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NCT Number: NCT05187897

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.

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Key information

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kenyatta National Hospital

Kisumu, Kenya

Location status: Recruiting

Location contact

John Kinuthia, MBChB, MMed, MPH

CONTACT

[email protected]

+254722799052

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Neonatal Mortality

    Time frame: 28 days postpartum

    Death during 1st 28 days of life

Secondary outcomes

  1. Cord care

    Time frame: 2-weeks postpartum

    Number of participants with no application of substances or chlorhexidine only to cord

  2. Thermal Care

    Time frame: 24-hours postpartum

    Number of participants giving infant a bath in 1st 24 hours of life

  3. Early Initiation of Breastfeeding

    Time frame: 1-hour postpartum

    Number of participants initiating breastfeeding in 1st hour of life

  4. Appropriate Care-Seeking

    Time frame: 6-weeks postpartum

    Proportion of illness episodes with danger signs where the infant attended a medical facility

  5. Maternal Knowledge of Neonatal Danger Signs

    Time frame: 6-weeks postpartum

    Number of danger signs or symptoms successfully named

Other outcomes

  1. Home Visit Coverage

    Time frame: 2 years of study implementation

    Number of home visits performed by CHVs

  2. Clinic Referrals

    Time frame: 2 years of study implementation

    Number of clinic referrals logged in dCHT by CHVs

  3. Provider Workload

    Time frame: 2 years of study implementation

    Time on all CHV/supervisor duties

  4. Acceptability

    Time frame: 2 years of study implementation

    Perception by CHVs that CHV-NEO is agreeable or satisfactory on the Acceptability of Intervention Measure (higher score is more acceptable)

  5. Adoption

    Time frame: 2 years of study implementation

    Proportion of client messages replied to by CHV

  6. Fidelity

    Time frame: 2 years of study implementation

    Number of client SMS responded to by CHV on time per SOP

Study contacts

Contact information is provided by the study sponsor or research team.

Lincoln Pothan

CONTACT

[email protected]

+1-206-685-4363

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2022
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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