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 — DRUG
    Clinical 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 — BEHAVIORAL
    Participants will earn prizes for progress towards tobacco abstinence, achieving tobacco abstinence, and progress in improving HIV and other related health conditions.
  • Teamlet booster — BEHAVIORAL
    Participants 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

Locations (5)

FacilityCityStateZIPSite coordinators
Bridgeport Hospital Primary Care Center Infectious Disease ClinicBridgeportConnecticut06610
Manisha Gupta, MD
(203) 384-3079
Yale Center for Infectious DiseasesNew HavenConnecticut06511
Erika Payne, PharmD
(203) 200-6899
Center for Comprehensive Care at Jersey City Medical CenterJersey CityNew Jersey07305
Nina Cooperman, PhD
(201) 395-7600
Center for Comprehensive Care at St. Joseph's HealthPatersonNew Jersey07503
Nina Cooperman, PhD
(973) 754-4701
Special Treatment And Research (STAR) at SUNY DownstateBrooklynNew York11203
Jessica Yager, MD
(718) 270-3745

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