2017 — 2019 |
Brewer, Noel Todd Gilkey, Melissa B (co-PI) [⬀] |
U01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
Impact of Afix and Physician-to-Physician Engagement On Hpv Vaccination in Primary Care: An Rct @ Univ of North Carolina Chapel Hill
PROJECT SUMMARY/ABSTRACT Widespread HPV vaccination could greatly reduce the burden of HPV-attributable cancers, but few U.S. adolescents receive HPV vaccine according to the recommended schedule. To address this problem, public health leaders have prioritized the goal of improving primary care providers? prescribing practices and vaccine delivery systems. An important resource in this effort is the CDC?s AFIX (Assessment, Feedback, Incentives, and eXchange) program. Implemented by state and regional health departments nationwide, AFIX offers an evidence-based approach to engaging providers in immunization quality improvement. However, little is known about how to most effectively capitalize on our national AFIX infrastructure to increase HPV vaccination. To address this gap, the proposed study seeks to evaluate three approaches for improving HPV vaccination in primary care. In the first approach, we will partner with 3 state health departments to harmonize their routine adolescent AFIX programs with CDC recommendations. In the second, we will train physician educators to deliver outreach and education to primary care physicians, remotely via webinar. In the third, we will combine these approaches into a multi-level intervention. To evaluate these approaches, we will conduct a 4-arm RCT, randomizing 120 clinics in each of 3 partner states (or 360 total) to receive: AFIX delivered by the state?s health department (AFIX); physician-to-physician engagement delivered remotely by a physician educator (P2P); both AFIX and P2P engagement (AFIX+P2P); or neither intervention (control). The overall goal of this trial is to compare the effectiveness and efficiency of the AFIX, P2P, and AFIX+P2P approaches. To evaluate effectiveness (Aim 1), we will assess a range of vaccination outcomes, including vaccination coverage changes for HPV vaccine initiation (?1 dose), between baseline and 12-month follow-up, for adolescents ages 11-12. We hypothesize that AFIX and P2P, whether delivered alone or in combination, will increase coverage compared to the control, but that coverage changes will be largest for clinics receiving AFIX+P2P. To assess efficiency (Aim 2), we will conduct a mixed-methods process evaluation, including a cost analysis, to assess factors including reach, delivery cost, and best practice adoption. We anticipate that the multi-level AFIX+P2P approach will reach fewer clinics and cost more per clinic to deliver, but will also result in greater adoption of best practices and lower cost per vaccine dose. To further explore efficiency (Aim 3), we will evaluate the impact of delivering AFIX and P2P ?booster? visits at 12- month follow-up. We hypothesize that booster visits will further improve HPV vaccination coverage. The proposed trial builds on the work of a long-standing and productive team of collaborators to create highly scalable solutions to the problem of HPV vaccine underuse. By establishing how and for whom AFIX and P2P are effective, this study seeks to increase options available to public health leaders for mobilizing resources to ensure that our nation?s youth are protected from HPV-attributable cancers.
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0.988 |
2020 — 2021 |
Brewer, Noel Todd |
R01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
Informing Ends Policies: Studying the Impact of E-Cigarette Warnings On Behavior @ Univ of North Carolina Chapel Hill
ABSTRACT The US now requires e-cigarette packaging and advertising to have a single warning about nicotine addiction. FDA has the authority to require additional e-cigarette warnings and has stated that a single e-cigarette warning could ?grow stale over time.? No data are available on whether the current or other e-cigarette warnings affect vaping or undermine the motivation to quit smoking combustible cigarettes. Furthermore, little data are available on how and for whom e-cigarette warnings work, including among vulnerable populations. Ideally, e-cigarette warnings would discourage vaping initiation among non-users, reduce vaping among e- cigarette-only users, and support dual-users eventually quitting use of tobacco products. We propose to study the impact of the current e-cigarette warning and inform development of appropriate new warnings. In Aim 1, we will develop new e-cigarette warnings using data from 3 large surveys. We aim to create warnings that e-cigarette users endorse as being effective and that do not cause unintended consequences among adolescents, young adults, and adults, especially dual users. This evaluation will include the current US e-cigarette warning statement about nicotine addiction. The main product of Aim 1 will be the selection of warnings for use in the Aim 2 RCT. In Aim 2, we will evaluate the impact of e-cigarette warnings on vaping in an RCT. Young adult and adult e-cigarette users will receive 4 new warnings affixed to their e-cigarette devices and refills during the 4-week study, allocated in a random order. We will assess whether the e-cigarette warnings increase e-cigarette quit attempts and examine whether the warnings impact varies for dual users, vulnerable populations (young adult; low-income; and gay, lesbian, and bisexual [GLB] e- cigarette users). We will also examine whether the warnings increase Tobacco Warnings Model (TWM) antecedents to quitting in the context of e-cigarettes. The main product of Aim 2 will be an estimate of the impact of e-cigarette warnings on vaping, and an understanding of which TWM antecedents to behavior explain the impact. Finally, in Aim 3, we will examine whether e-cigarette warnings push e-cigarette users toward smoking. We will examine the impact of e-cigarette warnings on motivation to not smoke (defined as cigarette quit intentions among dual users, and susceptibility to smoke among e-cigarette only users), smoking behavior and inaccurate risk perceptions. We will examine if warnings' impact varies for vulnerable groups and warning size. The final product of Aim 3 will be an estimate of the impact of warnings on unintended consequences, including pushing people toward smoking. Across the three aims, we will develop generalizable principles on how to maximize the impact of e-cigarette warnings without pushing dual users toward smoking. Our findings will create an evidence base that can inform development of effective e-cigarette warnings, warnings and advertising policy in the US and globally, and other nicotine addiction and cancer prevention communication and countermarketing campaigns.
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0.988 |
2020 — 2021 |
Brewer, Noel Todd |
R01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
Understanding Uncontrolled Vaping Among Vulnerable Populations @ Univ of North Carolina Chapel Hill
PROJECT ABSTRACT Use of e-cigarettes or vapes is increasingly popular. Vulnerable populations most likely to vape include adolescents and young adults, sexual minorities, and people with poor mental health. Vaping is likely less harmful overall than smoking combustible cigarettes. Nevertheless, some users vape at frequencies that far exceed what they prefer, which we term uncontrolled vaping, augmenting health risks and producing greater addiction. In light of these concerns, some e-cigarette users may take actions intended to get their vaping under control. This vaping restraint could reduce health risks and support cessation of tobacco products including e-cigarettes. Vaping restraint strategies may present more challenges than efforts to reduce smoking because e-cigarette portions and refill sizes are unregulated, leaving users without familiar cues to encourage portion control (e.g., the end of a cigarette). However, the prevalence of uncontrolled vaping and restraint strategies is unknown, including for vulnerable populations. To fill these important gaps, the overarching goal of the proposed research is to understand uncontrolled vaping as well as vaping restraint strategies, which likely vary substantially across vulnerable populations, different device types, and dual use with combustible cigarettes. We build on the Process Model of Self-Control, hypothesizing greater impact of situational than cognitive restraint strategies. In Aim 1, we will develop measures of uncontrolled vaping and restraint strategies. We will conduct phone interviews with adolescent, young adult, and adult current e- cigarette users to identify language they employ to describe uncontrolled use and vaping restraint and then develop survey measures. In Aim 2, we will characterize the prevalence and correlates of both uncontrolled vaping and restraint strategies. We will survey a probability sample of current e-cigarette users (including adolescents, young adults and adults) and evaluate the suitability of the new measures among vulnerable populations. We will then calculate national estimates of uncontrolled use and vaping restraint strategies, and examine whether these outcomes are more common among vulnerable populations, certain device type users, and dual users. In Aim 3, we will establish the longitudinal impact of vaping restraint strategies on uncontrolled vaping. We will conduct a follow-up online survey at 12 months with the e- cigarette users from the Aim 2 sample. We will examine the association of baseline vaping restraint with uncontrolled vaping and smoking behavior 12 months later. Findings from the proposed research can inform regulatory science for e-cigarettes (e.g., by creating product standards for refill size and device features associated with uncontrolled use). The proposed research is responsive to FDA and NCI scientific interest areas of Addiction and Behavior.
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0.988 |