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：在美国有110万艾滋病毒感染者（PLH）：至少40%吸烟，大多数 想退出。目前几乎没有人能够获得旨在满足其特定需求的戒烟干预措施。 需要和关注。吸烟的PLH有很高的尼古丁依赖率，抑郁和孤独。肺 吸烟导致的癌症是艾滋病毒感染者（PLH）的主要杀手，占艾滋病患者的61.5%。 mortality.吸烟的PLH平均减少12.3年的预期寿命。缺乏获得经证明， 有效的、针对艾滋病毒的戒烟服务代表着一种最严重的健康差距。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群组的视频- 通过互联网访问会议是提供戒烟治疗的一个有前途的途径。 虽然戒烟计划被广泛提供给公众，但没有循证计划 专门为PLH提供，没有发现对这一人群长期有效的方案;没有方案提供群体- 基于视频会议（视频组的VG）;没有PLH特定计划提供戒烟 强化训练我们将做什么：在这项严格的试验中，PLH特异性戒烟计划（PSF- VG）在社会认知理论的指导下，将与注意力匹配控制条件（AMC; 预防与积极的）在随机对照试验。参与者将是N=482名PLH吸烟者， 佛罗里达州的人有动机在未来30天内辞职。所有参与者都将获得尼古丁替代品 治疗和简短的戒烟咨询，以及8次强化干预（PSF-VG 或AMC）。主要结局将是12个月时经生化学证实的7天时点戒烟率 随访，虽然30天的点患病率戒烟和持续戒烟（持续戒烟后， 2周宽限期后的离职日）也将进行评估。我们还将确定每个额外的成本 戒烟，戒烟的重要成本效益措施。我们将检验模型驱动的假设 关于治疗结果的介质（例如，知识，戒烟动机，自我效能），并探索效果 CD 4计数和病毒抑制影响：1）这项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中的戒烟率为40%。2)建立长期- VG戒烟计划对PLH的长期有效性，达到PLH“他们所在的地方”，将代表 在反对吸烟的斗争中取得了巨大的进步，并提供了一个更清晰的了解， 在艾滋病毒综合护理中采取有针对性的电子卫生保健干预措施。3)确定与此相关的成本 该计划将是至关重要的，使真实的世界的实施决定。4)建立效果调解人将有助于 确定PSF-VG在多大程度上按预期发挥作用，并帮助建立艾滋病毒吸烟的机制科学 停止5)检查CD 4和病毒载量的变化将增加我们对吸烟 戒烟有益于艾滋病毒携带者的健康。因此，这项研究可能会对该领域产生重大影响。