Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04801030
Status:
UNKNOWN
Last Update Posted:
2022-04-18
First Post:
2021-03-11
Brief Title:
COVID-19 Vaccine Hesitancy Among African Americans
Sponsor:
Meharry Medical College
Organization:
Meharry Medical College
Study Overview
Official Title:
Using Multi-strategies to Address COVID-19 Vaccine Hesitancy Among African Americans
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Coronavirus disease 2019 COVID-19 has created a state of emergency for African Americans in the US Recent findings indicate 31 of adults self-reported wait and see of the COVID-19 vaccine of which 16 were African American This project seeks to test the feasibility and impact of a multi-layered culturally-appropriate social marketing intervention targeting COVID-19 vaccine hesitant VH African Americans to increase vaccine confidence uptake and completion of multi-dose vaccine series in NashvilleDavidson County Tennessee This studys novelty lies in being the first to assess feasibility and preliminary efficacy of a multi-layered culturally-appropriate social marketing intervention to promote COVID-19 vaccination among African Americans in TN Clinical significance is increased vaccine uptake and decreased COVID-19 burden and disparities
Detailed Description:
The goal of this application is to develop and test the feasibility and impact of a multi-layered culturally-appropriate social marketing intervention targeting COVID-19 VH African Americans to increase uptake and completion of vaccine series in NashvilleDavidson County Tennessee TN Investigators will partner with members of National Association for the Advancement of Colored People Nashville Health Disparities Coalition and Congregational Health Education Network to serve as an advisory committee Investigators will also partner with Meharry Medical College MMC clinics and Tennessee Department of Healths TDH Immunization Program
Aim 1 Engage with key stakeholders to develop a multi-layered culturally-appropriate social marketing intervention targeting African Americans who are COVID-19 VH Investigators will adapt an existing message library using the Health Belief ModelTheory of Reasoned Action previous VH research preliminary data of investigators and feedback from community partners Next investigators will conduct semi-structured interviews with 25-30 VH individuals and 5-10 COVID-19 experts to elicit feedback on draft content Qualitative data will be collected and analyzed iteratively informing successive intervention modifications to cover a range of concerns for VH individuals enhance message relevance and determine media outlets for dissemination Next investigators will pre-test intervention prototypes with 16 COVID-19 VH individuals to make final modifications
Aim 2a Conduct a pilot study of the intervention and study protocol to demonstrate feasibility and assess impact Investigators will conduct a pilot study using an experimental field trial design in three TN counties Davidson County 1 intervention site and Shelby and Hamilton Counties 2 control sites COVID-19 vaccine uptake primary outcome assessed using 1 aggregate data from partner clinics and TN immunization registry TennIIS and 2 individual pre-post data from a marketing firm using random digit dialing RDD H1 COVID-19 vaccination rates will be higher for VH African Americans at intervention site compared to control sites Implementation outcomes are feasibility fidelity acceptability appropriateness and penetration
Aim 2b To retrospectively explore knowledge attitudes intentions and implementation outcomes post-intervention Investigators will use qualitative methods to identify perceived acceptance of different types of media and webpage along with perceived change in knowledge attitudes and intentions from African Americans by degree of VH Investigators will also explore appropriateness feasibility penetration and fidelity as it relates to the social marketing intervention from 3 providers 3 community-based organization CBO staff and 2 TDH staff Participants will be identified using RDD and community partner networks
Aim 1 Engage with key stakeholders to develop a multi-layered culturally-appropriate social marketing intervention targeting African Americans who are COVID-19 VH Investigators will adapt an existing message library using the Health Belief ModelTheory of Reasoned Action previous VH research preliminary data of investigators and feedback from community partners Next investigators will conduct semi-structured interviews with 25-30 VH individuals and 5-10 COVID-19 experts to elicit feedback on draft content Qualitative data will be collected and analyzed iteratively informing successive intervention modifications to cover a range of concerns for VH individuals enhance message relevance and determine media outlets for dissemination Next investigators will pre-test intervention prototypes with 16 COVID-19 VH individuals to make final modifications
Aim 2a Conduct a pilot study of the intervention and study protocol to demonstrate feasibility and assess impact Investigators will conduct a pilot study using an experimental field trial design in three TN counties Davidson County 1 intervention site and Shelby and Hamilton Counties 2 control sites COVID-19 vaccine uptake primary outcome assessed using 1 aggregate data from partner clinics and TN immunization registry TennIIS and 2 individual pre-post data from a marketing firm using random digit dialing RDD H1 COVID-19 vaccination rates will be higher for VH African Americans at intervention site compared to control sites Implementation outcomes are feasibility fidelity acceptability appropriateness and penetration
Aim 2b To retrospectively explore knowledge attitudes intentions and implementation outcomes post-intervention Investigators will use qualitative methods to identify perceived acceptance of different types of media and webpage along with perceived change in knowledge attitudes and intentions from African Americans by degree of VH Investigators will also explore appropriateness feasibility penetration and fidelity as it relates to the social marketing intervention from 3 providers 3 community-based organization CBO staff and 2 TDH staff Participants will be identified using RDD and community partner networks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None