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

项目总结 我们所知：美国有110万艾滋病毒携带者：至少40%吸烟，大多数 想不干了。几乎没有人目前正在接受戒烟干预，旨在满足他们的特定需求 需求和担忧。吸烟的PLH患者有很高的尼古丁依赖、抑郁和孤独感。肺 吸烟引起的癌症是艾滋病毒携带者(PLH)的头号杀手，占到 死亡率。吸烟的PLH患者的预期寿命平均减少12.3岁。无法获得已证实的、 有效的、为艾滋病毒量身定制的戒烟服务是一种首要的健康差距。八十一 %的PLH使用互联网，大多数人使用自己的技术-制作基于小组的视频- 会议-通过互联网访问，是提供戒烟治疗的一个有前途的途径。 尽管戒烟计划被广泛提供给普通公众，但还没有基于证据的计划 专门为PLH提供，没有发现对这一人群有效的长期；没有计划提供群体- 基于视频会议(用于视频组的VG)；没有专门针对PLH的戒烟程序 助推器会议。我们将做的是：在这项严格的试验中，针对PLH的戒烟计划(PSF- VG)，在社会认知理论的指导下，将其与注意匹配控制条件(AMC； 用阳性药物预防)随机对照试验。参与者将从以下地点招募N=482名公共卫生部门吸烟者 佛罗里达州有动力在接下来的30天内辞职。所有参与者都将获得尼古丁替代品 在8次强化干预(PSF-VG)的基础上进行治疗和短暂的戒烟咨询 或AMC)。主要结果将是生化证实的在12个月时7天的时点戒酒 随访，虽然30天点戒毒盛行率和持续戒断(持续戒断后- 在两周宽限期后的第二天辞职)也将被评估。我们还将确定每个额外的成本 戒烟，戒烟的一项重要的成本效益措施。我们将检验模型驱动的假说 关于治疗结果的中介因素(例如，知识、戒烟动机、自我效能)，并探索效果 关于CD_4计数和病毒学抑制。影响：1)这场审判将是最严格的审判之一 考虑到AMC和360天的随访期，到目前为止，在公共卫生部门中戒烟的风险很高。2)建立长效机制。 PLH的VG戒烟计划的长期疗效达到PLH的“他们所在的地方”将代表 在与公共卫生部门烟草使用的斗争中取得了巨大进展，并使人们更清楚地了解了 在全面的艾滋病毒护理中进行有针对性的电子健康健康干预。3)确定与此相关的成本 计划将是做出现实世界实施决策的关键。4)建立效果调解人将有所帮助 确定PSF-VG在多大程度上按预期工作，并帮助建立吸食艾滋病毒的机械科学 停止。5)检查CD4和病毒载量的变化将增加我们对吸烟的理解 戒烟对PLH患者的健康有好处。因此，这项研究很可能会对该领域产生很高的影响。

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.