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

针对吸烟的艾滋病毒感染者的减害策略试验

• 批准号: 10696463
• 负责人: Jonathan Shuter
• 金额: $ 74.53万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10696463
• 关键词: Abstinence; Acquired Immunodeficiency Syndrome; Age; Alcoholic beverage heavy drinker; American; American Heart Association; Antismoking; Appointment; Appointments and Schedules; Atherosclerosis; Behavior; Behavioral; Biochemical; Blood Pressure; Cardiology; Cardiovascular Diseases; Cardiovascular system; Caring; Cholesterol; Cigarette; Cigarette Smoker; Clinic; Clinical; Collaborations; Communities; Cost Effectiveness Analysis; Counseling; Country; Data; Data Set; Epidemic; Equation; Evaluation; Funding; Future; General Hospitals; Goals; Grant; Guidelines; HIV; Harm Reduction; Health; Health behavior; Helping to End Addiction Long-term; Hybrids; Individual; Internet; Intervention; Life; Malignant Neoplasms; Malignant neoplasm of lung; Massachusetts; Measurement; Medical; Medical center; Medicine; Methodology; Methods; Modeling; Morbidity - disease rate; Movement; Online Systems; Outcome; Participant; Persons; Pharmacotherapy; Population; Pregnant Women; Prevalence; Privatization; Process; Provider; Public Domains; Public Health; Published Comment; Publishing; Qualifying; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Reporting; Research; Resources; Risk; Role; Smoke; Smoker; Smoking; Smoking History; Social Justice; Subgroup; Textiles; Therapeutic; Time; Tobacco use; Translating; Transportation; United States National Institutes of Health; Work; World Health; arm; atherosclerosis risk; blood lipid; cancer risk; cardiometabolism; cerebrovascular; cigarette smoke; cigarette smoking; clinical care; clinical practice; cohort; college; cost effective; cost effectiveness; design; economic cost; economic outcome; evidence base; experience; improved; intervention effect; low dose computed tomography; lung cancer screening; models and simulation; mortality; mortality risk; online community; patient navigator; pharmacologic; prevent; primary outcome; programs; risk mitigation; simulation; smoking cessation; sobriety; tobacco control; tobacco user; treatment arm; treatment as usual; varenicline; web site

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.

项目摘要。美国大约一半的艾滋病毒（PWH）吸烟，最多 乐观的预测表明，尽管有积极的反吸烟努力，但其中的绝大多数 个人将继续吸烟。总体目标是评估减少伤害的潜力（HR） 改善PWH吸烟者的健康状况的策略，包括戒烟者和那些 继续吸烟。我们将为所有参与者提供基于证据的，密集的联合行为（积极地 在嵌入在bebeanex [ex+]在线社区中的网络上无烟）和药理学 停止治疗，然后对那些被随机分配给EX+/HR的人进行HR干预，并治疗为 在那些被随机分配给ex+/tau的人中通常（tau）。人力资源将包括一个鼓励的信息视频 那些尚未辞职的人，患者导航器辅助低剂量CT（LDCT）肺癌 筛查和转介到心脏代谢诊所以优化血压和脂质管理（后者 根据年龄，吸烟史，血压和/或胆固醇资格的人有两个推荐 测量）。具体的目的是（1）在Montefiore上比较这些方法的RCT 布朗克斯的医疗中心，有400名参与者随机1：1 to ex+/hr或ex+/tau与主要 （δ）#CIGARETTES每天抽烟（CPD）的变化结果，完成LDCT肺癌筛查的％，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）汇总队列方程评分（PCE），即动脉粥样硬化心血管疾病的风险 生化确认在9个月时的禁欲，（2）进行这两个的成本效益建模 与赠款期范围之外的项目一起采取措施，并估算国家影响 将方法传播到美国PWH人口的全部，（3）完成RE-AIM 对方法的分析，以评估其可行性，可持续性和概括性。 该研究的总体假设是EX+/HR方法将产生更大的 就肺癌和心血管疾病的死亡风险降低而言，这种优势转化为 在宏观水平上建模时，发病率和死亡率降低。 该项目将利用阿尔伯特·爱因斯坦医学院/蒙特菲尔的长期合作 医疗中心与真相倡议，Westat和医疗实践评估中心（MPEC） 马萨诸塞州综合医院（MGH），领导了研究和公共卫生界建模 行为和治疗策略的影响，包括烟草使用行为和治疗，对长期 美国及以后的PWH术语健康。他们将采用预防艾滋病的成本效益 并发症（CEPAC）微仿真方法与我们的试验和公共域中的输入 数据集估算我们两种方法对全国PWH吸烟者人群的影响。