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Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes

Montefiore Medical Center · with Westat, Massachusetts General Hospital · NCT05642715

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 40–79 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
400
US sites recruiting
1
Study start
April 4, 2024
Record last updated
April 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: EX+; Varenicline; HR; TAU

Conditions: Hiv; Tobacco Use

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

Study contacts (from the official record)

  • Jonathan Shuter, MD · 718-920-7845 · jshuter@montefiore.org
All smoking & vaping studies in New York →
Trial of a Harm Reduction Strategy for People With HIV Who Smoke… (NCT05642715) | Bored Studies