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

Launched by MONTEFIORE MEDICAL CENTER · Nov 30, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help people living with HIV who smoke cigarettes. Since smoking is a major cause of health problems and death for people with HIV in the U.S., the study is looking at a "harm reduction" approach. Instead of insisting that everyone quit smoking completely, this strategy encourages individuals to cut down on their smoking, get screened for lung cancer, and manage their blood pressure and cholesterol. The idea is that even small changes can significantly improve health.

To participate in this trial, you need to be between the ages of 40 and 79, currently smoke cigarettes, and have a confirmed HIV diagnosis. You'll also need access to the internet and be comfortable with reading at least at a seventh-grade level. If you join the study, you will receive support through a web-based program and may be offered a medication called varenicline to help with smoking cessation. This trial is currently recruiting participants, and it’s an opportunity to receive support while contributing to important research for people with HIV who smoke.

Gender

ALL

Eligibility criteria

• 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 exhaled carbon monoxide (ECO) level≥6ppm
• • 3. Lab-confirmed HIV
• • 4. Willingness to participate in a web-basedtobacco treatment+offer of varenicline
• • 5. Access to internet at least weekly and ability to read at ≥7th grade level (necessary to participate fully in EX+).
• • 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 virtually all of our participants have Medicaid, ADAP, Medicare, or private insurance)
• • 3. Contraindication to varenicline
• • 4. Concurrent receipt of other cessation treatments
• • 5. Evaluation in CM 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.

Trial Officials