Grant Number:	7R01CA285331-02 Interpret this number
Primary Investigator:	Vilardaga, Roger
Organization:	Wake Forest University Health Sciences
Project Title:	Hybrid Trial of a Tailored Smoking Cessation Digital Therapeutic for Persons Living with HIV
Fiscal Year:	2024

PROJECT ABSTRACT Tobacco use has alarmingly high rates among people with HIV (PWH), 43% compared with 15% in the general population. Due to the development of highly effective treatments for HIV and the resulting increased longevity among PWH, this population now loses more life years to smoking than to HIV infection itself. Novel and effective models to deliver wider reaching smoking cessation interventions for PWH are highly needed and indicated as a priority for NIH. Digital therapeutics (DTx) may be a novel, scalable, and highly available approach for engaging and treating smoking in this population. However, although DTx for smoking cessation have been shown effective in the general population, no large trial to date has examined the effectiveness of a tailored DTx for smoking cessation in PWH, and no implementation science work has examined barriers and facilitators of implementation of DTx for smoking cessation in this population. In prior early-phase work, we developed LTQ-H, a user-centered smoking cessation DTx tailored to the needs of PWH (R21 CA243911). This novel DTx is based on a mental health intervention -- Acceptance and Commitment Therapy -- that has been shown effective as a treatment for smoking cessation. LTQ-H also provides recommendations from U.S. Clinical Practice Guidelines. We tested LTQ-H in a remote pilot randomized controlled trial. Consistent with our conceptual model, results indicated significant effects on the pilot’s primary outcomes: (1) high levels of objective user engagement, (2) adherence to smoking cessation content, and (3) features that effectively addressed our targeted components (e.g., mental health, cognitive deficits, and HIV stigma). LTQ-H’s quit rates were high compared to prior mobile behavioral smoking cessation interventions for this population, though the trial was not powered to detect smoking outcome differences with the control group. The trial recruited a demographically diverse sample of patients from 9 U.S. states and established relationships with several HIV clinics in the eastern U.S. In this project, we will conduct a type 1 hybrid effectiveness implementation trial informed by the Consolidated Framework for Implementation Research. The trial aims to: (1) compare the effectiveness of LTQ-H to QuitGuide, an evidence-based DTx for the general population, and (2) evaluate acceptability, appropriateness, costs, and feasibility of DTx for smoking cessation among PWH and HIV clinics. The trial focuses on two high-priority research areas in the NIH Strategic Plan for HIV-Related Research and the Cancer Moonshot Research Initiative: (1) the incorporation of state-of-the-art technology to improve access to hard-to-reach populations and settings, and (2) the use of implementation science to address cancer health disparities. This study will generate the necessary clinical effectiveness data and implementation strategies for the general application of DTx in a future type 3 hybrid trial.





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