Does Framing and Humor Improve the Effectiveness of Messages About COVID-19 Vaccine

July 28, 2023 updated by: Johns Hopkins Bloomberg School of Public Health

A Randomized Controlled Trial Testing the Efficacy of Humor and Framing in Messaging to Correct Misperceptions About COVID-19 Vaccines

This study seeks to assess the efficacy of educational messages to correct misperceptions. People hold a number of misperceptions that are relevant to public health, including misperceptions regarding COVID vaccines. Some people incorrectly think the COVID vaccines authorized by FDA are not safe or effective. These misperceptions can reduce adherence to public health recommendations and result in continued spread of COVID. This study will test if humor and different types of framing increase the efficacy of messages to correct misperceptions about FDA's authorized coronavirus vaccine safety and effectiveness. The frames tested will include: framing the vaccine as a way to boost economic recovery and framing the vaccine as a way to increase freedom to choose how to behave. The addition of humor will also be tested. Message efficacy will be measured via improved accuracy of beliefs after being exposed to the message. In other words, participants will be asked how safe and effective FDA authorized COVID vaccines are before seeing a message, then they will see a message about why the COVID vaccines are safe and effective, and then they will again be asked how safe and effective they think the vaccines are. This study will also assess the accuracy of inferential beliefs. This will be accomplished by asking participants questions about other vaccines that either are or are not authorized by FDA. If participants have understood the messages and updated their mental models of how FDA evaluates vaccines, they should be able to infer if other vaccines are safe and effective based on their FDA authorization status.

Hypotheses

H1: Participants who are exposed to A.) a message with humor, B.) a message with an economic recovery fame, or C.) a message with a freedom frame will be more likely to increase their agreement with the statement that the FDA will only authorize coronavirus vaccines that are safe and effective after message exposure than participants exposed to the control condition.

H2: Participants who are exposed to A.) a message with humor, B.) a message with an economic recovery fame, or C.) a message with a freedom frame will agree more strongly with the statement that the FDA approved flu vaccine is safe and effective after message exposure than participants exposed to the control condition.

H3. Participants who are exposed to A.) a message with humor, B.) a message with an economic recovery fame, or C.) a message with a freedom frame will agree more strongly with the statement that the ResVax vaccine, which was not approved by the FDA for the treatment of RSV, is a safe and effective after message exposure than participants exposed to the control condition.

H4. Participants who are exposed to A.) a message with humor, B.) a message with an economic recovery fame, or C.) a message with a freedom frame will be more likely to increase behavioral intentions to get an FDA authorized COVID vaccine after message exposure than participants exposed to the control condition.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Bloomberg School of Public Health

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Are 21 years of age or older.
  • Have not participated in the cognitive interview.
  • Have not yet received a COVID vaccine.
  • Are registered with MTurk in the United States.
  • Have completed >= 5,000 HIITs within the MTurk system
  • Have a HIIT approval rating of >= 97%
  • Rate their agreement with the following statement as less than or equal to 50 out of 100: "To what extent do you agree with the following: "The FDA only authorizes COVID vaccines that are safe and effective."

Exclusion Criteria:

  • Are younger than 21 years of age
  • Participated in the cognitive interviews
  • Have already received a COVID vaccine.
  • Are not registered with MTurk in the US
  • Have completed < 5,000 HIITS
  • Have a HIIT approval rating of <97%
  • Rate their agreement with the following statement as greater than 50 out of 100: "To what extent do you agree with the following: "The FDA only authorizes COVID vaccines that are safe and effective."

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Vaccine Corrective Control
A message that explains why people are hesitant to accept the FDA authorized COVID vaccines are safe and effective and how the vaccines are evaluated as safe and effective by FDA.
Behavioral: Corrective message framing and humor
The main content of the messages will be the same. Experimental conditions (arms 2-4) will additionally include consequent framing as a result of getting vaccinated (e.g. economic recovery for arm 2 and freedom for arm 3) and humor for arm 4. Participants will be randomized to view one of the four messages.
Experimental: Vaccine corrective with economic recovery framing
The content of the control message with the addition of the text, "If everyone gets vaccinated, we can keep schools, stores, and other businesses open so more Americans can keep working and supporting their families." The message will also include a picture of an "open for business" sign.
Behavioral: Corrective message framing and humor
The main content of the messages will be the same. Experimental conditions (arms 2-4) will additionally include consequent framing as a result of getting vaccinated (e.g. economic recovery for arm 2 and freedom for arm 3) and humor for arm 4. Participants will be randomized to view one of the four messages.
Experimental: Vaccine corrective with freedom framing
The content of the control message with the addition of the text, "Everyone getting vaccinated is the key to freedom! A vaccine can give us the freedom to hang out with friends, shop, and worship together again safely." The message will also include a picture of an American flag.
Behavioral: Corrective message framing and humor
The main content of the messages will be the same. Experimental conditions (arms 2-4) will additionally include consequent framing as a result of getting vaccinated (e.g. economic recovery for arm 2 and freedom for arm 3) and humor for arm 4. Participants will be randomized to view one of the four messages.
Experimental: Vaccine corrective with humor
The content of the control message with the addition of the text, "Unfortunately, everyone getting vaccinated means leaving the house again." The message will include a meme of a cat being pulled/rescued from a window with text boxes labeling the cat as "People at home working in sweatpants" and the rescuer as "COVID Vaccines."
Behavioral: Corrective message framing and humor
The main content of the messages will be the same. Experimental conditions (arms 2-4) will additionally include consequent framing as a result of getting vaccinated (e.g. economic recovery for arm 2 and freedom for arm 3) and humor for arm 4. Participants will be randomized to view one of the four messages.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Accuracy of the Belief That FDA Authorized COVID-19 Vaccines Are Safe and Effective
Time Frame: Baseline and up to 5 minutes after receiving the corrective message
Assessed by change in response to the question To what extent do you agree or disagree with the following statement: The FDA has only authorized COVID vaccines that are safe and effective; with response options on a continuous scale from 0 "I do not agree at all" to 100, "I completely agree."
Baseline and up to 5 minutes after receiving the corrective message
Accuracy of Inferential Belief That the FDA Authorized Flu Vaccine is Safe and Effective
Time Frame: Up to 5 minutes after receiving the corrective message
Assessed by response to the question To what extent do you agree with the following: The FDA authorized flu vaccine is safe and effective.; with response options on a continuous scale from 0 "I do not agree at all" to 100, "I completely agree."
Up to 5 minutes after receiving the corrective message
Accuracy of Inferential Belief That RexVax is Safe and Effective
Time Frame: Up to 5 minutes after receiving the corrective message

Assessed by response to the question, The FDA recommended more testing of ResVax and did NOT authorize the vaccine because it did not prevent enough RSV infections.

To what extent do you agree with the following: ResVax is safe and effective; with response options on a continuous scale from 0 "I do not agree at all" to 100, "I completely agree."
Up to 5 minutes after receiving the corrective message
Change in Intention to Get a COVID-19 Vaccine
Time Frame: Baseline and up to 5 minutes after receiving the corrective message
Assessed by change in response to the statement: I plan on getting an FDA authorized coronavirus vaccine; with response options on a continuous scale from 0 "I do not agree at all" to 100, "I completely agree."
Baseline and up to 5 minutes after receiving the corrective message

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins Bloomberg School of Public Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meghan Moran, PhD, Johns Hopkins Bloomberg School of Public Health

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00015120B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon request, deidentified participant data collected during the study may be shared. Upon request, we may also share the study protocol, survey, and informed consent form. Data will be made available upon request beginning 3 months following publication of the final article from this study, with no end date. Data will be made available for analyses deemed appropriate by the study PI. Proposals should be directed to mmoran22@jhu.edu. Data requestors will need to sign a data access agreement.

IPD Sharing Time Frame

Starting 3 months following publication of the final article from this study, with no end date.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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