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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04876885
Other study ID # 12902
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 6, 2021
Est. completion date June 6, 2021

Study information

Verified date May 2021
Source McMaster University
Contact Sarrah M Lal, MBA
Phone 289.808.8597
Email lals2@mcmaster.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators aim to study whether education, in the form of three two-minute educational videos about COVID-19 vaccine development and dissemination, reduces vaccine hesitancy and increases intent to vaccinate. The investigators intend to use insights from this research study to develop a framework for video-based 'education prescriptions' that reduce vaccine hesitancy and increase intent to vaccinate across a number of infectious diseases. This may have wide-ranging impact: inform practice for health promotions and public health, as well as support infectious disease related work done by healthcare professionals (e.g. those working in travel medicine, where vaccination rates are also low).


Description:

The World Health Organization listed vaccine hesitancy as one of the leading threats to global health in 2019. Vaccine hesitancy is defined as the "reluctance or refusal to vaccinate despite the availability of vaccines". Given the novelty of the COVID-19 pandemic, hesitancy towards use of COVID-19 vaccine may be linked to the process of vaccine development and clinical trial validation of safety and/or efficacy, rather than hesitations regarding vaccines in general. This has already inspired several education campaigns. It is unclear whether education leads to reduced hesitance and whether reduced hesitance leads to increased intent to vaccinate. Further, early surveys demonstrating high COVID-19 vaccine acceptance and intent to vaccinate may not reflect actual uptake, as shown by comparisons to flu vaccination uptake at a time when flu vaccines are both available, validated and largely freely accessible. Inspiring vaccine confidence is a multifaceted challenge, and the COVID-19 pandemic has shed light on one of its aspects, specifically the public health approach to health information dissemination. The lack of evidence-based knowledge and preparedness coupled with pandemic fatigue impacts the uptake of recommended health behaviours and puts human lives at risk. Different people adopt different responses to health promotion materials based on a variety of socioeconomic factors. For example, in an American study on vaccination in children, it was found that children who had never received a vaccine tended to come from affluent, college educated families, while those who had only received some recommended vaccinations came from minority families that were single parent, low-income and less likely to have completed higher education. Almost 50% of the parents of the unvaccinated children cited concerns about vaccine safety. The strength of beliefs leading to hesitancy may change the ability to affect intent to vaccinate. These beliefs may be contributed to by cultural dimensions in Canada and cultures of recently immigrated individuals, with regards to individualism, collectivism, perceptions of social benefits, etc. These factors might also impact the choice to vaccinate. The existence of many outlets for highly varied information underscores the need for unbiased and credible education on COVID-19 vaccinations. The investigators aim to study whether education, in the form of three two-minute educational videos about COVID-19 vaccine development and dissemination, reduces vaccine hesitancy and increases intent to vaccinate. The investigators intend to use insights from this research study to develop a framework for video-based 'education prescriptions' that reduce vaccine hesitancy and increase intent to vaccinate across a number of infectious diseases. This may have wide-ranging impact: inform practice for health promotions and public health, as well as support infectious disease related work done by healthcare professionals (e.g. those working in travel medicine, where vaccination rates are also low).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date June 6, 2021
Est. primary completion date June 6, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: For the general public arm: - An understanding of the English language at a grade 8 written level - Reside in Ontario For the healthcare professionals and public health professionals arm: - Licensed to practice as a healthcare professional in Ontario - An understanding of the English language at a grade 8 written level - Reside in Ontario Exclusion Criteria: - Any individuals under age 16

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Educational video
Three two-minute educational videos about COVID-19 vaccine development and dissemination

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
McMaster University

References & Publications (5)

Dodd RH, Cvejic E, Bonner C, Pickles K, McCaffery KJ; Sydney Health Literacy Lab COVID-19 group. Willingness to vaccinate against COVID-19 in Australia. Lancet Infect Dis. 2021 Mar;21(3):318-319. doi: 10.1016/S1473-3099(20)30559-4. Epub 2020 Jun 30. — View Citation

Edwards B, Biddle N, Gray M, Sollis K. COVID-19 vaccine hesitancy and resistance: Correlates in a nationally representative longitudinal survey of the Australian population. PLoS One. 2021 Mar 24;16(3):e0248892. doi: 10.1371/journal.pone.0248892. eCollection 2021. — View Citation

Harrison EA, Wu JW. Vaccine confidence in the time of COVID-19. Eur J Epidemiol. 2020 Apr;35(4):325-330. doi: 10.1007/s10654-020-00634-3. Epub 2020 Apr 22. — View Citation

Malik AA, McFadden SM, Elharake J, Omer SB. Determinants of COVID-19 vaccine acceptance in the US. EClinicalMedicine. 2020 Sep;26:100495. doi: 10.1016/j.eclinm.2020.100495. Epub 2020 Aug 12. — View Citation

Sherman SM, Smith LE, Sim J, Amlôt R, Cutts M, Dasch H, Rubin GJ, Sevdalis N. COVID-19 vaccination intention in the UK: results from the COVID-19 vaccination acceptability study (CoVAccS), a nationally representative cross-sectional survey. Hum Vaccin Immunother. 2020 Nov 26:1-10. doi: 10.1080/21645515.2020.1846397. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants indicating intent to vaccinate against COVID-19 The primary end point of the study is "intent to vaccinate against COVID-19" within the general public survey. We are looking for an increase in intent to vaccinate after the educational videos are completed. This is a yes/no answer choice. A change in response may be indicative of the impact of education on vaccination intent. One month
Secondary Change in score regarding vaccine hesitation after exposure to educational materials The study seeks to understand whether providing video-based educational materials yields a positive change in score regarding vaccine hesitation (at least one point decrease) after exposure to educational materials. A change in score may indicate that educational materials support a decrease in COVID-19 vaccination hesitancy in the population. The scale title will be "Level of concern about the COVID-19 vaccine". Values will range from 1-5, where 1 indicates no concern and 5 indicates high concern. One month
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