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

摘要 与美国相比，吸烟在艾滋病毒携带者(PLWH)中的比例更高 这一现象日益加剧了这一群体的高发病率和高死亡率。 传统的戒烟方法在PLWH中接受度较低，这表明有必要 制定新的和创新的策略，以改善这一人群的戒烟情况。移动健康(MHealth)支持 Promise作为在美国人口中提供循证戒烟干预的工具，具有 大多数HIV阳性吸烟者都拥有智能手机，之前的mHealth研究显示有希望治疗 PLWH中的烟草依赖。然而，在回顾经验性的移动健康文献时，我们发现 对mHealth戒烟应用程序进行严格的早期研究是至关重要的，以确保 开发可用的、可接受的和基于理论的戒烟mHealth技术。在之前的工作中，我们 开发了LTQ，这是一个基于证据的戒烟应用程序，它结合了一个很有前途的 以正念为基础的干预，符合美国临床实践指南。LTQ是为与 慢性精神疾病，与PLWH有着相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，一种严格的 为PLWH量身定做戒烟应用程序，并在试点随机对照试验中进行测试。我们的第一次 目的是：(1)组成一个专家小组，为LTQ适应PLWH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一项试点随机对照试验，以测试其可行性、可接受性和 LTQ-H的初步疗效及其对艾滋病毒特异性结局的影响。提议的团队--Dr。 Pacek，Vilardaga，McClernon--在(1)PLWH中对烟草依赖，(2)戒烟方面拥有专业知识 医疗弱势人群的移动健康发展，(3)临床试验，和(4)公共卫生政策--a 将早期阶段的翻译工作转化为“现实世界”实施所急需的背景知识。这个 拟议的工作与跨NIH艾滋病毒相关研究计划(NOT-OD-15-137)一致， 融入最先进的技术，以改善接触到难以接触的人群的机会，并解决艾滋病毒- 相关的合并症和并发症。来自这些早期阶段研究的数据将为设计 更大的R01资助的RCT和必要的监管战略，以批准LTQ-H作为处方药 可以成为临床环境中PLWH的标准护理。

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.