Community-Engaged Bidirectional Pandemic Crisis and Emergency Risk Communication With COVID-19 Vaccine Messages to Minority Populations (CERC)

July 28, 2021 updated by: Mark L Wieland, Mayo Clinic

Community-Engaged Bidirectional Pandemic Crisis and Emergency Risk Communication With Minority Populations

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 101 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm - Receives COVID-19 Vaccine messages
Group to receive COVID-19 Vaccine messages during the first two weeks of the study.
Other: Educational, culturally appropriate COVID-19 messages
Educational, culturally appropriate COVID-19 messages will be developed and shared by RHCP.
Experimental: Delayed Intervention Arm
Group to receive COVID-19 Vaccine messages during the last two weeks of the study.
Other: Educational, culturally appropriate COVID-19 messages
Educational, culturally appropriate COVID-19 messages will be developed and shared by RHCP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 attitudes
Time Frame: 4 weeks
Related to perceived susceptibility and preventive measures will be assessed through 3 survey instruments, based on 7-point Likert scale.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Mark Mark, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2021

Primary Completion (Actual)

April 3, 2021

Study Completion (Actual)

April 3, 2021

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 19, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Actual)

July 30, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-000205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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