NCT05642715 Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes
| NCT ID | NCT05642715 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montefiore Medical Center |
| Condition | Hiv |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-04-04 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2024-04-04 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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?" 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
Contact & Investigator
Jonathan Shuter, MD
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT05642715 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 79 Years, studying Hiv. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05642715 currently recruiting?
Yes, NCT05642715 is actively recruiting participants. Contact the research team at jshuter@montefiore.org for enrollment information.
Where is the NCT05642715 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT05642715 clinical trial?
NCT05642715 is sponsored by Montefiore Medical Center. The principal investigator is Jonathan Shuter, MD at Montefiore Medical Center. The trial plans to enroll 400 participants.
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