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COVIDVaxStories: Randomized Trial to Reduce COVID-19 Vaccine Hesitancy in Populations of Color

COVIDVaxStories: A Pilot Double-blind Randomized, Parallel Design Trial of Storytelling to Reduce COVID-19 Vaccine Hesitation in Populations of Color Using a Respondent-driven Sampling Design

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06297876
Enrollment
100
Registered
2024-03-07
Start date
2023-05-19
Completion date
2024-08-09
Last updated
2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccine Hesitancy

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

Detailed description

Intervention Development The investigators will recruit 64-80 Black and Hispanic community members for storytelling development groups (described below) through our already established COVID community advisory board (C-CAB). The C-CAB represents ten community organizations throughout the Greater Worcester area including churches and community centers. Further information on procedures for intervention development can be found in the study procedures section. Pilot Randomized Controlled Trial (RCT) The investigators will conduct a pilot feasibility randomized controlled trial. The investigators will enroll approximately 50 Black persons who identify as Black and/or Hispanic in Central Massachusetts. The investigators will use a Respondent-Driven Sampling (RDS) Design, a quantitative form of the snowballing approach that has been proven effective in under-represented groups19-22 to pilot our recruitment strategy. In RDS a preset number of seeds are selected with the assistance of community partners. The seeds are community members with large social networks. Each seed recruits a preset number of participants utilizing their social networks and this process continues in waves until the predetermined sample size is met. Each seed is linked to their recruits to enable social network analysis. Study procedures from consent to intervention will be delivered through Qualtrics, an online service that allows researchers to design and deliver online research instruments with minimal time and effort, and without extensive programming experience (Qualtrics.com). A short screening survey, e-informed-consent form, surveys, and videos (both English and Spanish versions) will be uploaded into Qualtrics. Qualtrics is available on both mobile devices and desktops,14 through mobile app or internet. The University of Massachusetts Chan Medical School (UMMS) has a university license to use Qualtrics, which provide robust data safety and privacy and is approved by our Institutional Review Board (IRB). The investigators will utilize the Quantitative Methods Core (QMC), a service core that has been formed under the auspices of the Division of Biostatistics and Health Services Research within the Department of Population and Health Sciences as well as our current research coordinator who have partnered to create a Qualtrics interface that delivers pre-intervention surveys, randomization, intervention delivery, and post intervention surveys, for our completed Enhancing racial and ethnic diversity in COVID-19 research participation through storytelling (COVIDstory)study. Qualtrics has also previously been used for the aforementioned features for an intervention aimed at increasing uptake of the Human Papillomavirus (HPV) vaccine among young Asian women.14 The investigators will build on this infrastructure to tailor the randomization, surveys, and intervention delivery for this intervention in this population. Participants will be randomly assigned to either the storytelling arm or the comparison arm through a randomization algorithm embedded within Qualtrics. A stratified approach will be used, with equal enrollment by racial/ethnic category: Black or Hispanic. Each person recruited will be directed to Qualtrics which will be set to proceed in a systematic and sequential manner until the full sample size of 25 participants in the intervention group and 25 participants in the comparison group, stratified by race/ethnicity, are attained. Study subjects and investigators will be blinded as to group assignment. As with our current NCI funded project, all participant-facing aspects of Qualtrics (screening, consent, randomization, surveys, intervention videos) will be available in both English and Spanish. .

Interventions

BEHAVIORALStorytelling

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

BEHAVIORALLearn More (Active Comparator)

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

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
University of Massachusetts, Worcester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 105 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Change in Vaccine HesitancyFrom beginning of survey to end of survey typically, 30 minutesValidated vaccine hesitancy questionnaire

Secondary

MeasureTime frameDescription
Vaccine Uptake6 months after participationPercent in each study arm whose vaccination status changed post intervention by querying the participant. The investigators will also pilot test their willingness to provide the investigators with proof of vaccination (e.g., documentation from vaccinating entity or excerpt from electronic health record, if a change is reported

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026