NCT06274359

Brief Summary

While the COVID-19 pandemic has highlighted health disparities, Black children have unduly suffered and died from seasonal influenza for decades. Through sustained partnership with Black community stakeholders, novel community-engaged research methods, and an innovative intervention approach, this proposal will explore, develop, and test a Digital Storytelling intervention to reduce influenza vaccination disparities in Black children aged 6 months to 5 years. This project will advance our understanding of engagement methods and interventions that improve health equity and serve as a model for future work to address vaccination disparities, ensuring all individuals have the chance to fulfill their potential free of preventable diseases.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

August 2, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2025

Completed
Last Updated

May 14, 2025

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

January 18, 2024

Last Update Submit

May 12, 2025

Conditions

Keywords

influenzadigital storytellingchildrenhealth disparities

Outcome Measures

Primary Outcomes (1)

  • Child influenza vaccination status at influenza season's end (defined as March 31, 2025 for season 1 and March 31, 2026 for season 2 if a 2nd season of recruitment is necessary)

    Binary variable: Vaccinated (if a child received 1 or more doses of influenza vaccine), Unvaccinated (if a child received 0 doses)

    Baseline, up to 1 year

Secondary Outcomes (3)

  • Intervention Feasibility

    through study completion, an average of 1 year

  • Intervention Acceptability

    through study completion, an average of 1 year

  • Intervention Appropriateness

    through study completion, an average of 1 year

Study Arms (2)

Digital storytelling group

EXPERIMENTAL

Caregivers will receive a series of digital stories by text message designed to increase influenza vaccine confidence.

Behavioral: Digital storytelling

Control group

NO INTERVENTION

Caregivers will receive standard care.

Interventions

Caregivers will receive text messages with embedded digital stories and messaging to encourage influenza vaccination.

Digital storytelling group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caregivers of a child who is empaneled at Denver Health (e.g. had 1 well child visit in last 18 months)
  • Child will be aged 6 months to 5 years during the influenza season in which the trial will be conducted (season 1: 10/1/24-3/31/25; season 2 (if needed): 10/1/25-3/31/26)
  • Child has no medical contraindications to vaccination (e.g., severe allergy to one of the vaccine ingredients, history of Guillan-Barre Syndrome)

You may not qualify if:

  • \- Caregivers whose first language is not English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Denver Health Eastside Clinic

Denver, Colorado, 80205, United States

Location

Denver Health Park Hill Clinic

Denver, Colorado, 80207, United States

Location

Related Publications (2)

  • Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  • Williams JTB, Kurlandsky K, Stein AB, Bharadwaj N, Hambidge SJ, Pereira RI, O'Leary SC, Johnson D, O'Leary ST. Narrative Reminder Recall to Improve Pediatric Influenza Vaccination: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2552149. doi: 10.1001/jamanetworkopen.2025.52149.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Caregivers will be assigned randomly to receive a series of digital stories by text message or to receive usual care.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2024

First Posted

February 23, 2024

Study Start

August 2, 2024

Primary Completion

March 10, 2025

Study Completion

March 10, 2025

Last Updated

May 14, 2025

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Only aggregate data will be shared

Locations