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

• Status: Not yet recruiting
• Trial end date: 2028-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Montefiore Medical Center
• Collaborators: Massachusetts General Hospital; National Cancer Institute (NCI); Truth Initiative; Westat
• Treatments: Varenicline

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. Prior LDCT screening or evaluation in CM Clinic

6. To minimize study contamination, eligible individuals who are spouses, partners, or roommates of participants will be excluded.