Comparative effectiveness of mobile health smoking cessation approaches among underserved patients in primary care: Study protocol for the PROMOTE-UP trial

Introduction: Tobacco smoking is the leading cause of preventable disease, disability, and premature death in the United States. Recent advances have led to two efficacious mobile health (mHealth) treatments for smoking cessation: iCanQuit, an Acceptance and Commitment Therapy-based behavioral treatment promoting cessation through accepting triggers and committing to values; and Motiv8, a contingency management intervention promoting smoking cessation with financial incentives via biochemically verified abstinence. This study will evaluate the comparative effectiveness of the Florida Quitline, iCanQuit alone, and iCanQuit+Motiv8 in a pragmatic trial among patients who smoke in underserved primary care settings. Methods: The study will be an individually-randomized controlled trial with three arms (Florida Quitline, iCanQuit alone, iCanQuit+Motiv8 combined) conducted in multiple primary care practices affiliated with the OneFlorida+ Clinical Research Consortium. Adult patients who smoke will be randomized to one of the 3 study arms (n = 444/arm), stratified by healthcare setting (academic vs. community). The primary outcome will be 7day point prevalence smoking abstinence at 6 months post-randomization. Secondary outcomes will be 12-month smoking abstinence, patient satisfaction with the interventions, and changes in patient quality of life and selfefficacy. The study will also assess how and for whom the interventions help sub-group patients in achieving smoking abstinence by measuring theory-derived factors that mediate smoking outcome-specific baseline moderators. Conclusions: Results from this study will provide evidence for the comparative effectiveness of mHealth smoking cessation interventions in healthcare settings. Use of mHealth interventions can make smoking cessation resources more equitably accessible and have far-reaching impact on community and population health. Trial registration: ClinicalTrials.gov, NCT05415761, Registered 13 June 2022.