Addressing COVID-19 Vaccine Hesitancy With Muliti-Level Interventions in Appalachia

NCT ID: NCT06505993

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 2250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-09-30
• Study Completion Date: 2027-09-30

Brief Summary

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.

Detailed Description

The intervention trial will be a community-based, three-arm cluster randomized controlled trial. The three arms are: (1) multilevel invention (vaccine communication campaign + community-level structural intervention),(2) health communications only intervention, and (3) control/standard of care. Randomization will take place at the county level. The 15 participating counties will first be matched into blocks of three, with each block being matched as closely as possible on recent county influenza vaccination rates. After matching, the three counties within each matched block will be randomly assigned to one of the three study arms. This technique of randomizing to study arm within each matched block of counties increases confidence that community-level factors that might influence vaccine uptake are equally distributed across study arms. Following randomization, the intervention process will begin in counties in the multilevel and communication campaign intervention arms. Assessment of primary and secondary study outcomes will take place 6 months after initiation of the intervention. Finally, after assessment of outcomes is complete, the intervention components will be offered to the control counties.

Conditions

COVID-19; Vaccine Hesitancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Health Communication

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 Type: EXPERIMENTAL

Health Communication

Intervention Type: BEHAVIORAL

Participants will experience a coordinated social marketing campaign including targeted messaging related to vaccine education, self-efficacy, and informative resources to receive the COVID-19 vaccine. The intervention messaging will be strategically layered and disseminated to this intervention arm predominately via Facebook by trusted and local communicators in the study counties.

Health Communication + Structural

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 Type: EXPERIMENTAL

Health Communication + Structural

Intervention Type: BEHAVIORAL

This multi-level intervention will include the defined health messaging intervention components, as well as a combination of structural-level intervention strategies targeted to better facilitate access to community-based vaccination delivery. Health organizations will receive a toolkit, which will include community-specific resources and training modules such as: up to date evidence-based vaccination guidance that can be delivered to patients; strategies for navigating conversations with patients about vaccination; any applicable reimbursement, insurance, or qualifying enrollment information specific to the healthcare organization; identifying locations that facilitate access for the community members; provided advertising to promote the locations and timing of the vaccinations; and generating community-based branding for all vaccination delivery based on the trusted information sources identified.

Standard of Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Health Communication

Participants will experience a coordinated social marketing campaign including targeted messaging related to vaccine education, self-efficacy, and informative resources to receive the COVID-19 vaccine. The intervention messaging will be strategically layered and disseminated to this intervention arm predominately via Facebook by trusted and local communicators in the study counties.

Intervention Type: BEHAVIORAL

Health Communication + Structural

This multi-level intervention will include the defined health messaging intervention components, as well as a combination of structural-level intervention strategies targeted to better facilitate access to community-based vaccination delivery. Health organizations will receive a toolkit, which will include community-specific resources and training modules such as: up to date evidence-based vaccination guidance that can be delivered to patients; strategies for navigating conversations with patients about vaccination; any applicable reimbursement, insurance, or qualifying enrollment information specific to the healthcare organization; identifying locations that facilitate access for the community members; provided advertising to promote the locations and timing of the vaccinations; and generating community-based branding for all vaccination delivery based on the trusted information sources identified.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Must be a current Homeplace client

2. Live in one of the 15 selected study counties

3. Over the age of 18

4. Have the ability to complete the survey in English

Exclusion Criteria

1. Not a current Homeplace client

2. Primary residence is not in one of the 15 study counties

3. Not within the ages of 18-99 years old

4. English is not your primary language

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Marc Kiviniemi

OTHER

Sponsor Role: lead

Responsible Party

Marc Kiviniemi

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marc T. Kiviniemi, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Kathryn M. Cardarelli, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Kentucky Center of Excellence in Rural Health

Hazard, Kentucky, United States

Countries

United States

Other Identifiers

R01MD016864

Identifier Type: NIH

Identifier Source: secondary_id

View Link

88486

Identifier Type: -

Identifier Source: org_study_id