Population reach, feasibility and acceptability of digital therapeutics for smoking cessation among people living with HIV: Results of the Quitting Matters pilot trial.
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2026-02
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Introduction
Tobacco use is disproportionately prevalent among people living with HIV (PWH) and is a significant contributor to morbidity and mortality in this population. Reaching communities of PWH to facilitate smoking cessation is challenging. Digital Therapeutics (DTx) can facilitate widespread implementation and adoption of smoking cessation treatments for PWH.Methods
We compared the feasibility and acceptability (primary outcomes) and preliminary efficacy (secondary outcome) of a DTx tailored to PWH -- Learn to Quit-HIV (LTQ-H) -- versus a gold standard smoking cessation DTx (QuitGuide) in a remote pilot randomized controlled trial. All participants received nicotine replacement therapy and were assessed at weeks 4, 8, and 12.Results
During a 13-month period, we remotely recruited a sample of PWH (n = 41) across the United States, with randomization leading to a higher proportion of LTQ-H users with high levels of cannabis use. Digital markers of DTx use indicated that compared to QuitGuide, assignment to LTQ-H led to significantly greater number of device interactions (3610 vs 2086; RR=93.14; 95 % CI: 14.70-590; p < 0.001), and a four-fold increase in mean interactions with active smoking cessation content (8.5 vs. 2.15; Cohen's d=0.91; p < 0.001). At week 12, in an adjusted model, LTQ-H resulted in numerically greater, but not statistically significant, biochemically verified 7-day point prevalence abstinence versus QuitGuide (18.2 % vs 15.8 %; aOR=6.97, 95 % CI: 0.65-74.33).Conclusions
While participants assigned to LTQ-H had proportionally more features known to predict low quit rates (e.g. cannabis use), LTQ-H showed promising population reach, device engagement, and smoking outcomes. A hybrid effectiveness-implementation trial will evaluate this novel DTx in a larger sample of PWH.Implications
The study highlights the potential of DTx to address the high prevalence of tobacco use among people with HIV. Compared to QuitGuide (gold standard DTx developed by NCI), LTQ-H showed promising participant engagement and smoking cessation outcomes. These findings suggest that LTQ-H could be a valuable tool for smoking cessation in people with HIV, warranting further investigation in larger trials to evaluate its effectiveness and implementation feasibility.Type
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Vilardaga, R, FJ McClernon, O Akingbule, P Mannelli, SM Thomas, JM Davis, MF Gray, C Arnold, et al. (2026). Population reach, feasibility and acceptability of digital therapeutics for smoking cessation among people living with HIV: Results of the Quitting Matters pilot trial. Drug and alcohol dependence, 279. p. 113015. 10.1016/j.drugalcdep.2025.113015 Retrieved from https://hdl.handle.net/10161/34761.
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Scholars@Duke
F Joseph McClernon
Joseph McClernon, Ph.D., is a professor in the Department of Psychiatry and Behavioral Sciences and founder/director of the Center for Addiction Science and Technology (CfAST). He is the Associate Director of the Duke Clinical and Translational Science Institute (CTSI). During his tenure with CTSI, his leadership has been critical to building a culture of evaluation and continuous improvement, in strengthening the institute’s partnership with North Carolina Central University and other regional partners, and in planning strategy and development for the institute.
Dr. McClernon earned a Ph.D. in clinical psychology in 2001 from Southern Illinois University-Carbondale and completed a postdoctoral fellowship at Duke in 2002. He served as Director of the Addiction Division in Psychiatry and Behavioral Sciences from 2012-2020. His research is focused on increasing our understanding of tobacco use, developing new and more effective interventions to treat nicotine dependence, and informing the FDA’s regulation of tobacco products. He has served as a site-PI and Co-I for more than ten years in the Center for the Evaluation of Nicotine in Cigarettes (CENIC)— a national consortium that has provided the bulk of evidence to the FDA for informing national policies that will reduce nicotine in cigarettes to non-addictive levels, thus saving millions of lives. Dr. McClernon is now leading efforts to transition CENIC’s focus to public health interventions that ensure the new policy will be implemented in ways that enable equitable outcomes for marginalized groups. Other regulatory science research has evaluated the effects of nicotine in cigarettes on a model of cigarette experimentation, the impact of flavors in cigarettes and e-cigarettes, and the influence of product characteristics and policy on multiple tobacco product use. He has led other groundbreaking research on the influence of drug-associated environments on drug use, relapse, and treatment; tobacco use disparities among individuals with comorbid psychiatric (e.g., ADHD, serious mental illness) and health (e.g., HIV; chronic pain) problems.
Dr. McClernon has actively mentored early career individuals from high school students through early career faculty. His former postdoctoral fellows are faculty or staff scientists at academic medical centers, government agencies, and research institutes. He has been continuously NIH-, FDA-, and foundation- funded since 2002. He has authored/co-authored more than 170 peer-reviewed publications, has two patents, has served as chair of NIH grant review panels, and is the recipient of numerous awards including the Society for Research on Nicotine and Tobacco Jarvik-Russell New Investigator Award. In 2024 he was recognized for excellence in mentoring when he was awarded the Career Mentoring Award in Clinical Research by the Duke University School of Medicine.
Paolo Mannelli
James Davis
Dr. James Davis is a practicing physician of Internal Medicine, and serves as the Medical Director for Duke Center for Smoking Cessation, Director of the Duke Smoking Cessation Program and Co-Director of the Duke-UNC Tobacco Treatment Specialist Credentialing Program. His research focuses on development of new pharmaceutical treatments for smoking cessation. He is principal investigator on several trials including a study on “adaptive” smoking cessation and several trials on new medications for smoking cessation. The new medications leverage more novel neurobiological mechanisms - NMDA receptor antagonism, nicotinic receptor antagonism, which impact addiction-based learning and cue response. Additionally, Dr. Davis serves as co-investigator on trials on lung cancer screening, e-cigarettes, minor nicotine alkaloids, imaging trials, lung function trials and others. Dr. Davis leads the Duke Smoke-Free Policy Initiative, is co-author on a national tobacco dependence treatment guideline, and provides training in tobacco dependence treatment for the Duke School of Medicine, Duke Internal Medicine, Family Practice and Psychiatry residency programs.
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