A Harm Reduction Approach for Improving Risk Management in People with HIV who Smoke, HARM-less Trial

Status: active

This clinical trial evaluates whether a “harm reduction” approach can result in significant decreases in the risk for the health harms of cigarette smoking in people with HIV (PWH). PWH smoke cigarettes at higher rates than the general population, and those who smoke are at high risk for lung cancer, heart attacks, and strokes. These risks can be reduced by quitting smoking, cutting down on smoking (for those who do not quit), getting low-dose computed tomography (LDCT) scan screening for lung cancer, and controlling blood pressure and cholesterol. The vast majority (~85%) of PWH who smoke and receive intensive cessation treatment combining behavioral and drug treatment (such as varenicline or nicotine patches) continue to smoke. Varenicline, also known as Chantix, is a pill that helps people quit smoking and has been shown to be safe in PWH in several studies. A harm reduction approach (i.e. cut down, get screened for lung cancer, control blood pressure and cholesterol) has the potential to yield significant benefits in terms of the private and public health of PWH in the United States. A harm reduction approach may help improve and manage the health risks factors of cigarette smoking in PWH who smoke.

Inclusion Criteria

Age 40-79 (the American College of Cardiology/American Heart Association [ACC/AHA Pooled Cohort Equation score [PCEs] risk score is only valid in this age range)
Current cigarette smoking (answering "Yes" to the questions, "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 an exhaled carbon monoxide (ECO) level ≥ 6ppm
Laboratory-confirmed HIV-infection
Willingness to participate in a web-based tobacco treatment (EX+) + offer of varenicline
Access to internet at least weekly and ability to read at ≥ 7th grade level (necessary to participate fully in the EX+ program)
Willingness to be randomized to either an HR strategy which may include LDCT lung cancer screening (age ≥ 45 and ≥ 20 pack years smoking history) and/or referral to cardiometabolic clinic for management of hypertension (HTN) (systolic BP >130 mmHg) and/or hyperlipidemia (low-density lipoprotein [LDL] cholesterol >100 mg/dl).
Spanish-speakers will be fully included

Exclusion Criteria

Pregnancy
Lack of insurance coverage for specialty referral (we expect this exclusion to be rare because the great majority of PWH in the Montefiore Medical Center [MMC] clinic have Medicaid or AIDS Drug Assistance Program [ADAP])
Contraindication to varenicline
Concurrent receipt of other cessation treatments
Evaluation in cardiometabolic clinic (based on our collective experience we expect the number of exclusions on this basis to be extremely low) within the past 12 months

PRIMARY OBJECTIVE:

I. 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).

OUTLINE:

STAGE 1: Some participants attend a focus group over 30 minutes on study to provide feedback about the harm reduction video scripts, figures, and graphics in order to inform the development of the final harm reductions video. Participants also participate in an interview over 45 minutes on study to provide feedback about the appearance and content of newly incorporated Positively Smoke Free materials.

Participants are randomized to 1 of 2 groups.

STAGE 2, GROUP I: Participants view the BecomeAnEX+ online tobacco treatment program and offered standard of care (SOC) varenicline for 12 weeks. Participants view harm reduction (HR) counonseling video emphasizing abstinence as the best outcome for those who have quit or provide rationale for cutting down, detail the likely benefits associated with reduction in order to increase motivation, and suggest specific strategies that are commonly employed in reduction for those who have not quit, and mindful of the frequency of relapse in those who have as well as explaining the importance of lung cancer screening, blood pressure (BP) and lipid control over 30 minutes for 12 weeks. Participants may be offered a referral for LDCT screening, cardiometabolic (CM) clinic, and patient navigator (PN) services on study. Additionally, participants undergo blood sample collection at baseline and follow-up, measurement of carbon monoxide and may undergo saliva sample collection during follow-up.

STAGE 2, GROUP II: Participants view the BecomeAnEX+ online tobacco treatment program and offered SOC varenicline for 12 weeks. Participants continue to receive usual care from their primary care providers (PCP) on study. Additionally, participants undergo blood sample collection at baseline and follow-up, measurement of carbon monoxide and may undergo saliva sample collection during follow-up.

After completion of study intervention, participants are followed up at 3, 6, and 9 months.

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A Harm Reduction Approach for Improving Risk Management in People with HIV who Smoke, HARM-less Trial

Inclusion Criteria

Exclusion Criteria

United States

New York

Bronx

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A Harm Reduction Approach for Improving Risk Management in People with HIV who Smoke, HARM-less Trial

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