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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

16 septembre 2026 mis à jour par: Yale University

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

794

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • Connecticut
      • Bridgeport, Connecticut, États-Unis, 06610
        • Bridgeport Hospital Primary Care Center Infectious Disease Clinic
        • Contact:
      • New Haven, Connecticut, États-Unis, 06511
        • Yale Center for Infectious Diseases
        • Contact:
    • New Jersey
      • Jersey City, New Jersey, États-Unis, 07305
        • Center for Comprehensive Care at Jersey City Medical Center
        • Contact:
      • Paterson, New Jersey, États-Unis, 07503
        • Center for Comprehensive Care at St. Joseph's Health
        • Contact:
    • New York
      • Brooklyn, New York, États-Unis, 11203
        • Special Treatment And Research (STAR) at SUNY Downstate
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Clinical pharmacist-prescribed MTUD with teamlet booster
Médicament: nicotine patch, nicotine 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.

Comportemental: Teamlet booster

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.
Expérimental: Clinical pharmacist-prescribed MTUD + teamlet delivered CM and booster
Médicament: nicotine patch, nicotine 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.

Comportemental: Teamlet booster

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.

Comportemental: Multi-target Contingency Management

Participants will earn prizes for progress towards tobacco abstinence, achieving tobacco abstinence, and progress in improving HIV and other related health conditions.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)
Délai: 12 weeks

Self-reported tobacco abstinence over the past 7 days, confirmed by eCO of <6ppm
12 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)
Délai: 24 weeks

Self-reported tobacco abstinence over the past 7 days, confirmed by eCO <6ppm
24 weeks
Self-reported 7 day point prevalence smoking abstinence
Délai: Week 18
Week 18
Cigarettes per day
Délai: Week 12

Self-reported reduction in mean number of cigarettes per day
Week 12
Cigarettes per day
Délai: Week 18

Self-reported reduction in mean number of cigarettes per day
Week 18
Cigarettes per day
Délai: Week 24

Self-reported reduction in mean number of cigarettes per day
Week 24
HIV viral load, detectable
Délai: Week 24

HIV viral load greater than 50 copies per milliliter of blood and detectable on standard lab test
Week 24

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Yale University

Collaborateurs

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Les enquêteurs

  • Chercheur principal: E. Jennifer Edelman, MD, MHS, Yale University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

30 septembre 2027

Achèvement primaire (Estimé)

30 septembre 2030

Achèvement de l'étude (Estimé)

30 septembre 2031

Dates d'inscription aux études

Première soumission

16 septembre 2026

Première soumission répondant aux critères de contrôle qualité

16 septembre 2026

Première publication (Réel)

23 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2000043556

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage IPD

All de-identified data will be made available after completion of the project and publication of related work and will remain available indefinitely.

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • ANALYTIC_CODE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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