Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297876
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2023-05-01
Brief Title:
COVIDVaxStories Randomized Trial to Reduce COVID-19 Vaccine Hesitancy in Populations of Color
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pilot randomized controlled trial testing the investigators 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 andor 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 Qualtricscom 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 desktops14 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 COVIDstorystudy 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 women14 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 racialethnic 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 raceethnicity 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
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 andor 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 Qualtricscom 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 desktops14 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 COVIDstorystudy 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 women14 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 racialethnic 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 raceethnicity 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None