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

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.

Study Overview

• Status: Recruiting
• Conditions: Perinatal Death; Neonatal Death
• Intervention / Treatment: Behavioral: CHV-NEO

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 Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lincoln Pothan; Phone Number: +1-206-685-4363; Email: lpothan@uw.edu

Study Locations

• Kenya
  • Kisumu, Kenya
    • Recruiting
    • Kenyatta National Hospital
    • Contact: John Kinuthia, MBChB, MMed, MPH; Phone Number: +254722799052; Email: kinuthia@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Exclusion Criteria:

• participating in another study
• previously participated in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care Control; CHVs based at facilities in the control arm will continue to implement the standard of care.
Experimental: CHV-NEO Intervention; CHVs based at facilities in the Intervention arm will implement the integrated CHV-NEO two-way SMS messaging intervention with their clients.	Behavioral: CHV-NEO; CHV-NEO is a two-way SMS platform that supports communication between mothers and community health volunteers between home visits. The platform engages mothers with SMS communication and brings timely information and support - asking critical questions at crucial times in order to assess the needs and health of newborns and assist in care seeking decisions. The CHV-NEO SMS intervention is integrated into the current digital community health toolkit (dCHT) to support CHV workflow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Mortality	Death during 1st 28 days of life	28 days postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thermal Care	Number of participants giving infant a bath in 1st 24 hours of life	24-hours postpartum
Early Initiation of Breastfeeding	Number of participants initiating breastfeeding in 1st hour of life	1-hour postpartum
Maternal Knowledge of Neonatal Danger Signs	Number of danger signs or symptoms successfully named	6-weeks postpartum
Cord care	Number of participants with no application of substances or chlorhexidine only to cord	2-weeks postpartum
Appropriate Care-Seeking	Proportion of illness episodes with danger signs where the infant attended a medical facility	6-weeks postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home Visit Coverage	Number of home visits performed by CHVs	2 years of study implementation
Clinic Referrals	Number of clinic referrals logged in dCHT by CHVs	2 years of study implementation
Provider Workload	Time on all CHV/supervisor duties	2 years of study implementation
Fidelity	Number of client SMS responded to by CHV on time per SOP	2 years of study implementation
Acceptability	Perception by CHVs that CHV-NEO is agreeable or satisfactory on the Acceptability of Intervention Measure (higher score is more acceptable)	2 years of study implementation
Adoption	Proportion of client messages replied to by CHV	2 years of study implementation

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Bill and Melinda Gates Foundation; BRAC University
• Investigators: Principal Investigator: Keshet Ronen, MPH, PhD, University of Washington; Study Director: John Kinuthia, MBChB, MPH, Kenyatta National Hospital

Publications and helpful links

General Publications

• Ronen K, Pothan LC, Apondi V, Otieno FA, Mwakanema D, Otieno FO, Osborn L, Dettinger JC, Shrestha P, Manguerra H, Mukumbang F, Masinde M, Waweru E, Amulele M, Were C, Wasunna B, John-Stewart G, Weiner B, Means AR, Richardson BA, Hedstrom AB, Unger JA, Kinuthia J. Digital communication between mothers and community health workers to support neonatal health (CHV-NEO): study protocol for a randomized controlled trial. Trials. 2024 Oct 4;25(1):657. doi: 10.1186/s13063-024-08501-2.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 24, 2021
• First Submitted That Met QC Criteria: December 24, 2021
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Kenya; mHealth; Neonate; Implementation Science; SMS; Essential Newborn Care; Community Health Volunteer
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Death; Pathological Conditions, Signs and Symptoms; Perinatal Death
• Other Study ID Numbers: STUDY00012725; R01HD103581 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from CHV-NEO will be available at end of the project by contacting the study team at the University of Washington (chv-neo@uw.edu) or accessing data on GitHub.
• IPD Sharing Time Frame: At the end of the project.
• IPD Sharing Access Criteria: After publication of original data, data may be shared upon request with other investigators at academic, non-profit, or Kenyan government institutions in a limited data set. The final dataset will be stripped of identifiers prior to release for sharing. Investigators requesting access to data must sign a data-sharing agreement that provides for a commitment to: (1) using the data only for research purposes and not to identify any individual participant; (2) securing the data using appropriate computer technology; (3) not sharing the data with third parties, and (4) destroying or returning the data after analyses are completed. We reserve the right to limit data provided to outside investigators if we believe there is a possibility of deductive disclosure of subjects with unusual characteristics.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No