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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if different communication strategies can increase COVID-19 vaccine uptake in certain counties. One group will receive messages encouraging vaccination, while another group will receive these messages plus additional support to simplify the vaccination process. The trial seeks participants who are clients of Homeplace, reside in one of the 15 selected counties, and can complete a survey in English.

As an unphased trial, this study offers participants the opportunity to contribute to important research that could enhance public health communication strategies.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that communication strategies are generally safe and well-tolerated. A review of studies found that various communication methods can effectively increase COVID-19 vaccine uptake without causing harm.

The Health Communication + Structural approach combines these communication methods with strategies to improve vaccine accessibility. Studies on similar approaches have reported no negative effects. Instead, they emphasize making vaccines more accessible and changing public perception.

Both methods involve sharing information and improving access, presenting no risks like those associated with new drugs or medical procedures. Overall, these strategies are safe and aim to help more people feel comfortable getting vaccinated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for COVID-19 vaccine hesitancy because they focus on personalized communication strategies. Unlike the standard approaches, which often involve general public health messages, these treatments are tailored to specific communities and delivered by trusted local figures. The Health Communication arm uses theory-based messaging that addresses attitudes and social norms, while the Health Communication + Structural arm adds strategies to make vaccines more accessible. By engaging directly with community-specific themes and influencers, these interventions aim to significantly boost vaccine uptake in hesitant populations.

What evidence suggests that this trial's treatments could be effective for increasing COVID-19 vaccine uptake?

Studies have shown that effective communication can increase COVID-19 vaccination rates. In this trial, one arm will focus on health communication strategies, involving trusted local leaders sharing messages to change attitudes and social norms. Another arm, the Health Communication + Structural arm, combines these strategies with practical support, such as making vaccines easier to access, to tackle obstacles beyond just providing information. Research has shown that addressing both knowledge and access leads to higher vaccination rates, especially in economically challenged communities. Overall, both communication and combined strategies show promise in encouraging more people to get vaccinated. ^{1 2 6 7 8}

Who Is on the Research Team?

Marc T. Kiviniemi, PhD

Principal Investigator

University of Kentucky

Kathryn M. Cardarelli, PhD, MPH

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

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

Must be a current Homeplace client

Have the ability to complete the survey in English

Live in one of the 15 selected study counties

Exclusion Criteria

Not a current Homeplace client

Primary residence is not in one of the 15 study counties

I am either younger than 18 or older than 99 years old.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12086885/

Communication-based interventions to increase COVID-19 ... This systematic review investigates the effectiveness of different communication strategies to increase COVID-19 vaccine uptake and willingness.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X2500698X

Communication interventions to reduce parental vaccine ... This review evaluates 33 interventions targeting parental vaccine hesitancy. Behavior change was harder to achieve than perception change.

3. frontiersin.org frontiersin.org/journals/political-science/articles/10.3389/fpos.2021.630133/full

Encouraging COVID-19 Vaccine Uptake Through Effective ... We investigate the effectiveness of three different health communication frames hypothesized to increase vaccine intention.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8949230/

The Effectiveness of Interventions for Increasing COVID-19 ... The aim of this systematic review is to identify and evaluate the effectiveness of interventions to increase COVID-19 vaccine uptake.

5. nature.com nature.com/articles/s41591-024-02939-2

Influence of COVID-19 on trust in routine immunization ... Revisiting COVID-19 vaccine hesitancy around the world using data from 23 countries in 2021. Article Open access 01 July 2022. A survey of ...

6. nature.com nature.com/articles/s41467-022-31441-x

Revisiting COVID-19 vaccine hesitancy around the world ... COVID-19 vaccine hesitancy literature focuses on four interrelated subjects: (1) vaccine safety; (2) vaccine efficacy; (3) perception of risk; ...

7. ccjm.org ccjm.org/content/91/9_suppl_1/S50

Meeting the challenge of vaccine hesitancy Vaccine hesitancy is a long-standing issue that became alarming at the height of the COVID-19 pandemic, fueled by misinformation and amplified through social ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2784594

Communication Strategies for Mitigating COVID-19 ... This survey study examines communication interventions that may encourage the uptake of less-preferred vaccines against COVID-19.