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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD016864 | U.S. NIH Grant/Contract | View source |
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Potential study redesign
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 Vaccination Behaviors | 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. |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc T. Kiviniemi, PhD | University of Kentucky | Principal Investigator |
| Kathryn M. Cardarelli, PhD, MPH | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Center of Excellence in Rural Health | Hazard | Kentucky | 41701 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000088823 | Vaccination Hesitancy |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D058015 | Health Communication |
| ID | Term |
|---|---|
| D005159 | Health Care Facilities Workforce and Services |
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| 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. |
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| Baseline and 6 months |
| COVID-19 Attitudes | 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):
| Baseline and 6 months |
| COVID-19 Risk Perceptions | 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:
| Baseline and 6 months |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072758 | Vaccination Refusal |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |