Montefiore Medical Center
Cigarette smoking is now the leading killer of people with HIV (PWH) in the US, and most cessation strategies tried to date have failed to increase long-term quit rates. An "all or none" approach to smoking cessation in PWH offers little benefit to the large majority of PWH who are unable or unwilling to quit. In this proposal we argue that a harm reduction approach (i.e., cut down, get screened for lung cancer, control your blood pressure and cholesterol) has the potential to yield significant benefits in terms of the private and public health of PWH in the US.
This will be a single-center, prospective, randomized controlled trial (RCT) enrolling 400 participants who are living with HIV and smoke cigarettes in the Bronx, New York. The vast majority (\~85%) of people with HIV (PWH) who smoke and receive intensive cessation treatment combining behavioral and drug treatment (such as varenicline or nicotine patches) continue to smoke. The overall goal of this RCT is to compare a harm reduction (HR) strategy aimed at mitigating the harms of cigarette smoking, such as lung cancer and heart disease, in all PWH smokers, both those who are able to quit and th…
Inclusion Criteria: 1. Age 40-79 (the ACC/AHA PCEs risk score is only valid in this age range). 2. Current cigarette smoking ("Yes" to: "Have you smoked more than 100 cigarettes in your lifetime?" AND "Have you smoked a cigarette, even a puff, in the past 7 days?" 3. Lab-confirmed HIV infection 4. Willingness to participate in a web-based tobacco treatment (EX+) AND offer of varenicline 5. Access to internet at least weekly and ability to read at ≥7th grade level (necessary to participate fully in EX+ program). 6. Willingness to be randomized to one of the two study conditions Exclusion Crit…
All participants, regardless of study arm, will be offered: BecomeAnEX, an online tobacco treatment with support community PLUS Positively Smoke Free on the Web (an intervention targeting people with HIV who smoke) integrated into the BecomeAnEX site.
All participants, regardless of study arm, will be offered: A 12-week course of varenicline dosed according to product label.
Participants allocated to the EX+/HR arm will be offered: 30-minute video urging smokers who cannot or will not quit to cut down on cigarettes, and also to control their risk for lung cancer and cardio or cerebrovascular disease by undergoing low-dose CT screening for lung cancer (for those meeting prespecified criteria), and referral to Cardiometabolic Clinic (for those meeting prespecified criteria).
Participants allocated to the EX+/TAU arm will be offered: Medical treatment as usual from their regular providers after completing Stage 1 of the study
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