Tobacco Use Disorder/Cigarette SmokingPhase 4NCT07835555
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
A Phase 4 study testing nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion, Multi-target Contingency Management and Teamlet booster in people with Tobacco Use Disorder/Cigarette Smoking and HIV, run by Yale University at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder/Cigarette Smoking, HIV
- What is being tested?
- nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion, Multi-target Contingency Management and Teamlet booster
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 794 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Sep 2027to 30 Sep 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
Bridgeport Hospital Primary Care Center Infectious Disease Clinic
Bridgeport, Connecticut, 06610
Manisha Gupta, MD, (203) 384-3079, Manisha.Gupta@bpthosp.org
Special Treatment And Research (STAR) at SUNY Downstate
Brooklyn, New York, 11203
Jessica Yager, MD, (718) 270-3745, jessica.yager@downstate.edu
Center for Comprehensive Care at Jersey City Medical Center
Jersey City, New Jersey, 07305
Nina Cooperman, PhD, (201) 395-7600, cooperna@rwjms.rutgers.edu
Yale Center for Infectious Diseases
New Haven, Connecticut, 06511
Erika Payne, PharmD, (203) 200-6899, erika.payne@ynhh.org
Center for Comprehensive Care at St. Joseph's Health
Paterson, New Jersey, 07503
Nina Cooperman, PhD, (973) 754-4701, cooperna@rwjms.rutgers.edu
About this study
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.
Read the detailed description
Cigarette smoking is a major threat to health among persons with HIV (PWH). Via direct effects and link with TUD-related conditions (behaviors and medical conditions that drive poor outcomes), smoking causes more lost life years than treated HIV. Cardiovascular disease, lung disease, and cancer are indeed leading causes of death among PWH. Guidelines recommend medications for TUD (MTUD) and behavioral interventions to promote smoking cessation. Data also support use of contingency management (CM) to target smoking cessation and treatment adherence. Yet, adoption of these approaches in HIV clinics has been suboptimal. Past projects have found that clinical pharmacist-prescribed TUD treatment involving MTUD with CM integrated in HIV clinics offers a feasible, acceptable, and practical solution to overcome multi-level challenges to adoption of such TUD treatments. Past projects have identified opportunities for enhanced patient-centeredness with: 1) creation of teamlets (little teams) to collaborate with clinical pharmacists to address challenges with MTUD access and implement CM; 2) use of multi-target CM to reward progress in addressing TUD-related care, HIV, and TUD-related conditions plus smoking abstinence; 3) promotion of patient choice in MTUD selection and flexibility for remote versus in-person services; and 4) focus on reducing health disparities. Grounded in the socioecological model and implementation science principles, this project will include a randomized trial to compare the effectiveness of teamlet-delivered CM as an adjunct to clinical pharmacist prescribed MTUD with teamlet telephone booster over 12 weeks among 794 PWH receiving care in one of six sites. This study will develop procedures directly informed by perspectives of PWH. The primary outcome is exhaled carbon monoxide-confirmed 7-day smoking abstinence at week 12 (Aim 1). This study will explore whether the effectiveness of the interventions differ based on access to basic needs (Aim 2). Consistent with a hybrid type 2 effectiveness-implementation approach, this study will include an implementation-focused evaluation incorporating perspectives of PWH, clinical pharmacists, and other teamlet members using qualitative and quantitative data; measures of intervention delivery; and economic viability via micro-costing and cost-effectiveness analyses (Aim 3). The research team brings together expertise in HIV, pharmacy, addiction medicine, smoking cessation, CM, clinical trials, health disparities, implementation science, and health economics. Innovative features of the proposal are: 1) clinical pharmacist delivered TUD treatment with teamlets integrated in HIV clinics; and 2) collaboratively created multi-target CM program to address smoking, HIV, and TUD-related conditions. The study has potential for high impact by generating data on and associated costs of a reproducible, scalable, sustainable strategy suitable for transforming TUD treatment in HIV clinics nationally.
- Conditions
- Tobacco Use Disorder/Cigarette Smoking, HIV
- Being tested
- nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion, Multi-target Contingency Management, Teamlet booster
- Keywords
- tobacco use disorder, cigarette smoking, contingency management, HIV
- Medical subject headings
- Tobacco Use Disorder, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropionDrug
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 ManagementBehavioural
Participants will earn prizes for progress towards tobacco abstinence, achieving tobacco abstinence, and progress in improving HIV and other related health conditions.
Teamlet boosterBehavioural
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 group | Role | What they receive |
|---|---|---|
| Clinical pharmacist-prescribed MTUD with teamlet booster | Experimental | Not described Receives: Drug: nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion; Behavioral: Teamlet booster |
| Clinical pharmacist-prescribed MTUD + teamlet delivered CM and booster | Experimental | Not described Receives: Drug: nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion; Behavioral: Multi-target Contingency Management; Behavioral: Teamlet booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (6)
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)
Self-reported tobacco abstinence over the past 7 days, confirmed by eCO <6ppm
Measured: 24 weeks
Self-reported 7 day point prevalence smoking abstinence
Measured: Week 18
Cigarettes per day
Self-reported reduction in mean number of cigarettes per day
Measured: Week 12
Cigarettes per day
Self-reported reduction in mean number of cigarettes per day
Measured: Week 18
Cigarettes per day
Self-reported reduction in mean number of cigarettes per day
Measured: Week 24
HIV viral load, detectable
HIV viral load greater than 50 copies per milliliter of blood and detectable on standard lab test
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start30 Sep 2027 (estimated)
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use Disorder/Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 794 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- E. Jennifer Edelman, MD, MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835555
- Sponsor's protocol ID
- 2000043556
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07835555
- Acronym / sponsor ID
- 2000043556
- Conditions
- Tobacco Use Disorder/Cigarette Smoking, HIV
- Keywords
- tobacco use disorder, cigarette smoking, contingency management, HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 794 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 30 Sep 2027 (estimated)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cigarette smoking is a major threat to health among persons with HIV (PWH). Via direct effects and link with TUD-related conditions (behaviors and medical conditions that drive poor outcomes), smoking causes more lost life years than treated HIV. Cardiovascular disease, lung disease, and cancer are indeed leading causes of death among PWH. Guidelines recommend medications for TUD (MTUD) and behavioral interventions to promote smoking cessation. Data also support use of contingency management (CM) to target smoking cessation and treatment adherence. Yet, adoption of these approaches in HIV clinics has been suboptimal. Past projects have found that clinical pharmacist-prescribed TUD treatment involving MTUD with CM integrated in HIV clinics offers a feasible, acceptable, and practical solution to overcome multi-level challenges to adoption of such TUD treatments. Past projects have identified opportunities for enhanced patient-centeredness with: 1) creation of teamlets (little teams) to collaborate with clinical pharmacists to address challenges with MTUD access and implement CM; 2) use of multi-target CM to reward progress in addressing TUD-related care, HIV, and TUD-related conditions plus smoking abstinence; 3) promotion of patient choice in MTUD selection and flexibility for remote versus in-person services; and 4) focus on reducing health disparities. Grounded in the socioecological model and implementation science principles, this project will include a randomized trial to compare the effectiveness of teamlet-delivered CM as an adjunct to clinical pharmacist prescribed MTUD with teamlet telephone booster over 12 weeks among 794 PWH receiving care in one of six sites. This study will develop procedures directly informed by perspectives of PWH. The primary outcome is exhaled carbon monoxide-confirmed 7-day smoking abstinence at week 12 (Aim 1). This study will explore whether the effectiveness of the interventions differ based on access to basic needs (Aim 2). Consistent with a hybrid type 2 effectiveness-implementation approach, this study will include an implementation-focused evaluation incorporating perspectives of PWH, clinical pharmacists, and other teamlet members using qualitative and quantitative data; measures of intervention delivery; and economic viability via micro-costing and cost-effectiveness analyses (Aim 3). The research team brings together expertise in HIV, pharmacy, addiction medicine, smoking cessation, CM, clinical trials, health disparities, implementation science, and health economics. Innovative features of the proposal are: 1) clinical pharmacist delivered TUD treatment with teamlets integrated in HIV clinics; and 2) collaboratively created multi-target CM program to address smoking, HIV, and TUD-related conditions. The study has potential for high impact by generating data on and associated costs of a reproducible, scalable, sustainable strategy suitable for transforming TUD treatment in HIV clinics nationally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical pharmacist-prescribed MTUD with teamlet booster | Experimental | Drug: nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion, Behavioral: Teamlet booster |
| Clinical pharmacist-prescribed MTUD + teamlet delivered CM and booster | Experimental | Drug: nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion, Behavioral: Multi-target Contingency Management, Behavioral: Teamlet booster |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropionClinical 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. | Drug | Clinical pharmacist-prescribed MTUD + teamlet delivered CM and booster, Clinical pharmacist-prescribed MTUD with teamlet booster |
| Multi-target Contingency ManagementParticipants will earn prizes for progress towards tobacco abstinence, achieving tobacco abstinence, and progress in improving HIV and other related health conditions. | Behavioural | Clinical pharmacist-prescribed MTUD + teamlet delivered CM and booster |
| Teamlet boosterParticipants will receive a booster call by a teamlet member after MTUD is prescribed to address any MTUD access issues and answer MTUD related questions. | Behavioural | Clinical pharmacist-prescribed MTUD + teamlet delivered CM and booster, Clinical pharmacist-prescribed MTUD with teamlet booster |
Primary outcome
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)
Time frame: 12 weeks
Self-reported tobacco abstinence over the past 7 days, confirmed by eCO of <6ppm
6 secondary outcomes
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)
Time frame: 24 weeks
Self-reported 7 day point prevalence smoking abstinence
Time frame: Week 18
Cigarettes per day
Time frame: Week 12
Cigarettes per day
Time frame: Week 18
Cigarettes per day
Time frame: Week 24
HIV viral load, detectable
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Tobacco Use Disorder/Cigarette Smoking
Not yet recruiting
Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation
Smoking Cessation, Cigarette Smoking
Recruiting
Quitting Matters Human Immunodeficiency Virus Hybrid Trial
Tobacco, Tobacco Abstinence
Recruiting
Trauma-Informed Care for Smoking Cessation for Pregnancy
Smoking Cessation, Tobacco Smoking
Active, not recruitingPhase 3
Optimizing Tobacco Use Treatment for PLWHA
HIV/AIDS, Nicotine Dependence
RecruitingPhase 4
Varenicline for Smoking Reduction in Veterans Not Ready To Quit
Veterans, Tobacco Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
E. Jennifer Edelman, MD, MHS principal investigator
Yale University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion, Multi-target Contingency Management and Teamlet booster in people with Tobacco Use Disorder/Cigarette Smoking and HIV, run by Yale University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact E. Jennifer Edelman, MD, MHS (203-737-7115, ejennifer.edelman@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.