CHV-NEO: Community-based Digital Communication to Support Neonatal Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CHV-NEO.
- Who it may be relevant to
- Registry conditions: Neonatal Death, Perinatal Death. Basic parameters: from 14 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kenya
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Behavioral CHV-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.
Primary outcome measures
- Neonatal Mortality [Time frame: 28 days postpartum]
Secondary outcome measures (5)
- Cord care [Time frame: 2-weeks postpartum]
- Thermal Care [Time frame: 24-hours postpartum]
- Early Initiation of Breastfeeding [Time frame: 1-hour postpartum]
- Appropriate Care-Seeking [Time frame: 6-weeks postpartum]
- Maternal Knowledge of Neonatal Danger Signs [Time frame: 6-weeks postpartum]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Kenya · 1 center
- Kenyatta National Hospital — Kisumu
Publications
- Ronen K, Pothan LC, Apondi V, Otieno FA, Mwakanema D, Otieno FO, Osborn L, Dettinger JC, Shrestha P, Manguerra H, Mukumbang F, Masinde M, Waweru E, Amulele M, Were C, Wasunna B, John-Stewart G, Weiner B, Means AR, Richardson BA, Hedstrom AB, Unger JA, Kinuthia J. Digital communication between mothers and community health workers to support neonatal health (CHV-NEO): study protocol for a randomized PMID 39367450
Identifiers
NCT: NCT05187897 · STUDY00012725 · R01HD103581