Scholars@Duke publication: Population reach, feasibility and acceptability of digital therapeutics for smoking cessation among people living with HIV: Results of the Quitting Matters pilot trial.

Population reach, feasibility and acceptability of digital therapeutics for smoking cessation among people living with HIV: Results of the Quitting Matters pilot trial.

Publication , Journal Article

Vilardaga, R; McClernon, FJ; Akingbule, O; Mannelli, P; Thomas, SM; Davis, JM; Gray, MF; Arnold, C; Chow Kai Reyes, I; Ashare, R; Paukner, M ...

Published in: Drug Alcohol Depend

February 1, 2026

Published version (DOI) Link to item

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.