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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要我们所知道的：美国有 110 万艾滋病毒感染者 (PLH)：至少 40% 吸烟，大多数人吸烟目前几乎没有人正在接受旨在满足其特定需求的戒烟干预措施。吸烟的 PLH 具有较高的尼古丁依赖、抑郁和孤独感。烟草使用引起的癌症是艾滋病毒感染者 (PLH) 的主要杀手，占艾滋病毒感染者 (PLH) 感染者的 61.5% 吸烟者的死亡率平均降低 12.3 年。有效且针对艾滋病毒量身定制的戒烟服务代表了第一级的健康差距。 % 的 PLH 使用互联网，并且大多数人使用自己的技术（制作基于群组的视频）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。尽管戒烟计划广泛向公众提供，但没有基于证据的计划专为 PLH 提供，但没有发现对这一人群长期有效，没有任何计划提供群体治疗；基于视频会议（视频组的 VG）；并且没有针对 PLH 的特定计划提供戒烟服务我们将做什么：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，将与注意力匹配控制条件（AMC；随机对照试验中的参与者为 N=482 名 PLH 吸烟者。佛罗里达州所有有动机在未来 30 天内戒烟的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 次疗程的强化干预（PSF-VG 或 AMC）。主要结果将是 12 个月时生化确认的 7 天点戒断率。随访，尽管 30 天点患病率和持续戒断（持续戒断后）两周宽限期后的戒烟日）也将进行评估，我们还将确定每次额外的费用。戒烟是戒烟的一项重要的成本效益指标，我们将检验模型驱动的假设。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 CD4 计数和病毒学抑制的影响：1) 该试验将是最严格的试验之一。考虑到 AMC 和 360 天的随访期，迄今为止 PLH 中的戒烟率 2) 建立长期戒烟。 VG 戒烟计划对 PLH 的长期疗效，达到 PLH“所在位置”，将代表在 PLH 中打击烟草使用方面取得了巨大进步，并让人们更清楚地了解了烟草使用的作用在全面的艾滋病毒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。计划对于制定现实世界的实施决策至关重要 4) 建立效果中介将有所帮助。确定 PSF-VG 在多大程度上按预期发挥作用，并帮助建立 HIV 吸烟的机制科学 5) 检查 CD4 和病毒载量的变化将增加我们对吸烟的了解。戒烟对 PLH 的健康有益，因此，这项研究可能会对该领域产生重大影响。