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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
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

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

14 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    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)
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    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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