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

Part of paid clinical trials in The Bronx, New York.

Sponsor: Montefiore Medical Center
Study ID: NCT05642715
Status: Recruiting

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Conditions

Hiv
Tobacco Use

Eligibility Criteria

Sex: ALL
Age: 40 Years - 79 Years
Healthy Volunteers: Accepted

Interventions

EX+ — BEHAVIORAL
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.
Varenicline — DRUG
All participants, regardless of study arm, will be offered: A 12-week course of varenicline dosed according to product label.
HR — BEHAVIORAL
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).
TAU — BEHAVIORAL
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

Study Details

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.