Status:
COMPLETED
A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Tobacco Use Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Many people living with HIV (PLWH) smoke. Smoking in these individuals is often undertreated. This study plans to assess the ability of various clinical pathways involving tobacco treatment medication...
Detailed Description
Using a Sequential Multiple Assignment Randomized Trial (SMART) design, this project is a two-arm, two-stage randomized trial of 320 adult PWH who smoke cigarettes and receive care in one of three hea...
Eligibility Criteria
Inclusion
- HIV positive;
- \>= 18 years old
- Receiving HIV care at Yale-New Haven Hospital, Bridgeport Hospital, Mount Sinai Hospital, or SUNY Downstate STAR clinic;
- Have smoked \>= 100 cigarettes in lifetime;
- Currently smokes some days or every day;
- Smokes, on average, \>= 5 cigarettes per day;
- Able to provide written informed consent.
Exclusion
- Using only non-cigarette nicotine products (i.e., e-cigs, Juul, etc.);
- Currently using NRT, VAR, or bupropion (defined as use in the prior 7 days);
- Self-report or urine testing confirming pregnancy, nursing, or trying to conceive;
- Life-threatening or unstable medical, surgical, or psychiatric condition;
- Inability to provide at least one collateral contact (family member or friend);
- Living out of state;
- Unable to read or understand English (except at Mount Sinai site).
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2025
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT04490057
Start Date
July 27 2020
End Date
October 24 2025
Last Update
January 5 2026
Active Locations (4)
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1
Bridgeport Hospital Infectious Disease Clinic
Bridgeport, Connecticut, United States, 06110
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
3
SUNY Downstate STAR Clinic
Brooklyn, New York, United States, 11203
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029