Harm reduction approach for people with HIV who smoke cigarettes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate a harm reduction strategy for individuals living with HIV who smoke cigarettes, as traditional cessation methods have proven ineffective for many. The study will enroll 400 participants from the Bronx, New York, and will compare the harm reduction approach, which includes reducing smoking and managing health risks, against standard treatment. Participants will receive intensive cessation support and will be monitored for changes in health indicators over a nine-month period. The trial seeks to provide a more effective alternative for those unable or unwilling to quit smoking entirely.

Why it matters

Who can join: the full rules

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?"
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

Where it's running

• Montefiore Medical Center
  The Bronx, New York, United States Recruiting

Study contacts

• Principal investigator: Jonathan Shuter, MD — Montefiore Medical Center
• Study coordinator: Jonathan Shuter, MD
• Email: jshuter@montefiore.org
• Phone: 718-920-7845

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.