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

NCT05490329 | Completed Results

• 2 other identifiers: 21-1746R01MD016834
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Vaccine Uptake

Keywords

Vaccine Hesitancy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• COVID Vaccine Confidence

  Up to 3 Months

• COVID Vaccine Hesitancy

  Up to 3 Months

Study Arms (2)

Standard of Care (Control)

NO INTERVENTION

Research staff will provide COVID vaccine materials from the Centers for Disease Control (CDC) to those participants in the Standard of Care (SOC) arm.

TT-C Intervention

EXPERIMENTAL

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

Interventions

Tough Talks COVID BEHAVIORAL

Intervention participants will download the TT-C app from the iOS or Google Play store and complete the intervention within one month.

TT-C Intervention

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Florida State University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Related Publications (3)

• Budhwani H, Stoner MCD, Stocks JB, Browne E, Soberano Z, Bond CL, Michaels J, Mancuso N, Larsen MA, Maragh-Bass AC, Tolley EE, Comello MLG, Muessig KE, Pettifor AE, Hightow-Weidman LB. Tough talks COVID-19 (TT-C) digital health intervention: multistate randomized controlled trial. Sci Rep. 2025 Jul 1;15(1):21988. doi: 10.1038/s41598-025-05386-2.

  PMID: 40594178 DERIVED

• Budhwani H, Yigit I, Stocks JB, Stoner MCD, Browne E, Pettifor AE, Hightow-Weidman LB. Development and validation of the mpox stigma scale (MSS) and mpox knowledge scale (MKS). BMC Public Health. 2024 Sep 10;24(1):2469. doi: 10.1186/s12889-024-19868-x.

  PMID: 39256711 DERIVED

• Budhwani H, Maragh-Bass AC, Tolley EE, Comello MLG, Stoner MCD, Adams Larsen M, Brambilla D, Muessig KE, Pettifor A, Bond CL, Toval C, Hightow-Weidman LB. Tough Talks COVID-19 Digital Health Intervention for Vaccine Hesitancy Among Black Young Adults: Protocol for a Hybrid Type 1 Effectiveness Implementation Randomized Controlled Trial. JMIR Res Protoc. 2023 Feb 13;12:e41240. doi: 10.2196/41240.

  PMID: 36689557 DERIVED

MeSH Terms

Conditions

COVID-19; Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Lisa Hightow-Weidman, MD, MPH
• Organization: Florida State University

lhightowweidman@fsu.edu

8506443296

Study Officials

• Lisa Hightow-Weidman, MD, MPH

  Florida State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 5, 2022
• Study Start: March 13, 2023
• Primary Completion: December 15, 2023
• Study Completion: June 15, 2024
• Last Updated: March 28, 2025
• Results First Posted: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The results will be shared beginning 9 to 36 months following publication.
• Access Criteria: Requesting investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)