CHV-NEO: Community-based Digital Communication to Support Neonatal Health

Not Applicable

Recruiting

• Conditions: Neonatal Death; Perinatal Death
• Interventions: Behavioral: CHV-NEO

• Registration Number: NCT05187897
• Lead Sponsor: University of Washington

Brief Summary

Neonatal mortality (defined as death in the first 28 days of life) remains unacceptably high in sub-Sarahan Africa. The concentrated risk of neonatal illness in the first weeks of life and its potential to rapidly deteriorate means that expanding mothers' access to timely information and support during this period is critical to reducing neonatal mortality. This cluster-randomized control trial aims to integrate a 2 way interactive SMS text messaging intervention into existing digital infrastructure supporting Community Health Volunteer (CHV) workflow in Western Kenya (dCHT) to enable remote communication by mothers with CHVs between home visits.

Detailed Description

In Kenya, the neonatal mortality rate is 22.6 per 1000 live births, ranking among the countries with the highest number of neonatal deaths (\~40,000 per year). Community health volunteers (CHVs) are a large cadre of lay health workers whose role is to promote access to preventative care and treatment in resource-limited settings. In Kenya, CHVs conduct monthly home visits to pregnant and postpartum women to provide education and screen for complications. Several counties in Kenya have adopted a digital community health toolkit (dCHT) that supports CHV workflow by tracking clients, managing tasks, and guiding home visits. Even so, the concentrated risk of neonatal illness in the first weeks of life and its potential to rapidly deteriorate mean that even monthly home visits leave mothers and neonates in need of on-demand support.

Our team developed an interactive SMS text messaging intervention, Mobile WACh Neo (NEO), that connects mothers with healthcare workers remotely in the high-risk period immediately following birth to improve maternal and neonatal health. NEO sends automated, theory-based, actionable daily messages that systematically guide mothers to evaluate neonatal danger signs, and facilitates real-time dialogue with a healthcare worker to triage medical concerns and augment maternal social support.

The overarching goal of this project is to integrate NEO interactive SMS into the existing digital infrastructure supporting CHV workflow in Western Kenya (dCHT) to enable remote communication by mothers with CHVs between home visits. This is a cluster-randomized control trial consisting of 20 facility clusters (10 control, 10 intervention) in Western Kenya.

AIM 1: Employ a human-centered design approach to develop a NEO interactive SMS module in the dCHT, named CHV-NEO.

AIM 2: a) Evaluate CHV-NEO's impact on neonatal mortality, b) clinic visit attendance, and caregiver provision of essential newborn care (cord care, thermal care and initiation of breastfeeding), in a pragmatic cluster-randomized trial.

AIM 3: a) Determine the effect of CHV-NEO on CHV and supervisor workflow, and b) evaluate determinants of CHV-NEO's acceptability, adoption and fidelity of use.

Study Timeline

• Study First Submitted: 2021-12-24
• Study First Submitted QC: 2021-12-24
• Study First Posted: 2022-01-12
• Status Verified: 2024-01
• Study Start: 2024-01-10
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

• Pregnant
• 26-36 weeks gestation
• Daily access to a mobile phone (own or shared)
• Willing to receive SMS
• Age ≥14 years
• Able to read and respond to text messages in English, Kiswahili or Luo, or have someone in the household who can help
• Receiving antenatal care at study facility
• Plan to be in the area for at least 3 months postpartum

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Exclusion Criteria

• participating in another study
• previously participated in this study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHV-NEO Intervention	CHV-NEO	CHVs based at facilities in the Intervention arm will implement the integrated CHV-NEO two-way SMS messaging intervention with their clients.

Primary Outcome Measures

Name	Time	Method
Neonatal Mortality	28 days postpartum	Death during 1st 28 days of life

Secondary Outcome Measures

Name	Time	Method
Early Initiation of Breastfeeding	1-hour postpartum	Number of participants initiating breastfeeding in 1st hour of life
Cord care	2-weeks postpartum	Number of participants with no application of substances to cord
Thermal Care	24-hours postpartum	Number of participants giving infant a bath in 1st 24 hours of life
Maternal Knowledge of Neonatal Danger Signs	6-weeks postpartum	Number of danger signs or symptoms successfully named
Appropriate Care-Seeking	6-weeks postpartum	Number of clinic visits reported with danger sign and/or hospital admission

Trial Locations

Locations (1)

Kenyatta National Hospital; 🇰🇪 Kisumu, Kenya