A SMARTTT approach to Treating Tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study.
A SMARTTT approach to Treating Tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study.
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DOI：
10.1016/j.cct.2021.106379
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发表时间：
2021-11
影响因子：
2.2
通讯作者：
Bernstein SL
中科院分区：
文献类型：
--
作者：
Edelman EJ;Dziura J;Deng Y;Bold KW;Murphy SM;Porter E;Sigel KM;Yager JE;Ledgerwood DM;Bernstein SL
烟草使用障碍是对接受抗逆转录病毒治疗的艾滋病毒感染者健康的主要威胁，确定促进戒烟的最佳治疗方法至关重要。我们描述了一项新研究的基本原理、目的和设计，该研究是一项序贯多分配随机试验，名为“治疗艾滋病毒感染者烟草使用障碍的SMART方法（SMARTTT）”。在美国东北部三个卫生系统的HIV诊所中，患有烟草使用障碍的PWH被随机分配到尼古丁替代疗法（NRT），有或没有应急管理（NRT与NRT+CM）。有反应的参与者（定义为在第12周时呼出的一氧化碳（eCO）确认戒烟）继续相同的治疗12周。无反应的参与者被重新随机化，将药物从NRT转换为伐尼克兰或强化治疗至更高的CM奖励计划。干预措施由艾滋病毒诊所的临床药剂师提供。主要结局是eCO证实的戒烟;次要结局包括CD 4细胞计数、HIV病毒载量抑制和退伍军人老龄化队列研究（VACS）指数2.0评分（基于实验室数据的发病率和死亡率的有效测量）。与混合型1有效性-实施设计相一致，并以实施科学框架为基础，我们将并行进行以实施为中心的过程评估。已就COVID-19疫情作出相关研究方案调整。SMARTTT预计将产生新的结果的影响，成本和实施的适应性临床药师提供的干预，涉及药物和CM，以促进PWH戒烟。 NCT04490057
Tobacco use disorder is a leading threat to the health of persons with HIV (PWH) on antiretroviral treatment and identifying optimal treatment approaches to promote abstinence is critical. We describe the rationale, aims, and design for a new study, “A SMART Approach to Treating Tobacco Use Disorder in Persons with HIV (SMARTTT),” a sequential multiple assignment randomized trial. In HIV clinics within three health systems in the northeastern United States, PWH with tobacco use disorder are randomized to nicotine replacement therapy (NRT) with or without contingency management (NRT vs. NRT+CM). Participants with response (defined as exhaled carbon monoxide (eCO)-confirmed smoking abstinence at week 12), continue the same treatment for another 12 weeks. Participants with non-response, are re-randomized to either switch medications from NRT to varenicline or intensify treatment to a higher CM reward schedule. Interventions are delivered by clinical pharmacists embedded in HIV clinics. The primary outcome is eCO-confirmed smoking abstinence; secondary outcomes include CD4 cell count, HIV viral load suppression, and the Veterans Aging Cohort Study (VACS) Index 2.0 score (a validated measure of morbidity and mortality based on laboratory data). Consistent with a hybrid type 1 effectiveness-implementation design and grounded in implementation science frameworks, we will conduct an implementation-focused process evaluation in parallel. Study protocol adaptations related to the COVID-19 pandemic have been made. SMARTTT is expected to generate novel findings regarding the impact, cost, and implementation of an adaptive clinical pharmacist-delivered intervention involving medications and CM to promote smoking abstinence among PWH. NCT04490057
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影响因子：
2.8
作者：
Edelman EJ;Gordon KS;Glover J;McNicholl IR;Fiellin DA;Justice AC
通讯作者：
Justice AC
影响因子：
2.2
作者：
Edelman, E. Jennifer;Maisto, Stephen A.;Fiellin, David A.
通讯作者：
Fiellin, David A.
影响因子：
4.4
作者：
Cyders, Melissa A.;Littlefield, Andrew K.;Coffey, Scott;Karyadi, Kenny A.
通讯作者：
Karyadi, Kenny A.
DOI：
10.1080/09540121.2018.1500007
发表时间：
2019-04-03
影响因子：
1.7
作者：
Bell, Stephanie K.;Mena, Gabriela;Gartner, Coral
通讯作者：
Gartner, Coral
影响因子：
3.5
作者：
Bernstein, Steven L.;Rosner, June;Toll, Benjamin
通讯作者：
Toll, Benjamin