- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05085613
Does Framing and Humor Improve the Effectiveness of Messages About COVID-19 Vaccine
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins Bloomberg School of Public Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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.
|
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."
|
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
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
Investigators
- Principal Investigator: Meghan Moran, PhD, Johns Hopkins Bloomberg School of Public Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 00015120B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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