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Principal Investigator: Rebecca Ashare
Organization: WAKE FOREST UNIVERSITY HEALTH SCIENCES
Fiscal Year: 2024
Award: $675,089
Funding agency: National Cancer Institute
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.
Terms: <AIDS Virus><Abstinence><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><Address><Adherence><African American><Afro American><Afroamerican><Anti-Retroviral Agents><Area><Assess implementation><Behavioral><Biochemical><Cancer Control><Cancer Control Science><Cancers><Cigarette><Clinic><Clinical><Clinical Practice Guideline><Clinical effectiveness><Cognitive deficits><Communities><Confidence Intervals><Consolidated Framework for Implementation Research><Consolidated Framework for Implementation Science><Consolidated Framework for Implementing Change><Control Groups><Data><Development><Disease><Disorder><Effectiveness><Electronic cigarette><Future><General Population><General Public><Guidelines><HIV><HIV Infections><HTLV-III Infections><HTLV-III-LAV Infections><Health><Health Care Providers><Health Personnel><Healthcare Providers><Healthcare worker><Human Immunodeficiency Viruses><Human T-Lymphotropic Virus Type III Infections><Hybrids><Implementation assessment><Improve Access><Individual><Intervention><Intervention Strategies><Interview><LAV-HTLV-III><Learning><Length of Life><Life><Longevity><Lymphadenopathy-Associated Virus><Malignant Neoplasms><Malignant Tumor><Malignant Tumor of the Lung><Malignant neoplasm of lung><Measures><Mental Health><Mental Hygiene><Methodology><Methods><Modeling><Morbidity><Morbidity - disease rate><NCI Organization><NIH><National Cancer Institute><National Institutes of Health><Nicotine Replacement Therapy><Outcome><Patient Self-Report><Patients><Persons><Phase><Pilot Projects><Play><Population><Population Intervention><Prevalence><Psychological Health><Public Health><Pulmonary Cancer><Pulmonary malignant Neoplasm><QOL><Quality of life><Randomized, Controlled Trials><Recommendation><Reporting><Research><Research Design><Research Priority><Sampling><Secure><Self-Report><Services><Smoke><Smoking><Smoking Cessation Intervention><Strategic Planning><Stress><Study Type><Survey Instrument><Surveys><Technology><Testing><Tobacco Consumption><Tobacco Use Disorder><Tobacco use><Uncertainty><United States National Institutes of Health><Virus-HIV><Voice><Work><anti-retroviral><arm><assess effectiveness><cancer diagnosis><cancer disparity><cancer health disparity><cancer-related health disparity><cease smoking><clinical practice and guidelines><cognitive defects><community advisory board><community advisory committee><community advisory panel><compare effectiveness><cost><craving><design><designing><determine effectiveness><developmental><digital app><digital applications><digital intervention><digital therapeutics><digital therapy><digital treatment><disparity in cancer><doubt><e-cig><e-cigarette><ecig><ecigarette><effective therapy><effective treatment><effectiveness and implementation trial><effectiveness assessment><effectiveness evaluation><effectiveness/implementation hybrid trial><effectiveness/implementation trial><evaluate effectiveness><evaluate implementation><evaluation of implementation><evidence base><examine effectiveness><experience><facilitators to implementation><health care personnel><health care worker><health equity><health provider><health workforce><healthcare personnel><implementation evaluation><implementation facilitators><implementation science><implementation strategy><interest><intervention design><interventional strategy><lung cancer><malignancy><medical personnel><mortality><multidisciplinary><neoplasm/cancer><nicotine replacement><novel><pilot study><pilot trial><population based intervention><population specific intervention><prevent><preventing><primary outcome><quit smoking><randomized control trial><recruit><research into practice><research to practice><secondary outcome><smoking cessation><smoking cessation treatment><smoking prevalence><smoking-related cancer><social><social stigma><stigma><stop smoking><strategies for implementation><study design><substance use><substance using><therapeutic biomarker><therapeutic marker><therapy adherence><therapy compliance><therapy design><tobacco disorder><tobacco product use><treatment design><treatment effect><treatment provider><user centered design>