Digital communication between mothers and community health workers to support neonatal health (CHV-NEO): study protocol for a randomized controlled trial.
Keshet Ronen, Lincoln C Pothan, Violet Apondi...
https://pubmed.ncbi.nlm.nih.gov/39367450Actively Recruiting
Phase Not Applicable
Age: 14Years +
FEMALE
Healthy Volunteers
ID05187897
CHV-NEO: Community-based Digital Communication to Support Neonatal Health
Led by University of Washington · Updated on 2025-12-11
3000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Neonatal mortality, defined as death within the first 28 days of life, remains very high in sub-Saharan Africa, including Kenya where about 40,000 neonatal deaths occur yearly. This trial evaluates a two-way interactive SMS messaging program, called CHV-NEO, designed to improve communication between mothers and community health volunteers (CHVs) during the critical early weeks after birth. The study is a cluster-randomized control trial conducted in Western Kenya to assess whether this digital support can reduce neonatal deaths and improve newborn care. CHV-NEO integrates with an existing digital community health toolkit (dCHT) used by CHVs to manage their workflow and client visits. Mothers in the intervention group receive daily automated messages that guide them in recognizing danger signs in their newborns and allow real-time text communication with CHVs between monthly home visits. The control group continues with standard care, meaning CHVs provide usual monthly visits without the SMS support. This trial includes 20 facility clusters randomly assigned to either control or intervention. Participants will be pregnant women 26-36 weeks gestation who have daily mobile phone access and can read or have help reading messages in English, Kiswahili, or Luo. Researchers will track neonatal mortality up to 28 days after birth and assess newborn care practices like cord care, thermal care, breastfeeding initiation, and care-seeking behavior. Maternal knowledge of neonatal danger signs will also be measured. The study involves follow-up up to 6 weeks postpartum to monitor outcomes and acceptability of the SMS intervention.
CONDITIONS
Brief Title
CHV-NEO: Community-based Digital Communication to Support Neonatal Health
Who Can Participate
Age: 14Years +
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Pregnant
- Between 26 and 36 weeks gestation
- Daily access to a mobile phone (own or shared)
- Willing to receive SMS messages
- Female aged 14 years or older
- Able to read and respond to text messages in English, Kiswahili, or Luo, or have household help
- Receiving antenatal care at the study facility
- Plan to stay in the area for at least 3 months postpartum
You will not qualify if you...
- Currently participating in another study
- Previously participated in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - From enrollment through 6 weeks postpartum
Participants receive the CHV-NEO two-way SMS messaging intervention, which supports communication between mothers and community health volunteers between home visits to promote neonatal health.
Monthly home visits and ongoing SMS communication
Follow-up
Duration - Up to 6 weeks postpartum after treatment
Participants are observed for neonatal outcomes and caregiving practices up to 6 weeks postpartum after the intervention period.
Follow-up assessments at 24 hours, 1 hour, 2 weeks, and 6 weeks postpartum
Trial Site Locations
Total: 1 location
1
Kenyatta National Hospital
Kisumu, Kenya
Actively Recruiting
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Research Team
L
Lincoln Pothan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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