Appalachian Tobacco Regulatory Science Team (AppalTRuST)

阿巴拉契亚烟草监管科学团队 (AppalTRuST)

• 批准号: 10665319
• 负责人: SETH S HIMELHOCH
• 金额: $ 392.32万
• 依托单位: UNIVERSITY OF KENTUCKY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10665319
• 关键词: Address; Adult; Affect; Age; Appalachian Region; Area; Behavior; Biometry; Calibration; Cancer Center; Collaborations; Communities; Community Outreach; County; Data; Data Science; Discipline of Nursing; Disparity; Ecological momentary assessment; Education; Ensure; Environment; Epidemiology; Evaluation; Future; Goals; Heterogeneity; Individual; Informatics; Infrastructure; Kentucky; Knowledge; Link; Marketing; Measures; Medicine; Menthol; Mentors; Methodology; Nicotine; Outcome; Participant; Patient Recruitments; Pattern; Pharmaceutical Preparations; Policies; Population; Probability Samples; Public Health; Randomized; Regulation; Research; Research Institute; Research Personnel; Resources; Rural; Rural Community; Sampling; Science; Shapes; Subgroup; Time; Tobacco; Tobacco use; Traumeel S; Universities; Variant; career; cohort; college; community engaged research; cost efficient; data integration; data warehouse; design; experience; health economics; health equity; innovation; low nicotine content cigarette; multidisciplinary; novel; patient engagement; peri-urban; polytobacco use; programs; prospective; public policy on tobacco; recruit; rural area; rurality; synergism; tobacco advertising; tobacco products; tobacco regulation; tobacco regulatory science; tobacco user; young adult

ABSTRACT The overall goal of the Appalachian Tobacco Regulatory Research Team (AppalTRuST) is to investigate the impact of Federal Drug Administration Center for Tobacco Products (FDA CTP) regulatory policies in rural communities, a vulnerable and understudied population, through collaboration, education and pioneering regulatory scientific research. Our multidisciplinary team will investigate this question with two aims. Aim 1. Facilitate and pioneer regulatory science research in rural communities. Our multidisciplinary team of researchers will evaluate current and potential regulatory policies across Projects 1-3 that are methodologically coherent and interrelated with a focus on the regulatory scientific domains of Behavior, Marketing, and Impact Analysis. P1-P3 will leverage the AppalTRuST Cohort to address the critical regulatory question of whether FDA CTP policy actions will be beneficial, shifting individuals to lower harm products or quitting tobacco in rural communities, or not, in a way that assesses the association between outcomes and level of rurality. P1 will measure the factors associated with tobacco use behaviors of conventional and novel products, including initiation, progression, dual/poly tobacco use, product switching, and cessation-related behaviors across levels of rurality over time. P2 will evaluate how FDA regulations may affect patterns of use for conventional and novel products among young adults across levels of rurality. P3 will use a randomized parallel groups trial to assess the impact of three proposed tobacco regulations using an Experimental Tobacco Marketplace to estimate effects of regulatory policies on use behavior across levels of rurality. Aim 2. Support and create new opportunities for innovative tobacco regulatory science and contribute to the national efforts to advance TCORS research through education and collaboration. The following four cores will support the projects to ensure Center coordination, integration, and collaboration: (1) an Administrative Core to provide efficient, collaborative infrastructure to enhance synergies across the three program projects and four cores as well as collaboration with the wider TCORS community; (2) a Community Outreach and Participant Engagement Core to engage rural and peri-urban Appalachian communities to support our AppalTRuST Cohort; (3) a Biostatistics and Informatics Core to build a centralized, integrated data warehouse supported by statistical and informatics expertise to collect, harmonize, and analyze data and provide statistical support for projects and cores; and (4) a Career Enhancement Core to create a transformative environment offering mentored, multidisciplinary and immersive experiences to expand and support TRS scholars, with emphasis on the impact of regulatory policies in rural areas. Impact: AppalTRuST will provide the scientific resources needed to evaluate the effects of the introduction of novel products and potential restrictions on flavored and high-nicotine products in rural communities so that regulatory decisions will be made using a health equity lens and guided by a definition of rurality that is diverse and heterogeneous.

抽象的 阿巴拉契亚烟草监管研究团队（AppalTrust）的总体目标是调查 联邦药物管理局烟草产品中心（FDA CTP）在农村的监管政策的影响 通过协作，教育和开拓性的社区，一个脆弱和研究的人口 监管科学研究。我们的多学科团队将以两个目标调查这个问题。 目标1。促进农村社区的促进和开拓性的监管科学研究。我们的多学科 研究人员团队将评估1-3项目的当前和潜在监管政策 从方法上讲是连贯的，并且关注行为的监管科学领域，相互关联， 营销和影响分析。 P1-P3将利用AppalTrust队列来解决关键的监管 FDA CTP政策行动是否会有益的问题，将个人转移到降低危害产品或 在农村社区中退出烟草，以评估结果与 乡村水平。 P1将衡量与常规和新颖的烟草使用行为相关的因素 产品，包括启动，进度，双/聚烟草使用，产品切换和与戒烟有关的产品 随着时间的流逝，乡村级别的行为。 P2将评估FDA法规如何影响使用模式 对于遍布乡村的年轻人的传统和新型产品。 P3将使用随机 并行组试验，以评估使用实验的三个提议的烟草法规的影响 烟草市场估计监管政策对乡村级别的使用行为的影响。 目标2。支持并为创新的烟草监管科学创造新的机会，并贡献 通过教育和协作来推动TCORS研究的全国努力。下列 四个核心将支持这些项目，以确保中心协调，集成和协作：（1） 行政核心提供高效，协作的基础架构，以增强这三个基础结构 计划项目和四个核心以及与更广泛的TCORS社区的合作； （2）一个社区 宣传和参与者参与核心，使农村和城市周边的阿巴拉契亚社区与 支持我们的AppalTrust队列； （3）生物统计学和信息学核心，以构建集中的集成数据 由统计和信息学专业知识支持的仓库，以收集，协调和分析数据以及 为项目和核心提供统计支持； （4）创建职业增强核心 提供指导，多学科和沉浸式体验的变革性环境，以扩展和 支持TRS学者，重点是农村地区的监管政策的影响。影响：AppalTrust 将提供评估新产品引入效果所需的科学资源和 农村社区中对风味和高云蛋白产品的潜在限制，因此监管决策 将使用健康平等镜头制成，并以多种多样和异质性的乡村定义为指导。