Pilot Testing of an mHealth App for Tobacco Cessation in People Living With HIV: Protocol for a Pilot Randomized Controlled Trial

Background: An estimated 40% of people living with HIV smoke cigarettes. Although smoking rates in the United States 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 2-arm RCT 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 through 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 or 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 October 2023. All data collection is expected to be completed by the end of January 2024. 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 or tobacco abstinence at their 12-week follow-up. Results from this pilot study will be disseminated to the research community following the completion of all data collection.Conclusions: The Sense2Quit study leverages mHealth so that it can help smokers 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 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.Trial Registration: ClinicalTrials.gov NCT05609032; https://clinicaltrials.gov/study/NCT05609032International Registered Report Identifier (IRRID): DERR1-10.2196/49558