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Grant Details

Grant Number: 5R21CA243911-02 Interpret this number
Primary Investigator: Vilardaga, Roger
Organization: Duke University
Project Title: Early-Phase Studies of a Tailored Evidence-Based Smoking Cessation Mhealth App for Persons Living with HIV
Fiscal Year: 2020


ABSTRACT Smoking is disproportionately prevalent among persons living with HIV (PLWH) as compared to the United States general population, increasingly contributing to high levels of morbidity and mortality in this population. Conventional smoking cessation modalities have low acceptability among PLWH, indicating the need to develop new and innovative strategies to improve cessation in this population. Mobile health (mHealth) holds promise as a tool to provide evidence-based smoking cessation interventions in the US population, with a majority of HIV-positive smokers owning a smartphone, and previous mHealth studies showing promise to treat tobacco dependence among PLWH. However, in a review of the empirical mHealth literature we found that rigorous early-phase studies of mHealth apps for smoking cessation are critically necessary to ensure the development of usable, acceptable and theory-based smoking cessation mHealth technology. In prior work we developed Learn to Quit (LTQ), an evidence-based smoking cessation app that combines a promising mindfulness-based intervention with U.S. Clinical Practice Guidelines. LTQ was tailored to persons living with chronic mental illness, a population that shares similar user-centered design challenges with PLWH (e.g., psychiatric symptoms, cognitive deficits). On that premise, we propose to develop LTQ-H, a rigorously designed smoking cessation app tailored to PLWH, and test it in a pilot randomized controlled trial. Our first aim is to: (1) form an expert panel to inform LTQ adaptations to PLWH, (2) conduct user-centered design research to ideate and test an LTQ-H prototype, (3) work with a software vendor to develop the LTQ-H app. Our second aim is to conduct a pilot randomized controlled trial to test the feasibility, acceptability and preliminary efficacy of LTQ-H, as well as its effects on HIV-specific outcomes. The proposed team -- Drs. Pacek, Vilardaga, McClernon -- has expertise in (1) tobacco dependence in PLWH, (2) smoking cessation mHealth development in medically vulnerable populations, (3) clinical trials, and (4) public health policy -- a much needed background to turn early-phase translational work into “real world” implementation. The proposed work is consistent with the Trans-NIH Plan for HIV-Related Research (NOT-OD-15-137), incorporating state-of-the-art technology to improve access to hard-to-reach populations, and addressing HIV- associated comorbidities and complications. Data from these early-phase studies will inform the design of a larger R01-funded RCT and the necessary regulatory strategy to approve LTQ-H as a prescription device that could become standard of care of PLWH in clinical settings.


The Impact of the COVID-19 Pandemic on Stress, Isolation, Smoking Behaviors, and Motivation to Quit in People with HIV Who Smoke.
Authors: Cioe P.A. , Schnoll R. , Hoeppner B.B. , Gross R. , Hitsman B.L. , Leone F.T. , Ashare R. , Vilardaga R. , Tashima K. , Pinkston M. , et al. .
Source: AIDS and behavior, 2023 Jun; 27(6), p. 1862-1869.
EPub date: 2022-11-11.
PMID: 36357808
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Regulatory oversight of behavioral digital therapeutics for addiction treatment: A commentary on Khadjesari et al.
Authors: Vilardaga R. , McClernon F.J. .
Source: Addiction (Abingdon, England), 2021 Dec; 116(12), p. 3287-3289.
EPub date: 2021-10-18.
PMID: 34658104
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COVID-19 Challenges Confronted by Smoking Cessation Clinical Trials for People Living With HIV: The Experience of Grantees of the US National Cancer Institute.
Authors: Schnoll R. , Bernstein S.L. , Kaufman A. , Gross R. , Catz S.L. , Cioe P.A. , Hitsman B. , Marhefka S.L. , Pacek L.R. , Vidrine D.J. , et al. .
Source: Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2021-08-18; 23(9), p. 1629-1632.
PMID: 33657227
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Usability and Acceptability of Two Smartphone Apps for Smoking Cessation Among Young Adults With Serious Mental Illness: Mixed Methods Study.
Authors: Gowarty M.A. , Longacre M.R. , Vilardaga R. , Kung N.J. , Gaughan-Maher A.E. , Brunette M.F. .
Source: JMIR mental health, 2021-07-07; 8(7), p. e26873.
EPub date: 2021-07-07.
PMID: 34255699
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The United States National Cancer Institute's Coordinated Research Effort on Tobacco Use as a Major Cause of Morbidity and Mortality among People with HIV.
Authors: Ashare R.L. , Bernstein S.L. , Schnoll R. , Gross R. , Catz S.L. , Cioe P. , Crothers K. , Hitsman B. , Marhefka S.L. , McClure J.B. , et al. .
Source: Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2021-01-22; 23(2), p. 407-410.
PMID: 32803251
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Review of Popularity and Quality Standards of Opioid-Related Smartphone Apps.
Authors: Vilardaga R. , Fisher T. , Palenski P.E. , Kumaresan V. , Mannelli P. , Sweitzer M.M. , McClernon F.J. , Engelhard M.M. , Sabo P.L. , Garrison K.A. .
Source: Current addiction reports, 2020 Dec; 7(4), p. 486-496.
EPub date: 2020-11-10.
PMID: 33777644
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Rapid increase in the prevalence of cannabis use among people with depression in the United States, 2005-17: the role of differentially changing risk perceptions.
Authors: Pacek L.R. , Weinberger A.H. , Zhu J. , Goodwin R.D. .
Source: Addiction (Abingdon, England), 2020 May; 115(5), p. 935-943.
EPub date: 2019-12-20.
PMID: 31797462
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Theoretical Grounds of Pain Tracker Self Manager: An Acceptance and Commitment Therapy Digital Intervention for Patients with Chronic Pain.
Authors: Vilardaga R. , Davies P.S. , Vowles K.E. , Sullivan M.D. .
Source: Journal of contextual behavioral science, 2020 Jan; 15, p. 172-180.
EPub date: 2020-01-03.
PMID: 32269915
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Mobile Applications for the Treatment of Tobacco Use and Dependence.
Authors: Vilardaga R. , Casellas-Pujol E. , McClernon J.F. , Garrison K.A. .
Source: Current addiction reports, 2019 Jun; 6(2), p. 86-97.
EPub date: 2019-05-09.
PMID: 32010548
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