A Phase 4 interventional study of nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion and Multi-target Contingency Management in Tobacco Use Disorder/Cigarette Smoking and HIV, sponsored by Yale University. Not yet recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Yale University · Phase 4, Interventional, and Treatment
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.
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.
1,027 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's planned enrollment of 794 is above the median of 90 across 892 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion · Behavioral: Teamlet booster
Drug: nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion · Behavioral: Multi-target Contingency Management · Behavioral: Teamlet booster
Drug pages: Nicotine Patch · Nicotine Chewing Gum · Nicotine Lozenge · Varenicline · Bupropion
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.
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
Time frame: 12 weeks
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)
Self-reported tobacco abstinence over the past 7 days, confirmed by eCO \<6ppm
Time frame: 24 weeks
Self-reported 7 day point prevalence smoking abstinence
Time frame: Week 18
Cigarettes per day
Self-reported reduction in mean number of cigarettes per day
Time frame: Week 12
Cigarettes per day
Self-reported reduction in mean number of cigarettes per day
Time frame: Week 18
Cigarettes per day
Self-reported reduction in mean number of cigarettes per day
Time frame: Week 24
HIV viral load, detectable
HIV viral load greater than 50 copies per milliliter of blood and detectable on standard lab test
Time frame: Week 24
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.
Data sharing details ↗ · www.icpsr.umich.edu
No publications or documents are linked to this record.
Start is estimated for Sep 2027; primary completion for Sep 2030, 36 months later.
Of 38 non-industry phase 4 interventional studies under Tobacco Use Disorder, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 55. This study's planned 36 months is below that.
Counting every sponsor, half of 38 studies reached it within 41 months; a quarter within 30 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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