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

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)

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Vaccine Uptake
• Intervention / Treatment: Behavioral: Tough Talks COVID

Detailed Description

The study staff will recruit and enroll 360 AA-YA from communities in Alabama, Georgia, and North Carolina. After collecting informed consent, participants will be randomized using block randomization to the control condition or TT-C (remote), each with a balanced 180 participants (N=360). The standard of care (SOC) control will be the provision of COVID vaccine materials from the CDC.

After screening eligible and agreeing to be contacted, eligible responses will be reviewed individually by study staff to determine authenticity and legitimacy. In addition to eligibility criteria, staff will review bot detection values as well as location based on IP address & latitude/longitude. If determined eligible, staff complete the Verification CRF and REDCap emails the individual with a unique consent form link to complete. Once completed, REDCap sends the baseline survey linked to their unique ID in REDCap.

After the baseline survey is complete, study staff will randomize the participant with the Randomization CRF to either the intervention or control group. Based on the study arm, study staff will either email the participant with the developed SOC materials or email the participant with a unique link to create their account for the TT-C app. If SOC, study staff will compensate the participant $50 for enrolling.

If participant is randomized to intervention arm, they will be prompted to create their account with the provided link, then will be directed to download and login to the TT-C app. Once account creation is confirmed in the administrator portal, study staff will compensate the participant $50 for enrolling.

TT-C arm: Once enrolled, participants will be emailed a unique link to create their TT-C account and instructions on how to download the TT-C (remote) app from the iOS or Google Play store. They will be asked to complete the intervention within one month. Participants will be compensated $50 for completing the baseline and reminded that they will be asked to return in 1 and 3 months for follow-up.

SOC arm: Research staff will provide COVID vaccine materials from the CDC to those participants in the SOC arm. Participants will be compensated $50 for completing the baseline and reminded that they will be asked to complete 1 and 3-month follow- up surveys. To provide the maximum benefit through this trial, after the completion of the data collection associated with the primary RCT, those randomized to the control arm who still report VH will be offered the opportunity to accept the TT-C intervention delivered remotely.

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Florida State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID Vaccine Confidence	COVID Vaccine Confidence is measured by self-reported ability to receive any primary series of booster vaccination at 1 and 3-month follow-up Vaccine confidence was a mean score of 7 items with response options ranging from 1-5, and higher scores indicating greater confidence (5=Strongly Agree). Example items were "vaccines are safe" and "vaccines do a good job in preventing the diseases they are intended to prevent." Gilkey MB, Reiter PL, Magnus BE, McRee A-L, Dempsey AF, Brewer NT. Validation of the Vaccination Confidence Scale: A Brief Measure to Identify Parents at Risk for Refusing Adolescent Vaccines. Academic Pediatrics. 2016/01/01/ 2016;16(1):42-49. doi:https://doi.org/10.1016/j.acap.2015.06.007	Up to 3 Months
COVID Vaccine Hesitancy	COVID Vaccine Hesitancy is measured by self-reported refusal to receive any primary series or booster vaccination at 1 and 3-month follow-up Vaccine hesitancy was a mean score of a 9-item scale with response ranging from 1-5, and higher scores indicating greater hesitancy (5=Strongly Disagree). Example items included "vaccines are important for my health" and "vaccines are effective." Shapiro GK, Tatar O, Dube E, et al. The vaccine hesitancy scale: Psychometric properties and validation. Vaccine. 2018/01/29/ 2018;36(5):660-667. doi:https://doi.org/10.1016/j.vaccine.2017.12.043	Up to 3 Months

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Lisa Hightow-Weidman, MD, MPH, Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): June 15, 2024

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Vaccine Hesitancy
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: 21-1746; R01MD016834 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: The results will be shared beginning 9 to 36 months following publication.
• IPD Sharing Access Criteria: Requesting investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No