Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505993
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Addressing COVID-19 Vaccine Hesitancy With Muliti-Level Interventions in Appalachia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
COVID19 -- Health Communication and Structural Intervention Evaluation -- K-VAC Kentucky Vaccinating All Communities
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
K-VAC
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 structuralenvironmental 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 intervention2 health communications only intervention and 3 controlstandard 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None