CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 360 enrolled
Drug / intervention
Tough Talks COVIDbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05490329
NCT05490329N/ACompleted

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)

Florida State University·interventional·Posted Aug 5, 2022·Updated Mar 28, 2025

In Brief

A clinical study evaluating Tough Talks COVID for COVID-19 and Vaccine Uptake. Completed, enrolled 360 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2023202420252026
First PostedAug 5, 2022
Enrollment StartMar 13, 2023
Primary CompletionDec 15, 2023
Study CompletionJun 15, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.9 years ago

Interventions

Tough Talks COVIDbehavioral

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