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NCT Number: NCT06505993

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

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.

Why the study stopped: Study redesign
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Key information

Conditions

COVID-19 Behavior Coronaviridae Infections Coronavirus Infections Health Behavior Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Treatment Adherence and Compliance Treatment Refusal Vaccination Hesitancy Vaccination Refusal Vaccine Hesitancy Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky Center of Excellence in Rural Health

Hazard, Kentucky, 41701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Up to 2,250 participants will take part in the study --- approximately 150 residents in each of the 15 participating Appalachian Kentucky Counties. In each of the fifteen counties, the investigators will collect survey data from 150 adults who are served by Homeplace, a medical and social services organization run by the UK Center for Excellence in Rural Health, which provides services in each of the 15 partner counties. Homeplace provides services to adults who are medically underserved and typically at 100-133% of the federal poverty level, primarily through service delivery by trained local Community Health Workers (CHWs). CHWs will recruit participants and collect the survey data from the identified individuals. Importantly, the criteria for qualification for Homeplace services are equivalent across the 15 counties, providing equivalence of sample across counties. A random sample of 150 individuals per county will be drawn from the Homeplace client database for that county. Gender, ethnic background, and health status will roughly mirror that of the demographics of the county.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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 + 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.

Primary outcomes

  1. COVID-19 vaccination uptake

    Time frame: Baseline and 6 months

    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.

Secondary outcomes

  1. COVID-19 Vaccination Behaviors

    Time frame: Baseline and 6 months

    The investigators will assess individual-level vaccination behaviors with a survey among adults in each study county. To capture, participants will be asked to self-report their responses to following statements with multiple choice answer choices provided to allow for quantitative analysis: 1) "Have you or do you think you have had COVID-19?" 1= Yes I was tested or a doctor diagnosed me; 2= Maybe I had some symptoms but was not tested; 3= No. 2) "How many times have you had COVID-19?" 1= Once, 2= Twice, 3= Three or more times. Additionally, the investigators will use a 4-point Likert scale (1= strongly disagree, 2= disagree, 3= agree, 4= strongly agree) to assess respondent likeliness of intention to vaccinate with either a COVID-19 booster, or COVID-19 vaccine, in the next 12-months.

  2. COVID-19 Attitudes

    Time frame: Baseline and 6 months

    The investigators will assess individual-level vaccination attitudes and beliefs with a survey among adults in each study county. Participants will be asked to self-report their responses to following statements utilizing a 4-point Likert scale (1= strongly disagree, 2= disagree, 3= agree, 4= strongly agree):

    • "I feel safe about getting the COVID-19 vaccine."
    • "The COVID-19 vaccine may cause short term problems, like fever or discomfort."
    • "The COVID-19 vaccine is being pushed to make money for drug companies."
    • "The COVID-19 vaccine was not tested enough for safety."
    • "The COVID-19 vaccine may cause lasting health problems."
    • "I am concerned that the COVID-19 vaccine will cost more than I can pay."
    • "The COVID-19 vaccine was developed too quickly."

  3. COVID-19 Risk Perceptions

    Time frame: Baseline and 6 months

    The investigators will assess individual-level risk perceptions about vaccination with a survey among adults in each study county. Participants will be asked to self-report their responses to following questions with a 4-point Likert scale:

    • "How likely are you to get COVID-19 in the next 6 months?" 1= very unlikely to 4= very likely
    • "How afraid are you of getting COVID-19 in the next 6 months?" 1= not afraid at all to 4= extremely afraid
    • "If you were to get COVID-19 in the next 6 months, how serious would it be?" 1= not serious at all to 4= extremely serious

Sponsors and collaborators

Lead sponsor

Marc Kiviniemi

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

COVID19 -- Health Communication and Structural Intervention Evaluation -- K-VAC: Kentucky Vaccinating All Communities

Acronym: K-VAC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2024
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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