Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 2, 2023
Date Accepted: Sep 8, 2023
The Sense2Quit Protocol Paper: Pilot testing of an mHealth app for tobacco cessation in people living with HIV
ABSTRACT
Background:
An estimated 40% of people living with HIV smoke cigarettes. Although smoking rates in the U.S. have been declining in recent years, people living with HIV continue to smoke cigarettes at twice the rate of the general population. Mobile health (mHealth) technology is an effective tool for people living with a chronic illness, such as HIV, as currently 84% of households in the United States report that they have a smartphone. Although many studies have used mHealth interventions for smoking cessation, few studies have recruited people living with HIV who smoke.
Objective:
The objective of the pilot randomized controlled trial (RCT) is to examine the feasibility, acceptability, and preliminary efficacy of the Sense2Quit App as a tool for people living with HIV who are motivated to quit smoking.
Methods:
The Sense2Quit study is a two-arm randomized controlled trial for people living with HIV who smoke cigarettes (n=60). Participants are randomized to either the active intervention condition which consists of an 8-week supply of nicotine replacement therapy, standard smoking cessation counseling, and access to the Sense2Quit mobile app and smartwatch, or the control condition which consists of standard smoking cessation counseling and a referral to the New York State Smokers’ Quitline. The Sense2Quit app is a mobile app connected via Bluetooth to a smartwatch that tracks smoking gestures and distinguishes them from other everyday hand movements. In the Sense2Quit app, participants can view their smoking trends which are recorded through their use of the smartwatch, including how often/how much they smoke and the amount of money that they are spending on cigarettes, watch videos with quitting tips, information and distractions, play games, set reminders, and communicate with a study team member.
Results:
Enrollment of study participants began in March 2023 and is expected to end in September of 2023. All data collection is expected to be completed by the end of December 2023. This RCT will test the difference in outcomes between the control and intervention arms. The primary outcome will be the percentage of participants with biochemically verified 7-day point prevalence smoking/tobacco abstinence at their 12-week follow-up. Results from this pilot study will be disseminated to the research community following completion of all data collection.
Conclusions:
The Sense2Quit study leverages mHealth so that it can help smokers to improve their efforts at smoking cessation. Our research has the potential to not only increase quitting rates among people living with HIV who may need a prolonged, tailored intervention, but also to inform further development of mHealth for people living with HIV. This mHealth study will contribute significant findings to the greater mHealth research community, providing evidence as to how mHealth should be developed and tested among the target population. Clinical Trial: ClinicalTrials.gov NCT05609032
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.