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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 79
Healthy Volunteers: t
View:

• 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? and exhaled carbon monoxide (ECO) level≥6ppm

• Lab-confirmed HIV

• Willingness to participate in a web-basedtobacco treatment+offer of varenicline

• Access to internet at least weekly and ability to read at ≥7th grade level (necessary to participate fully in EX+).

• Willingness to be randomized to one of the two study conditions.

Locations
United States
New York
Montefiore Medical Center
RECRUITING
The Bronx
Contact Information
Primary
Jonathan Shuter, MD
jshuter@montefiore.org
718-920-7845
Time Frame
Start Date: 2024-04-04
Estimated Completion Date: 2027-03
Participants
Target number of participants: 400
Treatments
Experimental: EX+/HR
The harm reduction arm (described in detail elsewhere)
Active_comparator: EX+/TAU
The treatment as usual arm
Related Therapeutic Areas
Sponsors
Collaborators: Massachusetts General Hospital, Truth Initiative, Westat, National Cancer Institute (NCI)
Leads: Montefiore Medical Center

This content was sourced from clinicaltrials.gov