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

Neonatal Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05187897
• Other study ID #: STUDY00012725
• Secondary ID: R01HD103581
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: August 2025

Study information

• Verified date: January 2024
• Source: University of Washington
• Contact: Lincoln Pothan
• Phone: +1-206-685-4363
• Email: lpothan[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Neonatal Death
• Perinatal Death

Intervention

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.

Locations

Country	Name	City	State
Kenya	Kenyatta National Hospital	Kisumu

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Home Visit Coverage	Number of home visits performed by CHVs	2 years of study implementation
Other	Clinic Referrals	Number of clinic referrals logged in dCHT by CHVs	2 years of study implementation
Other	Provider Workload	Time on all CHV/supervisor duties	2 years of study implementation
Other	Acceptability	Perception by CHVs that CHV-NEO is agreeable or satisfactory on the Acceptability of Intervention Measure (higher score is more acceptable)	2 years of study implementation
Other	Adoption	Number of client SMS read by CHV	2 years of study implementation
Other	Fidelity	Number of client SMS responded to by CHV on time per SOP	2 years of study implementation
Primary	Neonatal Mortality	Death during 1st 28 days of life	28 days postpartum
Secondary	Cord care	Number of participants with no application of substances to cord	2-weeks postpartum
Secondary	Thermal Care	Number of participants giving infant a bath in 1st 24 hours of life	24-hours postpartum
Secondary	Early Initiation of Breastfeeding	Number of participants initiating breastfeeding in 1st hour of life	1-hour postpartum
Secondary	Appropriate Care-Seeking	Number of clinic visits reported with danger sign and/or hospital admission	6-weeks postpartum
Secondary	Maternal Knowledge of Neonatal Danger Signs	Number of danger signs or symptoms successfully named	6-weeks postpartum