COVIDVaxStories: Randomized Trial to Reduce COVID-19 Vaccine Hesitancy in Populations of Color
NCT ID: NCT06297876
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2023-05-19
2024-08-09
Brief Summary
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Detailed Description
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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. .
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
SINGLE
Study Groups
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Storytelling
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.
Storytelling
Narrative stories will be videos that are 2-3 minutes long and will show community members speaking based on community identified themes.
Learn More
Participants will view short informational videos that provide factual information on the COVID-19 vaccines.
Learn More (Active Comparator)
Informational videos that are of similar length and on the same topic as the storytelling videos.
Interventions
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Storytelling
Narrative stories will be videos that are 2-3 minutes long and will show community members speaking based on community identified themes.
Learn More (Active Comparator)
Informational videos that are of similar length and on the same topic as the storytelling videos.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* identifies as Black and/or Hispanic
* lives in Massachusetts
* vaccinated for COVID-19.
Exclusion Criteria
* Has not completed the primary series of COVID-19 vaccinations (2 shots for Moderna or Pfizer, one shot for Johnson \& Johnson).
18 Years
105 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
University of Massachusetts, Worcester
OTHER
Responsible Party
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Jeroan Allison
Chair, Population and Quantitative Health Sciences
Locations
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University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Countries
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Other Identifiers
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H00023815
Identifier Type: -
Identifier Source: org_study_id