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

NCT06505993 | Suspended

• 2 other identifiers: 88486R01MD016864
• Study Type: interventional
• Target: 2,250
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Vaccine Hesitancy

Keywords

COVID-19; Multi-Level Intervention; Vaccine Hesitancy; Rural

Outcome Measures

Primary Outcomes (1)

• COVID-19 vaccination uptake

  Change in \*county-level\* vaccination rates- to assess uptake, the investigators will ascertain the number of individuals in each county who received the COVID-19 vaccination during the intervention period as well as during an equivalent time frame prior to the intervention. This assessment will be obtained from existing, deidentified vaccination rate data maintained by the KY Department of Public Health. The primary outcome variable will be the number of individuals receiving vaccination.

  Baseline and 6 months

Secondary Outcomes (3)

• COVID-19 Vaccination Behaviors

  Baseline and 6 months

• COVID-19 Attitudes

  Baseline and 6 months

• COVID-19 Risk Perceptions

  Baseline and 6 months

Study Arms (3)

Health Communication

EXPERIMENTAL

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.

Behavioral: Health Communication

Health Communication + Structural

EXPERIMENTAL

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.

Behavioral: Health Communication + Structural

Standard of Care

NO 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.

Interventions

Health Communication + Structural 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.

Health Communication + Structural

Health Communication 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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be a current Homeplace client
• Live in one of the 15 selected study counties
• Over the age of 18
• Have the ability to complete the survey in English

You may not qualify if:

• Not a current Homeplace client
• Primary residence is not in one of the 15 study counties
• Not within the ages of 18-99 years old
• English is not your primary language

Sponsors & Collaborators

• Marc Kiviniemi: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Kentucky Center of Excellence in Rural Health

Hazard, Kentucky, 41701, United States

Location

MeSH Terms

Conditions

COVID-19; Vaccination Hesitancy

Interventions

Health Communication

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Marc T. Kiviniemi, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Kathryn M. Cardarelli, PhD, MPH

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 17, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)