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CRRTC Project Abstracts and Investigator Contacts Selected Project Contacts If you would like to discuss your proposal ideas with one of CRRTC’s investigators, contact any of the individuals listed below. Investigator Marcy Boynton Noel Brewer Role Biostatistical and Survey Methods Core Deputy Director Project 1 PI Adam Goldstein Seth Noar Project 3 PI Leah Ranney Project 3 Co-I Kurt Ribisl Erin Sutfin Overall PI for CRRTC Project 2 PI Mark Wolfson Project 2 Co-I Communication Core Co-Director Affiliation UNC-CH, Lineberger Comprehensive Cancer Center UNC-CH, Health Behavior UNC-CH, Family Medicine UNC-CH, School of Journalism and Mass Communication UNC-CH, Family Medicine UNC-CH, Health Behavior WFSM, Social Science and Health Policy WFSM, Social Science and Health Policy E-mail [email protected] [email protected] [email protected] [email protected] [email protected] [email protected] [email protected] [email protected] CRRTC Abstract Title. “Effective Communication on Tobacco Product Risk and FDA Authority” PI. Kurt M. Ribisl Abstract. We propose a Center for Regulatory Research on Tobacco Communication that uses communication science to improve messages about cigarette smoke constituents, emerging tobacco products, and FDA's regulatory authority over tobacco products. Consistent with FDA's authority and responsibility to protect public health, the Center will conduct a series of integrated research projects addressing 11 CTP priority areas to assist FDA in communicating effectively with diverse audiences. Studies will oversample vulnerable populations with high rates of smoking (Black, gay, lesbian, bisexual, low income) and adolescents and young adults who are at greatest risk for tobacco use initiation. Overall Center aims are to (1) characterize the public's awareness and beliefs about tobacco products and FDA regulatory authority through mixed methods approaches, using focus groups and multiple population-based telephone surveys of 9,200 adults and 1 adolescents in the United States, (2) create potent messages on risk and FDA authority, (3) conduct RCTs that assess messages' impact on tobacco use intentions and behaviors in real world contexts, and (4) build capacity for tobacco communication research through training programs and dissemination activities. Research Project 1 focuses on how soon-tobe-released information on tobacco smoke constituents will change perceived risk and discouragement from wanting to smoke. Research Project 2 looks at the impact of health warnings for new and emerging tobacco products not yet regulated by FDA, including ecigarettes, hookah tobacco, and cigarillos/little cigars.. Research Project 3 emphasizes increasing credibility of FDA communications regarding regulatory authority over tobacco products. The training and pilot/developmental funding programs will expand the Center's research impact by training new and established researchers as tobacco control regulatory scientists and providing funds for innovations in health and risk communication across our Center and other TCORS sites. Scientific findings will advance regulatory science and assist FDA in communicating more effectively with the public, including tobacco users and nonusers, thereby impacting public health by reducing tobacco product initiation and increasing cessation. Project Abstracts Project 1 Title. “Communicating the Risks of Harmful Cigarette Smoke Constituents” PD. Noel Brewer Abstract. The 2009 Family Smoking Prevention and Tobacco Control Act requires tobacco manufacturers to disclose the prevalence of harmful and potentially harmful constituents in each of their products by brand and sub-brand. This wealth of data will be novel and informative, but it’s likely impact on the public remains wholly unknown. The proposed project aims to understand the impact of the new constituent information on smokers’ risk beliefs and cigarette smoking, building toward a randomized controlled trial that examines whether constituent disclosures on cigarette packs that smokers use every day alter cessation behavior. The project will interview enough adolescents, Blacks, Hispanics, and gay, lesbians, and bisexuals to allow subgroup analyses for these key populations. Aim 1 will identify tobacco constituents that adults and adolescents find threatening and that discourage them from wanting to smoke. First, we will conduct 6 focus groups to qualitatively assess how adults and adolescents think about constituents. To quantify constituents’ effect on risk beliefs and discouragement from wanting to smoke, we will then conduct a population-based phone survey (n=4,600, ages 13-65), jointly with our Center’s other research projects. Aim 2 will develop a library of constituent disclosures about Aim 1 constituents that are most likely to discourage people from smoking. We will test these messages qualitatively using 14 focus groups and quantitatively through an online survey with adults and adolescents. The research team will select two especially promising messages that discourage smoking in all groups for use on cigarette packs for further experimental testing. In Aim 3, we will randomly assign 672 adult smokers to receive cigarettes with no constituent disclosure or one of the two disclosures identified in Aim 2. The study design will determine which labels most effectively increase adult smokers’ cessation behaviors (quitting, attempting to quit, or smoking fewer cigarettes), including stratified analyses for Black smokers. 2 Project 2 Title. “Effective Risk Communication on New and Emerging Tobacco Products” PD. Erin Sutfin The Family Smoking Prevention and Tobacco Control Act (FSPTCA) gave the Food and Drug Administration (FDA) broad authority to regulate cigarettes, roll-your-own tobacco and smokeless tobacco to protect public health. The FSPTCA also gave the FDA authority to assert jurisdiction over other tobacco products, which the FDA indicated it intends to do. This will include new tobacco products widely used by adolescents and young adults, including electronic cigarettes, hookah tobacco, and cigarillos/little cigars, collectively known as “other tobacco products” (OTPs). While cigarette smoking by adolescents and young adults has decreased, OTP use appears to be on the rise. Although OTPs contain harmful constituents and have negative health consequences, adolescents and young adults often underestimate the health risks of OTP use. Once the FDA asserts jurisdiction over OTPs, it will have a unique opportunity to inform the public about the health risks and constituents of OTPs. To do so, the FDA will need evidence, which is currently limited, on how to convey accurate risk perceptions to consumers. We propose to develop and test OTP warning messages, with a focus on vulnerable populations, including adolescents and young adults and gays, lesbians, and bisexuals. In Aim 1 we will identify perceived risks, knowledge of, and attitudes towards harmful constituents and health risks of each type of OTP among adolescents (age 13-17) and young adults (age 18-25) to inform the development of OTP risk messages. First, we will conduct focus groups with adolescents and young adults to explore attitudes, perceived risks, and knowledge of OTPs. Next we will conduct a population-based phone survey (n=1,600, ages 13-25) to assess OTP attitudes among a large national sample. In Aim 2 we will develop a library of OTP risk messages that increase accurate risk perceptions. We will test these messages qualitatively using a second round of focus groups and quantitatively through an online survey with 880 adolescents and young adults. Based on these studies, we will select the two most promising messages for each OTP that increase accurate risk perceptions for further testing. In Aim 3, we will establish the real-world impact of OTP risk messages (developed in Aim 2) appearing at the point-of-sale. To do so, we will conduct a cluster randomized trial at 30 convenience stores to assess OTP message impact on 3,000 adolescent and young adult patrons’ risk perceptions; attitudes, knowledge, and susceptibility among non-users; and quit intentions among users. Project 3 Title. “Enhancing Source Credibility in Tobacco Regulatory Communications” PD. Adam Goldstein Abstract. Under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), the Food and Drug Administration (FDA) has regulatory authority over tobacco product manufacture, marketing, and distribution. The FDA seeks to foster new communications research on tobacco regulation. The Center for Regulatory Research on Tobacco Communication (CRRTC) addresses communication components of the FDA’s Center for Tobacco Products (CTP) messaging by: a) determining factors that influence public perceptions of information sources (e.g., the FDA), b) exploring ways to engage tobacco 3 users, c) investigating communication issues within vulnerable populations, and d) evaluating how source message characteristics impact tobacco use. The study aims of this research are to 1) characterize perceptions of FDA tobacco regulation, 2) examine variations in message frames (i.e., source sponsor, source depiction, and source engagement) that increase source credibility (i.e., trustworthiness) of tobacco regulation messaging, and 3) assess the degree to which optimizing source credibility affects behavioral intentions. Aim 1 will characterize perceptions of the FDA regulatory authority, credibility, and tobacco control communication campaigns among adolescents, young adults and adults, and vulnerable populations (Black and gay, lesbian, and bisexual (GLB)). We will conduct seven focus groups with members of these populations in North Carolina (NC) to assess existing perceptions of the FDA. We will conduct a national, cross-sectional survey in years 2 and 4 to collect data from 3800 young adult and adult tobacco users and non-users, and 800 adolescents. The survey will collect data to monitor changes in public perceptions of the FDA, and determine which source sponsors are deemed most credible. Aim 2 will examine determinants of source credibility in FDA regulatory communication messages to create and test optimally framed messages with current smokers. We will conduct 10 focus groups with young adult, adult, Black and GLB smokers to design communication messages with high source credibility. Multiple combinations of source credibility determinants will be reduced to two optimal message frames. Using a withinsubjects experimental design and eye-tracking technology, we will interview 300 NC young adult, adult, Black and GLB smokers to determine if optimally framed messages improve message effectiveness compared to sub-optimally framed messages. Aim 3 will use a randomized controlled trial of 352 young adult and adult smokers to test the impact of optimally framed FDA cigarette constituent messages on intentions to quit. We hypothesize that FDA messages with optimal source credibility will lead to stronger behavioral intentions compared to messages with sub-optimal source credibility. 4