Effectivenss of an Integrated Treatment to Address Smoking Cessation and Anxiety/Depression in People Living with HIV

摘要 尽管吸烟的流行率在过去50年里有所下降，但烟草使用方面的巨大差异 仍然存在于几个亚群中，特别是处境不利和健康受损的人群。1吸烟者 艾滋病毒携带者在美国和世界上是一个主要的健康差距人口 一般来说，他们独特的保健需求没有得到充分满足。2对于艾滋病毒携带者， 吸烟与较差的存活率有关，3，4以及那些坚持抗逆转录病毒治疗的人 养生方法，吸烟减少的预期寿命超过艾滋病毒。5-7主要促成因素维持 携带艾滋病毒的吸烟者的吸烟复发包括暴露于多种应激源的增加 与艾滋病毒有关，这往往会加剧焦虑/抑郁。 建议的干预在一定程度上是因为我们最近完成的NIDA资助的R34的成功 研究项目(1R34DA031038-01A1)，在该项目中，我们在一个小型公开试验中进行了指定和测试，然后进行了试点 随机对照试验(RCT)的可行性、可接受性和初步疗效的9个疗程，认知- 以行为为基础的干预(称为戒烟)通过减少焦虑和 通过特定的情绪脆弱性(焦虑敏感、耐受痛苦和快感缺乏)导致的抑郁。这 专门为携带艾滋病毒的吸烟者调整和设计了干预措施。这项研究的结果 研究显示，与常规对照干预(Etau)的短暂强化治疗相比，患者 被分配戒烟的人短期内获得了更高的成就(治疗结束[EOT]：戒烟：59%对Etau：9%)和长期- 长期(6个月随访：戒烟率：46%对Etau：5%)戒酒率 我们现在建议进行一项全功率、三臂的疗效/有效性试验。我们建议招收180人 三个实施地点的吸烟者艾滋病毒携带者[(1)马萨诸塞州传染病诊所 波士顿综合医院(MGH)，(2)波士顿芬威社区健康中心，(3)托马斯街道健康中心 休斯顿中心]。我们试图在增加的时间点测试戒烟干预的效果。 普遍戒酒(主要结果)，通过减少焦虑和抑郁(次要结果)，以及 确定它是否优于主动、可信的时间匹配控制和护理标准(SOC)控制。这个 资源利用与成本效益分析的整合与第三代SOC控制臂支持 成本和效益的估算。如果成功，干预将为翻译研究做好准备 检查实施情况并将其传播到“真实世界”的健康、心理健康和社会服务环境。

ABSTRACT Although the prevalence of smoking has declined over the past 50 years, large disparities in tobacco use remain across several subgroups, particularly disadvantaged and health compromised populations.1 Smokers living with HIV represent a major health disparity population in the United States (US) and the world more generally, and their unique healthcare needs are not being adequately addressed.2 For people living with HIV, smoking is related to poorer survival3,4 and among those who are adherent to their antiretroviral treatment regimens, smoking reduces life expectancy more than HIV.5–7 Major contributing factors to the maintenance and relapse of smoking among smokers living with HIV include increased exposure to multiple stressors associated with HIV, which often exacerbates anxiety/depression.8 The proposed intervention is informed, in part, by the success of our recently completed NIDA-funded R34 research project (1R34DA031038-01A1) in which we specified and tested in a small open trial, and then, a pilot randomized controlled trial (RCT) the feasibility, acceptability and initial efficacy of a 9-session, cognitive- behavioral-based intervention (named QUIT) to address smoking cessation by reducing anxiety and depression via specific emotional vulnerabilities (anxiety sensitivity, distress tolerance, and anhedonia). This intervention was specifically adapted and designed for smokers living with HIV. The results from this study revealed that, when compared to a brief enhanced treatment as usual control intervention (ETAU), patients assigned to QUIT achieved higher short-term (end of treatment [EOT]: QUIT: 59% vs. ETAU: 9%) and long- term (6-month follow-up: QUIT: 46% vs. ETAU: 5%) abstinence rates.9 We now propose to conduct a fully powered, 3-arm efficacy/effectiveness trial. We propose to enroll 180 smokers living with HIV across three implementation sites [(1) Infectious Disease Clinic, Massachusetts General Hospital (MGH), Boston, (2) Fenway Community Health, Boston, and (3) Thomas Street Health Center, Houston]. We seek to test the efficacy/effectiveness of the QUIT intervention at increasing point prevalence abstinence (primary outcome), by reducing anxiety and depression (secondary outcomes), and to determine if it outperforms an active, credible time-matched control, and a standard-of-care (SOC) control. The integration of resource utilization and cost-effectiveness analyses and the third SOC control arm support estimation of cost and effectiveness. If successful, the intervention would be ready for translation studies to examine implementation and dissemination into “real-world” health, mental health, and social service settings.