Tough Talks COVID for COVID-19

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Alabama at Birmingham, Birmingham, AL
COVID-19+1 More
Tough Talks COVID - Behavioral
Eligibility
18 - 65
All Sexes
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Study 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.

Eligible Conditions

  • COVID-19
  • Vaccine Uptake

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Month 3

Month 1
COVID Vaccine Uptake at Month 1
Month 3
COVID Vaccine Uptake at Month 3
Up to 3 Months
COVID Vaccine Confidence
COVID Vaccine Hesitancy

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Standard of Care (Control)
1 of 2
TT-C Intervention
1 of 2
Active Control
Experimental Treatment

360 Total Participants · 2 Treatment Groups

Primary Treatment: Tough Talks COVID · No Placebo Group · N/A

TT-C Intervention
Behavioral
Experimental Group · 1 Intervention: Tough Talks COVID · Intervention Types: Behavioral
Standard of Care (Control)NoIntervention Group · 1 Intervention: Standard of Care (Control) · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: month 3
Closest Location: University of Alabama at Birmingham · Birmingham, AL
Photo of university of alabama at birmingham  1Photo of university of alabama at birmingham  2Photo of university of alabama at birmingham  3
1991First Recorded Clinical Trial
15 TrialsResearching COVID-19
1067 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 4 Total Inclusion Criteria

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You must be able to speak and read English.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.