Harm reduction approach for people with HIV who smoke cigarettes
Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes
This study is testing a new way to help people with HIV who smoke cigarettes by focusing on reducing their smoking and managing health risks instead of just trying to get them to quit completely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 40 Years to 79 Years |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT05642715 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40-79 who are living with HIV and currently smoke cigarettes.
Not a fit: Patients who are pregnant or have contraindications to varenicline will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve health outcomes for people with HIV who smoke by reducing smoking-related harms.
How similar studies have performed: While traditional smoking cessation strategies have shown limited success in this population, the harm reduction approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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?"
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 this trial is running
The Bronx, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.