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.

摘要 阿巴拉契亚烟草监管研究小组(AppalTRuST)的总体目标是调查 联邦烟草制品药品管理中心(FDA CTP)监管政策对农村的影响 通过协作、教育和开拓，将弱势群体和未得到充分研究的群体纳入社区 监管科学研究。我们的多学科团队将出于两个目的来调查这个问题。 目标1.促进和开创农村社区的监管科学研究。我们的多学科 研究团队将跨项目1-3评估当前和潜在的监管政策，这些项目包括 在方法上连贯和相互关联，重点放在行为的规范科学领域， 市场营销和影响分析。P1-P3将利用AppalTRuST团队来解决关键的监管问题 FDA的CTP政策行动是否有益，将个人转移到危害较低的产品或 在农村社区戒烟或不戒烟，以评估结果和 乡村生活的水平。P1将衡量与传统和新型烟草使用行为相关的因素 产品，包括开始、进展、双重/复合烟草使用、产品转换和戒烟相关 随着时间的推移，不同级别的乡村行为。P2将评估FDA的法规可能如何影响使用模式 适用于不同层次的年轻人的传统和新奇产品。P3将使用随机化的 平行分组试验评估三个拟议的烟草法规的影响使用试验性 烟草市场评估监管政策对不同等级的烟草使用行为的影响。 目标2.支持和创造创新烟草管制科学的新机会，并作出贡献 通过教育和合作推动TCORS研究的国家努力。以下是 四个核心将为项目提供支持，以确保中心协调、集成和协作：(1)和 管理核心，提供高效、协作的基础设施，以增强三方之间的协同效应 计划项目和四个核心以及与更广泛的TCORS社区的协作；(2)社区 外展和参与者参与核心，使阿巴拉契亚农村和城市周边社区参与 支持我们的AppalTRuST队列；(3)生物统计和信息学核心，以构建集中、集成的数据 由统计和信息学专业知识支持的仓库，用于收集、协调和分析数据以及 为项目和核心提供统计支持；以及(4)职业提升核心，以创建 变革性环境，提供指导性、多学科和身临其境的体验，以扩展和 支持TRS学者，重点关注农村地区监管政策的影响。影响：AppalTRuST 将提供所需的科学资源，以评估引入新产品和 农村社区对调味和高尼古丁产品的潜在限制，以便监管决定 将使用健康公平的视角，并以多样化和异质性的乡村定义为指导。