- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04706403
Views on COVID-19 and Vaccination
If We Build It, Will They Come? A Pilot Study to Develop and Test Messages to Maximize Uptake of Coronavirus Vaccine When Available
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly instigated a global pandemic. As of this writing, there are approximately 65 million documented cases of infection worldwide, and over 1.5 million deaths. In the United States (US), coronavirus disease 2019 (COVID-19) has disrupted the economy, overwhelmed healthcare system, led to widespread school cancellations, and caused more than 274,000 deaths since March 2020. A vaccine against COVID-19 is widely viewed as the key to controlling the pandemic and enabling a return to "normal" life. Vaccine development is proceeding at an unprecedented pace with 10 vaccines currently in phase 3 trials. Experts have projected that a safe and effective vaccine may be available by mid-2021. At the same time, a growing body of evidence indicates that a significant proportion of adults in the U.S. may not accept vaccination against COVID-19. Even more alarming, COVID-19 vaccine hesitancy (refusal or reluctance to accept a vaccine) appears to be increasing as the vaccine approval process becomes increasingly politicized. Just as efforts to develop vaccine production and delivery capacity have been undertaken in advance of having a proven effective vaccine, parallel efforts are needed to identify effective messages and communication strategies to overcome COVID-19 vaccine hesitancy.
The study team recently surveyed a nationally representative sample of approximately 1,000 adults in the United States and found that only 57% intended to be vaccinated when a coronavirus vaccine becomes available. This percentage was even lower among people who identified as Black or Hispanic (39% and 43% respectively), those with a high school education or less (46%), and those in the lowest income groups (49% of those reporting a household income of $30,000 or less, compared to 72% of those reporting a household income of $100,000 or more). The investigators asked those who indicated they would not or might not get vaccinated for their reasons and found that some individuals may be willing to be vaccinated if provided specific information about the vaccine such as side effects and effectiveness. Others expressed generalized skepticism, fear, and distrust of vaccines, with some even referring to anti-vaccine conspiracy theories. These findings are consistent with an extensive body of research documenting that people often do not behave rationally and highlight the urgent need to proactively develop and test interventions to maximize vaccination rates when a coronavirus vaccine becomes available. To address this need, in the present study, the investigators aim to create and test targeted messages to address the concerns of subgroups of people at risk for not being vaccinated, with the ultimate goal of maximizing vaccine uptake when a vaccine for COVID-19 becomes available. The investigators will accomplish this by working with an existing online panel of volunteers, which will allow efficient, focused data gathering. Results of the survey will provide a nuanced, current description of how vulnerable adults perceive the coronavirus and available vaccines, which will be used as the basis for developing messages and communication strategies. Participants will be randomized to receive one of five different versions of a message from a healthcare provider regarding vaccination. Specific wording and content of these messages will vary systematically in order to address concerns of those at risk for not being vaccinated. This project will ultimately result in a set of tested, evidence-derived messages about vaccination for COVID-19. The investigators will make these messages available, together with evidence of how these influence members of vulnerable populations' understanding of vaccination, and disease risk, as well as intent to be vaccinated. The messages will be freely available for use by organizations and providers seeking to improve communication about a coronavirus vaccine.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01605
- Meyers Health Care Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult (age 18 and over) who are members of an online panel (Prolific). Members of this panel joined the panel specifically to receive invitations to participate in research surveys and similar activities.
- Able to complete an online survey in English.
Exclusion Criteria:
• None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Message 1
Participants were randomized to receive version #1 of 5 different versions of a message from a physician regarding the COVID-19 vaccination.
All messages included a statement that the vaccine is very safe and very effective.
In Message 1, this statement was followed by a participatory-style recommendation ("What do you think?")
|
Participants who expressed hesitation about getting vaccinated against COVID-19 were randomized to receive one of five different versions of messages from a physician.
The messages that participants in each group received varied slightly and systematically.
Specific content and wording of these messages were developed to address and mitigate concerns of those at risk for not being vaccinated.
|
EXPERIMENTAL: Message 2
Participants were randomized to receive version #2 of 5 different versions of a message from a physician regarding vaccination.
All messages included a statement that the vaccine is very safe and very effective.
In Message 2, this statement was followed by a comparison of the COVID-19 vaccine to the flu shot and an explicit recommendation ("I recommend that you get it").
|
Participants who expressed hesitation about getting vaccinated against COVID-19 were randomized to receive one of five different versions of messages from a physician.
The messages that participants in each group received varied slightly and systematically.
Specific content and wording of these messages were developed to address and mitigate concerns of those at risk for not being vaccinated.
|
EXPERIMENTAL: Message 3
Participants were randomized to receive version #3 of 5 different versions of a message from a physician regarding vaccination.
All messages included a statement that the vaccine is very safe and very effective.
In Message 3, this statement was followed by a statement that millions of people have already received the COVID-19 vaccine and an explicit recommendation ("I recommend that you get it").
|
Participants who expressed hesitation about getting vaccinated against COVID-19 were randomized to receive one of five different versions of messages from a physician.
The messages that participants in each group received varied slightly and systematically.
Specific content and wording of these messages were developed to address and mitigate concerns of those at risk for not being vaccinated.
|
EXPERIMENTAL: Message 4
Participants were randomized to receive version #4 of 5 different versions of a message from a physician regarding vaccination.
All messages included a statement that the vaccine is very safe and very effective.
In Message 4, this statement was followed by an acknowledgment of concerns and reassurance that the physician personally reviewed the safety data and an explicit recommendation ("I recommend that you get it").
|
Participants who expressed hesitation about getting vaccinated against COVID-19 were randomized to receive one of five different versions of messages from a physician.
The messages that participants in each group received varied slightly and systematically.
Specific content and wording of these messages were developed to address and mitigate concerns of those at risk for not being vaccinated.
|
EXPERIMENTAL: Message 5
Participants were randomized to receive version #5 of 5 different versions of a message from a physician regarding vaccination.
All messages included a statement that the vaccine is very safe and very effective.
In Message 5, this statement was followed by an emphasis on protecting others an explicit recommendation ("I recommend that you get it").
|
Participants who expressed hesitation about getting vaccinated against COVID-19 were randomized to receive one of five different versions of messages from a physician.
The messages that participants in each group received varied slightly and systematically.
Specific content and wording of these messages were developed to address and mitigate concerns of those at risk for not being vaccinated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Became Less Hesitant About the COVID-19 Vaccine After Receiving a Physician Message
Time Frame: Through survey completion, an average of 12 minutes
|
All participants were asked about their intent to be vaccinated against COVID-19 prior to exposure to one of the five physician messages (Response options: Yes, No, Not sure).
After participants were randomly assigned to receive one of the five physician messages, reduction in COVID-19 vaccine hesitancy was assessed with the question: "Would you get vaccinated at this visit".
Response options included yes, no, not sure.
For participants whose initial vaccination intent was "not sure", a response of "yes" on re-assessment was defined as less hesitant.
Response of "not sure" or "yes" were defined as less hesitant for participants whose initial vaccination intent was "no".
|
Through survey completion, an average of 12 minutes
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Fisher KA, Bloomstone SJ, Walder J, Crawford S, Fouayzi H, Mazor KM. Attitudes Toward a Potential SARS-CoV-2 Vaccine : A Survey of U.S. Adults. Ann Intern Med. 2020 Dec 15;173(12):964-973. doi: 10.7326/M20-3569. Epub 2020 Sep 4.
- Brewer NT, Chapman GB, Rothman AJ, Leask J, Kempe A. Increasing Vaccination: Putting Psychological Science Into Action. Psychol Sci Public Interest. 2017 Dec;18(3):149-207. doi: 10.1177/1529100618760521.
- Godinho CA, Yardley L, Marcu A, Mowbray F, Beard E, Michie S. Increasing the intent to receive a pandemic influenza vaccination: Testing the impact of theory-based messages. Prev Med. 2016 Aug;89:104-111. doi: 10.1016/j.ypmed.2016.05.025. Epub 2016 May 25.
- Mowbray F, Marcu A, Godinho CA, Michie S, Yardley L. Communicating to increase public uptake of pandemic flu vaccination in the UK: Which messages work? Vaccine. 2016 Jun 14;34(28):3268-74. doi: 10.1016/j.vaccine.2016.05.006. Epub 2016 May 8.
- Nowak GJ, Sheedy K, Bursey K, Smith TM, Basket M. Promoting influenza vaccination: insights from a qualitative meta-analysis of 14 years of influenza-related communications research by U.S. Centers for Disease Control and Prevention (CDC). Vaccine. 2015 Jun 4;33(24):2741-56. doi: 10.1016/j.vaccine.2015.04.064. Epub 2015 Apr 28.
- Redelings MD, Piron J, Smith LV, Chan A, Heinzerling J, Sanchez KM, Bedair D, Ponce M, Kuo T. Knowledge, attitudes, and beliefs about seasonal influenza and H1N1 vaccinations in a low-income, public health clinic population. Vaccine. 2012 Jan 5;30(2):454-8. doi: 10.1016/j.vaccine.2011.10.050. Epub 2011 Oct 30.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H00022244
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Covid19
-
Anavasi DiagnosticsNot yet recruiting
-
Ain Shams UniversityRecruiting
-
Israel Institute for Biological Research (IIBR)Completed
-
Colgate PalmoliveCompleted
-
Christian von BuchwaldCompleted
-
Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdActive, not recruiting
-
University of ZurichLabor Speiz; Swiss Armed Forces; Universitätsspital ZürichEnrolling by invitation
-
Alexandria UniversityCompleted
Clinical Trials on Communication from a physician about the COVID-19 Vaccine
-
University of Massachusetts, WorcesterBoston University; National Heart, Lung, and Blood Institute (NHLBI)WithdrawnCovid19 | Vaccination
-
Barbara Ann Karmanos Cancer InstituteCompletedMultiple Myeloma | AL Amyloidosis | Chronic Lymphocytic LeukemiaUnited States
-
Aga Khan UniversityCompletedCOVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Lower Respiratory InfectionPakistan
-
Xavier University of Louisiana.CompletedCovid19 | Vaccine Hesitancy | Vaccine RefusalUnited States
-
Diskapi Yildirim Beyazit Education and Research...CompletedDepression | Covid19 | Burnout, Student | Educational ProblemsTurkey
-
Public health and reforms Center of Ministry of...World Health Organization; Ministry of Health of Azerbaijan RepublicRecruitingCovid19 | Vaccine RefusalAzerbaijan
-
BioNTech SEPfizerRecruiting
-
University of California, Los AngelesRecruitingCOVID-19 | VaccinesUnited States
-
Duke UniversityColumbia University; Centers for Disease Control and Prevention; Children's Hospital... and other collaboratorsRecruitingFever | Fever After Vaccination | Seizures FeverUnited States
-
Hamid Al-Essa Organ Transplant CenterMinistry of Health, KuwaitCompletedCovid19 | Risk Factor, Cardiovascular | Kidney Transplant Infection | Outcome, Fatal | Immunosuppression | Graft FailureKuwait