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

• 批准号: 10335352
• 负责人: Ming-Chun Huang
• 金额: $ 21.5万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10335352
• 关键词: Abstinence; Address; Adult; Area; Artificial Intelligence; 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; 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 Messaging; Time; Tobacco; Tobacco Use Cessation; Tobacco use; Tobacco-Related Carcinoma; United States; Viral Load result; base; cigarette smoking; computer human interaction; cost; craving; design; disorder later incidence prevention; evidence base; experience; former smoker; health disparity; improved; improved outcome; innovation; intelligent algorithm; mHealth; mortality; multi-component intervention; nicotine replacement; 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

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.

项目总结 此应用程序直接响应PAR-19-309，将系统地开发和试点测试Sense2Quit App以 改善艾滋病毒携带者的戒烟情况。公共卫生署的吸烟情况如下： 是美国普通成年人的三倍多(美国)人口。吸烟的高流行率 PLWH中与烟草相关的癌症和其他与吸烟相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戒烟的证据并不充分。至 为了满足这一需求，我们的团队建议开发并试点测试Sense2Quit App，这是一款多组件智能手机应用程序 它提供及时的反馈；具体解决公共卫生部门戒烟的挑战：滑倒、复发、 和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(由我们的研究小组验证)解释来自智能手表的数据 检测吸烟的手部动作--一项准确率超过98%的技术，可以区分“点烟”和其他 类似的动作。Sense2Quit应用程序利用智能手表数据并检测吸烟活动发生的时间和地点 可以将消息实时发送给参与者，以帮助他们管理单据(一两个)，使其不会成为 旧病复发。这种及时的反馈是至关重要的，尤其是在戒烟尝试的头几周。此外，全球 定位系统数据可以帮助参与者避免触发因素(咖啡店、吸烟的亲戚或朋友的家等)。 最后，Sense2Quit App提供吸烟者戒烟计划Support的进展情况 小贴士和激励工具(即，与不买烟省钱有关的徽章)。《公约》的具体目标 建议的研究是：1)利用定性的方法，探索和确定可接受和适当的APP内容和 Sense2Quit应用程序的功能，支持吸烟的PLWH戒烟和预防复发；2)进行 用于检查Sense2Quit应用程序的可行性、可接受性和初步疗效的试点随机对照试验 在60名吸烟的PLWH中的样本中；以及3)使用RE-AIM框架来评估 Sense2Quit应用。作为试点试验的一部分，我们将随机选择60名HIV阳性吸烟者使用Sense2Quit App，标准 戒烟咨询和尼古丁替代疗法(积极状态)与标准戒烟 咨询加尼古丁替代疗法(对照组)和观察组戒烟尝试率、7天积分的差异 普遍禁欲和持续禁欲。我们将计算Sense2Quit App的效果大小估计来指导， 部分原因是更大规模的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最需要戒烟的人的戒烟情况 鉴于我们的团队在每个领域的独特和互补的专业知识，以开发创新的 戒烟干预改善PLWH患者的预后，我们相信这项研究的结果 将很容易扩大以进行进一步测试，以确保改善PLWH的健康结果。