Skip to content

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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05187897
Enrollment
3000
Registered
2022-01-12
Start date
2024-01-10
Completion date
2026-06-30
Last updated
2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Death, Perinatal Death

Keywords

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

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.

Interventions

BEHAVIORALCHV-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.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
BRAC University
CollaboratorOTHER
Bill and Melinda Gates Foundation
CollaboratorOTHER
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Neonatal Mortality28 days postpartumDeath during 1st 28 days of life

Secondary

MeasureTime frameDescription
Cord care2-weeks postpartumNumber of participants with no application of substances or chlorhexidine only to cord
Thermal Care24-hours postpartumNumber of participants giving infant a bath in 1st 24 hours of life
Early Initiation of Breastfeeding1-hour postpartumNumber of participants initiating breastfeeding in 1st hour of life
Appropriate Care-Seeking6-weeks postpartumProportion of illness episodes with danger signs where the infant attended a medical facility
Maternal Knowledge of Neonatal Danger Signs6-weeks postpartumNumber of danger signs or symptoms successfully named

Other

MeasureTime frameDescription
Home Visit Coverage2 years of study implementationNumber of home visits performed by CHVs
Clinic Referrals2 years of study implementationNumber of clinic referrals logged in dCHT by CHVs
Provider Workload2 years of study implementationTime on all CHV/supervisor duties
Acceptability2 years of study implementationPerception by CHVs that CHV-NEO is agreeable or satisfactory on the Acceptability of Intervention Measure (higher score is more acceptable)
Adoption2 years of study implementationProportion of client messages replied to by CHV
Fidelity2 years of study implementationNumber of client SMS responded to by CHV on time per SOP

Countries

Kenya

Contacts

Primary ContactLincoln Pothan
lpothan@uw.edu+1-206-685-4363

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026