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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06297876
Other study ID # H00023815
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 19, 2023
Est. completion date May 2025

Study information

Verified date March 2024
Source University of Massachusetts, Worcester
Contact Sarah Forrester, PhD
Phone 5088568338
Email sarah.forrester@umassmed.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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. .


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date May 2025
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 105 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States University of Massachusetts Chan Medical School Worcester Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
University of Massachusetts, Worcester Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Vaccine Hesitancy Validated vaccine hesitancy questionnaire From beginning of survey to end of survey typically, 30 minutes
Secondary Vaccine Uptake Percent 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 6 months after participation
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