Health Communication + Support for COVID-19 Vaccine Hesitancy

(K-VAC Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Marc Kiviniemi

Disqualifiers: Not Homeplace client, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2250 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems unlikely that you would need to stop, as the study focuses on communication strategies for COVID-19 vaccine uptake.

What data supports the effectiveness of the treatment Health Communication + Structural for COVID-19 vaccine hesitancy?

Research shows that effective communication strategies, such as using humble inquiry, compassionate listening, and storytelling, can help address vaccine hesitancy by providing accurate information and engaging with individuals' concerns. Additionally, hope-oriented messages have been found to motivate public action more effectively than fear-based messages during the COVID-19 pandemic. ^{1 2 3 4 5}

Is Health Communication + Support for COVID-19 Vaccine Hesitancy safe for humans?

The research does not provide specific safety data for Health Communication + Support for COVID-19 Vaccine Hesitancy, but it emphasizes the importance of clear and accurate communication to address vaccine hesitancy. ^{6 7 8 9 10}

How does the treatment 'Health Communication + Support for COVID-19 Vaccine Hesitancy' differ from other treatments for vaccine hesitancy?

This treatment is unique because it focuses on improving trust in health professionals, enhancing health literacy (understanding health information), and boosting self-efficacy (confidence in one's ability to take action) to address vaccine hesitancy. It uses structured communication strategies and behavioral insights to make vaccination more accessible and socially relevant, which is different from traditional medical treatments. ^{10 11 12 13 14}

What is the purpose of this trial?

The purpose of this community-engaged study is to test the ability of county-level strategies to increase uptake of COVID-19 vaccination. In this study the key objective is to test whether health communication strategies or health communication + county-specific structural/environmental support increases COVID-19 vaccine uptake and changes perceptions and beliefs about the vaccination at the county-level.

Research Team

Kathryn M. Cardarelli, PhD, MPH

Principal Investigator

University of Louisville

Marc T. Kiviniemi, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for individuals living in Appalachia who may be hesitant to receive a COVID-19 vaccine. The study aims to include diverse participants from this region to understand and address their concerns about vaccination.

Inclusion Criteria

I am over 18 years old.

Have the ability to complete the survey in English

Must be a current Homeplace client

Exclusion Criteria

Not a current Homeplace client

Primary residence is not in one of the 15 study counties

English is not my first language.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of health communication strategies and structural interventions to increase COVID-19 vaccine uptake

6 months

Assessment

Assessment of primary and secondary study outcomes, including vaccination behaviors, attitudes, and risk perceptions

6 months

Follow-up

Participants are monitored for changes in vaccination uptake and attitudes after the intervention

4 weeks

Treatment Details

Interventions

• Health Communication
• Health Communication + Structural

Trial Overview The study is testing if health communication alone or combined with county-specific support can increase COVID-19 vaccine uptake. It will also assess changes in perceptions and beliefs about the vaccine at the community level.

Participant Groups

Group I: Health Communication + Structural Experimental Treatment 1 Intervention

This intervention arm will include the conditions outlined and included in the health communication arm, however, they will be coupled with a series of structural and/or environmental intervention strategies as well, which are targeted to facilitate vaccine accessibility and uptake among adults in the randomly assigned study counties.

Group II: Health Communication Experimental Treatment 1 Intervention

This intervention arm will include exclusively health communication messaging strategies that is both theory-based and community-targeted to encourage uptake of the COVID-19 vaccine delivered by trusted local communicators. Pre-identified theory-based components are attitudes, social norms, perceived behavioral control, response efficacy, and implementation intentions. The development process for the messaging will be based through a conjoint process of identification of theory- based determinants of decision-making relevant to the desired behavior change and a community-engaged process of identifying: a) community-specific messaging themes; b) trusted communicators within the target population; and c) community-specific messaging, imaging, and themes to achieve targeting.

Group III: Standard of Care Active Control 1 Intervention

No study-specific intervention strategies (as outlined above) will be implemented in control counties at the time of the study period. Any ongoing and/or pre-existing efforts within the scope of the project's outcomes will continue as it would have i.e. a health department operating a health fair.

Who Is Running the Clinical Trial?

Marc Kiviniemi

Lead Sponsor

Trials

1

Recruited

2,300+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

Effective communication strategies are crucial for improving participation in COVID-19 vaccine clinical trials, especially in the context of widespread misinformation about vaccines.

The proposed ASK (Assume, Seek, Know) approach encourages transparency about options, collaboration with stakeholders, and understanding of trial data to enhance decision-making and potentially reduce vaccine hesitancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Communication and Decision Making about Vaccine Clinical Trials during a Pandemic. Langford, AT.[2022]

A survey of 295 health professions students revealed that those in medical and biomedical science programs had the highest vaccine acceptance scores, indicating strong positive attitudes towards vaccination.

The overall knowledge score about vaccines was 67.7%, with medical students scoring the highest at 79.0%, suggesting that enhancing vaccine education in health professions can help combat vaccine hesitancy among future healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring vaccine acceptance and knowledge within health professions education. Singh, H., Chase, AJ.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

COVID-19 topics and emotional frames in vaccine hesitation: A social media text and sentiment analysis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Communicate hope to motivate the public during the COVID-19 pandemic. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Health Communication and Decision Making about Vaccine Clinical Trials during a Pandemic. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Measuring vaccine acceptance and knowledge within health professions education. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Addressing the Challenges of Vaccine Hesitancy Broadly and Related to COVID-19 Vaccines. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Evidence-based policies in public health to address COVID-19 vaccine hesitancy. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Web-Based Reporting of Post-Vaccination Symptoms for Inactivated COVID-19 Vaccines in Jordan: A Cross-Sectional Study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Reporting rates for VAERS death reports following COVID-19 vaccination, December 14, 2020-November 17, 2021. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

COVID-19 Vaccine Hesitancy: The Perils of Peddling Science by Social Media and the Lay Press. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Characterizing discourses about COVID-19 vaccines on Twitter: a topic modeling and sentiment analysis approach. [2023]

11. Canada pubmed.ncbi.nlm.nih.gov

Contributions of Trustworthiness, Health Literacy, and Self-Efficacy in Communicating With COVID-19 Vaccine-Hesitant Audiences: Web-Based Survey Study. [2022]

12. Italy pubmed.ncbi.nlm.nih.gov

[Addressing the vaccination hesitancy: communication, behavior and literature.] [2021]

13. England pubmed.ncbi.nlm.nih.gov

Motivating COVID-19 Vaccination through Persuasive Communication: A Systematic Review of Randomized Controlled Trials. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

The prevalence and determinants of COVID-19 vaccine hesitancy in the age of infodemic. [2022]