CHV-NEO: Community-based Digital Communication to Support Neonatal Health
Primary Purpose
Neonatal Death, Perinatal Death
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CHV-NEO
Sponsored by
About this trial
This is an interventional prevention trial for Neonatal Death focused on measuring SMS, Essential Newborn Care, Kenya, Community Health Volunteer, Neonate, mHealth, Implementation Science
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Care Control
CHV-NEO Intervention
Arm Description
CHVs based at facilities in the control arm will continue to implement the standard of care.
CHVs based at facilities in the Intervention arm will implement the integrated CHV-NEO two-way SMS messaging intervention with their clients.
Outcomes
Primary Outcome Measures
Neonatal Mortality
Death during 1st 28 days of life
Secondary Outcome Measures
Cord care
Number of participants with no application of substances to cord
Thermal Care
Number of participants giving infant a bath in 1st 24 hours of life
Early Initiation of Breastfeeding
Number of participants initiating breastfeeding in 1st hour of life
Appropriate Care-Seeking
Number of clinic visits reported with danger sign and/or hospital admission
Maternal Knowledge of Neonatal Danger Signs
Number of danger signs or symptoms successfully named
Full Information
NCT ID
NCT05187897
First Posted
December 24, 2021
Last Updated
December 24, 2021
Sponsor
University of Washington
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT05187897
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Death, Perinatal Death
Keywords
SMS, Essential Newborn Care, Kenya, Community Health Volunteer, Neonate, mHealth, Implementation Science
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Care Control
Arm Type
No Intervention
Arm Description
CHVs based at facilities in the control arm will continue to implement the standard of care.
Arm Title
CHV-NEO Intervention
Arm Type
Experimental
Arm Description
CHVs based at facilities in the Intervention arm will implement the integrated CHV-NEO two-way SMS messaging intervention with their clients.
Intervention Type
Behavioral
Intervention Name(s)
CHV-NEO
Intervention Description
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 Measure Information:
Title
Neonatal Mortality
Description
Death during 1st 28 days of life
Time Frame
28 days postpartum
Secondary Outcome Measure Information:
Title
Cord care
Description
Number of participants with no application of substances to cord
Time Frame
2-weeks postpartum
Title
Thermal Care
Description
Number of participants giving infant a bath in 1st 24 hours of life
Time Frame
24-hours postpartum
Title
Early Initiation of Breastfeeding
Description
Number of participants initiating breastfeeding in 1st hour of life
Time Frame
1-hour postpartum
Title
Appropriate Care-Seeking
Description
Number of clinic visits reported with danger sign and/or hospital admission
Time Frame
6-weeks postpartum
Title
Maternal Knowledge of Neonatal Danger Signs
Description
Number of danger signs or symptoms successfully named
Time Frame
6-weeks postpartum
Other Pre-specified Outcome Measures:
Title
Home Visit Coverage
Description
Number of home visits performed by CHVs
Time Frame
2 years of study implementation
Title
Clinic Referrals
Description
Number of clinic referrals logged in dCHT by CHVs
Time Frame
2 years of study implementation
Title
Provider Workload
Description
Time on all CHV/supervisor duties
Time Frame
2 years of study implementation
Title
Acceptability
Description
Perception by CHVs that CHV-NEO is agreeable or satisfactory on a 4-item scale
Time Frame
2 years of study implementation
Title
Adoption
Description
Number of client SMS read by CHV
Time Frame
2 years of study implementation
Title
Fidelity
Description
Number of client SMS responded to by CHV on time per SOP
Time Frame
2 years of study implementation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lincoln Pothan
Phone
+1-206-685-4363
Email
lpothan@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keshet Ronen, MPH, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBChB, MPH
Organizational Affiliation
Kenyatta National Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from CHV-NEO will be available at end of the project by contacting the study team at the University of Washington (chv-neo@uw.edu) or accessing data on GitHub.
IPD Sharing Time Frame
At the end of the project.
IPD Sharing Access Criteria
After publication of original data, data may be shared upon request with other investigators at academic, non-profit, or Kenyan government institutions in a limited data set. The final dataset will be stripped of identifiers prior to release for sharing. Investigators requesting access to data must sign a data-sharing agreement that provides for a commitment to: (1) using the data only for research purposes and not to identify any individual participant; (2) securing the data using appropriate computer technology; (3) not sharing the data with third parties, and (4) destroying or returning the data after analyses are completed. We reserve the right to limit data provided to outside investigators if we believe there is a possibility of deductive disclosure of subjects with unusual characteristics.
Learn more about this trial
CHV-NEO: Community-based Digital Communication to Support Neonatal Health
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