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.

摘要 与美国相比，吸烟在艾滋病毒感染者（PLWH）中不成比例地普遍存在。 国家的一般人口，越来越多地导致高发病率和死亡率在这一人口。 传统的戒烟方式在PLWH中的可接受性较低，这表明需要 制定新的和创新的战略，以改善这一人群的戒烟。移动的健康（mHealth）持有 承诺作为一种工具，在美国人口中提供基于证据的戒烟干预措施， 大多数艾滋病毒阳性吸烟者拥有智能手机，之前的mHealth研究显示， 艾滋病毒携带者对烟草的依赖。然而，在对移动健康实证文献的回顾中，我们发现， 对戒烟的mHealth应用程序进行严格的早期研究对于确保 开发可用的、可接受的和基于理论的戒烟mHealth技术。在先前的工作中， 开发了学习戒烟（LTQ），这是一个基于证据的戒烟应用程序，结合了一个有前途的 正念干预与美国临床实践指南。LTQ是为患有 慢性精神疾病，与PLWH共享类似的以用户为中心的设计挑战的人群（例如， 精神症状、认知缺陷）。在此前提下，我们建议开发LTQ-H， 设计了一款专为PLWH量身定制的戒烟应用程序，并在一项试点随机对照试验中进行测试。我们的第一 目的是：（1）组成专家小组，告知LTQ适应PLWH，（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一项试点随机对照试验，以测试可行性，可接受性和 LTQ-H的初步疗效及其对HIV特异性结局的影响。团队介绍-Drs Pacek，Vilardaga，McClernon --在（1）PLWH的烟草依赖，（2）戒烟方面具有专业知识 医疗弱势群体的移动健康发展，（3）临床试验，（4）公共卫生政策-- a 将早期阶段的转化工作转化为“真实的世界”的实施所急需的背景。的 拟议的工作与跨NIH HIV相关研究计划（NOT-OD-15-137）一致， 采用最先进的技术，以改善难以接触到的人群，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 更大规模的R 01资助的RCT和必要的监管策略，以批准LTQ-H作为处方器械， 可以成为临床环境中PLWH的标准治疗。