 1:1 的比例随机分配，一组提供国家 eCHIS 与集成的 CHV-NEO 消息传递（干预），另一组提供没有 CHV-NEO 的标准 eCHIS（对照）。我们将根据从 7200 名孕妇中提取的 eCHIS 数据，比较两组之间的新生儿死亡率。次要结果包括根据在妊娠登记和产后 6 周的研究访问中参加的 2000 名妇女的问卷调查，比较两组之间提供基本新生儿护理（适当的脐带护理、热护理和及时开始母乳喂养）、新生儿危险信号知识和寻求新生儿疾病治疗的情况。我们还将确定 CHV-NEO 对 CHW 工作流程的影响，并通过问卷、个人访谈和消息传递数据来评估干预措施可接受性、采用和使用一致性的决定因素。
我们假设 CHV-NEO 直接面向客户的沟通策略可以成功地整合到现有的 CHW 工作流程和基础设施中，改善在家中提供基本新生儿护理的情况，增加及时将新生儿疾病转诊到医疗机构的情况，并降低新生儿死亡率。如果该干预措施具有临床效果并成功实施，那么它整合到国家 eCHIS 工具中将会促进快速推广。
ClinicalTrials.gov，NCT05187897。CHV-NEO 研究于 2022 年 1 月 12 日注册。
