Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes

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 those who continue smoking versus treatment as usual (TAU). All participants will have their blood pressure (BP) and lipid (cholesterol) profile checked at baseline. All participants will complete a questionnaire about their sociodemographic, clinical, and tobacco behavior histories at baseline, 3-months, 6-months, and 9-months. All participants who enroll in the trial will be randomized 1:1 (like a coin-flip) to the HR arm, called EX+/HR in this proposal, or the TAU arm, called EX+/TAU in this proposal. All participants will be offered intensive cessation treatment immediately after enrollment in the form of the BecomeAnEX+ online tobacco treatment program, which includes the web's largest online support community of people trying to quit, and an offer of a 12-week supply of varenicline. This stage of the trial, Stage 1, will extend from enrollment until 90-day post-enrollment. After that, in Stage 2, participants will be informed of their randomization assignment, i.e. to EX+/HR or EX+/TAU. Those who are assigned to EX+/HR will undergo the following: (A patient navigator \[PN\] will be assigned to each EX+/HR participant in order to facilitate all of the following activities.) 1. Harm reduction (HR) counseling. A 30-minute videosession that will emphasize abstinence as the best outcome, and that those who have quit should strive to remain abstinent for life. For those who have not quit, and mindful of the frequency of relapse in those who have, the video will provide rationale for cutting down, will detail the likely benefits associated with reduction in order to increase motivation, and will suggest specific strategies that are commonly employed in reduction interventions, namely (1) choosing specific cigarettes during the day to give up (2) increasing time intervals between cigarettes (3) smoking only during even or odd hours (4) restricting smoking to certain places (5) delaying the first cigarette of the day and (6) trying to avoid smoking completely on certain days. The video will go on to explain the importance of lung cancer screening and BP and lipid control in both selected smokers and ex-smokers and review the resources available to accomplish these goals, i.e. LDCT screening, Cardiometabolic (CM) Clinic, and patient navigator (PN) services. 2. Evaluation of eligibility for LDCT screening and referral for those who meet eligibility criteria. These trial.show_full_description

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 Criteria: 1. Pregnancy 2. Lack of insurance for specialty referral (we expect this exclusion to be rare because the great majority of people with HIV (PWH) at the Montefiore Medical Center have Medicaid or AIDS Drug Assistance Program (ADAP) 3. Contraindication to varenicline 4. Concurrent receipt of other cessation treatments 5. Evaluation in Cardiometabolic Clinic within the 12 months prior to enrollment 6. To minimize study contamination, eligible individuals who are spouses, partners, or roommates of participants will be excluded