Back to resultsCommunity-Engaged Bidirectional Pandemic Crisis and Emergency Risk Communication With COVID-19 Vaccine Messages to Minority Populations (CERC)
Primary Purpose
Vaccine Preventable Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational, culturally appropriate COVID-19 messages
Sponsored by
About this trial
This is an interventional supportive care trial for Vaccine Preventable Disease focused on measuring hesitancy
Eligibility Criteria
Inclusion Criteria:
- Self-identification within a CLs social network
- Age 18 or greater
- Functional internet access.
Exclusion Criteria:
- Does not self-identify within a CLs social network
- Is under the age of 18
- Does not have functional internet access.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intervention Arm - Receives COVID-19 Vaccine messages
Delayed Intervention Arm
Arm Description
Group to receive COVID-19 Vaccine messages during the first two weeks of the study.
Group to receive COVID-19 Vaccine messages during the last two weeks of the study.
Outcomes
Primary Outcome Measures
COVID-19 attitudes
Related to perceived susceptibility and preventive measures will be assessed through 3 survey instruments, based on 7-point Likert scale.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04765839
Brief Title
Community-Engaged Bidirectional Pandemic Crisis and Emergency Risk Communication With COVID-19 Vaccine Messages to Minority Populations
Acronym
CERC
Official Title
Community-Engaged Bidirectional Pandemic Crisis and Emergency Risk Communication With Minority Populations
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 12, 2021 (Actual)
Primary Completion Date
April 3, 2021 (Actual)
Study Completion Date
April 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A cluster randomized trial will be conducted prior to widespread vaccine availability to the general public. Community-informed COVID-19 vaccine messages will be disseminated to participants. At baseline, 2 weeks and 4 weeks, the study team will survey participants to assess knowledge and attitudes about COVID-19 vaccines, including intention to be vaccinated.
Detailed Description
A cluster randomized trial with 80 participants from the social networks of 8 CLs will be conducted prior to widespread vaccine availability to the general public. Four CLs and social networks (cluster of 10 per network) will be randomly assigned to receive the intervention immediately or after a delay of 2 weeks. Intervention participants will be invited to a closed social media group on the platform of their choice. CLs, selected for trustworthiness within vulnerable populations, will disseminate community-informed COVID-19 vaccine messages to members of their social networks and engage in bidirectional communication with CEnR partners to refine messages. At baseline, 2 weeks and 4 weeks, participants will be surveyed to assess knowledge and attitudes about COVID-19 vaccines, including intention to be vaccinated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccine Preventable Disease
Keywords
hesitancy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Randomization outcomes will not be disclosed to participants.
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm - Receives COVID-19 Vaccine messages
Arm Type
Experimental
Arm Description
Group to receive COVID-19 Vaccine messages during the first two weeks of the study.
Arm Title
Delayed Intervention Arm
Arm Type
Experimental
Arm Description
Group to receive COVID-19 Vaccine messages during the last two weeks of the study.
Intervention Type
Other
Intervention Name(s)
Educational, culturally appropriate COVID-19 messages
Intervention Description
Educational, culturally appropriate COVID-19 messages will be developed and shared by RHCP.
Primary Outcome Measure Information:
Title
COVID-19 attitudes
Description
Related to perceived susceptibility and preventive measures will be assessed through 3 survey instruments, based on 7-point Likert scale.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
101 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Self-identification within a CLs social network
Age 18 or greater
Functional internet access.
Exclusion Criteria:
Does not self-identify within a CLs social network
Is under the age of 18
Does not have functional internet access.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Mark
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Community-Engaged Bidirectional Pandemic Crisis and Emergency Risk Communication With COVID-19 Vaccine Messages to Minority Populations
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