Erin L. Sutfin, Ph.D. - US grants

DESCRIPTION (provided by applicant): The United States Public Health Services (PHS) provides clinicians and healthcare systems with evidence- based practices for tobacco control and treatment through widely disseminated guidelines ("PHS Guidelines"). Interventions as brief as three minutes can significantly increase quit rates among adult daily smokers. Despite an estimated three million college student smokers in the U.S., the majority of who have made at least one quit attempt, little research exists on college students and smoking cessation. Although the PHS Guidelines have been widely disseminated and are intended to be implemented in a variety of clinical settings, student health clinics do not appear to have fully adopted these strategies. Student health clinics provide care to a large number of students, making them an ideal setting to encourage tobacco cessation in this population. This proposal seeks to provide formative data testing the implementation of evidence-based tobacco cessation strategies in student health clinics on college campuses in North Carolina. Specific aims are to: (1) Increase student health centers'organizational adoption and implementation of the PHS Guidelines through system- level changes;and (2) Increase college student health care providers'adoption and implementation of the PHS Guidelines to promote tobacco cessation behaviors among college student tobacco users. A Secondary Aim is to preliminarily assess the efficacy of implementing the PHS Guidelines in student health centers on students'readiness to quit to estimate sample sizes for a future larger efficacy trial. Using a clinic-level randomized design, the intervention targets both organizations providing healthcare and clinicians within those organizations through system-level changes and increased provider training. The intervention will be evaluated using key informant interviews, environmental scans, provider surveys, and patient exit surveys. The proposed pilot study will mark the first time implementation of the PHS Guidelines has been tested in a college student health center setting. Results will be used to: (1) estimate effect sizes for a future trial that will test both implementation and efficacy in a larger sample;and (2) inform implementation of this intervention in other clinical settings, including community colleges. The proposed research study responds to an unmet need for the successful implementation of evidence-based tobacco cessation strategies for college students. The overall intent of this research is to ultimately close the gap between research discovery and program delivery in the area of tobacco control. PUBLIC HEALTH RELEVANCE: Despite an estimated three million college student smokers in the U.S., little is known about college students and smoking cessation. The United States Public Health Services has widely disseminated guidelines for tobacco treatment which are intended to be implemented in a variety of clinical settings;however, student health clinics do not appear to have fully adopted these strategies. The goal of the proposed research is to test the implementation of evidence-based tobacco cessation strategies in student health clinics on college campuses.

? DESCRIPTION (provided by applicant): Emerging adulthood is a discrete developmental period, spanning the ages of 18-25. This period is distinct demographically, psychologically, and subjectively from other developmental periods. Many individual-level changes experienced during emerging adulthood can be attributed to social role transitions in educational, occupational, social, and family structure domains. Social role changes are in turn associated with changes in environments. These major changes in social roles and environments are thought to influence the trajectories of substance use. Emerging adulthood is a period of tobacco use experimentation and transition to regular use and dependence. College students make up a large proportion of emerging adults and have high rates of tobacco use, especially novel products, such as hookahs and cigarillos. Moreover, college students are targeted by the tobacco industry, making them a particularly vulnerable group. Upon graduation, these emerging adults experience significant social role and environmental changes, which may be associated with changes in tobacco use. However, few studies have evaluated the longitudinal trajectories of use of these products during the post-college period, and those few were focused exclusively on cigarettes. As a result, significant knowledge gaps exist in our understanding of (a) longitudinal patterns of tobacco use - given the diversity of products available, which hampers the development of effective interventions; and (b) how social role transitions and environmental context impact tobacco use during this important developmental period. The proposed study aims to fill these gaps. This renewal application builds on our previous research on tobacco use trajectories among college students by proposing to continue to follow a large cohort of 3,146 participants recruited from 11 colleges in North Carolina and Virginia. Using a prospective longitudinal design, participants were recruited during their first semester (fall 2010, and followed through fall 2014, one semester post-college (for most). By wave 6 (fall senior year), 75% had used at least one tobacco product in their lifetime, and 36% were current users, with 18% currently using more than one product. Given the changing market and emerging need for new public health approaches, this work remains critical to continue. In this application, we propose to follow the cohort for 4 additional years, surveying them every 6 months, and ultimately spanning a total of 8 years. Thus, the aims of the proposed study are to: (1) prospectively assess trajectories of tobacco use, including experimentation, progression to regular use, product switching, poly-tobacco use, and cessation during the post-college period; and (2) assess how prior tobacco use, social role transitions, and changes in environmental contexts relate to tobacco use patterns during the post-college period. The multidisciplinary team, led by a highly qualified Early Stage Investigator, has unique skills and expertise. The ultimate goal of this research is to identify those most at risk for nicotine dependence, by pinpointing social role transitions and environments associated with increased tobacco use, allowing for the development of effective interventions.

Project Summary Waterpipe tobacco (WT) smoking in the U.S. is common among young adults, with approximately 5.5 million current users. WT smoking is associated with many of the same health risks as cigarette smoking, but consumers often erroneously believe WT smoking is less harmful and less addictive than cigarette smoking. Marketing, including package design and digital marketing (websites and social media), is an effective tool used by the tobacco industry to communicate product health information to consumers. The Food and Drug Administration (FDA) has begun to prohibit certain claims on WT packaging and in marketing. Under Section 911 of the Family Smoking Prevention and Tobacco Control Act, manufacturers and retailers are prohibited from making unauthorized modified risk tobacco product (MRTP) claims, including statements that the product or its smoke: (1) results in reduced harm; (2) contains a reduced level of or presents a reduced exposure to a substance; (3) does not contain or is free of a substance; and (4) statements that use modified risk descriptors such as light, mild, low, or similar descriptors. In addition, manufacturers and retailers are also prohibited from making false and misleading claims on packaging and in marketing under Section 903. Some prohibited claims are easily identifiable, but others are more difficult to identify due to lack of specificity in the law and the implicit nature of some claims. Evidence is needed, specific to WT packaging and marketing, to identify claims and determine their influence on consumer harm misperceptions to inform future regulatory actions. The proposed study will address this gap by documenting claims on WT packaging and in digital marketing (websites and social media) and how such claims influence consumer perceptions and willingness to try WT. In Aim 1, we will identify WT product packaging and digital marketing through a comprehensive website review to identify manufacturers (who make WT) and retailers (who sell WT for onsite use, such as cafés and lounges). We will create a sampling frame of WT brands and flavors and will randomly select five flavors from 30 brand to purchase packaging. For digital marketing, we will use the same 30 brands of WT manufacturers and a random sample of 30 retailers with websites and social media accounts. We will capture all website content and 20 of the most recent posts from Facebook and Instagram, the two most popular social media platforms among young adults. In Aim 2, we will content analyze all of the packaging and digital marketing captured in Aim 1. We will then use an expert panel to determine whether claims found on packaging and in digital marketing are examples of prohibited claims. In Aim 3, we will conduct a randomized, online experiment with a nationally-representative sample of young adults to evaluate the impact of prohibited claims present on WT packaging and in digital media on young adults' willingness to try the product, perceptions of harm, and product appeal. The findings will help the FDA determine which claims consumers interpret in ways that the law prohibits; which could prompt the FDA to engage in additional rulemaking so consumers are not misled.

Project Summary Young adults have the highest prevalence of waterpipe tobacco smoking (WTS) of any age group in the U.S. Extensive evidence shows that they consistently misperceive WTS as less harmful and less addictive than cigarette smoking, and these misperceptions are positively associated with WTS. Despite these widely held misperceptions, WTS is associated with serious acute and chronic harms, even among infrequent users. In addition, WTS is prospectively associated with cigarette smoking initiation putting young adults at greater risk for cancer. Considerable evidence shows that cigarette warnings effectively convey health information to consumers, resulting in increased motivation to quit and quit attempts. Waterpipe warnings have the potential to convey accurate information about health harms to consumers, but the currently-mandated text warning, focused solely on nicotine addiction, is likely to have limited impact. The goal of this project is to develop warnings to promote greater understanding of harms and to reduce WTS behavior among young adults. We will use a systematic, evidence-driven, rigorous approach to develop waterpipe warnings and test these newly- developed warnings in two contexts: (1) on waterpipe tobacco packaging; and (2) in an ecologically-valid waterpipe café setting. In Aim 1, we will develop text and pictorial waterpipe tobacco warnings to effectively communicate a broad range of health harms. We will first develop 30 text warnings based on the most robust science; then vet warnings with experts in WTS epidemiology, toxicity, and regulation. We will next conduct a national survey to determine the five most effective text warnings, which will then each be paired with three different images creating 15 pictorial warnings. We will conduct a second national survey to determine the most promising image for each of the five text warning statements, resulting in five text and five corresponding pictorial warnings to be carried forward to Aim 2. In Aim 2, we will evaluate the effect of text or pictorial warnings on waterpipe tobacco packaging on WTS intentions using a nationally representative sample of 1,500 young adults and will determine the two text and two corresponding pictorial warnings with the highest perceived effectiveness for use in Aim 3. In Aim 3, we will determine the impact of text and pictorial warnings displayed at waterpipe cafés on WTS behavior. We will conduct a three-arm (text, pictorial, no warning control) cluster randomized crossover trial in 18 waterpipe cafés to determine the effect of warning type on young adults' WTS behavior using an objective, biological marker of waterpipe tobacco consumption (expired carbon monoxide). This study will contribute to a growing body of research on how best to design health warnings to discourage WTS, and will identify important behavioral antecedents, which may include negative affect, cognitive elaboration, perceived risks, and knowledge. The proposed research has the potential to make a significant contribution towards cancer prevention by reducing WTS through the development and testing of warnings that could influence local, state, and federal policies.