NCT05642715Recruiting
Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 30 Nov 2022
- Start date
- 4 Apr 2024
- Primary completion date
- Mar 2027
- Lead sponsor
- Montefiore Medical Center
- Diseases
- HIV
- NCT number
- NCT05642715
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 4 Apr 2024 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent receipt of other cessation treatments
- Evaluation in Cardiometabolic Clinic within the 12 months prior to enrollment
Other illness
- 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)
Other
- Pregnancy
- Contraindication to varenicline
- To minimize study contamination, eligible individuals who are spouses, partners, or roommates of participants will be excluded
Who the study is looking for
- 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
Age in the registry: 40 years to 79 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.