NCT06297876

Brief Summary

Pilot randomized controlled trial testing the investigator's previously developed storytelling method to create an interactive, multi-media storytelling intervention to address community-identified reasons for vaccine hesitancy among Black and Hispanic individuals in Central Massachusetts

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

May 19, 2023

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2024

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

1.2 years

First QC Date

May 1, 2023

Last Update Submit

December 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Vaccine Hesitancy

    Validated vaccine hesitancy questionnaire

    From beginning of survey to end of survey typically, 30 minutes

Secondary Outcomes (1)

  • Vaccine Uptake

    6 months after participation

Study Arms (2)

Storytelling

EXPERIMENTAL

Participants will view short video narratives of community members speaking about why they chose to get vaccinated against Coronavirus Disease of 2019 (COVID-19) and how they overcame hesitancy. Participants will also view the informational videos described below.

Behavioral: Storytelling

Learn More

OTHER

Participants will view short informational videos that provide factual information on the COVID-19 vaccines.

Behavioral: Learn More (Active Comparator)

Interventions

StorytellingBEHAVIORAL

Narrative stories will be videos that are 2-3 minutes long and will show community members speaking based on community identified themes.

Also known as: Narrative
Storytelling

Informational videos that are of similar length and on the same topic as the storytelling videos.

Learn More

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>= 18 years of age
  • identifies as Black and/or Hispanic
  • lives in Massachusetts
  • vaccinated for COVID-19.

You may not qualify if:

  • Unable to provide consent in English or Spanish
  • Has not completed the primary series of COVID-19 vaccinations (2 shots for Moderna or Pfizer, one shot for Johnson \& Johnson).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Vaccination Hesitancy

Interventions

Narrative Therapy

Condition Hierarchy (Ancestors)

Vaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will view either storytelling videos or learn more videos. They will not know which video they will get ahead of time nor will they know that they may get one or the other.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Population and Quantitative Health Sciences

Study Record Dates

First Submitted

May 1, 2023

First Posted

March 7, 2024

Study Start

May 19, 2023

Primary Completion

August 9, 2024

Study Completion

August 9, 2024

Last Updated

December 4, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations