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

 描述（由申请人提供）：美国有110万艾滋病毒感染者（PLWH）：60%吸烟，75%有兴趣戒烟。三分之二的艾滋病毒携带者使用互联网，使其成为提供戒烟治疗的一个有希望的途径。目前，几乎没有人能够获得旨在满足其具体需求和关切的戒烟干预措施。吸烟是导致艾滋病毒感染者死亡的24%-61%，以及30%的非艾滋病定义的恶性肿瘤的原因。它正在推动这一高度脆弱人群中肺癌的惊人增长。无法获得经证实的、有效的、文化上适当的戒烟服务是一种最严重的健康差距。 戒烟网站为吸烟者提供方便，低（或无）成本和匿名性;然而，没有公开的基于网络的戒烟计划专门为PLWH吸烟者设计。携带艾滋病毒的吸烟者有很高的尼古丁依赖率，焦虑，抑郁，孤独和物质使用。我们开发了积极无烟网络（PSFW），一个理论驱动的，文化定制的基于网络的计划，旨在解决PLWH吸烟者的具体需求。我们的NCI-Funded R21试点PSFW表现出中高水平的依从性，与标准治疗相比，3个月的禁欲率更高（10% vs. 4%）。我们之前对基于网络的戒烟干预的研究表明，参与在线社区的吸烟者-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之后，也有两倍多的可能性实现戒烟。在准备拟议的研究中，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（现在的“PSFW+”），为PLWH吸烟者种子用户开发培训协议（以提供社交网络参与者的临界质量），并招募和培训11名PLWH吸烟者担任此角色，增强和现代化PSFW。原型PSFW+应用程序已经成功地进行了alpha和beta测试，以期待随机对照试验。 我们提出了一项研究，将比较PSFW+戒烟网站的有效性，以促进心血管健康的注意力匹配网站在一项随机对照试验中，在基线，1，3和6个月重复测量。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治疗。据推测 PSFW+在随机化后6个月时7天时点戒烟率的主要结局方面优于对照条件。次要目的和探索性分析将检查关于治疗结果的中介和调节因素的理论驱动假设（例如，抑郁、焦虑、社会支持、孤独、自我效能）。建立一个基于网络的戒烟计划的有效性，具有广泛的影响力，并可以扩展到整个美国的吸烟者，不仅代表着在打击吸烟的PLWH的巨大进步，但也将提供一个更清晰的了解有针对性的，基于网络的健康干预措施在全面的艾滋病毒护理的作用。

 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.