Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes
Recruiting · NCT05642715 · Interventional (participants receive a specific treatment) · Lead sponsor: Montefiore Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
40 Years to 79 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age 40-79 (the ACC/AHA PCEs risk score is only valid in this age range).
- 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?"
- Lab-confirmed HIV infection
- Willingness to participate in a web-based tobacco treatment (EX+) AND offer of varenicline
- Access to internet at least weekly and ability to read at ≥7th grade level (necessary to participate fully in EX+ program).
- Willingness to be randomized to one of the two study conditions
Exclusion criteria
- Pregnancy
- 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)
- Contraindication to varenicline
- Concurrent receipt of other cessation treatments
- Evaluation in Cardiometabolic Clinic within the 12 months prior to enrollment
- To minimize study contamination, eligible individuals who are spouses, partners, or roommates of participants will be excluded
Where it is running
1 location listed across 1 US state.
- Montefiore Medical Center - The Bronx, New York, United States