Clinical trial NCT05187897: CHV-NEO: Community-based Digital Communication to Support Neonatal Health
Official title: CHV-NEO: Community-based Digital Communication to Support Neonatal Health
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neonatal Death
Perinatal Death
Keywords: SMS
Essential Newborn Care
Kenya
Community Health Volunteer
Neonate
mHealth
Implementation Science
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-01-12
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Neonatal Mortality
timeFrame: 28 days postpartum
Secondary outcomes:
measure: Cord care
timeFrame: 2-weeks postpartum
measure: Thermal Care
timeFrame: 24-hours postpartum
measure: Early Initiation of Breastfeeding
timeFrame: 1-hour postpartum
measure: Appropriate Care-Seeking
timeFrame: 6-weeks postpartum
measure: Maternal Knowledge of Neonatal Danger Signs
timeFrame: 6-weeks postpartum
Other outcomes:
measure: Home Visit Coverage
timeFrame: 2 years of study implementation
measure: Clinic Referrals
timeFrame: 2 years of study implementation
measure: Provider Workload
timeFrame: 2 years of study implementation
measure: Acceptability
timeFrame: 2 years of study implementation
measure: Adoption
timeFrame: 2 years of study implementation
measure: Fidelity
timeFrame: 2 years of study implementation
Locations:
city: Kisumu
country: Kenya
facility: Kenyatta National Hospital
Study officials:
affiliation: University of Washington
name: Keshet Ronen, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kenyatta National Hospital
name: John Kinuthia, MBChB, MPH
role: STUDY_DIRECTOR
References: