Covid19CEALNCT05023512
Understanding Public Attitudes Towards the COVID-19 Vaccination
A study testing Communication about the COVID-19 vaccination from the Massachusetts Department of Public Health in people with Covid19 and Vaccination, run by University of Massachusetts, Worcester.
Trial summary
The objective of this study is to better understand public attitudes towards coronavirus disease 2019 (COVID-19) vaccination. This understanding will inform the development of community engagement strategies to be used in future interventions and studies aimed at addressing factors that impact the disproportionate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Vaccination
- What is being tested?
- Communication about the COVID-19 vaccination from the Massachusetts Department of Public Health
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 Oct 2021to 1 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Massachusetts resident
- Adult (age 18 and over)
- English or Spanish speaking
Who cannot join
- Non-English or Spanish speaking
About this study
Official title: Together Researching Understanding, Solidarity, and Trust Around COVID - TRUST Study
The objective of this study is to better understand public attitudes towards coronavirus disease 2019 (COVID-19) vaccination. This understanding will inform the development of community engagement strategies to be used in future interventions and studies aimed at addressing factors that impact the disproportionate burden of COVID-19 in under-served and vulnerable communities.
Read the detailed description
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly instigated a global pandemic. As of this writing, there are more than 33 million documented cases of infection in the United States (US). Furthermore, in the US, COVID-19 has disrupted the economy, overwhelmed the healthcare system, led to widespread school cancellations, and caused more than 595,000 deaths since March 2020.
The availability of three highly effective vaccines against COVID-19 within a year of the start of the pandemic is an extraordinary achievement and cause for great optimism. However, a significant proportion of adults in the U.S. have not accepted vaccination against COVID-19. Efforts are needed to identify effective messages and communication strategies to overcome COVID-19 vaccine hesitancy.
To address this need, the investigators plan to conduct two rapid surveys among Massachusetts residents, to assess attitudes towards COVID-19 vaccination.
- Conditions
- Covid19, Vaccination
- Being tested
- Communication about the COVID-19 vaccination from the Massachusetts Department of Public Health
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication about the COVID-19 vaccination from the Massachusetts Department of Public HealthBehavioural
Participants will be randomized to receive one of two different versions of messages from the Massachusetts Department of Public Health. The message that participants in each experimental group receive will vary slightly and systematically. Specific content and wording of these messages were developed to address and mitigate concerns about the Covid-19 vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Message 1 | Experimental | Participants will be randomized to receive version #1 of 2 different versions of a message from the Massachusetts Department of Public Health regarding the COVID-19 vaccination. Receives: Behavioral: Communication about the COVID-19 vaccination from the Massachusetts Department of Public Health |
| Message 2 | Experimental | Participants will be randomized to receive version #2 of 2 different versions of a message from the Massachusetts Department of Public Health regarding the COVID-19 vaccination. Receives: Behavioral: Communication about the COVID-19 vaccination from the Massachusetts Department of Public Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intent to be vaccinated against Covid-19 among unvaccinated participants
The survey includes a question that assesses participants' willingness to be vaccinated against Covid-19 if they are unvaccinated. Responses include Yes, No, or Not Sure to being vaccinated against Covid-19.
Measured: Through survey completion, an average of 12 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start28 Oct 2021
- Primary completion15 Jul 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Why it stopped: This study is not a clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Fisher, University of Massachusetts, Worcester
- Investigators
- Kimberly Fisher, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023512
- Sponsor's protocol ID
- H00023672
- Other IDs
- 1OT2HL156812-01
- Acronym
- CEAL
- Status last verified
- Jun 2022
- First submitted
- 24 Aug 2021
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Together Researching Understanding, Solidarity, and Trust Around COVID - TRUST Study
- ClinicalTrials.gov ID
- NCT05023512
- Acronym / sponsor ID
- CEAL / H00023672
- Conditions
- Covid19, Vaccination
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study is not a clinical trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Boston University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 26 Aug 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.
The objective of this study is to better understand public attitudes towards coronavirus disease 2019 (COVID-19) vaccination. This understanding will inform the development of community engagement strategies to be used in future interventions and studies aimed at addressing factors that impact the disproportionate burden of COVID-19 in under-served and vulnerable communities.
Detailed description
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly instigated a global pandemic. As of this writing, there are more than 33 million documented cases of infection in the United States (US). Furthermore, in the US, COVID-19 has disrupted the economy, overwhelmed the healthcare system, led to widespread school cancellations, and caused more than 595,000 deaths since March 2020.
The availability of three highly effective vaccines against COVID-19 within a year of the start of the pandemic is an extraordinary achievement and cause for great optimism. However, a significant proportion of adults in the U.S. have not accepted vaccination against COVID-19. Efforts are needed to identify effective messages and communication strategies to overcome COVID-19 vaccine hesitancy.
To address this need, the investigators plan to conduct two rapid surveys among Massachusetts residents, to assess attitudes towards COVID-19 vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Message 1 | Experimental | Behavioral: Communication about the COVID-19 vaccination from the Massachusetts Department of Public HealthParticipants will be randomized to receive version #1 of 2 different versions of a message from the Massachusetts Department of Public Health regarding the COVID-19 vaccination. |
| Message 2 | Experimental | Behavioral: Communication about the COVID-19 vaccination from the Massachusetts Department of Public HealthParticipants will be randomized to receive version #2 of 2 different versions of a message from the Massachusetts Department of Public Health regarding the COVID-19 vaccination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Massachusetts resident
- Adult (age 18 and over)
- English or Spanish speaking
Key exclusion criteria (1 listed)
- Non-English or Spanish speaking
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 |
|---|---|---|
| Communication about the COVID-19 vaccination from the Massachusetts Department of Public HealthParticipants will be randomized to receive one of two different versions of messages from the Massachusetts Department of Public Health. The message that participants in each experimental group receive will vary slightly and systematically. Specific content and wording of these messages were developed to address and mitigate concerns about the Covid-19 vaccination. | Behavioural | Message 1, Message 2 |
Primary outcome
Intent to be vaccinated against Covid-19 among unvaccinated participants
Time frame: Through survey completion, an average of 12 minutes
The survey includes a question that assesses participants' willingness to be vaccinated against Covid-19 if they are unvaccinated. Responses include Yes, No, or Not Sure to being vaccinated against Covid-19.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- 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.
Kimberly Fisher, MD principal investigator
University of Massachusetts, Worcester
Questions about this trial
What is this clinical trial studying?
A study testing Communication about the COVID-19 vaccination from the Massachusetts Department of Public Health in people with Covid19 and Vaccination, run by University of Massachusetts, Worcester.
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 1 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: withdrawn, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Intent to be vaccinated against Covid-19 among unvaccinated participants (time frame: Through survey completion, an average of 12 minutes). 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 6 Jun 2022.