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Vaccine RefusalNCT04960228

Exploring Changes in COVID-19 Vaccination Intentions by Prompting Altruistic Motives Using a Video Intervention

A study testing Altruism Video and COVID-19 Informational Text in people with Vaccine Refusal, run by Zeev Rosberger at 1 site in Canada.

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

As Canada records over 1,400,000 COVID-19 infections and 26,000 deaths, the need to stop the spread of the virus has become increasingly critical. Although younger individuals (aged 20-39) have lower hospitalisation and death rates than older adults, they have high rates of infection and may be less willing to accept… Read more about this study

Who is it for?
Ages 20 to 39 yearsHealthy volunteers can take part
Conditions the study is for
Vaccine Refusal
What is being tested?
Altruism Video and COVID-19 Informational Text
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,097 participants
Where
1 siteCanada
Study dates
30 Jul 2021to 13 Sep 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 20 to 39 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Residing within Canada and aged between 20 and 39 years.

Who cannot join

  • Having received at least one dose of a COVID-19 vaccine

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Lady Davis Insitutute for Medical Research

    Montreal, Quebec, H3T 1E2

Other trials in Canada

About this study

Official title: Enhancing COVID-19 Vaccination Intentions by Eliciting Prosocial Altruistic Motives: Evaluating the Efficacy of a Brief Video-Based Intervention

As Canada records over 1,400,000 COVID-19 infections and 26,000 deaths, the need to stop the spread of the virus has become increasingly critical. Although younger individuals (aged 20-39) have lower hospitalisation and death rates than older adults, they have high rates of infection and may be less willing to accept a vaccine because they consider the disease to be less dangerous for themselves. It is of concern that around 30% of Canadians, especially younger adults, will not be willing to accept a COVID-19 vaccine. Vaccination will be the best method to control the pandemic in the future and protect those at higher risk of hospitalisation and death (e.g., elderly, those with chronic diseases). Therefore, achieving high rates of vaccination coverage among younger adults is very important in the long run to protect not only themselves but also others. For the experimental condition, the investigators will develop a brief video that will promote the vaccine's protection of others (altruism). For the control condition, the investigators will create an informational text on COVID-19 preventative health measures based on recommendations from the Public Health Agency of Canada. 2630 younger adults (aged 20 to 39) who have not yet received a dose of a COVID-19 vaccine will be recruited. To match Canadian demographics, participants will be recruited using the following quotas to reflect census data from Statistics Canada: 50% male and 50% female; 80% Anglophone and 20% Francophone; 80% urban and 20% rural; and 50% household income level less than $75,000 and 50% household income greater than $75,000. Half of the participants will be randomly assigned to watch the video, with the other half reading the text. In both groups, participants will complete a short online survey before and after viewing the video or reading the text. The goal is to assess the efficacy of the video on increasing younger adults' willingness to get a COVID-19 vaccine. The research team is partnering in this study with key agencies, e.g., Public Health Agency of Canada (PHAC), National Advisory Committee on Immunization (NACI), and the Institut National de Santé Publique du Québec (INSPQ) to help communicate the research findings to the general population.

Read the detailed description

The COVID-19 vaccine is the most effective way to arrest the pandemic. A high vaccine acceptance rate is needed to achieve community immunity; however, current COVID-19 vaccine acceptance rate remains low, particularly among younger Canadians. There have been no studies that have examined the impact of altruism on COVID-19 vaccine intentions using a video-based intervention. The investigators will examine the efficacy of a video intervention eliciting altruism on increasing younger Canadians' (ages 20-39) intentions to receive the COVID-19 vaccine using a randomized control trial. The results of this study will be used by public health authorities to increase COVID-19 vaccine uptake. There are two objectives of the study: 1) to assess the within-participant efficacy of the video intervention in increasing vaccine intentions; 2) to assess the between-participant efficacy of the video intervention in increasing vaccine intentions.

A 10-minute survey will be administered online to a sample of 2630 Canadian residents aged 20-39 years old and is available in both English and French. To calculate the required sample size for the within-participant change in vaccine hesitancy (i.e., pre-post video intervention) the investigators used survey data showing that approximately 40% of Canadians in this age group are COVID-19 vaccine hesitant i.e., don't know yet or would refuse vaccination. Estimating a 5% decrease of hesitancy in the video intervention group and a correlation of about 0.45 between paired observations, this group requires a sample size of 1315 pairs for detecting a 5% change of marginal proportions at a power of 80% and two-sided significance of 5%.

Participants will be randomized using a one-to-one ratio. Thus, 50% will be allocated to the video intervention and 50% to the text intervention. Using equal size groups will allow for the detection of a between group difference in vaccine intentions of 5-6% with a power of 0.8 and a two-sided significance of 5%. The total sample required for this study is 2630 participants i.e., 1315 in the video intervention group and 1315 in the text intervention group.

The investigators have contracted Dynata, the world's largest first-party data and insight platform, to conduct recruitment and host the survey. Dynata will send invitations in various forms (e.g., e-mail invitations, text messages and in-app alerts) to recruit eligible participants from their existing panel (individuals who have signed with Dynata and have expressed willingness to receive invitations to various appropriate surveys) until recruitment goals and quotas are met.

Stratified randomization will be used to allocate participants to either: 1) video intervention: viewing a 2-minute altruism-eliciting video, or 2) text intervention: reading a text containing information from the Public Health Agency of Canada about general health behaviours and public health recommendations concerning COVID-19, e.g., hand hygiene and respiratory etiquette, wearing non-medical masks, physical distancing, etc. Within each stratum (first language, sex, population density and household income), participants will be allocated randomly using a one-to-one ratio (one to the video intervention and one to the text intervention).

Participants will first be asked to answer several socio-demographic questions and will be asked to choose one of the following categories which describe their COVID-19 vaccine decision-making stage according to the Precaution Adoption Process Model (PAPM): unengaged, undecided, decided not to receive the vaccine, or decided to receive the vaccine. Subsequently, depending on their randomly assigned condition, participants will either be shown a 2-minute altruism-eliciting video, or a brief informational text. After viewing this content, to ensure that participants paid attention, participants will answer questions about the contents to check their understanding. Finally, participants will: 1) once again be asked to choose their COVID-19 vaccine decision-making stage; 2) be asked questions regarding previous vaccination history (e.g., seasonal influenza), lifestyle factors, self-perceived health status, personal history of SARS-CoV-2 infection, and preferred health-information channels; and 3) complete validated scales regarding altruism, empathy, personal distress, and vaccine hesitancy.

To test the outcome for objective 1, the McNemar's test will be used to compare paired (pre-post video intervention) proportions. To control for the potential effect of other factors (e.g., sociodemographics, previous influenza vaccination, lifestyle factors), the investigators will conduct multivariate analyses (General Estimating Equations) and estimate the associations between these factors and changes in COVID-19 vaccine intentions. For objective 2, the difference in proportions between the video intervention and text intervention will be analyzed using the Chi-square test. The investigators will test for significant differences in predictor variables between the two groups and use logistic regression analyses to estimate the associations between these variables and the outcome (vaccine acceptability). The significance level will be set at α = 0.05.

Conditions
Vaccine Refusal
Being tested
Altruism Video, COVID-19 Informational Text
Keywords
Vaccine Hesitancy, Vaccine Decision Making, COVID-19
Medical subject headings
Vaccination Refusal, Vaccination Hesitancy, COVID-19

What participants receive

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

  • Altruism VideoBehavioural

    The video provides three vignettes about a diverse set of people who may be more vulnerable to serious health consequences from COVID-19. In each of the stories, high vaccine uptake of those around these vulnerable individuals serves to protect them. This communicates that getting the COVID-19 vaccine can be done for prosocial reasons and to foster a sense of community, as it provides protection not only to oneself, but also to others.

  • COVID-19 Informational TextBehavioural

    The topics included in the text are how COVID-19 spreads, hygiene, physical distancing, and travel restrictions. Participants will complete three comprehension questions, one after each of the following sections: hygiene, physical distancing, and travel restrictions.

Study groups in NCT04960228
Study groupRoleWhat they receive
Altruism Video InterventionExperimentalParticipants will watch a 3-minute video about COVID-19 vaccination that elicits altruistic motives. The role of this arm is to test whether altruistic themes are an effective way to promote COVID-19 vaccination amongst young people and whether a video format is preferable for this group.
Receives: Behavioral: Altruism Video
Informational Text InterventionActive comparatorParticipants will read a brief informational text including information drawn from the Public Health Agency of Canada website (https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/prevention-risks.html#self). The purpose of this arm is to provide an active comparator with information about COVID-19 preventative health behaviors that has been strongly recommended to the public since the beginning of the pandemic. By doing this, we will assess if the video intervention changes vaccination intentions more than a presentation of general, well-known COVID-19 related information.
Receives: Behavioral: COVID-19 Informational Text

What is being measured

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

  1. Post Intervention Vaccine Intentions

    Vaccine intentions are measured using one item: "Which of the following best describes your thoughts about a COVID-19 vaccine?". Participants will then indicate their vaccine intention stage, adapted from the Precaution Adoption Process Model (PAPM): I have not thought about receiving the COVID-19 vaccine, I am undecided about receiving the COVID-19 vaccine, I do not want to receive the COVID-19 vaccine, and I do want to receive the COVID-19 vaccine. Participants will answer this item before (pre) and after (post) the intervention has been administered, all within the same survey.

    Measured: Pre-post intervention, within the same survey. The length of the survey is projected to be about 10 minutes.

Timeline

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

  1. First posted13 Jul 2021
  2. Study start30 Jul 2021
  3. Primary completion13 Sep 2021
  4. Study completion13 Sep 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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be assigned to either the video intervention or informational text control condition using a 1:1 randomization ratio.
Masking
Single blind
Who is masked
Investigator
Enrolment
2,097 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04960228
Sponsor's protocol ID
2022-2877
Status last verified
Feb 2022
First submitted
30 Jun 2021
Last updated
21 Feb 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Consent form, data collection method, and organizational policy means only aggregated data will be shared with other researchers.

Publications

  • Li M, Taylor EG, Atkins KE, Chapman GB, Galvani AP. Stimulating Influenza Vaccination via Prosocial Motives. PLoS One. 2016 Jul 26;11(7):e0159780. doi: 10.1371/journal.pone.0159780. eCollection 2016.

    PubMed 27459237
  • 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.

    PubMed 29611455
  • Rieger M. Triggering altruism increases the willingness to get vaccinated against COVID- 19. Social Health and Behavior. 2020; 3(3): 78.

  • Zhu P, Tatar O, Griffin-Mathieu G, Perez S, Haward B, Zimet G, Tunis M, Dube E, Rosberger Z. The Efficacy of a Brief, Altruism-Eliciting Video Intervention in Enhancing COVID-19 Vaccination Intentions Among a Population-Based Sample of Younger Adults: Randomized Controlled Trial. JMIR Public Health Surveill. 2022 May 30;8(5):e37328. doi: 10.2196/37328.

    PubMed 35544437

Questions about this trial

What is this clinical trial studying?

A study testing Altruism Video and COVID-19 Informational Text in people with Vaccine Refusal, run by Zeev Rosberger at 1 site in Canada.

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 1 inclusion and 1 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 21 Feb 2022. 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 Canada. 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 21 Feb 2022). 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?

Post Intervention Vaccine Intentions (time frame: Pre-post intervention, within the same survey. The length of the survey is projected to be about 10 minutes.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04960228, which also lists 4 linked publications.

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 21 Feb 2022.

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