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
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 4
Kontakty a umístění
Studijní kontakt
- Jméno: E. Jennifer Edelman, MD, MHS
- Telefonní číslo: 203-737-7115
- E-mail: ejennifer.edelman@yale.edu
Studijní záloha kontaktů
- Jméno: June-Marie Weiss, MA, MEd
- Telefonní číslo: 203-737-3347
- E-mail: junemarie.weiss@yale.edu
Studijní místa
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Connecticut
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Bridgeport, Connecticut, Spojené státy, 06610
- Bridgeport Hospital Primary Care Center Infectious Disease Clinic
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Kontakt:
- Manisha Gupta, MD
- Telefonní číslo: (203) 384-3079
- E-mail: Manisha.Gupta@bpthosp.org
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New Haven, Connecticut, Spojené státy, 06511
- Yale Center for Infectious Diseases
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Kontakt:
- Erika Payne, PharmD
- Telefonní číslo: (203) 200-6899
- E-mail: erika.payne@ynhh.org
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New Jersey
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Jersey City, New Jersey, Spojené státy, 07305
- Center for Comprehensive Care at Jersey City Medical Center
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Kontakt:
- Nina Cooperman, PhD
- Telefonní číslo: (201) 395-7600
- E-mail: cooperna@rwjms.rutgers.edu
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Paterson, New Jersey, Spojené státy, 07503
- Center for Comprehensive Care at St. Joseph's Health
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Kontakt:
- Nina Cooperman, PhD
- Telefonní číslo: (973) 754-4701
- E-mail: cooperna@rwjms.rutgers.edu
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New York
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Brooklyn, New York, Spojené státy, 11203
- Special Treatment And Research (STAR) at SUNY Downstate
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Kontakt:
- Jessica Yager, MD
- Telefonní číslo: (718) 270-3745
- E-mail: jessica.yager@downstate.edu
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Clinical pharmacist-prescribed MTUD with teamlet booster
|
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 receive a booster call by a teamlet member after MTUD is prescribed to address any MTUD access issues and answer MTUD related questions. |
|
Experimentální: Clinical pharmacist-prescribed MTUD + teamlet delivered CM and booster
|
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 receive a booster call by a teamlet member after MTUD is prescribed to address any MTUD access issues and answer MTUD related questions. Participants will earn prizes for progress towards tobacco abstinence, achieving tobacco abstinence, and progress in improving HIV and other related health conditions. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)
Časové okno: 12 weeks
|
Self-reported tobacco abstinence over the past 7 days, confirmed by eCO of <6ppm |
12 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)
Časové okno: 24 weeks
|
Self-reported tobacco abstinence over the past 7 days, confirmed by eCO <6ppm |
24 weeks
|
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Self-reported 7 day point prevalence smoking abstinence
Časové okno: Week 18
|
Week 18
|
|
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Cigarettes per day
Časové okno: Week 12
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Self-reported reduction in mean number of cigarettes per day |
Week 12
|
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Cigarettes per day
Časové okno: Week 18
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Self-reported reduction in mean number of cigarettes per day |
Week 18
|
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Cigarettes per day
Časové okno: Week 24
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Self-reported reduction in mean number of cigarettes per day |
Week 24
|
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HIV viral load, detectable
Časové okno: Week 24
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HIV viral load greater than 50 copies per milliliter of blood and detectable on standard lab test |
Week 24
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: E. Jennifer Edelman, MD, MHS, Yale University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Duševní poruchy
- Poruchy související s látkami
- Chemicky indukované poruchy
- Chování
- Kouření
- Kouření tabáku
- Užívání tabáku
- Porucha užívání tabáku
- Kouření cigaret
- Organické chemikálie
- Heterocyklické sloučeniny
- Heterocyklické sloučeniny, 2-prsten
- Heterocyklické sloučeniny, fúzované kroužek
- Terapeutika
- Jídlo
- Strava, jídlo a výživa
- Fyziologické jevy
- Jídlo a nápoje
- Uhlohydráty
- Polymery
- Makromolekulární látky
- Polysacharidy
- Benzazepiny
- Ketony
- Biopolymery
- Quinoxaliny
- Rostlinné dásně
- Bonbón
- Žvýkačka
- Profiofenony
- Vareniklin
- Bupropion
- Zařízení pro ukončení tabáku
- Nicotinová žvýkačka
Další identifikační čísla studie
- 2000043556
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Časový rámec sdílení IPD
All de-identified data will be made available after completion of the project and publication of related work and will remain available indefinitely.
Kritéria přístupu pro sdílení IPD
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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
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