Recruiting

Harm Reduction

Sponsor:

Montefiore Medical Center

Code:

NCT05642715

Conditions

Hiv

Tobacco Use

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

EX+

Varenicline

HR

TAU

Study Details

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.

Conditions

Hiv

Tobacco Use

Study ID

NCT05642715

Start date

Apr 4, 2024

Status verified date

Apr, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: EX+/HR

The harm reduction arm (described in detail elsewhere)

active comparator: EX+/TAU

The treatment as usual arm

Interventions

EX+

All participants, regardless of study arm, will be offered: BecomeAnEX, an online tobacco treatment with support community PLUS Positively Smoke Free on the Web (an intervention targeting people with HIV who smoke) integrated into the BecomeAnEX site.

Varenicline

All participants, regardless of study arm, will be offered: A 12-week course of varenicline dosed according to product label.

HR

Participants allocated to the EX+/HR arm will be offered: 30-minute video urging smokers who cannot or will not quit to cut down on cigarettes, and also to control their risk for lung cancer and cardio or cerebrovascular disease by undergoing low-dose CT screening for lung cancer (for those meeting prespecified criteria), and referral to Cardiometabolic Clinic (for those meeting prespecified criteria).

TAU

Participants allocated to the EX+/TAU arm will be offered: Medical treatment as usual from their regular providers after completing Stage 1 of the study

Primary outcome measure

  • Change in cigarettes smoked per day (CPD) [ Time Frame: From baseline to 9 months ]
  • Occurrence of low-dose CT (LDCT) screening for lung cancer [ Time Frame: Up to 9 months ]
  • Change in systolic blood pressure (SBP) [ Time Frame: From baseline to 9 months ]
  • Change in total cholesterol [ Time Frame: From baseline to 9 months ]
  • Change in American College of Cardiology/American Heart Association Pooled Cohort Equation score (ACC/PCEs) [ Time Frame: From baseline to 9 months ]
  • Biochemically-confirmed 7-day point-prevalence abstinence (PPA) [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

More Information

Sponsor

Montefiore Medical Center

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • HIV
  • Tobacco
  • Cigarette
  • Smoking
  • Harm reduction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-04-21.