Trial of a harm reduction strategy for people with HIV who smoke cigarettes

项目总结。在美国，大约有一半的艾滋病毒携带者(PWH)吸烟，其中 乐观的预测表明，尽管积极的反吸烟努力，这些人中的绝大多数 个人将继续吸烟。总体目标是评估减少危害(HR)的潜力 改善更多威尔斯亲王医院吸烟者健康的战略，包括戒烟者和吸烟者 继续抽烟。我们将为所有参与者提供基于证据的、密集的组合行为(积极的 嵌入BecomeAnEX[ex+]在线社区的网络无烟)和药理学 在那些被随机分为EX+/HR和AS治疗的患者中，停药治疗后进行HR干预 通常(TAU)在那些被随机分为EX+/TAU的人中。人力资源部将由一段鼓励 那些尚未戒除的人，和患者导航器辅助的低剂量CT(LDCT)肺癌 筛查和转诊至心脏代谢诊所，以优化血压和血脂管理(后者 根据年龄、吸烟史、血压和/或胆固醇获得资格的人的两次转介 测量)。具体目标是(1)在蒙特菲奥雷完成一项比较这些方法的随机对照试验 布朗克斯的医疗中心，有400名参与者，随机1：1到EX+/HR或EX+/TAU与初级 变化的结果(Δ)、每天吸烟的香烟数量、完成低密度CT肺癌筛查的百分比、Δ 收缩压、Δ总胆固醇和Δ美国心脏病学院/美国心脏协会 (ACC/AHA)动脉粥样硬化性心血管疾病风险的合并队列方程评分(PCEs)，以及 生物化学证实在9个月内戒酒，(2)对这两种情况进行成本-效果模型 在赠款期间之外进行预测的方法，以及在以下情况下对国家影响的估计 向全美PWH人群传播了方法，以及(3)完成RE-AIM 对这些方法进行分析，以评估其可行性、可持续性和普适性。 这项研究的主要假设是，EX+/HR方法将产生显著更多的 在降低肺癌和心血管疾病死亡风险方面的优势，这些优势转化为 在宏观层面上建模时，降低了发病率和死亡率。 该项目将利用阿尔伯特·爱因斯坦医学院/蒙特菲奥雷的长期合作 医疗中心与真相倡议，西雅特，和医疗实践评估中心(MPEC) 马萨诸塞州综合医院(MGH)在研究和公共卫生界领先的建模 行为和治疗策略，包括烟草使用行为和治疗，对长期健康的影响。 威尔斯亲王在美国及其他地区的长期健康状况。他们将利用他们预防艾滋病的成本效益 并发症(CEPAC)微模拟方法，来自我们的试验和公共领域的输入 数据集来估计我们的两种方法将对全国PWH吸烟者人口产生的影响。

Project summary. Approximately half of people with HIV (PWH) in the US smoke cigarettes, and the most optimistic predictions indicate that notwithstanding aggressive anti-smoking efforts, the large majority of these individuals will continue to smoke. The overall goal is to evaluate the potential of a harm reduction (HR) strategy to improve the health of a much broader swath of PWH smokers, both those who quit and those who continue smoking. We will offer all participants an evidence-based, intensive combined behavioral (Positively Smoke Free on the Web embedded within the BecomeAnEX [EX+] online community) and pharmacologic cessation treatment followed by a HR intervention in those who are randomized to EX+/HR and treatment as usual (TAU) in those who are randomized to EX+/TAU. HR will consist of an informational video encouraging those who have not yet quit to cut down, and patient navigator assisted low-dose CT (LDCT) lung cancer screening and referral to Cardiometabolic Clinic to optimize blood pressure and lipid management (the latter two referrals for those who qualify based on age, smoking history, blood pressure, and/or cholesterol measurements). The specific aims are to (1) complete an RCT comparing these approaches at Montefiore Medical Center in the Bronx with 400 participants randomized 1:1 to EX+/HR or EX+/TAU with the primary outcomes of change in (Δ) # cigarettes smoked per day (CPD), % completing LDCT lung cancer screening, Δ systolic blood pressure, Δ total cholesterol, and Δ American College of Cardiology/American Heart Association (ACC/AHA) Pooled Cohort Equation score (PCEs) for risk of atherosclerotic cardiovascular disease, and biochemically confirmed abstinence at 9-months, (2) to perform cost-effectiveness modeling of these two approaches with projections beyond the horizon of the grant period and estimates for national impact if the approaches were disseminated to the entirety of the US PWH population, and (3) to complete RE-AIM analyses of the approaches in order to assess their feasibility, sustainability, and generalizability. The overarching hypothesis of the research is that the EX+/HR approach will generate significantly greater advantages in terms of reduced risk for death from lung cancer and cardiovascular disease that translate into reduced morbidity and mortality when modeled on a macro level. The project will leverage the long-term collaborations of the Albert Einstein College of Medicine/Montefiore Medical Center with Truth Initiative, Westat, and the Medical Practice Evaluation Center (MPEC) of the Massachusetts General Hospital (MGH), which has led the research and public health world in modeling the effects of behaviors and therapeutic strategies, including tobacco use behaviors and treatments, on the long- term health of PWH in the US and beyond. They will employ their Cost-Effectiveness of Preventing AIDS Complications (CEPAC) microsimulation methodology with inputs from our trial and from public-domain datasets to estimate the effects that our two approaches would have on the PWH smoker population nationally.