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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：E. Jennifer Edelman, MD, MHS
- 电话号码：203-737-7115
- 邮箱：ejennifer.edelman@yale.edu
研究联系人备份
- 姓名：June-Marie Weiss, MA, MEd
- 电话号码：203-737-3347
- 邮箱：junemarie.weiss@yale.edu
学习地点
-
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Connecticut
-
Bridgeport、Connecticut、美国、06610
- Bridgeport Hospital Primary Care Center Infectious Disease Clinic
-
接触：
- Manisha Gupta, MD
- 电话号码：(203) 384-3079
- 邮箱：Manisha.Gupta@bpthosp.org
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New Haven、Connecticut、美国、06511
- Yale Center for Infectious Diseases
-
接触：
- Erika Payne, PharmD
- 电话号码：(203) 200-6899
- 邮箱：erika.payne@ynhh.org
-
-
New Jersey
-
Jersey City、New Jersey、美国、07305
- Center for Comprehensive Care at Jersey City Medical Center
-
接触：
- Nina Cooperman, PhD
- 电话号码：(201) 395-7600
- 邮箱：cooperna@rwjms.rutgers.edu
-
Paterson、New Jersey、美国、07503
- Center for Comprehensive Care at St. Joseph's Health
-
接触：
- Nina Cooperman, PhD
- 电话号码：(973) 754-4701
- 邮箱：cooperna@rwjms.rutgers.edu
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-
New York
-
Brooklyn、New York、美国、11203
- Special Treatment And Research (STAR) at SUNY Downstate
-
接触：
- Jessica Yager, MD
- 电话号码：(718) 270-3745
- 邮箱：jessica.yager@downstate.edu
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
|
实验性的：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)
大体时间：12 weeks
|
Self-reported tobacco abstinence over the past 7 days, confirmed by eCO of <6ppm |
12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)
大体时间：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
大体时间：Week 18
|
Week 18
|
|
|
Cigarettes per day
大体时间：Week 12
|
Self-reported reduction in mean number of cigarettes per day |
Week 12
|
|
Cigarettes per day
大体时间：Week 18
|
Self-reported reduction in mean number of cigarettes per day |
Week 18
|
|
Cigarettes per day
大体时间：Week 24
|
Self-reported reduction in mean number of cigarettes per day |
Week 24
|
|
HIV viral load, detectable
大体时间：Week 24
|
HIV viral load greater than 50 copies per milliliter of blood and detectable on standard lab test |
Week 24
|
合作者和调查者
调查人员
- 首席研究员：E. Jennifer Edelman, MD, MHS、Yale University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2000043556
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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.
IPD 共享时间框架
All de-identified data will be made available after completion of the project and publication of related work and will remain available indefinitely.
IPD 共享访问标准
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.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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