CHV-NEO: Community-based Digital Communication to Support Neonatal Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age14+
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant
26-36 weeks gestation
Daily access to a mobile phone (own or shared)
Willing to receive SMS
Disqualifiers
participating in another study
previously participated in this study
Trial design
Design model
Parallel
Treatments tested in this trial
CHV-NEO
BehavioralCHV-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.
Treatment groups
3,000 Participants
are divided into 2 treatment groupsGroup A: Standard Care ControlNo intervention 0 interventions
Group B: CHV-NEO InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Neonatal Mortality
Death during 1st 28 days of life
Time frame
28 days postpartumSecondary outcomes
1
Cord care
Number of participants with no application of substances or chlorhexidine only to cord
Time frame
2-weeks postpartum2
Thermal Care
Number of participants giving infant a bath in 1st 24 hours of life
Time frame
24-hours postpartum3
Early Initiation of Breastfeeding
Number of participants initiating breastfeeding in 1st hour of life
Time frame
1-hour postpartum4
Appropriate Care-Seeking
Proportion of illness episodes with danger signs where the infant attended a medical facility
Time frame
6-weeks postpartumOther outcomes
1
Home Visit Coverage
Number of home visits performed by CHVs
Time frame
2 years of study implementation2
Clinic Referrals
Number of clinic referrals logged in dCHT by CHVs
Time frame
2 years of study implementation3
Provider Workload
Time on all CHV/supervisor duties
Time frame
2 years of study implementation4
Acceptability
Perception by CHVs that CHV-NEO is agreeable or satisfactory on the Acceptability of Intervention Measure (higher score is more acceptable)
Time frame
2 years of study implementationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
BRAC University
Collaborator
Bill and Melinda Gates Foundation
Collaborator
Source ClinicalTrials.gov