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Flu, HumanNCT04160975

Persuasion in Medicine: Experimental Evidence on Sender and Signal Effects

A study testing Video about safety and effectiveness of adult seasonal flu vaccination in people with Flu, Human and Influenza, Human, run by Harvard University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to identify what sender/signal combinations are most persuasive in encouraging low socioeconomic males living in the U.S. to take-up seasonal flu vaccination. Read more about this study

Who is it for?
Ages 18 to 51 years, men onlyHealthy volunteers can take part
Conditions the study is for
Flu, Human, Influenza, Human, Covid19
What is being tested?
Video about safety and effectiveness of adult seasonal flu vaccination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,245 participants
Where
1 siteUnited States
Study dates
20 Dec 2019to 19 Feb 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 51 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age: See above.
  • Education: Less than a college degree.
  • Gender: Male.
  • Race: Caucasian or African American.
  • Miscellaneous: Has not received the flu shot in the current flu season yet.
  • Miscellaneous: Has sound on his device turned on.

Who cannot join

  • Fast survey-taking: subjects who are among the 5% fastest in terms of total time spent on survey within race and treatment group.
  • Nonsense answers (those that do not have decipherable English) in the open text sections that suggest low effort.
  • Inconsistent responses to questions (such as being willing to give up $10 to receive a flu coupon but not $1).
  • Repeat survey takers as indicated by duplicate emails or IP addresses in survey data.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Harvard University

    Cambridge, Massachusetts, 02138

Other trials in United States

About this study

The aim of the study is to identify what sender/signal combinations are most persuasive in encouraging low socioeconomic males living in the U.S. to take-up seasonal flu vaccination. The investigators plan to recruit male subjects and randomly assign them to four persuasion treatments: three of which vary dimensions of the sender of a medical recommendation (racial concordance and authority treatments) and one which varies the signal (standard vs. empathetic). Specifically, the investigators will show subjects videos of either Black or white actors/actresses providing scripted information on the flu vaccination. The investigators will randomize the race of the sender and if the subject is Black, also randomize the authority of the sender, with the actor portraying either a doctor or a layperson. In addition, the investigators will vary the script used in the experiment between one that acknowledges past injustices (indicated as an empathetic script hereafter) and one that does not (indicated as a standard script hereafter). The investigators will provide subjects a free flu shot coupon and elicit the price at which subjects would be willing to give up this coupon for a cash reward. Lastly, in light of the relevance of vaccination take-up in combating COVID-19 pandemic, the investigators will assess demand for information about a COVID-19 vaccine, with subjects invited to receive results of a safety and efficacy review from a trusted or standard source. The design requires the collection of baseline and endline surveys combined with administrative data from pharmacies about coupon redemption. The primary outcomes of interest are posterior beliefs about seasonal flu vaccination, demand and willingness-to-pay (WTP) for a free flu shot coupon, redemption of the coupon, and demand for information about a COVID-19 vaccine.

Read the detailed description

The investigators will recruit approximately 3350 African-American or Caucasian adult males with a high-school diploma or less. A pilot study, which ran during the 2019-20 flu season, recruited approximately 850 subjects, and a planned scale-up will recruit an additional 2500 subjects during the 2020-21 flu season. The investigators will oversample African American individuals, emphasizing low-income and minority men because these characteristics are correlated with lower relative take-up of flu vaccination. After informed consent is obtained, subjects will be asked about sociodemographic information (age, education, income and marital status), healthcare experience and past medical history, knowledge and beliefs about flu vaccination, and location of the nearest pharmacy. The investigators will then randomly assign the adult male subjects to videos which contain one of Black or white actors playing the role of either a doctor or a layperson as well as different scripts. The content of the infomercial will be the safety and effectiveness of adult seasonal flu vaccination. After the video, the investigators will obtain information on beliefs regarding vaccination, feedback on the video, attention to the video and willingness-to-pay for a flu shot coupon. The final baseline module will consist of a randomly assigned invitation to receive the results of an upcoming review of a COVID-19 vaccine, with subjects assigned to receive information from a trusted or standard source. The investigators will track flu coupon redemption, which is redeemable at most pharmacies nationwide.

Being tested
Video about safety and effectiveness of adult seasonal flu vaccination
Keywords
Belief Updating, Preventive Care, Racial Disparity
Medical subject headings
Influenza, Human, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video about safety and effectiveness of adult seasonal flu vaccinationBehavioural

    The investigators will show subjects videos of either Black or white male actors providing scripted information on the flu vaccination. The content of the video will be the safety and effectiveness of adult seasonal flu vaccination. The videos contain one of Black or white actors playing the role of either a doctor or a layperson as well as different scripts.

Study groups in NCT04160975
Study groupRoleWhat they receive
Black R/Race C/Doctor/Standard ScriptExperimentalVideo which contains a racially concordant actor playing a doctor and reading a standard script. The receiver of the message will be Black.
Receives: Behavioral: Video about safety and effectiveness of adult seasonal flu vaccination
Black R/Race C/Layperson/Standard ScriptExperimentalVideo which contains a racially concordant actor playing a layperson and reading a standard script. The receiver of the message will be Black.
Receives: Behavioral: Video about safety and effectiveness of adult seasonal flu vaccination
Black R/Race D/Doctor/Standard ScriptExperimentalVideo which contains a racially discordant actor playing a doctor and reading a standard script. The receiver of the message will be Black.
Receives: Behavioral: Video about safety and effectiveness of adult seasonal flu vaccination
Black R/Race D/Doctor/Acknowledgement ScriptExperimentalVideo which contains a racially discordant actor playing a doctor and reading an acknowledgement script. The receiver of the message will be Black.
Receives: Behavioral: Video about safety and effectiveness of adult seasonal flu vaccination
White R/Race C/Doctor/Standard ScriptExperimentalVideo which contains a racially concordant actor playing a doctor and reading a standard script. The receiver of the message will be White.
Receives: Behavioral: Video about safety and effectiveness of adult seasonal flu vaccination
White R/Race D/Doctor/Standard ScriptExperimentalVideo which contains a racially discordant actor playing a doctor and reading a standard script. The receiver of the message will be White.
Receives: Behavioral: Video about safety and effectiveness of adult seasonal flu vaccination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rating of Sender

    This is an inverse-covariance-weighted index comprised of responses to survey questions regarding:

    1. whether the respondent was interested in further medical advice from the given sender (measured as a binary outcome);
    2. whether the respondent trusted advice from the sender measured on a scale of 1 to 5;
    3. and whether the respondent's assessment of the sender's qualification to provide medical advice measured on a scale of 1 to 5.

    It is standardized to a mean of 0 and standard deviation of 1. Scores less than 0 indicate lower ratings of the sender rated by participants in Arm A (described in each arm/group description) compared to the rating rated by participants in Arm B (also described in each arm/group description). Scores greater than 0 indicate higher ratings of the sender by Arm A compared to by Arm B. For example, an index score of .18 indicates that participants in Arm A rate the sender 0.18 index (in standard deviation units) higher than those in Arm B.

    Measured: This outcome was assessed during Baseline survey, which took approximately 20 minutes.

  2. Rating of Signal

    This is an inverse-covariance-weighted index comprised of responses to survey questions on:

    1. recommending the video to friends and family measured on a scale of 0 to 10;
    2. recommending the flu shot to friends and family measured on a scale of 0 to 10;
    3. and the respondent's assessment of the extent to which the information contained in the video was useful measured on a scale of 1 to 5.

    It is standardized to a mean of 0 and standard deviation of 1. An index score of 0 is equal to the mean. Scores less than 0 indicate lower ratings of the signal rated by participants in Arm A (described in each arm/group description) compared to the rating rated by participants in Arm B (also described in each arm/group description). Scores greater than 0 indicate higher ratings of the signal by Arm A compared to by Arm B. For example, an index score of 0.14 indicates that participants in Arm A rate the signal 0.14 index (in standard deviation units) higher than those in Arm B.

    Measured: This outcome was assessed during Baseline survey, which took approximately 20 minutes.

  3. Signal Content Recall

    This is an inverse-covariance-weighted index comprised of responses to survey questions on:

    1. whether age group for whom the flu vaccine is recommended (measured as a binary outcome); and
    2. whether the flu shot contains the flu virus (recall of information discussed in the video) (measured as a binary outcome).

    It is standardized to a mean of 0 and standard deviation of 1. An index score of 0 is equal to the mean. Scores less than 0 indicate lower level of recalling signal content among participants in Arm A (described in each arm/group description) compared to the level among participants in Arm B (also described in each arm/group description). Scores greater than 0 indicate a higher level of recalling signal content among participants in Arm A compared to those in Arm B. For example, an index score of 0.02 indicates that participants in Arm A recall signal content 0.02 index (in standard deviation units) higher than those in Arm B.

    Measured: This outcome will be assessed during Baseline survey, which takes approximately 20 minutes.

  4. Safety Beliefs

    This is an inverse-covariance-weighted index comprised of:

    1. the point belief on the likelihood to contract the flu from the flu shot measured by a Likert scale and rescaled to have a support of -1 to 1.
    2. the certainty measured with a balls and bins method and rescaled to have a support of -1 to 1.

    It is standardized to a mean of 0 and standard deviation of 1. An index score of 0 is equal to the mean. Scores less than 0 indicate a lower level of beliefs in the safety of flu vaccine among participants in Arm A (described in each arm/group description) compared to the level among participants in Arm B (also described in each arm/group description). Scores greater than 0 indicate a higher level of beliefs among participants in Arm A compared to those in Arm B. For example, an index score of -0.1 indicates that participants in Arm A hold such beliefs 0.1 index (in standard deviation units) lower than those in Arm B.

    Measured: This outcome will be assessed during Baseline survey, which takes approximately 20 minutes.

  5. Coupon Interest

    This is an inverse-covariance-weighted index comprised of revealed preference measures of demand for a free flu shot coupon:

    1. Willingness to pay (WTP) for the coupon measured as $0, $1, $2, $5, or $10
    2. demand for information regarding locations to redeem the coupon measured as a binary outcome

    It is standardized to a mean of 0 and standard deviation of 1. An index score of 0 is equal to the mean. Scores less than 0 indicate a lower level of interest in a free flu shot coupon distributed after survey completion among participants in Arm A (described in each arm/group description) compared to the level among participants in Arm B (also described in each arm/group description). Scores greater than 0 indicate a higher level of interest among participants in Arm A compared to those in Arm B. For example, an index score of -0.01 indicates that participants in Arm A hold such interest -0.01 index (in standard deviation units) higher than those in Arm B.

    Measured: This outcome was assessed during Baseline survey, which took approximately 20 minutes.

  6. (Posterior) Flu Vaccine Intent

    This is the respondent's likelihood to receive the flu vaccine before the end of the flu season. This was elicited on an 11-point Likert scale (0 extremely unwilling, 10 extremely willing) after the video message treatment. We re-scaled this outcome to have a scale of 0 to 1. The reported results of the outcome compare participants in Arm A and Arm B (described in each arm/group description). For example, an intent of 0.03 indicates that participants in Arm A are 0.03 units on a scale more likely to intent to take up the flu vaccine compared to those in Arm B.

    Measured: This outcome was assessed after the video treatment during Baseline survey, which took approximately 20 minutes.

  7. COVID-19 Vaccine Intent

    This is the respondent's likelihood to take up the COVID-19 vaccine if made available free of charge. This was elicited on an 11-point Likert scale (0 extremely unwilling, 10 extremely willing) after the video message treatment. We re-scaled this outcome to have a scale of 0 to 1. The reported results of the outcome compare participants in Arm A and Arm B (described in each arm/group description). For example, an intent of 0.04 indicates that participants in Arm A are 0.04 units on a scale more likely to intent to take up the COVID-19 vaccine compared to those in Arm B.

    Measured: This outcome was assessed after the video treatment during Baseline survey, which took approximately 20 minutes.

  8. Flu Vaccine Take-up

    This is respondents' self-report in the follow-up survey on whether they or their family members had received the flu shot or redeemed the coupon since the intervention. The reported results of the outcome compare participants in Arm A and Arm B (described in each arm/group description). For example, 15.0 percentage points indicate that participants in Arm A are more likely to report that they and/or another household member received the flu vaccine by 15.p percentage points compared to those in Arm B.

    Measured: This outcome was assessed during the follow-up survey which was conducted at least two weeks after the initial baseline survey.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2019
  2. Study start20 Dec 2019
  3. Primary completion19 Feb 2021
  4. Study completion19 Feb 2021

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
3,245 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04160975
Sponsor's protocol ID
IRB19-1424
Status last verified
Jun 2021
First submitted
8 Nov 2019
Last updated
29 Jun 2021
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Video about safety and effectiveness of adult seasonal flu vaccination in people with Flu, Human and Influenza, Human, run by Harvard 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 6 inclusion and 4 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 29 Jun 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?

Yes. Results are posted in the registry (first posted 29 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Rating of Sender (time frame: This outcome was assessed during Baseline survey, which took approximately 20 minutes.). The study lists 8 primary outcomes in all. 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 29 Jun 2021.

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