Early-phase Studies of a Tailored Evidence-Based Smoking Cessation mHealth App for Persons Living with HIV

针对艾滋病毒感染者量身定制的循证戒烟 mHealth 应用程序的早期研究

• 批准号: 10016254
• 负责人: Roger Vilardaga
• 金额: $ 17.51万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-11 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10016254
• 关键词: Abstinence; Address; Adherence; Biochemical; Blood specimen; Cellular Phone; Clinical; Clinical Practice Guideline; Clinical Trials; Cognitive deficits; Collaborations; Computer software; Data; Development; Devices; Dose; Ensure; FDA approved; Funding; Future; General Population; Goals; HIV; HIV Infections; HIV Seropositivity; Health; Health Personnel; Health Policy; Health Technology; Human immunodeficiency virus test; Improve Access; Individual; Intervention; Learning; Literature; Longevity; Malignant Neoplasms; Malignant neoplasm of lung; Medical; Mobile Health Application; Modality; Modification; Morbidity - disease rate; Outcome; Patients; Persons; Phase; Play; Population; Population Intervention; Public Health; Quality of life; Randomized Controlled Trials; Reporting; Research; Research Design; Research Priority; Role; Sampling; Services; Smoke; Smoker; Smoking; Smoking Behavior; Smoking Cessation Intervention; Source; Technology; Testing; Tobacco Dependence; Tobacco use; Training; United States; United States National Institutes of Health; Vendor; Viral Load result; Vulnerable Populations; Work; base; behavior change; cancer diagnosis; care providers; cigarette smoke; cigarette smoking; clinical care; comorbidity; cost effective; design; digital; effective intervention; effective therapy; efficacy trial; evidence base; experience; improved; innovation; interest; mHealth; mindfulness intervention; mortality; participant safety; prevent; primary outcome; prototype; psychiatric symptom; recruit; secondary outcome; severe mental illness; smoking cessation; smoking prevalence; standard of care; theories; tool; trend; trial comparing; usability; user centered design

ABSTRACT Smoking is disproportionately prevalent among persons living with HIV (PLWH) as compared to the United States general population, increasingly contributing to high levels of morbidity and mortality in this population. Conventional smoking cessation modalities have low acceptability among PLWH, indicating the need to develop new and innovative strategies to improve cessation in this population. Mobile health (mHealth) holds promise as a tool to provide evidence-based smoking cessation interventions in the US population, with a majority of HIV-positive smokers owning a smartphone, and previous mHealth studies showing promise to treat tobacco dependence among PLWH. However, in a review of the empirical mHealth literature we found that rigorous early-phase studies of mHealth apps for smoking cessation are critically necessary to ensure the development of usable, acceptable and theory-based smoking cessation mHealth technology. In prior work we developed Learn to Quit (LTQ), an evidence-based smoking cessation app that combines a promising mindfulness-based intervention with U.S. Clinical Practice Guidelines. LTQ was tailored to persons living with chronic mental illness, a population that shares similar user-centered design challenges with PLWH (e.g., psychiatric symptoms, cognitive deficits). On that premise, we propose to develop LTQ-H, a rigorously designed smoking cessation app tailored to PLWH, and test it in a pilot randomized controlled trial. Our first aim is to: (1) form an expert panel to inform LTQ adaptations to PLWH, (2) conduct user-centered design research to ideate and test an LTQ-H prototype, (3) work with a software vendor to develop the LTQ-H app. Our second aim is to conduct a pilot randomized controlled trial to test the feasibility, acceptability and preliminary efficacy of LTQ-H, as well as its effects on HIV-specific outcomes. The proposed team -- Drs. Pacek, Vilardaga, McClernon -- has expertise in (1) tobacco dependence in PLWH, (2) smoking cessation mHealth development in medically vulnerable populations, (3) clinical trials, and (4) public health policy -- a much needed background to turn early-phase translational work into “real world” implementation. The proposed work is consistent with the Trans-NIH Plan for HIV-Related Research (NOT-OD-15-137), incorporating state-of-the-art technology to improve access to hard-to-reach populations, and addressing HIV- associated comorbidities and complications. Data from these early-phase studies will inform the design of a larger R01-funded RCT and the necessary regulatory strategy to approve LTQ-H as a prescription device that could become standard of care of PLWH in clinical settings.

抽象的 与曼联相比 州普通人口越来越多地导致该人群的高水平发病率和死亡率。 常规的戒烟方式在PLWH中的可接受性较低，表明需要 制定新的创新策略来改善该人群的停止。移动健康（MHealth）举行 承诺作为在美国人口提供基于证据的戒烟干预措施的工具， 大多数拥有智能手机的艾滋病毒阳性吸烟者和以前的MHealth研究表明有望治疗 PLWH中的烟草依赖性。但是，在对经验MHealth文献的回顾中，我们发现 对戒烟的MHealth应用程序进行严格的早期研究至关重要，以确保 开发可用，可接受和理论的戒烟MHealth技术。在先前的工作中 开发学习退出（LTQ），这是一种基于证据的戒烟应用，结合了诺言 美国临床实践指南基于正念的干预。 LTQ是针对与之生活的人量身定制的 慢性精神疾病，一种与PLWH共同以用户为中心的设计挑战的人群（例如， 精神病症状，认知缺陷）。在这个前提下，我们建议开发LTQ-H，这是一个严格的 设计了针对PLWH量身定制的戒烟应用程序，并在试点随机对照试验中对其进行测试。我们的第一个 目的是：（1）组成专家小组，以告知LTQ适应PLWH，（2）进行以用户为中心的设计 研究和测试LTQ-H原型，（3）与软件供应商一起开发LTQ-H应用程序。 我们的第二个目的是进行一项飞行员随机对照试验，以测试可行性，可接受性和 LTQ-H的初步有效性及其对HIV特异性结果的影响。拟议的团队 - 博士。 Pacek，Vilardaga，McClernon-在PLWH中具有（1）烟草依赖性方面的专业知识，（2）戒烟 医学脆弱人群的MHealth发展，（3）临床试验和（4）公共卫生政策 - 将早期翻译工作变成“现实世界”实施的急需背景。这 拟议的工作与与HIV相关研究的Trans-NIH计划一致（NOT-OD-15-137）， 合并最先进的技术，以改善难以到达的人群的访问，并解决HIV- 相关的合并症和并发症。这些早期研究的数据将为A的设计提供信息 较大的R01资助RCT和批准LTQ-H作为处方设备的必要监管策略 可以成为临床环境中PLWH的护理标准。