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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

基本信息

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
项目类别：
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

项目摘要

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.

项目总结。在美国，大约一半的艾滋病毒感染者（PWH）吸烟，而且是最多的