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
1 other identifier
interventional
794
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2027
Longer than P75 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2026
CompletedFirst Posted
Study publicly available on registry
September 23, 2026
CompletedStudy Start
First participant enrolled
September 30, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2030
Study Completion
Last participant's last visit for all outcomes
September 30, 2031
September 23, 2026
September 1, 2026
3 years
September 16, 2026
September 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)
Self-reported tobacco abstinence over the past 7 days, confirmed by eCO of \<6ppm
12 weeks
Secondary Outcomes (6)
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)
24 weeks
Self-reported 7 day point prevalence smoking abstinence
Week 18
Cigarettes per day
Week 12
Cigarettes per day
Week 18
Cigarettes per day
Week 24
- +1 more secondary outcomes
Study Arms (2)
Clinical pharmacist-prescribed MTUD with teamlet booster
EXPERIMENTALClinical pharmacist-prescribed MTUD + teamlet delivered CM and booster
EXPERIMENTALInterventions
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.
Participants will earn prizes for progress towards tobacco abstinence, achieving tobacco abstinence, and progress in improving HIV and other related health conditions.
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.
Eligibility Criteria
You may qualify if:
- Have been diagnosed with HIV;
- Receive care at one of the participating sites;
- Are \>18 years old;
- Have smoked \>100 cigarettes lifetime;
- Smoke everyday or some days;
- Smoke, on average, \>5 cigarettes per day; and
- Provide written informed consent.
You may not qualify if:
- Exclusive use of non-cigarette tobacco or nicotine products, including e-cigarettes;
- Self-report or urine testing confirming pregnancy, nursing, or trying to conceive;
- Life-threatening or unstable medical, surgical, or psychiatric condition;
- Anticipate being unable to return for follow-up for any reason, such as travel, planned procedure;
- Inability to provide \>1 form of contact information;
- Inability to read or understand English or Spanish.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Bridgeport Hospital Primary Care Center Infectious Disease Clinic
Bridgeport, Connecticut, 06610, United States
Yale Center for Infectious Diseases
New Haven, Connecticut, 06511, United States
Center for Comprehensive Care at Jersey City Medical Center
Jersey City, New Jersey, 07305, United States
Center for Comprehensive Care at St. Joseph's Health
Paterson, New Jersey, 07503, United States
Special Treatment And Research (STAR) at SUNY Downstate
Brooklyn, New York, 11203, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
E. Jennifer Edelman, MD, MHS
Yale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2026
First Posted
September 23, 2026
Study Start (Estimated)
September 30, 2027
Primary Completion (Estimated)
September 30, 2030
Study Completion (Estimated)
September 30, 2031
Last Updated
September 23, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- All de-identified data will be made available after completion of the project and publication of related work and will remain available indefinitely.
- Access Criteria
- A Data Dictionary will be created, and the study Data Manager and the Program Manager will work with National Addiction \& HIV Data Archive Program (NAHDAP), an NIH-funded repository, to define an appropriate data structure, if one does not already exist. Data will be formatted to align with NAHDAP standards to promote interoperability and data reuse.
This project will generate data from patients with HIV and tobacco use disorder being seen for HIV primary care. Data generated will include responses to standardized ratings scales/questionnaires on tobacco use, alcohol, other substance use, depression, hypertension, physical activity, HIV symptoms, and lab data. Data will be collected at baseline, week 12, week 18, week 24. This study will also generate qualitative data and codebooks from in-depth interviews to inform revision and refinement of the intervention and post study participant experiences. Finally, this study will generate longitudinal mixed methods data on teamlet member implementation experiences from surveys and focus groups as well as cost data. Data describing the patient sample, outcome measures, and cost analyses will be de-identified and shared. Interview/focus group guides and codebooks will also be shared. Recordings and transcripts will not be shared publicly since voice is PHI.