Development, Implementation, and Evaluation of a Smoking Cessation Intervention Tailored to Rural Young Adult African American Men: Toward Scalability

摘要 尽管每天吸烟较少，但非洲裔美国人（AA）男性遭受的痛苦更大。 与烟草相关疾病相关的发病率和死亡率高于白人。我们 初步数据显示，39.9%的19至30岁的AA男性， 居住在亚拉巴马农村的人吸烟。虽然已经确定， 药物治疗和以咨询为导向的咨询和/或认知的组合 行为干预在促进戒烟方面是有效的， 这些基于证据的烟草依赖治疗方法尚未证明 有效/有效（或甚至可获得） 与烟草有关的发病率和死亡率。这个项目的总体目标是 可行性研究是为了适应这些基于证据的方法， 开发，实施，并检查的可行性和可扩展性的理论为基础， 对农村AA男性青年的文化相关戒烟干预 亚拉巴马人抽烟。我们的形成性评估指出- 由经过培训的社区卫生工作者提供的行为干预， 从一个“专家”医生谁可以提供药理成分通过Skype 通过一个综合的方法。拟议的研究将涉及以下三个步骤： 这一过程：制定干预措施、预测试和可行性。一是 根据社区咨询委员会的意见制定干预措施， 一个反复的过程，通过这个过程，目标受众将接触到材料， 提供反馈的消息（预测试）。一旦所有干预措施都 最后，我们将招募参与者，随机分配他们进行干预/控制， 分组，试点测试，并评估干预措施。对照组将是 亚拉巴马烟草戒烟线与8周的尼古丁替代疗法将成为 与提出的干预药理学方法一致。主 结果将是7天时点戒烟率（定义为过去没有吸烟 7天，并通过测量呼出的一氧化碳水平进行验证） 月随访。我们还将进行详细的治疗保真度和可扩展性 评估（可接受性、可行性、潜在范围和采用情况、 战略背景），为全面的疗效试验提供信息。

Abstract Despite smoking fewer cigarettes daily, African American (AA) men suffer higher morbidity and mortality associated with tobacco-related disorders than whites. Our preliminary data shows that 39.9% of AA men between 19 and 30 years of age who resided in rural Alabama smoke cigarettes. Although it has been well established that a combination of pharmacotherapy and advice-oriented counseling and/or cognitive behavioral interventions are efficacious in promoting smoking cessation across diverse populations, these evidence-based treatments for tobacco dependence have not proven to be effective/efficacious (or even accessible) among some subpopulations suffering disproportionally from tobacco-related morbidity and mortality. The overall goal of this feasibility study is to make adaptations to these evidence-based approaches, and develop, implement, and examine the feasibility and scalability of a theory-based, culturally relevant smoking cessation intervention for young adult AA men in rural Alabama who smoke cigarettes. Our formative assessments point to a cognitive- behavioral intervention delivered by a trained Community Health Worker with the support from an “expert” physician who can deliver the pharmacological component via Skype through an integrated approach. The proposed study will address the next three steps in this process: development of the intervention, pretesting, and feasibility. First, we will develop the intervention with input from a Community Advisory Committee, followed by an iterative process by which the target audience will be exposed to materials and messages to provide feedback (pretesting). Once all intervention components are finalized, we will recruit participants, randomly assign them to intervention/control groups, pilot test, and evaluate the intervention. The comparison group will be the Alabama Tobacco Quitline with 8 weeks of Nicotine Replacement Therapy to be consistent with the pharmacological approach proposed for the intervention. The primary outcome will be 7-day point prevalence abstinence (defined as no cigarettes in the past 7 days and verified through measurement of exhaled carbon monoxide levels) at 6- month follow-up. We will also conduct detailed treatment fidelity and scalability assessments (acceptability, feasibility, potential reach and adoption, alignment with the strategic context) to inform a full-scale efficacy trial.