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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Jul 20, 2022
Date Accepted: Jan 12, 2023
Date Submitted to PubMed: Jan 23, 2023

The final, peer-reviewed published version of this preprint can be found here:

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

Budhwani H, Maragh-Bass AC, Tolley EE, Comello MLG, Stoner MCD, Adams Larsen M, Brambilla D, Muessig KE, Pettifor AE, 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;12:e41240

DOI: 10.2196/41240

PMID: 36689557

PMCID: 9930921

Tough Talks COVID-19 Digital Health Intervention for Vaccine Hesitancy among Black Young Adults: Protocol for Hybrid Type 1 Effectiveness Implementation Randomized Controlled Trial

  • Henna Budhwani; 
  • Allysha C. Maragh-Bass; 
  • Elizabeth E. Tolley; 
  • Maria Leonora G. Comello; 
  • Marie C. D. Stoner; 
  • Margo Adams Larsen; 
  • Donald Brambilla; 
  • Kathryn E. Muessig; 
  • Audrey E Pettifor; 
  • Christyenne L. Bond; 
  • Christina Toval; 
  • Lisa B. Hightow-Weidman

ABSTRACT

Background:

Interventions to increase the uptake of novel coronavirus 2019 (COVID-19) vaccination among African American or Black young adults are central to ending the pandemic. African American or Black young adults also experience harms from structural forces such as racism and stigma that can impact receptivity to traditional public health messaging. As such, African American or Black young adults represent a priority population to focus efforts promoting COVID-19 vaccine uptake.

Objective:

This study includes three objectives. In Aims 1 and 2, the Tough Talks for HIV disclosure digital health intervention will be adapted to address COVID-19 vaccine hesitancy and tailored for African American or Black young adults in the southern United States (Tough Talks for COVID-19). In Aim 3, the newly adapted Tough Talks for COVID-19 digital health intervention will be tested across three Southern States (Alabama, Georgia, and North Carolina).

Methods:

This novel digital health intervention study includes both qualitative and quantitative assessments. An innovative combination of methodological techniques (including online surveys, choose-your-own-adventures, digital storytelling, user acceptability testing, and community based participatory approaches) will culminate in a hybrid type 1 effectiveness implementation randomized controlled trial where participants will be randomized to receive the Tough Talks for COVID-19 intervention or a standard of care control condition. Logistic regression will be used to determine the effect of treatment arm on the probability of vaccination uptake (primary COVID-19 vaccine series or recommended boosters); concurrently, implementation inner and outer contexts will be ascertained to inform future scale-up.

Results:

This study was funded at the end of April 2021. Approval from the University of North Carolina, Chapel Hill Institutional Review Board was obtained shortly thereafter. Aim 1 data collection concluded in early 2022. The entire study is expected to conclude by the end of January 2025.

Conclusions:

If effective, the intervention will be poised for rapid dissemination and implementation broadly and quickly in an effort to reduce COVID-19 morbidity and mortality among unvaccinated Black young adults in the southern United States. Findings also have the potential to inform efforts that seek to address medical mistrust through participatory approaches. Clinical Trial: Pending


 Citation

Please cite as:

Budhwani H, Maragh-Bass AC, Tolley EE, Comello MLG, Stoner MCD, Adams Larsen M, Brambilla D, Muessig KE, Pettifor AE, 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;12:e41240

DOI: 10.2196/41240

PMID: 36689557

PMCID: 9930921

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