Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04160975
Other study ID # IRB19-1424
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 20, 2019
Est. completion date February 19, 2021

Study information

Verified date June 2021
Source Harvard University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 3245
Est. completion date February 19, 2021
Est. primary completion date February 19, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 51 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Video about safety and effectiveness of adult seasonal flu vaccination
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.

Locations

Country Name City State
United States Harvard University Cambridge Massachusetts

Sponsors (4)

Lead Sponsor Collaborator
Harvard University Ludwig-Maximilians - University of Munich, Massachusetts Institute of Technology, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rating of Sender This is an inverse-covariance-weighted index comprised of responses to survey questions regarding:
whether the respondent was interested in further medical advice from the given sender (measured as a binary outcome);
whether the respondent trusted advice from the sender measured on a scale of 1 to 5;
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.
This outcome was assessed during Baseline survey, which took approximately 20 minutes.
Primary Rating of Signal This is an inverse-covariance-weighted index comprised of responses to survey questions on:
recommending the video to friends and family measured on a scale of 0 to 10;
recommending the flu shot to friends and family measured on a scale of 0 to 10;
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.
This outcome was assessed during Baseline survey, which took approximately 20 minutes.
Primary Signal Content Recall This is an inverse-covariance-weighted index comprised of responses to survey questions on:
whether age group for whom the flu vaccine is recommended (measured as a binary outcome); and
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.
This outcome will be assessed during Baseline survey, which takes approximately 20 minutes.
Primary Safety Beliefs This is an inverse-covariance-weighted index comprised of:
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.
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.
This outcome will be assessed during Baseline survey, which takes approximately 20 minutes.
Primary Coupon Interest This is an inverse-covariance-weighted index comprised of revealed preference measures of demand for a free flu shot coupon:
Willingness to pay (WTP) for the coupon measured as $0, $1, $2, $5, or $10
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.
This outcome was assessed during Baseline survey, which took approximately 20 minutes.
Primary (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. This outcome was assessed after the video treatment during Baseline survey, which took approximately 20 minutes.
Primary 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. This outcome was assessed after the video treatment during Baseline survey, which took approximately 20 minutes.
Primary 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. This outcome was assessed during the follow-up survey which was conducted at least two weeks after the initial baseline survey.
See also
  Status Clinical Trial Phase
Completed NCT05047692 - Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers Phase 1
Recruiting NCT04395768 - International ALLIANCE Study of Therapies to Prevent Progression of COVID-19 Phase 2
Completed NCT04506268 - COVID-19 SAFE Enrollment N/A
Terminated NCT04555096 - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 Phase 2
Completed NCT04508777 - COVID SAFE: COVID-19 Screening Assessment for Exposure
Completed NCT04961541 - Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine Phase 1/Phase 2
Active, not recruiting NCT04546737 - Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients N/A
Not yet recruiting NCT04543006 - Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19 N/A
Completed NCT04532294 - Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants Phase 1
Terminated NCT04581915 - PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19 Phase 2/Phase 3
Terminated NCT04542993 - Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy Phase 2
Completed NCT04494646 - BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19) Phase 2
Not yet recruiting NCT04527211 - Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel Phase 3
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04387292 - Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic N/A
Completed NCT04537663 - Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults Phase 4
Not yet recruiting NCT05038449 - Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19 N/A
Completed NCT04979858 - Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask N/A
Completed NCT04610502 - Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients Phase 2
Active, not recruiting NCT06042855 - ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin) Phase 3