Grant Number:	5R01CA275521-02 Interpret this number
Primary Investigator:	Shuter, Jonathan
Organization:	Albert Einstein College Of Medicine
Project Title:	Trial of a Harm Reduction Strategy for People with HIV Who Smoke Cigarettes
Fiscal Year:	2024

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.





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