Investigating Behavioral Mechanisms and Efficacy of a Provider-Directed Intervention for HPV Vaccine Promotion in Real-World Dental Settings

研究现实世界牙科环境中 HPV 疫苗推广的行为机制和提供者导向干预措施的效果

• 批准号: 10586610
• 负责人: Patricia Lombard Mabry
• 金额: $ 31.57万
• 依托单位: HEALTHPARTNERS INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-01 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10586610
• 关键词: Address; Adolescent; Adult; Behavior; Behavior Therapy; Behavioral; Behavioral Mechanisms; Behavioral Model; Clinic; Critical Pathways; Dental; Dental Care; Development; Effectiveness; Eligibility Determination; Fright; Future; Goals; Health; Human Papilloma Virus Vaccination; Human Papilloma Virus Vaccine; Human Papilloma Virus-Related Malignant Neoplasm; Human Papillomavirus; Human papilloma virus infection; Institutional Review Boards; Intervention; Knowledge; Malignant Neoplasms; Measures; Mediator; Methods; Modeling; Monitor; National Institute of Dental and Craniofacial Research; Newly Diagnosed; Oropharyngeal; Parents; Pathway interactions; Patients; Perception; Persons; Phase; Population; Prevalence; Provider; Randomized; Resources; Safety; Science; Self Efficacy; Surveys; Testing; Throat Cancer; Training; Treatment Efficacy; United States National Institutes of Health; Vaccinated; Vaccination; Vaccines; Visit; Work; behavior change; behavior measurement; design; efficacy testing; efficacy trial; head and neck cancer prevention; intervention effect; lifetime risk; malignant mouth neoplasm; malignant oropharynx neoplasm; negative affect; novel; pilot test; post intervention; prevent; provider behavior; provider-level barriers; randomized, clinical trials; theories; therapy design; therapy development; treatment as usual; vaccine acceptance

Project Summary Human papillomavirus (HPV) is the leading cause of oropharyngeal cancers in the US. Despite the safety and effectiveness of the HPV vaccine (HPV-V), coverage is far below that for other routine adolescent vaccines and the Healthy People 2030 goal of 80%. HPV-V promotion at dental visits is seen as a prime opportunity to prevent oropharyngeal and other cancers, yet many dental providers are not comfortable doing so due to lack of knowledge and self-efficacy, and fear of harming the patient-provider relationship. Using the NIH Stage Model of Behavioral Intervention Development as our guide, we propose to develop a theory-based intervention to address dental provider barriers to HPV-V promotion, elucidate the intervention's behavioral mechanisms, and test the real-world efficacy of the intervention in catalyzing provider HPV-V promotion. The intervention will consist of 1) provider training about HPV/HPV-V; 2) tailored scripts to aid providers in responding to patient/parent/guardian concerns about HPV-V. During the UG3 phase, we will randomize 21 HealthPartners Dental Group clinics to intervention vs. usual care (UC; n=~131 providers). UG3 aims are to: develop survey measures and pilot-test provider HPV-V promotion training (Aim 1) and tailored scripts (Aim 2); develop measures and methods for monitoring provider fidelity to the training and intervention activities (Aim 3); and draft compliance/study documents and obtain IRB/NIDCR approvals (Aim 4). During the UH3 phase, we will conduct a cluster (clinic)-randomized clinical trial (intervention vs. UC) to test the real-world efficacy of the intervention to increase HPV-V promotion activity (Aim 5). We will assess whether the intervention impacted the three intended behavioral mechanism targets: increased knowledge of HPV/HPV-V; increased self-efficacy for HPV-V promotion; and reduced fear of HPV-V promotion negatively affecting the patient- provider relationship (Aim 6). For each target, we will also assess whether the intervention's effects followed the full mechanistic pathway to the endpoint behavior, HPV-V promotion (Aim 7). Beyond our aims, we will conduct exploratory work examining two additional candidate behavioral mechanisms: adequacy of material resources to support dental providers in promoting HPV-V, and providers' perception that HPV-V promotion comports with their professional identity. We will also conduct an exploratory analysis of the intervention's efficacy in increasing HPV-V uptake (30-day post-visit patient vaccination rates). Our long-term goal is to reduce HPV and oropharyngeal cancer prevalence through HPV-V promotion by dental providers. Significant impact of the project includes: 1) developing the first theory-based behavioral intervention for HPV-V promotion aimed at dental providers; 2) delivering the first evidence of real-world efficacy of such an intervention; 3) illuminating behavioral mechanisms purported to underlie provider behavior change; 4) producing fundamental knowledge to guide future HPV-V promotion intervention development; and 5) advancing the science of behavior change by revealing behavioral principles underlying provider behavior change.

项目摘要 人乳头瘤病毒（HPV）是美国口咽癌的主要原因。尽管安全和 HPV疫苗（HPV-V）的有效性，覆盖率远低于其他常规青少年疫苗 健康人2030年的目标为80％。牙科访问时的HPV-V促销被视为一个最好的机会 预防口咽和其他癌症，但是许多牙科提供者由于缺乏而感到不舒服 知识和自我效能感，以及害怕伤害患者的关系。使用NIH阶段 行为干预发展的模型作为我们的指南，我们建议开发基于理论的 干预措施以解决HPV-V促销的牙科提供者障碍，阐明干预的行为 机制，并测试干预措施催化提供商HPV-V促进的现实世界疗效。这 干预将包括1）提供者培训有关HPV/HPV-V的培训； 2）量身定制的脚本以帮助提供商 应对患者/父母/监护人对HPV-V的担忧。在UG3阶段，我们将随机21 HealthPartners Dental Group诊所进行干预与常规护理（UC; n = 〜131个提供商）。 UG3的目标是： 制定调查措施和试点测试提供商HPV-V促销培训（AIM 1）和量身定制的脚本（AIM 2）； 制定措施和方法，以监测提供者忠诚度训练和干预活动（AIM 3）;并草案合规/研究文件并获得IRB/NIDCR批准（AIM 4）。在UH3阶段， 我们将进行集群（诊所）临时试验（干预与UC），以测试现实世界的功效 增加HPV-V促进活性的干预措施（AIM 5）。我们将评估是否干预 影响了三种预期的行为机制目标：增加了HPV/HPV-V的知识；增加 HPV-V促进的自我效能；并减少对HPV-V促进的恐惧，对患者产生负面影响 - 提供者关系（目标6）。对于每个目标，我们还将评估干预的影响是否遵循 端点行为的完整机械途径，HPV-V促销（AIM 7）。除了我们的目标之外，我们还将 进行探索性工作，研究其他两种候选行为机制：材料的充分性 支持牙科提供者促进HPV-V的资源，以及提供商对HPV-V促销的看法 与他们的专业身份相称。我们还将对干预措施进行探索性分析 增加HPV-V摄取的功效（参观后30天患者疫苗接种率）。我们的长期目标是 通过牙科提供者促进HPV-V促进，降低了HPV和口咽癌的患病率。重要的 该项目的影响包括：1）为HPV-V促进开发第一个基于理论的行为干预 针对牙科提供者； 2）提供这种干预措施现实世界疗效的第一个证据； 3） 阐明的行为机制是为基础提供者行为改变的基础； 4）生产基本 知识指导未来的HPV-V促进干预开发； 5）推进科学 通过揭示提供者行为行为的基础行为原则改变而改变行为。