COVID-19 Vaccine Hesitancy Among African Americans

Covid19 Clinical Trial

Official title:

Using Multi-strategies to Address COVID-19 Vaccine Hesitancy Among African Americans

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04801030
• Other study ID #: 21-03-1076
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: April 2022
• Source: Meharry Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communication
• COVID-19
• Covid19
• Vaccine Refusal

Intervention

Behavioral:
• YourCoViDVaxFacts
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.

Locations

Country	Name	City	State
United States	Meharry Medical College	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Meharry Medical College	St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rates	percent enrolled in study	6 months
Primary	Retention rates	percent completed baseline survey, percent completed follow-up survey	1 year
Primary	data collection processes	percent ascertained COVID 19 vaccine status post-intervention	1 year
Secondary	COVID-19 vaccine rates	Number of individuals vaccinated post-intervention	6 months
Secondary	Attitudes toward COVID-19 vaccine	Change in attitudes toward COVID-19 vaccine	6 months