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

针对艾滋病毒感染者的及时移动戒烟干预措施的开发和试点测试

基本信息

批准号：
10459617
负责人：
Ming-Chun Huang
金额：
$ 22.39万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-01 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10459617
关键词：
Abstinence Address Adult Area Behavior assessment Caring Cigarette Clinic Clinical Trials Coffee Communities Complex Counseling Data Development Ensure Equilibrium Feedback Focus Groups Friends General Population Geography Gestures Global Positioning System HIV HIV Seropositivity Hand Health Health Technology Health behavior Health behavior change High Prevalence Home Incidence Intervention Knowledge Life Expectancy Lighting Link Methodology Morbidity - disease rate Motion Motivation National Cancer Institute Neurocognitive Neurocognitive Deficit New York City Outcome Participant Patients Persons Population Prevalence Principal Investigator Qualitative Methods Quality of life Randomized Randomized Controlled Trials Reach Effectiveness Adoption Implementation and Maintenance Relapse Research Risk Factors Sample Size Sampling Savings Self Efficacy Series Smoke Smoker Smoking Smoking Cessation Intervention Software Engineering Technology Testing Text Text Messaging Time Tobacco Tobacco Use Cessation Tobacco use Tobacco-Related Carcinoma United States Viral Load result artificial intelligence algorithm base cigarette smoke cigarette smoking computer human interaction cost craving design disorder later incidence prevention evidence base experience former smoker health disparity improved improved outcome innovation mHealth mortality multi-component intervention nicotine replacement pilot test pilot trial prevent programs recruit reduce tobacco use response scale up sensor smart watch smartphone Application smoking cessation smoking prevalence smoking relapse smoking-related disease success tobacco cessation intervention tool usability wearable sensor technology

项目摘要

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.

项目摘要该应用程序直接响应PAR-19-309，将系统地开发和试点测试Sense 2 Quit应用程序，改善艾滋病毒感染者（PLWH）的戒烟情况。艾滋病毒携带者中吸烟的流行率是是美国成年人的三倍多。人口吸烟的高流行率艾滋病毒携带者中与烟草有关的癌症和其他与吸烟有关的疾病的高发病率要求迅速采取行动进行干预以降低烟草使用率。然而，指导PLWH戒烟的证据不足。到为了满足这一需求，我们的团队建议开发和试点测试Sense 2 Quit应用程序，一个多组件的智能手机应用程序提供及时的反馈;专门解决PLWH戒烟的挑战：滑倒，复发，与神经认知缺陷相关的困难;支持自我效能和决策平衡;并提供退出计划提醒。人工智能算法（经我们的研究团队验证）解释来自智能手表的数据检测吸烟的手部动作-一种在区分“点燃”与其他动作方面准确率超过98%的技术类似的动作。Sense 2 Quit应用程序利用智能手表数据，检测何时何地发生吸烟活动，可以在真实的时间内向参与者发送消息，以帮助他们管理失误（一两口），复发这种及时的反馈是至关重要的，特别是在戒烟尝试的最初几周。此外，全球定位系统数据可以帮助参与者避开触发点（咖啡馆、吸烟的亲戚或朋友家等）。最后，Sense 2 Quit应用程序提供有关吸烟者通过戒烟计划进展情况的信息，提示和激励工具（即，与不买香烟省钱有关的徽章）。该委员会的具体目标拟议的研究是：1）探索和确定，使用定性方法，可接受的和适当的应用程序的内容， Sense 2 Quit应用程序的功能，以支持吸烟的艾滋病毒携带者戒烟和预防复吸; 2）进行旨在检查Sense 2 Quit App的可行性、可接受性和初步疗效的初步随机对照试验在60名吸烟的PLWH样本中;以及3）采用RE-AIM框架评估潜在的规模扩大 Sense 2 Quit应用程序。作为试点试验的一部分，我们将60名HIV阳性吸烟者随机分配到Sense 2 Quit应用程序，标准戒烟咨询和尼古丁替代疗法（活动状态）与标准戒烟咨询加尼古丁替代疗法（对照），并检查组间戒烟尝试率的差异，7天时间点普遍性禁欲和持续性禁欲。我们将计算Sense 2 Quit应用程序的效应量估计，以指导，部分原因是大规模临床试验所需的样本量。从拟议的研究中获得的知识将使科学界和患者能够改善那些最需要戒烟的人的戒烟情况，美国鉴于我们的团队在每个领域的独特和互补的专业知识，戒烟干预，以改善结果PLWH，我们相信，从这项研究的结果，将很容易扩大规模进行进一步测试，以确保改善艾滋病毒携带者的健康结果。