Vaccine Preventable DiseaseCERCNCT04765839
Community-Engaged Bidirectional Pandemic Crisis and Emergency Risk Communication With COVID-19 Vaccine Messages to Minority Populations
A study testing Educational, culturally appropriate COVID-19 messages in people with Vaccine Preventable Disease, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 101 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Preventable Disease
- What is being tested?
- Educational, culturally appropriate COVID-19 messages
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2021to 3 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 101 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identification within a CLs social network
- Age 18 or greater
- Functional internet access.
Who cannot join
- Does not self-identify within a CLs social network
- Is under the age of 18
- Does not have functional internet access.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vaccine Preventable Disease
- Being tested
- Educational, culturally appropriate COVID-19 messages
- Keywords
- hesitancy
- Medical subject headings
- Vaccine-Preventable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational, culturally appropriate COVID-19 messagesOther
Educational, culturally appropriate COVID-19 messages will be developed and shared by RHCP.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm - Receives COVID-19 Vaccine messages | Experimental | Group to receive COVID-19 Vaccine messages during the first two weeks of the study. Receives: 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. Receives: Other: Educational, culturally appropriate COVID-19 messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 attitudes
Related to perceived susceptibility and preventive measures will be assessed through 3 survey instruments, based on 7-point Likert scale.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start12 Feb 2021
- Primary completion3 Apr 2021
- Study completion3 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine Preventable DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark L Wieland, Mayo Clinic
- Investigators
- Mark Mark, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765839
- Sponsor's protocol ID
- 21-000205
- Acronym
- CERC
- Status last verified
- Jul 2021
- First submitted
- 2 Feb 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Engaged Bidirectional Pandemic Crisis and Emergency Risk Communication With Minority Populations
- ClinicalTrials.gov ID
- NCT04765839
- Acronym / sponsor ID
- CERC / 21-000205
- Conditions
- Vaccine Preventable Disease
- Keywords
- hesitancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 3 Apr 2021 (actual)
- Study completion
- 3 Apr 2021 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm - Receives COVID-19 Vaccine messages | Experimental | Other: Educational, culturally appropriate COVID-19 messagesGroup to receive COVID-19 Vaccine messages during the first two weeks of the study. |
| Delayed Intervention Arm | Experimental | Other: Educational, culturally appropriate COVID-19 messagesGroup to receive COVID-19 Vaccine messages during the last two weeks of the study. |
Who may qualify
- Ages
- 18 to 101 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-identification within a CLs social network
- Age 18 or greater
- Functional internet access.
Key exclusion criteria (3 listed)
- Does not self-identify within a CLs social network
- Is under the age of 18
- Does not have functional internet access.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational, culturally appropriate COVID-19 messagesEducational, culturally appropriate COVID-19 messages will be developed and shared by RHCP. | Other | Delayed Intervention Arm, Intervention Arm - Receives COVID-19 Vaccine messages |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Mark principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational, culturally appropriate COVID-19 messages in people with Vaccine Preventable Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 attitudes (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.