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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05187897
Other study ID # STUDY00012725
Secondary ID R01HD103581
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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