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 与美国相比，吸烟在艾滋病毒感染者 (PLWH) 中的比例过高 州总人口，日益导致该人群的高发病率和死亡率。 传统的戒烟方式在艾滋病病毒感染者中的接受度较低，这表明有必要 制定新的创新策略来改善这一人群的戒烟情况。移动医疗（mHealth）持有 承诺作为一种工具，为美国人口提供基于证据的戒烟干预措施， 大多数艾滋病毒呈阳性的吸烟者拥有智能手机，之前的移动医疗研究表明有望治疗 PLWH 中的烟草依赖。然而，在回顾移动健康实证文献时，我们发现 对用于戒烟的移动医疗应用程序进行严格的早期研究至关重要，以确保 开发可用、可接受且基于理论的戒烟移动医疗技术。在之前的工作中我们 开发了 Learn to Quit (LTQ)，这是一款基于证据的戒烟应用程序，结合了有前途的戒烟应用程序 根据美国临床实践指南进行基于正念的干预。 LTQ 是为患有以下疾病的人量身定制的 慢性精神疾病，这一人群与 PLWH 有着类似的以用户为中心的设计挑战（例如， 精神症状、认知缺陷）。在此前提下，我们建议开发 LTQ-H，一种严格的 设计了针对 PLWH 的戒烟应用程序，并在试点随机对照试验中进行了测试。我们的第一个 目标是：(1) 组建专家小组，为 PLWH 的 LTQ 调整提供信息，(2) 进行以用户为中心的设计 研究构思和测试 LTQ-H 原型，(3) 与软件供应商合作开发 LTQ-H 应用程序。 我们的第二个目标是进行试点随机对照试验，以测试可行性、可接受性和 LTQ-H 的初步疗效及其对 HIV 特异性结果的影响。拟议的团队——Drs。 Pacek、Vilardaga、McClernon——在 (1) 艾滋病病毒感染者和艾滋病患者的烟草依赖方面拥有专业知识，(2) 戒烟 医疗弱势群体的移动医疗发展，(3) 临床试验，以及 (4) 公共卫生政策——a 将早期转化工作转化为“现实世界”实施所急需的背景。这 拟议的工作符合跨 NIH 艾滋病毒相关研究计划 (NOT-OD-15-137)， 结合最先进的技术来改善难以接触到的人群的服务，并解决艾滋病毒问题 相关的合并症和并发症。这些早期研究的数据将为设计提供信息 更大的 R01 资助的 RCT 和批准 LTQ-H 作为处方设备的必要监管策略 可能成为临床环境中 PLWH 的护理标准。