RecruitingNot ApplicableNCT05642715

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

Sponsor

Montefiore Medical Center

Enrollment

400 participants

Start Date

Apr 4, 2024

Study Type

INTERVENTIONAL

Conditions

HIV Tobacco Use

Summary

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.

Eligibility

Min Age: 40 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a harm reduction approach to help people living with HIV who smoke cigarettes — combining a web-based tobacco treatment program (EX+) with an offer of quit medication (varenicline) — to reduce the high cardiovascular risk smokers with HIV face. **You may be eligible if...** - You are between 40 and 79 years old - You have HIV (confirmed by lab) - You currently smoke cigarettes (have smoked more than 100 in your lifetime and smoked in the past 7 days) - You have access to the internet at least weekly and can read at a 7th grade level - You are willing to be randomized to one of the two study conditions **You may NOT be eligible if...** - You are pregnant - You already have established heart disease (atherosclerotic cardiovascular disease) - You do not have insurance for a specialist referral - You do not own or have access to a smartphone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALEX+

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.

DRUGVarenicline

All participants, regardless of study arm, will be offered: A 12-week course of varenicline dosed according to product label.

BEHAVIORALHR

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).

BEHAVIORALTAU

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

Locations(1)

Montefiore Medical Center

The Bronx, New York, United States

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NCT05642715

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