NCT06237374

Brief Summary

This study seeks to understand how to support community health workers (CHWs) to improve routine vaccination rates in high-need areas by testing a two-part intervention. The first part of the intervention is a digital training provided to CHWs, which includes videos and job aids on vaccine education to support patient communication. The second part of the intervention is a patient-facing chatbot that CHWs can share with their patients. The chatbot is designed to answer patient questions about routine immunization. The intervention will be implemented in two sub-counties in Migori County Kenya (Awendo and Nyatike) that Lwala Community Health Alliance has identified as high need with respect to vaccine education. We hypothesize that the intervention will increase knowledge about routine immunization among CHWs and patients, increase vaccine acceptance, intent-to-vaccinate, and vaccination rates among patients in the treatment group.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
795

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

January 24, 2024

Last Update Submit

April 15, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • CHW vaccine knowledge

    Knowledge about routine childhood vaccines based on a set of 15 knowledge questions draw directly from the digital training

    Collected after roughly 1 month of exposure to the training content

  • CHW vaccine beliefs

    Set of 5 Likert scale questions about beliefs about routine childhood vaccines regarding 1) the safety of childhood vaccines, 2) the effectiveness of childhood vaccines, 3) whether children should receive the new Malaria vaccine, 4) whether children receive too many vaccines, and 5) whether vaccination is compatible with one's personal beliefs.

    Collected after roughly 1 month of exposure to the training content

  • CHW vaccine education preparedness

    Set of 5 Likert scale questions about preparedness to educate patients about routine childhood vaccines including 1) preparedness to answer patient questions, 2) preparedness to explain complex health topics including immunization to patients, 3) adequate access to information about vaccines and the diseases they prevent, 4) preparedness to explain the need for so many childhood vaccines, and 5) preparedness to alleviate patients' fears about vaccination.

    Collected after roughly 1 month of exposure to the training content

  • Patient vaccine knowledge

    Knowledge about routine childhood vaccines based on a set of 15 knowledge questions draw directly from the digital training

    Collected roughly 4-6 months from CHW first exposure to the training content

  • Patient vaccine beliefs

    Set of 5 Likert scale questions about beliefs about routine childhood vaccines regarding 1) the safety of childhood vaccines, 2) the effectiveness of childhood vaccines, 3) whether children should receive the new Malaria vaccine, 4) whether children receive too many vaccines, and 5) whether vaccination is compatible with one's personal beliefs.

    Collected roughly 4-6 months from CHW first exposure to the training content

  • Patient vaccination uptake

    Vaccination uptake among patients of treatment CHWs measured by CHW records, patient self reports, and administrative health records (where available)

    Collected roughly 6 months from CHW first exposure to the training content

Secondary Outcomes (1)

  • CHW perceptions of patient vaccine beliefs

    Collected after roughly 1 month of exposure to the training content

Study Arms (2)

Treatment

EXPERIMENTAL

Community health workers (CHWs) will receive the intervention training videos, job aids and chatbot tool to share with patients via WhatsApp in addition to standard CHW training provided by Lwala Community Health Alliance.

Behavioral: Digital Vaccine Education Training & Patient-facing Chatbot ToolBehavioral: Standard Training

Control

ACTIVE COMPARATOR

Participants in the control group will receive standard community health worker (CHW) training provided by Lwala Community Health Alliance.

Behavioral: Standard Training

Interventions

The first part of the intervention is a digital training provided to CHWs, which includes videos and job aids on vaccine education to support patient communication. The second part of the intervention is a patient-facing chatbot designed to provide key information about routine immunization that CHWs can share with their patients through the social media and messenger application, WhatsApp.

Treatment

All CHWs in the study will receive the standard CHW training that is provided on an ongoing basis by Lwala Community Health Alliance.

ControlTreatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CHWs identified by Lwala Community Health Alliance in study area
  • Patients with children in the household of eligible age for routine immunization

You may not qualify if:

  • \- Patients without children in the household of eligible age for routine immunization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lwala Community Health Alliance

Rongo, Kenya

Location

MeSH Terms

Conditions

Vaccination HesitancyVaccination Refusal

Condition Hierarchy (Ancestors)

Treatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The CHWs will be blinded to treatment assignment and informed that they are taking part in a study to understand the CHW experiences and their communication with patients.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a cluster randomized trial with baseline covariate adjustment and stratification. The randomization unit is the Community Health Unit (CHU), the administrative unit in which community health workers (CHWs) are organized in the study region. The randomization will be stratified by geographic unit (wards) and whether a health facility is located in the ward. The following baseline characteristics will be measured and adjusted for in the main analysis of primary outcomes to increase statistical efficiency: 1) age, 2) gender, 3) language, 4) years of work experience, 5) vaccine beliefs, and 6) self-reported preparedness to educate patients about vaccination.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director, Stanford Center for Health Education

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 1, 2024

Study Start

January 16, 2024

Primary Completion

March 1, 2024

Study Completion

August 1, 2024

Last Updated

April 16, 2024

Record last verified: 2024-04

Locations