RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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?" and have exhaled carbon monoxide (ECO) level ≥ 6ppm 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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?" and have exhaled carbon monoxide (ECO) level ≥ 6ppm 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

Treatments Being Tested

BEHAVIORAL

EX+

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.

DRUG

Varenicline

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

BEHAVIORAL

HR

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).

BEHAVIORAL

TAU

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