Addressing Vaccine Hesitancy and Increasing COVID-19 Vaccine Uptake Among African American Young Adults in the South

Overview

The study staff will conduct a hybrid type 1 effectiveness implementation 2-arm trail with 360 Black young adults from Alabama, Georgia, and North Carolina. Participants will be randomized to receive the standard of care (control) or the TT-C intervention arm, each with a balance of 180 participants. Primary effectiveness outcome is COVID-19 vaccine uptake define as receipt of any vaccine (primary series or secondary booster). Secondary effectiveness outcomes are vaccine hesitancy, confidence, and knowledge, attitudes, and beliefs. The study staff will also conduct qualitative interviews with a group of purposively selected AA-YA participants (est. n=12-16) and site staff (est. n=6-8) to assess barriers and facilitators to implementation. The hypothesis is that the intervention arm will be more effective than the control arm at increasing vaccine uptake.

Full Title of Study: “A Multidimensional Digital Approach to Address Vaccine Hesitancy and Increase COVID-19 Vaccine Uptake Among African American Young Adults in the South (Tough Talks COVID)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2025

Interventions

  • Behavioral: Tough Talks COVID
    • Intervention participants will download the TT-C app from the iOS or Google Play store and complete the intervention within one month.

Arms, Groups and Cohorts

  • No Intervention: Standard of Care (Control)
    • Research staff will provide COVID vaccine materials from the Centers for Disease Control (CDC) to those participants in the Standard of Care (SOC) arm.
  • Experimental: TT-C Intervention
    • Research staff will provide access to the TT-COVID app for one-month, which will provide knowledge about the COVID-19 vaccine, address mis-information, and include multi-media digital stories from study participant’s peers.

Clinical Trial Outcome Measures

Primary Measures

  • COVID Vaccine Uptake at Month 1
    • Time Frame: Month 1
    • COVID Vaccine Uptake is measured by changes in self-reported receipt of any primary series or booster vaccination
  • COVID Vaccine Uptake at Month 3
    • Time Frame: Month 3
    • COVID Vaccine Uptake is measured by changes in self-reported receipt of any primary series or booster vaccination

Secondary Measures

  • COVID Vaccine Confidence
    • Time Frame: Up to 3 Months
    • COVID Vaccine Confidence is measured by self-reported ability to receive any primary series of booster vaccination at 1 and 3-month follow-up
  • COVID Vaccine Hesitancy
    • Time Frame: Up to 3 Months
    • COVID Vaccine Hesitancy is measured by self-reported refusal to receive any primary series or booster vaccination at 1 and 3-month follow-up

Participating in This Clinical Trial

Inclusion Criteria

  • Identify as African American/Black – Able to speak and read English – Has access to personal smartphone – Current resident of AL, GA, NC Exclusion Criteria:

  • Aged younger than 18 year or older than 29 years – Does not identify as African American/Black – Non-English speaking – Does not live in Al, GA, NC – Unable to provide informed consent – Receipt of full COVID vaccine series (including vaccination and booster or prior participation in a vaccine trial)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 29 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of North Carolina, Chapel Hill
  • Collaborator
    • University of Alabama at Birmingham
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lisa Hightow-Weidman, MD, MPH, Principal Investigator, University of North Carolina, Chapel Hill
  • Overall Contact(s)
    • Lisa Hightow-Weidman, MD, MPH, (919) 843-0033, lisa_hightow@med.unc.edu

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