RCT of An Internet Cessation Program Plus Online Social Network for HIV + Smokers

 描述(由申请人提供)：美国有110万艾滋病毒携带者(PLWH)：60%的人吸烟，75%的人有兴趣戒烟。三分之二的PLWH使用互联网，这使互联网成为提供戒烟治疗的一个有前途的途径。目前几乎没有人获得旨在满足他们特定需求和关切的戒烟干预措施。吸烟是PLWH中24%-61%的死亡原因，而在定义为恶性肿瘤的非艾滋病患者中，吸烟占30%。在这个高度脆弱的人群中，它正在推动肺癌发病率惊人的上升。无法获得经过验证的、有效的、符合文化的戒烟服务，这代表着第一批人的健康差距。戒烟网站为吸烟者提供方便、低(或零)成本和匿名性；然而，没有专门为PLWH吸烟者设计的公开可用的基于网络的戒烟计划。携带艾滋病毒的吸烟者尼古丁依赖、焦虑、抑郁、孤独和吸毒的比例很高。我们开发了Positive Smoke Free on the Web(PSFW)，这是一个理论驱动、文化定制的基于网络的计划，旨在满足PLWH吸烟者的特定需求。我们由NCI资助的PSFW R21试点项目显示出中-高水平的依从性，与标准护理相比，3个月的禁酒率更高(10%比4%)。我们之前对基于网络的戒烟干预措施的研究表明，参加在线社区的吸烟者--无论是被动阅读他人的帖子还是积极参与在线讨论--即使在控制了广泛的协变量后，实现戒烟的可能性也是前者的两倍以上。在准备拟议的研究时，我们在美国遗产基金会的合作伙伴通过整合在线社区平台(现为“PSFW+”)、为PLWH吸烟者种子用户开发培训方案(以提供足够数量的社交网络参与者)以及招募和培训11名PLWH吸烟者担任这一角色，对PSFW进行了增强和现代化。原型PSFW+应用程序已经成功地进行了阿尔法和贝塔测试，预计将进行随机对照试验。我们提出了一项研究，在基线、1个月、3个月和6个月重复测量的随机对照试验中，比较PSFW+戒烟网站和促进心血管健康的注意力匹配网站的有效性。参与者将是N=550名有兴趣在未来30天内戒烟的PLWH吸烟者。所有参与者都将接受尼古丁替代疗法。这是假设的 在随机化后6个月，PSFW+在7天时点戒断的主要结果上将优于对照条件。次要目标和探索性分析将检验关于治疗结果的中介和调节因素(例如，抑郁、焦虑、社会支持、孤独、自我效能)的理论驱动的假设。为PLWH建立一个基于网络的戒烟计划的有效性，该计划具有广泛的覆盖面，可以扩展到全美的PLWH吸烟者，这不仅代表着在PLWH打击烟草使用方面的巨大进步，而且还将使人们更清楚地了解有针对性的、基于网络的健康干预在全面艾滋病毒护理中的作用。

 DESCRIPTION (provided by applicant): There are 1.1 million persons living with HIV (PLWH) in the US: 60% smoke cigarettes and 75% are interested in quitting. Two-thirds of PLWH use the Internet, making this a promising avenue to deliver smoking cessation treatment. Almost none are currently accessing smoking cessation interventions designed to meet their specific needs and concerns. Cigarette smoking is responsible for 24%--61% of deaths among PLWH, and 30% of non-AIDS defining malignancies. It is driving the alarming rise in lung cancers in this highly vulnerable population. The lack of access to proven, effective, culturally appropriate tobacco cessation services represents a health disparity of the first order. Cessation websites offer smokers convenience, low (or no) cost, and anonymity; however, there are no publicly available web-based cessation programs specifically designed for PLWH smokers. Smokers living with HIV have high rates of nicotine dependence, anxiety, depression, loneliness, and substance use. We developed Positively Smoke Free on the Web (PSFW), a theory-driven, culturally tailored web-based program designed to address the specific needs of PLWH smokers. Our NCI-funded R21 pilot of PSFW demonstrated moderate-high levels of adherence and yielded higher 3-month abstinence rates compared to standard care (10% vs. 4%). Our prior research on web-based cessation interventions has shown that smokers who participate in an online community - whether passively reading posts by others or actively engaging in online discussions - are more than twice as likely to achieve abstinence even after controlling for a broad range of covariates. In preparation for the proposed study, our partners at the American Legacy Foundation have enhanced and modernized PSFW by integrating an online community platform (now "PSFW+"), developing a training protocol for PLWH smoker seed users (to provide a critical mass of social network participants), and recruiting and training 11 PLWH smokers for this role. The prototype PSFW+ application has been successfully alpha- and beta-tested in anticipation of the randomized controlled trial. We propose a study that will compare the efficacy of the PSFW+ smoking cessation website to an attention- matched website promoting cardiovascular health in a randomized controlled trial with repeated measures at baseline, 1, 3, and 6 months. Participants will be N=550 PLWH smokers interested in quitting in the next 30 days. All participants will be offered nicotine replacement therapy. It is hypothesized that PSFW+ will outperform the control condition on the primary outcome of 7-day point prevalence abstinence at 6 months post-randomization. Secondary aims and exploratory analyses will examine theory-driven hypotheses about the mediators and moderators of treatment outcome (e.g., depression, anxiety, social support, loneliness, self-efficacy). Establishing the effectiveness of a web-based smoking cessation program for PLWH that has broad reach and could be scaled to reach PLWH smokers throughout the US would not only represent an enormous advance in the fight against tobacco use in PLWH, but would also provide a clearer understanding of the role of targeted, web-based health interventions in comprehensive HIV care.