Appalachian Tobacco Regulatory Science Team (AppalTRuST)

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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.