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N/A N=360 Randomized Prevention

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

COVID-19 · Vaccine Uptake

Enrolled (actual)
360
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: COVID Vaccine Uptake at Month 1 — 6; 5 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Tough Talks COVID (Behavioral)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Florida State University
Primary completion
Dec 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
COVID Vaccine Uptake at Month 1
6; 5
PRIMARY
COVID Vaccine Uptake at Month 3
8; 13
SECONDARY
COVID Vaccine Confidence
3.57; 3.71
SECONDARY
COVID Vaccine Hesitancy
2.22; 2.00

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.

Eligibility Criteria

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05490329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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