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

NCT05187897 | Recruiting DMC

• 2 other identifiers: STUDY00012725R01HD103581
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Death; Perinatal Death

Keywords

SMS; Essential Newborn Care; Kenya; Community Health Volunteer; Neonate; mHealth; Implementation Science

Outcome Measures

Primary Outcomes (1)

• Neonatal Mortality

  Death during 1st 28 days of life

  28 days postpartum

Secondary Outcomes (5)

• Cord care

  2-weeks postpartum

• Thermal Care

  24-hours postpartum

• Early Initiation of Breastfeeding

  1-hour postpartum

• Appropriate Care-Seeking

  6-weeks postpartum

• Maternal Knowledge of Neonatal Danger Signs

  6-weeks postpartum

Other Outcomes (6)

• Home Visit Coverage

  2 years of study implementation

• Clinic Referrals

  2 years of study implementation

• Provider Workload

  2 years of study implementation

Study Arms (2)

Standard Care Control

NO INTERVENTION

CHVs based at facilities in the control arm will continue to implement the standard of care.

CHV-NEO Intervention

EXPERIMENTAL

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

Interventions

CHV-NEO BEHAVIORAL

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.

CHV-NEO Intervention

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant
• 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

You may not qualify if:

• participating in another study
• previously participated in this study

Sponsors & Collaborators

• University of Washington: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• BRAC University: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Kenyatta National Hospital

Kisumu, Kenya

RECRUITING

Related Publications (1)

• 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.

  PMID: 39367450 DERIVED

MeSH Terms

Conditions

Perinatal Death

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Keshet Ronen, MPH, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• John Kinuthia, MBChB, MPH

  Kenyatta National Hospital

  STUDY DIRECTOR

Central Study Contacts

Lincoln Pothan

CONTACT

+1-206-685-4363; lpothan@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Public Health: Global Health

Model Details: Facilities will be randomized to 1) Interactive two-way SMS dialogue integrated into CHV workflow or 2) Control (standard care), using 1:1 allocation. All participants at each study facility will receive the assigned treatment.

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 12, 2022
• Study Start: January 10, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: At the end of the project.
• 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.

Locations

KE (1)