||5R21CA243911-02 Interpret this number
||Early-Phase Studies of a Tailored Evidence-Based Smoking Cessation Mhealth App for Persons Living with HIV
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.
Regulatory oversight of behavioral digital therapeutics for addiction treatment: A commentary on Khadjesari et al.
, McClernon F.J.
Addiction (Abingdon, England), 2021-10-18; , .
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.
, Bernstein S.L.
, Schnoll R.
, Gross R.
, Catz S.L.
, Cioe P.
, Crothers K.
, Hitsman B.
, Marhefka S.L.
, McClure J.B.
, et al.
Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2021-01-22; 23(2), p. 407-410.
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.
, Weinberger A.H.
, Zhu J.
, Goodwin R.D.
Addiction (Abingdon, England), 2020 05; 115(5), p. 935-943.
Theoretical Grounds of Pain Tracker Self Manager: An Acceptance and Commitment Therapy Digital Intervention for Patients with Chronic Pain.
, Davies P.S.
, Vowles K.E.
, Sullivan M.D.
Journal of contextual behavioral science, 2020 Jan; 15, p. 172-180.