Providing nicotine replacement therapy to enhance the efficacy of a smoking cessation smartphone app for Hispanic adults

PROJECT SUMMARY/ABSTRACT (DESCRIPTION) Hispanic adults, the largest and fastest growing minority population in the United States (US), have disproportionate smoking-related morbidity and mortality. They lack access to standard smoking cessation treatments primarily due to the absence of medical insurance and guidance from healthcare providers to quit. Compounding the access problem are systemic racism within healthcare and scientific communities, along with a lack of value placed on conducting rigorous clinical research among Hispanic adults. Needed now is rigorous research on methods to enable Hispanic adults to access efficacious evidence-based interventions to quit smoking. Two widely available cessation methods that hold promise for Hispanic adults are: (1) smartphone applications (“apps”) providing behavioral intervention, and (2) nicotine replacement pharmacotherapy (NRT). Apps can be freely accessed and widely available, with 91% of Hispanic adults owning smartphones. iCanQuit, based on Acceptance and Commitment Therapy, is the only app proven efficacious for smoking cessation in a Phase III randomized trial (N = 2415). Among Hispanic participants (N = 220) in the parent iCanQuit trial, results showed significantly higher self-reported 12-month 30-day point prevalence abstinence (PPA) rates for iCanQuit participants compared to QuitGuide participants—an app that follows US Clinical Practice Guidelines (34% iCanQuit vs. 20% QuitGuide; OR = 2.20; 95% CI: 1.10, 4.41, P = .02). Regarding medications, NRT has high reach. While combining behavioral intervention with NRT generally results in higher quit rates than behavioral intervention alone, existing evidence primarily stems from in-person clinical and telephone-based trials focused on non-Hispanic adults. Although some research suggests underutilization of quit smoking medications among Hispanic adults, our research indicates that providing free NRT improves its uptake. Most pertinently, we found that Hispanic iCanQuit participants who used NRT on their own within 3 months post- randomization showed descriptively higher self-reported 12-month 30-day PPA rates compared to non-users (45.5% users vs. 28.8% non-users, OR = 2.24; 95% CI: 0.54, 9.27, P = .26). It is unknown whether providing Hispanic adults with free NRT in combination with iCanQuit cost-effectively yields higher biochemically verified quit rates than iCanQuit alone. Thus, in a fully-powered RCT, this proposal will: (1) determine whether iCanQuit combined with free NRT (n = 427) has significantly higher biochemically verified 30-day PPA than iCanQuit alone (n = 427) at 12 months post-randomization; (2) determine the cost-effectiveness of iCanQuit plus NRT vs. iCanQuit alone, as measured by cost per quitter, cost per life year gained, and cost per quality- adjusted life year (QALY) gained. We will also apply the RE-AIM dissemination framework and conduct qualitative research on the barriers and facilitators to dissemination of each intervention to Hispanic adults nationwide. This rigorous trial will determine whether providing iCanQuit alone is sufficient or whether adding NRT cost-effectively yields higher quit rates for Hispanic adults who smoke.