Tough talks COVID-19 (TT-C) digital health intervention: multistate randomized controlled trial.

Publication date: Jul 01, 2025

During the COVID-19 pandemic, rapid changes in variant virulence, limited personal protective equipment availability, and diminished hospital capacity necessitated aggressive vaccine distribution. To promote COVID-19 vaccination to historically underserved populations, the National Institutes of Health funded a small group of clinical trials, including the Tough Talks for COVID-19 vaccine (TT-C) digital health intervention (DHI) randomized controlled trial (RCT). Black young adults, 18-29 years, who were unvaccinated or insufficiently vaccinated against COVID-19 were recruited via social media in Alabama, Georgia, and North Carolina and randomized to the intervention or standard of care control (N = 360). Self-report data and vaccine cards were collected at baseline, 1- and 3-months post-randomization. Post-intervention, 6. 4% received a new COVID-19 vaccine (8. 4% intervention; 4. 7% control). Odds of new COVID-19 vaccination were 1. 88 (CI: 0. 76, 4. 69, p = 0. 174) times higher in intervention compared to control participants adjusting for state. At 3 months post-randomziation, vaccine hesitancy was lower among intervention than control participants (CI:-0. 34,-0. 03, p = 0. 02), and vaccine confidence and vaccine knowledge were higher in intervention versus control participants (CI:0. 00,0. 32, p = 0. 05, CI:0. 21,0. 79, p = 0. 01 respectively). Under rapidly changing conditions, the TT-C DHI produced promising results on vaccine attitudes but not behaviors among Southern Black young adults. The intervention could be adapted to address vaccine uptake among other minority populations. Trial registration: NCT05490329, registered on 03082022. https://clinicaltrials. gov/study/NCT05490329 .

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