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.