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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 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

794

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Clinical pharmacist-prescribed MTUD with teamlet booster
Medicamento: 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.

Comportamental: 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.
Experimental: Clinical pharmacist-prescribed MTUD + teamlet delivered CM and booster
Medicamento: 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.

Comportamental: 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.

Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)
Prazo: 12 weeks

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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)
Prazo: 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
Prazo: Week 18
Week 18
Cigarettes per day
Prazo: Week 12

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

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

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

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Yale University

Colaboradores

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

30 de setembro de 2027

Conclusão Primária (Estimado)

30 de setembro de 2030

Conclusão do estudo (Estimado)

30 de setembro de 2031

Datas de inscrição no estudo

Enviado pela primeira vez

16 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de setembro de 2026

Primeira postagem (Real)

23 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2000043556

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de IPD

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

Critérios de acesso de compartilhamento 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.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF
  • ANALYTIC_CODE

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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