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COVID-19 Vaccine Hesitancy Among African Americans

Primary Purpose

Covid19, Vaccine Refusal, Communication

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
YourCoViDVaxFacts
Sponsored by
Meharry Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • African American
  • Unvaccinated for COVID-19
  • Vaccine hesitant
  • 18 years and older
  • Speaks English

Exclusion Criteria:

  • Not African American
  • Receipt of COVID-19 vaccination
  • under 18 years of age
  • Does not speak English

Sites / Locations

  • Meharry Medical College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Culturally-appropriate social marketing campaign

Control Arm 1

Control Arm 2

Arm Description

Participants will receive a multi-layered, social marketing campaign which is deemed culturally appropriate. This will occur over a 6 month -time period. Rates will be observed at 0, 6, and 12 months.

Participants will receive no intervention, only to serve as a control site. Rates will be observed at 0, 6, and 12 months.

Participants will receive no intervention, only to serve as a control site. Rates will be observed at 0, 6, and 12 months.

Outcomes

Primary Outcome Measures

Recruitment rates
percent enrolled in study
Retention rates
percent completed baseline survey, percent completed follow-up survey
data collection processes
percent ascertained COVID 19 vaccine status post-intervention

Secondary Outcome Measures

COVID-19 vaccine rates
Number of individuals vaccinated post-intervention
Attitudes toward COVID-19 vaccine
Change in attitudes toward COVID-19 vaccine

Full Information

First Posted
March 11, 2021
Last Updated
April 11, 2022
Sponsor
Meharry Medical College
Collaborators
St. Jude Children's Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04801030
Brief Title
COVID-19 Vaccine Hesitancy Among African Americans
Official Title
Using Multi-strategies to Address COVID-19 Vaccine Hesitancy Among African Americans
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meharry Medical College
Collaborators
St. Jude Children's Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 Nashville/Davidson County, Tennessee. This study's 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 Nashville/Davidson 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 Health's (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 Model,Theory 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Vaccine Refusal, Communication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Culturally-appropriate social marketing campaign
Arm Type
Experimental
Arm Description
Participants will receive a multi-layered, social marketing campaign which is deemed culturally appropriate. This will occur over a 6 month -time period. Rates will be observed at 0, 6, and 12 months.
Arm Title
Control Arm 1
Arm Type
No Intervention
Arm Description
Participants will receive no intervention, only to serve as a control site. Rates will be observed at 0, 6, and 12 months.
Arm Title
Control Arm 2
Arm Type
No Intervention
Arm Description
Participants will receive no intervention, only to serve as a control site. Rates will be observed at 0, 6, and 12 months.
Intervention Type
Behavioral
Intervention Name(s)
YourCoViDVaxFacts
Intervention Description
The intervention will be delivered via multiple strategies- social media (YouTube, Facebook), radio, newspaper, tv ads, community partner networks. Participants receive culturally-tailored message on COVID-19 and the vaccine. The strategies will have a link that will open to a website that is optimized for viewing on a computer or mobile phone which has the look and feel of an app, but without requiring the user to download anything to the phone. On the website, participants will be prompted to select their top concerns from a list. Based on the responses, the top barriers or need will each be mapped to a corresponding educational message, which will be displayed to the user with appropriate images or graphics.
Primary Outcome Measure Information:
Title
Recruitment rates
Description
percent enrolled in study
Time Frame
6 months
Title
Retention rates
Description
percent completed baseline survey, percent completed follow-up survey
Time Frame
1 year
Title
data collection processes
Description
percent ascertained COVID 19 vaccine status post-intervention
Time Frame
1 year
Secondary Outcome Measure Information:
Title
COVID-19 vaccine rates
Description
Number of individuals vaccinated post-intervention
Time Frame
6 months
Title
Attitudes toward COVID-19 vaccine
Description
Change in attitudes toward COVID-19 vaccine
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: African American Unvaccinated for COVID-19 Vaccine hesitant 18 years and older Speaks English Exclusion Criteria: Not African American Receipt of COVID-19 vaccination under 18 years of age Does not speak English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer C Erves, PhD
Organizational Affiliation
Meharry Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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COVID-19 Vaccine Hesitancy Among African Americans

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