NCT04765839

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

February 12, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2021

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

February 2, 2021

Last Update Submit

July 28, 2021

Conditions

Vaccine Preventable Disease

Keywords

hesitancy

Outcome Measures

Primary Outcomes (1)

  • COVID-19 attitudes

    Related to perceived susceptibility and preventive measures will be assessed through 3 survey instruments, based on 7-point Likert scale.

    4 weeks

Study Arms (2)

Intervention Arm - Receives COVID-19 Vaccine messages

EXPERIMENTAL

Group to receive COVID-19 Vaccine messages during the first two weeks of the study.

Other: Educational, culturally appropriate COVID-19 messages

Delayed Intervention Arm

EXPERIMENTAL

Group to receive COVID-19 Vaccine messages during the last two weeks of the study.

Other: Educational, culturally appropriate COVID-19 messages

Interventions

Educational, culturally appropriate COVID-19 messagesOTHER

Educational, culturally appropriate COVID-19 messages will be developed and shared by RHCP.

Delayed Intervention ArmIntervention Arm - Receives COVID-19 Vaccine messages

Eligibility Criteria

Age18 Years - 101 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identification within a CLs social network
  • Age 18 or greater
  • Functional internet access.

You may not qualify if:

  • Does not self-identify within a CLs social network
  • Is under the age of 18
  • Does not have functional internet access.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Vaccine-Preventable Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Mark Mark

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Randomization outcomes will not be disclosed to participants.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Community Internal Medicine

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 23, 2021

Study Start

February 12, 2021

Primary Completion

April 3, 2021

Study Completion

April 3, 2021

Last Updated

July 30, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)