Smoking Cessation Medication And Rewards Using a Teamlet to Treat Tobacco Use Disorder (SMARTTT 2.0) Among Persons With HIV: A Multi-site Hybrid Type 2 Effectiveness-implementation Trial
Part of paid clinical trials in Bridgeport, Connecticut.
- Sponsor
- Yale University
- Study ID
- NCT07835555
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
- HIV
- Tobacco Use Disorder/Cigarette Smoking
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion — DRUGClinical pharmacist prescribed MTUD, based on participant choice: nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion. Participants on nicotine replacement may choose both a long acting (patch) and short acting (gum, lozenge) option to use at the same time.
- Multi-target Contingency Management — BEHAVIORALParticipants will earn prizes for progress towards tobacco abstinence, achieving tobacco abstinence, and progress in improving HIV and other related health conditions.
- Teamlet booster — BEHAVIORALParticipants will receive a booster call by a teamlet member after MTUD is prescribed to address any MTUD access issues and answer MTUD related questions.
Study Details
Cigarette smoking is an important cause of illness and death among persons with HIV (PWH). This project will study the impact of adding contingency management (use of financial rewards) to receiving medications and counseling on promoting smoking abstinence and other health outcomes among PWH. As treatments will be provided by clinical pharmacists and other team members in HIV clinics, factors relevant for implementing this model to inform real-world practice will also be evaluated.
Key Dates
- First listed
- Sep 23, 2026
- Start date
- Sep 30, 2027
- Status verified
- Sep 2026
- Primary completion
- Sep 30, 2030
- Completion
- Sep 30, 2031
Study Design
- Enrollment
- 794 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Clinical pharmacist-prescribed MTUD with teamlet booster
- Experimental: Clinical pharmacist-prescribed MTUD + teamlet delivered CM and booster
Primary Outcome Measure
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO) [ Time Frame: 12 weeks ]
Central Contacts
- E. Jennifer Edelman, MD, MHS203-737-7115
- June-Marie Weiss, MA, MEd203-737-3347
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Bridgeport Hospital Primary Care Center Infectious Disease Clinic | Bridgeport | Connecticut | 06610 | |
| Yale Center for Infectious Diseases | New Haven | Connecticut | 06511 | |
| Center for Comprehensive Care at Jersey City Medical Center | Jersey City | New Jersey | 07305 | |
| Center for Comprehensive Care at St. Joseph's Health | Paterson | New Jersey | 07503 | |
| Special Treatment And Research (STAR) at SUNY Downstate | Brooklyn | New York | 11203 |
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