VaccinationNCT04460703
COVID-19 Vaccine Messaging, Part 1
A study testing Baseline message, Personal freedom message and Economic freedom message in people with Vaccination and COVID-19, run by Yale University at 1 site in United States.
Trial summary
This study tests different messages about vaccinating against COVID-19 once the vaccine becomes available. Participants are randomized to 1 of 12 arms, with one control arm and one baseline arm. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccination, COVID-19
- What is being tested?
- Baseline message, Personal freedom message and Economic freedom message
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2020to 8 Jul 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- US resident
Who cannot join
- Younger than 18 years of age
- Non-US resident
- Do not consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Persuasive Messages for COVID-19 Vaccine Uptake: a Randomized Controlled Trial, Part 1
This study tests different messages about vaccinating against COVID-19 once the vaccine becomes available. Participants are randomized to 1 of 12 arms, with one control arm and one baseline arm. We will compare the reported willingness to get a COVID-19 vaccine at 3 and 6 months of it becoming available between the 10 intervention arms to the 2 control arms.
Study participants are recruited online by Lucid, which matches census based sampling in online recruitment.
- Conditions
- Vaccination, COVID-19
- Being tested
- Control message, Baseline message, Personal freedom message, Economic freedom message, Self-interest message
- Keywords
- messaging
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control messageOther
2/15 of the sample will be assigned to the pure control group, which is a passage on the costs and benefits of bird feeding.
Baseline messageOther
3/15 of the sample will be assigned to a control group with a message about the effectiveness and safety of vaccines.
Personal freedom messageOther
1/15 of the sample will be assigned to this intervention, which is a message about how COVID-19 is limiting people's personal freedom and by working together to get enough people vaccinated society can preserve its personal freedom.
Economic freedom messageOther
1/15 of the sample will be assigned to this intervention, which is a message about how COVID-19 is limiting peoples's economic freedom and by working together to get enough people vaccinated society can preserve its economic freedom.
Self-interest messageOther
1/15 of the sample will be assigned to this intervention, which is a message that COVID-19 presents a real danger to one's health, even if one is young and healthy. Getting vaccinated against COVID-19 is the best way to prevent oneself from getting sick.
Community interest messageOther
1/15 of the sample will be assigned to this intervention, which is a message about the dangers of COVID-19 to the health of loved ones. The more people who get vaccinated against COVID-19, the lower the risk that one's loved ones will get sick. Society must work together and all get vaccinated.
Economic benefit messageOther
1/15 of the sample will be assigned to this group, which is a message about how COVID-19 is wreaking havoc on the economy and the only way to strengthen the economy is to work together to get enough people vaccinated.
Guilt messageOther
1/15 of the sample will be assigned to this message. The message is about the danger that COVID-19 presents to the health of one's family and community. The best way to protect them is by getting vaccinated and society must work together to get enough people vaccinated. Then it asks the participant to imagine the guilt they will feel if they don't get vaccinated and spread the disease.
Embarrassment messageOther
1/15 of the sample will be assigned to this message. The message is about the danger that COVID-19 presents to the health of one's family and community. The best way to protect them is by getting vaccinated and by working together to make sure that enough people get vaccinated. Then it asks the participant to imagine the embarrassment they will feel if they don't get vaccinated and spread the disease.
Anger messageOther
1/15 of the sample will be assigned to this message. The message is about the danger that COVID-19 presents to the health of one's family and community. The best way to protect them is by getting vaccinated and by working together to make sure that enough people get vaccinated. Then it asks the participant to imagine the anger they will feel if they don't get vaccinated and spread the disease.
Trust in science messageOther
1/15 of the sample will be assigned to this message about how getting vaccinated against COVID-19 is the most effective way of protecting one's community. Vaccination is backed by science. If one doesn't get vaccinated that means that one doesn't understand how infections are spread or who ignores science.
Not bravery messageOther
1/15 of the sample will be assigned to this message which describes how firefighters, doctors, and front line medical workers are brave. Those who choose not to get vaccinated against COVID-19 are not brave.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Control message about birdfeeding Receives: Other: Control message |
| Baseline message | Active comparator | These participants will be assigned a message about the benefits of vaccination. All other treatment arms include this baseline language. Receives: Other: Baseline message |
| Personal freedom | Experimental | Experimental message arm. Receives: Other: Personal freedom message |
| Economic freedom | Experimental | Experimental message arm. Receives: Other: Economic freedom message |
| Social benefit, self-interest | Experimental | Experimental message arm. Receives: Other: Self-interest message |
| Social benefit, community interest | Experimental | Experimental message arm. Receives: Other: Community interest message |
| Economic benefit | Experimental | Experimental message arm. Receives: Other: Economic benefit message |
| Social pressure- guilt | Experimental | Experimental message arm. Receives: Other: Guilt message |
| Social pressure- embarrassment | Experimental | Experimental message arm. Receives: Other: Embarrassment message |
| Social pressure- anger | Experimental | Experimental message arm. Receives: Other: Anger message |
| Trust in science | Experimental | Experimental message arm. Receives: Other: Trust in science message |
| Not bravery arm | Experimental | Experimental message arm. Receives: Other: Not bravery message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention to get COVID-19 vaccine
This is a self reported measure, immediately after the intervention message, of the likelihood of getting a COVID-19 vaccination within 3 months and then 6 months of it becoming available. During analysis, responses among those assigned to different intervention messages will be compared to those in the control group.
Measured: Immediately after intervention, in the same survey in which the intervention message is provided
Secondary outcomes (4)
Vaccine confidence scale
This is a validated scale. This scale will be used to assess the impact of the messages on vaccine confidence. (Outcome assessed only for the half of the sample that answers these items post-treatment)
Measured: Immediately after intervention, in the same survey in which the intervention message is provided
Persuade others item
This is a measure of a willingness to persuade others to take the COVID-19 vaccine.
Measured: Immediately after intervention, in the same survey in which the intervention message is provided
Fear of those who have not been vaccinated
This is a measure of a comfort with an unvaccinated individual visiting an elderly friend after a vaccine becomes available
Measured: Immediately after intervention, in the same survey in which the intervention message is provided
Social judgment of those who do not vaccinate
This is a scale composed of 4 items measuring the trustworthiness, selfishness, likeableness, and competence of those who choose not to get vaccinated after a vaccine becomes available
Measured: Immediately after intervention, in the same survey in which the intervention message is provided
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start3 Jul 2020
- Primary completion8 Jul 2020
- Study completion8 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VaccinationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, 2/15 of participants will be assigned to a control message (bird feeding passage), 3/15 of sample to a baseline vaccine message, and 1/15 to each of the 10 other treatment arms.
- Masking
- None (open label)
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460703
- Sponsor's protocol ID
- 2000027983
- Status last verified
- Apr 2022
- First submitted
- 2 Jul 2020
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data and analysis code will be posted in a public replication archive after publication.
Publications
James EK, Bokemper SE, Gerber AS, Omer SB, Huber GA. Persuasive messaging to increase COVID-19 vaccine uptake intentions. Vaccine. 2021 Dec 3;39(49):7158-7165. doi: 10.1016/j.vaccine.2021.10.039. Epub 2021 Oct 22.
PubMed 34774363
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persuasive Messages for COVID-19 Vaccine Uptake: a Randomized Controlled Trial, Part 1
- ClinicalTrials.gov ID
- NCT04460703
- Acronym / sponsor ID
- 2000027983
- Conditions
- Vaccination, COVID-19
- Keywords
- messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 7 Jul 2020 (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.
This study tests different messages about vaccinating against COVID-19 once the vaccine becomes available. Participants are randomized to 1 of 12 arms, with one control arm and one baseline arm. We will compare the reported willingness to get a COVID-19 vaccine at 3 and 6 months of it becoming available between the 10 intervention arms to the 2 control arms.
Study participants are recruited online by Lucid, which matches census based sampling in online recruitment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 12
- Model description
- In this study, 2/15 of participants will be assigned to a control message (bird feeding passage), 3/15 of sample to a baseline vaccine message, and 1/15 to each of the 10 other treatment arms.
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: Control messageControl message about birdfeeding |
| Baseline message | Active comparator | Other: Baseline messageThese participants will be assigned a message about the benefits of vaccination. All other treatment arms include this baseline language. |
| Personal freedom | Experimental | Other: Personal freedom messageExperimental message arm. |
| Economic freedom | Experimental | Other: Economic freedom messageExperimental message arm. |
| Social benefit, self-interest | Experimental | Other: Self-interest messageExperimental message arm. |
| Social benefit, community interest | Experimental | Other: Community interest messageExperimental message arm. |
| Economic benefit | Experimental | Other: Economic benefit messageExperimental message arm. |
| Social pressure- guilt | Experimental | Other: Guilt messageExperimental message arm. |
| Social pressure- embarrassment | Experimental | Other: Embarrassment messageExperimental message arm. |
| Social pressure- anger | Experimental | Other: Anger messageExperimental message arm. |
| Trust in science | Experimental | Other: Trust in science messageExperimental message arm. |
| Not bravery arm | Experimental | Other: Not bravery messageExperimental message arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age
- US resident
Key exclusion criteria (3 listed)
- Younger than 18 years of age
- Non-US resident
- Do not consent
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 |
|---|---|---|
| Control message2/15 of the sample will be assigned to the pure control group, which is a passage on the costs and benefits of bird feeding. | Other | Control |
| Baseline message3/15 of the sample will be assigned to a control group with a message about the effectiveness and safety of vaccines. | Other | Baseline message |
| Personal freedom message1/15 of the sample will be assigned to this intervention, which is a message about how COVID-19 is limiting people's personal freedom and by working together to get enough people vaccinated society can preserve its personal freedom. | Other | Personal freedom |
| Economic freedom message1/15 of the sample will be assigned to this intervention, which is a message about how COVID-19 is limiting peoples's economic freedom and by working together to get enough people vaccinated society can preserve its economic freedom. | Other | Economic freedom |
| Self-interest message1/15 of the sample will be assigned to this intervention, which is a message that COVID-19 presents a real danger to one's health, even if one is young and healthy. Getting vaccinated against COVID-19 is the best way to prevent oneself from getting sick. | Other | Social benefit, self-interest |
| Community interest message1/15 of the sample will be assigned to this intervention, which is a message about the dangers of COVID-19 to the health of loved ones. The more people who get vaccinated against COVID-19, the lower the risk that one's loved ones will get sick. Society must work together and all get vaccinated. | Other | Social benefit, community interest |
| Economic benefit message1/15 of the sample will be assigned to this group, which is a message about how COVID-19 is wreaking havoc on the economy and the only way to strengthen the economy is to work together to get enough people vaccinated. | Other | Economic benefit |
| Guilt message1/15 of the sample will be assigned to this message. The message is about the danger that COVID-19 presents to the health of one's family and community. The best way to protect them is by getting vaccinated and society must work together to get enough people vaccinated. Then it asks the participant to imagine the guilt they will feel if they don't get vaccinated and spread the disease. | Other | Social pressure- guilt |
| Embarrassment message1/15 of the sample will be assigned to this message. The message is about the danger that COVID-19 presents to the health of one's family and community. The best way to protect them is by getting vaccinated and by working together to make sure that enough people get vaccinated. Then it asks the participant to imagine the embarrassment they will feel if they don't get vaccinated and spread the disease. | Other | Social pressure- embarrassment |
| Anger message1/15 of the sample will be assigned to this message. The message is about the danger that COVID-19 presents to the health of one's family and community. The best way to protect them is by getting vaccinated and by working together to make sure that enough people get vaccinated. Then it asks the participant to imagine the anger they will feel if they don't get vaccinated and spread the disease. | Other | Social pressure- anger |
| Trust in science message1/15 of the sample will be assigned to this message about how getting vaccinated against COVID-19 is the most effective way of protecting one's community. Vaccination is backed by science. If one doesn't get vaccinated that means that one doesn't understand how infections are spread or who ignores science. | Other | Trust in science |
| Not bravery message1/15 of the sample will be assigned to this message which describes how firefighters, doctors, and front line medical workers are brave. Those who choose not to get vaccinated against COVID-19 are not brave. | Other | Not bravery arm |
Primary outcome
Intention to get COVID-19 vaccine
Time frame: Immediately after intervention, in the same survey in which the intervention message is provided
This is a self reported measure, immediately after the intervention message, of the likelihood of getting a COVID-19 vaccination within 3 months and then 6 months of it becoming available. During analysis, responses among those assigned to different intervention messages will be compared to those in the control group.
4 secondary outcomes
Vaccine confidence scale
Time frame: Immediately after intervention, in the same survey in which the intervention message is provided
Persuade others item
Time frame: Immediately after intervention, in the same survey in which the intervention message is provided
Fear of those who have not been vaccinated
Time frame: Immediately after intervention, in the same survey in which the intervention message is provided
Social judgment of those who do not vaccinate
Time frame: Immediately after intervention, in the same survey in which the intervention message is provided
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 5 May 2022.
- Results publication: PubMed 34774363James EK, Bokemper SE, Gerber AS, Omer SB, Huber GA. Persuasive messaging to increase COVID-19 vaccine uptake intentions. Vaccine. 2021 Dec 3;39(49):7158-7165. doi: 10.1016/j.vaccine.2021.10.039. Epub 2021 Oct 22.
- Individual participant dataSharing planned: Yes. Anonymized data and analysis code will be posted in a public replication archive after publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline message, Personal freedom message and Economic freedom message in people with Vaccination and COVID-19, run by Yale University 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 2 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 5 May 2022. 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. Some participants in this study may receive a placebo. 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?
Intention to get COVID-19 vaccine (time frame: Immediately after intervention, in the same survey in which the intervention message is provided). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04460703, which also lists 1 linked publication.
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 5 May 2022.