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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neonatal Death, Perinatal Death

Intervention / Treatment
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* Behavioral: CHV-NEO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care Control<br>CHVs based at facilities in the control arm will continue to implement the standard of care. | |
| Experimental: CHV-NEO Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Mortality | Death during 1st 28 days of life | 28 days postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cord care | Number of participants with no application of substances to cord | 2-weeks postpartum | 
| Thermal Care | Number of participants giving infant a bath in 1st 24 hours of life | 24-hours postpartum | 
| Early Initiation of Breastfeeding | Number of participants initiating breastfeeding in 1st hour of life | 1-hour postpartum | 
| Appropriate Care-Seeking | Number of clinic visits reported with danger sign and/or hospital admission | 6-weeks postpartum | 
| Maternal Knowledge of Neonatal Danger Signs | Number of danger signs or symptoms successfully named | 6-weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SMS, Neonate, Essential Newborn Care, Kenya, Community Health Volunteer, mHealth, Implementation Science