Actively Recruiting

Phase Not Applicable
Age: 40Years - 79Years
All Genders
Healthy Volunteers
NCT05642715

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

Led by Montefiore Medical Center · Updated on 2026-04-21

400

Participants Needed

1

Research Sites

151 weeks

Total Duration

On this page

Sponsors

M

Montefiore Medical Center

Lead Sponsor

W

Westat

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 79Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 40 and 79 years
  • Current cigarette smoker (smoked more than 100 cigarettes in lifetime and smoked in past 7 days)
  • Lab-confirmed HIV infection
  • Willing to participate in web-based tobacco treatment and take varenicline
  • Has internet access at least weekly and can read at 7th grade level or higher
  • Willing to be randomized to one of the two study groups
Not Eligible

You will not qualify if you...

  • Pregnant
  • No insurance coverage for specialty referrals
  • Contraindication to varenicline
  • Currently receiving other smoking cessation treatments
  • Seen in Cardiometabolic Clinic in past 12 months
  • Spouse, partner, or roommate of an enrolled participant to avoid study contamination

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

Loading map...

Research Team

J

Jonathan Shuter, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here