Development and Pilot Testing of a Just in Time Mobile Smoking Cessation Intervention for Persons living with HIV

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PROJECT SUMMARY This application, in direct response to PAR-19-309, will systematically develop and pilot test the Sense2Quit App to improve tobacco cessation in persons living with HIV (PLWH). The prevalence of cigarette smoking among PLWH is more than three times that of the general adult United States (U.S.) population. The high prevalence of cigarette smoking and the high incidence of tobacco-related cancer and other smoking-related diseases among PLWH calls for swift action to intervene to reduce tobacco use rates. However, evidence to guide tobacco cessation in PLWH is inadequate. To address this need, our team proposes to develop, and pilot test the Sense2Quit App, a multi-component smartphone app which provides just-in-time feedback; specifically addresses challenges to tobacco cessation for PLWH: slips, relapses, and difficulties associated with neurocognitive deficits; supports both self-efficacy and decisional balance; and provides quit plan reminders. The artificial intelligence algorithm (validated by our study team) interprets data from a smartwatch to detect smoking hand motions – a technology with more than 98% accuracy in differentiating “lighting up” from other similar motions. The Sense2Quit App leverages smartwatch data and detects when and where smoking activity occurs so that a message can be sent in real time to the participant to help them manage the slip (a puff or two) from becoming a relapse. This just-in-time feedback is critical especially in the first few weeks of a quit attempt. Additionally, Global Positioning System data can help participants avoid triggers (coffee shops, smoking relatives, or friends' homes, etc.). Finally, the Sense2Quit App provides information on how well smokers are progressing through their quit plan, support tips, and motivational tools (i.e., badges related to saving money from not purchasing cigarettes). The specific aims of the proposed study are to: 1) Explore and identify, using qualitative methods, acceptable and appropriate app content and features of the Sense2Quit App to support smoking cessation and relapse prevention in PLWH who smoke; 2) Conduct a pilot randomized controlled trial to examine the feasibility, acceptability, and preliminary efficacy of the Sense2Quit App in a sample of 60 PLWH who smoke; and 3) Employ the RE-AIM framework to assess the potential scale-up of the Sense2Quit App. As part of the pilot trial, we will randomize 60 HIV-positive smokers to the Sense2Quit App, standard smoking cessation counseling, and nicotine replacement therapy (active condition) versus standard smoking cessation counseling plus nicotine replacement therapy (control) and examine group differences in rate of quit attempts, 7-day point prevalence abstinence, and sustained abstinence. We will calculate an effect size estimate of the Sense2Quit App to guide, in part, the sample size needed for a larger scale clinical trial. The knowledge gained from the proposed research will enable the scientific community and patients to improve tobacco cessation in those persons who are in most need in the U.S. Given our team's unique and complementary expertise in each of the areas necessary to develop an innovative smoking cessation intervention to improve outcomes among PLWH, we are confident that the findings from this study will be easily scaled-up for further testing to ensure improvement in health outcomes for PLWH.