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. .
