The Positively Quit Trial: Addressing disproportionate smoking rates among people living with HIV

积极戒烟试验：解决艾滋病毒感染者吸烟率过高的问题

• 批准号: 10245274
• 负责人: Stephanie Lynn Marhefka
• 金额: $ 58.18万
• 依托单位: UNIVERSITY OF SOUTH FLORIDA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10245274
• 关键词: AIDS/HIV problem; Abstinence; Accounting; Address; Adult; Affect; Area; Attention; Biochemical; CD4 Lymphocyte Count; Caring; Cessation Research; Chronic Obstructive Airway Disease; Control Groups; Counseling; Data; Elements; Enrollment; Ensure; Epidemic; Evidence based program; Face; Florida; Future; General Population; Geography; HIV; Health; Health Benefit; Heart Diseases; Individual; Internet; Intervention; Knowledge; Lead; Life; Life Expectancy; Light; Literature; Loneliness; Maintenance; Malignant neoplasm of lung; Measures; Mediating; Mediator of activation protein; Mental Depression; Meta-Analysis; Methodology; Modeling; Motivation; Nicotine Dependence; Online Systems; Outcome; Participant; Persons; Population; Positioning Attribute; Prevalence; Prevention; Pulmonary Emphysema; Randomized; Research; Research Personnel; Role; Science; Self Efficacy; Services; Smoke; Smoker; Smoking; Smoking Cessation Intervention; Stroke; Technology; Time; Tobacco; Tobacco Use Cessation; Tobacco use; Training; Travel; Treatment Efficacy; Treatment outcome; Underserved Population; United States National Institutes of Health; Videoconferencing; Viral Load result; Voice; anticancer research; base; cancer survival; comorbidity; control trial; cost; cost effectiveness; design; eHealth; economic evaluation; effectiveness measure; fight against; follow-up; health disparity; improved; innovation; insight; intervention effect; knowledge base; mortality; nicotine replacement; novel; pilot trial; post intervention; primary outcome; program costs; programs; prospective; recruit; response; smoking cessation; social cognitive theory; standard care; stressor; therapy design; treatment effect; treatment group; treatment strategy; virology

PROJECT SUMMARY What we know: There are 1.1 million persons living with HIV (PLH) in the US: at least 40% smoke and most want to quit. Almost none are currently accessing smoking cessation interventions designed to meet their specific needs and concerns. PLH who smoke have high rates of nicotine dependence, depression, and loneliness. Lung cancer due to tobacco use is a leading killer of people living with HIV (PLH), accounting for up to 61.5% of mortality. PLH who smoke reduce their life expectancy by 12.3 years on average. The lack of access to proven, effective, and HIV-tailored tobacco cessation services represents a health disparity of the first order. Eighty-one percent of PLH use the Internet and most do so on their own technology–making group-based video- conferencing–accessed through the Internet a promising avenue to deliver smoking cessation treatment. Although cessation programs are widely offered to the general public, there are no evidence-based programs available specifically for PLH and none found effective long-term for this population; no programs provide group- based video-conferencing (VG for video-groups); and no PLH-specific programs provide smoking cessation booster sessions. What we will do: In this rigorous trial, the efficacy of a PLH-specific cessation program (PSF- VG), guided by the Social Cognitive Theory, will be compared to an attention matched control condition (AMC; prevention with positives) in a randomized control trial. Participants will be N=482 PLH smokers recruited from Florida who are motivated to quit within the next 30 days. All participants will be offered nicotine replacement therapy and brief cessation counseling in addition to an 8-session intervention with booster sessions (PSF-VG or AMC). The primary outcome will be biochemically confirmed 7-day point prevalence abstinence at 12 months follow-up, although 30-day point prevalence abstinence and sustained abstinence (continuous abstinence post- quit day after a 2-week grace period) will be assessed, as well. We will also determine the cost per additional quit, an important cost-effectiveness measure for smoking cessation. We will examine model-driven hypotheses about the mediators of treatment outcome (e.g., knowledge, motivation to quit, self-efficacy), and explore effects on CD4 count and virologic suppression. Implications: 1) This trial will represent one of the most rigorous trials of tobacco cessation among PLH to date, given the AMC and 360-day follow-up period. 2) Establishing the long- term efficacy of a VG smoking cessation program for PLH, which reaches PLH “where they are,” will represent an enormous advance in the fight against tobacco use in PLH and provide a clearer understanding of the role of targeted, ehealth health interventions in comprehensive HIV care. 3) Determining the costs associated with this program will be critical for making real world implementation decisions. 4) Establishing effect mediators will help identify to what extent PSF-VG is working as intended and help build the mechanistic science of HIV smoking cessation. 5) Examining changes in CD4 and viral load will add to our understanding about how smoking cessation confers benefits for health in PLH. Thus, this study will likely have a high impact on the field.

项目摘要 我们所知道的：美国有110万人患有艾滋病毒（PLH）：至少40％的烟雾，大多数人 想退出。目前，几乎没有一个人正在接受旨在满足其特定的戒烟干预措施 需求和关注。吸烟的PLH具有很高的尼古丁依赖性，抑郁和孤独感。肺 烟草使用引起的癌症是艾滋病毒（PLH）患者的主要杀手，最多占61.5％ 死亡。吸烟的PLH平均将预期寿命降低了12。3年。缺乏证据的访问权限， 有效和艾滋病毒守则的烟草戒烟服务代表了第一阶的健康差异。八十一 PLH的百分比使用互联网，大多数是在他们自己的技术基于组的视频中这样做的 会议 - 通过互联网获得一条承诺的大道，以提供戒烟治疗。 尽管戒烟计划被广泛提供给公众，但没有基于证据的计划 专门用于PLH，没有人发现该人群有效的长期；没有计划提供团体 - 基于视频会议（视频组的VG）；而且没有PLH特定计划可以戒烟 助推器会议。我们将要做的事情：在这项严格的试验中，PLH特定戒烟计划的效率（PSF- 在社会认知理论的指导下，VG）将与注意匹配的控制条件进行比较（AMC; 在一项随机对照试验中进行预防。参与者将是n = 482 PLH吸烟者 佛罗里达州在接下来的30天内成长为退出。所有参与者将被提供尼古丁替代品 除了进行助推器会议（PSF-VG）的8条干预外，治疗和简短停止咨询 或AMC）。主要结果将在生物化学上证实，在12个月时戒酒率为7天 随访，尽管30天的普遍性戒酒和持续的禁欲（在 同样将评估为期2周的宽限期之后的一天）。我们还将确定每额外的成本 退出，这是一种重要的成本效益措施，用于戒烟。我们将检查模型驱动的假设 关于治疗结果的介体（例如，知识，戒烟的动机，自我效应）和探索效果 关于CD4计数和病毒学抑制。含义：1）该试验将代表最严格的试验之一 考虑到AMC和360天的随访期，迄今为止，PLH戒烟的戒烟。 2）建立长期 PLH的VG戒烟计划的期限效率，该计划达到PLH的“位置”将代表 在PLH中与烟草使用的斗争中的巨大进步，并更清楚地了解 针对全面的艾滋病毒护理中的eHealth健康干预措施。 3）确定与此相关的成本 计划对于做出现实世界实施决策至关重要。 4）建立效果调解员将有助于 确定PSF-VG在多大程度上按预期工作，并有助于建立艾滋病毒吸烟的机械科学 停止。 5）检查CD4和病毒负荷的变化将增加我们对吸烟的理解 停止在PLH中承认对健康的益处。这是这项研究可能会对该领域产生很大的影响。