Clinical Takeaway
A digital therapeutic tailored specifically for people living with HIV showed strong feasibility and acceptability as a smoking cessation tool in this pilot trial, suggesting this population can be reached and engaged through app-based interventions. Tobacco use remains a leading driver of illness and death among people with HIV, making scalable cessation tools clinically important. These findings support further investigation of HIV-tailored digital therapeutics as a practical complement to standard cessation care in this high-risk group.
#22 Population reach, feasibility and acceptability of digital therapeutics for smoking cessation among people living with HIV: Results of the Quitting Matters pilot trial.
Citation: Vilardaga R et al.. 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. 2026. PMID: 41512654.
Design: 5 Journal: 0 N: 1 Recency: 3 Pop: 2 Human: 1 Risk: -2
This pilot trial demonstrates that digital therapeutic interventions can effectively reach and engage people living with HIV for smoking cessation treatment, addressing a major implementation barrier in a population with disproportionately high tobacco-related mortality. The feasibility and acceptability data provide evidence supporting broader digital deployment of evidence-based cessation interventions specifically designed for PWH, potentially reducing a significant source of preventable morbidity in this already medically complex population. Given the high treatment engagement barriers in HIV care settings, demonstrating that DTx can achieve adequate reach and acceptability offers a scalable alternative to traditional clinic-based cessation programs.
Quality Gate Alerts:
- Preclinical only
Abstract: 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 d
? While this pilot trial appropriately addresses tobacco cessation in an underserved population with substantial health disparities, several important considerations merit attention before widespread clinical adoption of digital therapeutics in PWH. The study’s focus on feasibility and acceptability rather than robust efficacy outcomes means we lack definitive data on whether digital interventions meaningfully improve quit rates compared to standard care or in-person counseling, particularly given potential digital literacy barriers and the complex psychosocial factors that drive tobacco use in this population. Additionally, PWH often experience concurrent substance use, mental health comorbidities, and antiretroviral medication interactions that may not be adequately captured in a pilot design, potentially limiting generalizability to real-world clinic populations. The preliminary nature of this work suggests that while digital therapeutics show promise as an accessible adjunct tool for reaching geographically isolated or underserved patients, clinicians should continue offering multimodal cessation approaches including pharmacotherapy and counseling rather than viewing DTx as a replacement for established interventions. In
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