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: 10893076
• 负责人: Patricia Lombard Mabry
• 金额: $ 5.37万
• 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: 2023-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10893076
• 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 人类乳头瘤病毒(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，覆盖率远远低于其他常规青少年疫苗 而2030年健康人口的目标是80%。在看牙医时推广HPV-V被视为一个绝佳机会 预防口咽癌和其他癌症，但由于缺乏，许多牙科提供者对此并不满意 对知识和自我效能感的恐惧，以及对损害患者与提供者关系的恐惧。使用NIH阶段 行为干预发展模型作为我们的指导，我们建议制定一个以理论为基础的 解决牙科提供者对HPV-V推广的障碍的干预措施，阐明干预措施的行为 机制，并测试干预在催化提供者HPV-V促进方面的真实效果。这个 干预将包括1)提供商关于HPV/HPV-V的培训；2)为提供商提供帮助的量身定制的脚本 回应患者/家长/监护人对HPV-V的担忧。在UG3阶段，我们将随机选择21个 HealthPartners牙科集团诊所进行干预与常规护理(UC；n=~131个提供者)。UG3的目标是： 制定调查措施和试点测试提供者HPV-V推广培训(目标1)和定制脚本(目标2)； 制定监测提供者对培训和干预活动的忠诚度的措施和方法(目标 3)；起草合规/研究文件并获得IRB/NIDCR批准(目标4)。在UH3阶段， 我们将进行一项整群(临床)随机临床试验(干预与UC)，以测试 增加HPV-V宣传活动的干预措施(目标5)。我们将评估干预是否会 影响了三个预期的行为机制目标：增加了对HPV/HPV-V的知识；增加了 促进HPV-V感染的自我效能；减少对HPV-V感染对患者产生负面影响的恐惧- 提供者关系(目标6)。对于每个目标，我们还将评估干预的效果是否随之而来 终点行为的全机械途径，HPV-V促进(目标7)。超越我们的目标，我们将 进行探索性工作，检查另外两个候选行为机制：材料的充分性 支持牙科提供者推广HPV-V的资源，以及提供者对推广HPV-V的看法 符合他们的职业身份。我们还将对干预措施进行探索性分析 增加HPV-V感染的有效性(患者就诊后30天的疫苗接种率)。我们的长期目标是 通过牙科提供者推广HPV-V，降低HPV和口咽癌的患病率。意义重大 该项目的影响包括：1)开发了第一个针对HPV-V推广的基于理论的行为干预 针对牙科提供者；2)提供此类干预措施实际效果的第一个证据；3) 阐明据称是提供商行为改变的行为机制；4)产生基本的 指导未来HPV-V促进干预发展的知识；以及5)促进 通过揭示提供商行为变化背后的行为原则来实现行为变化。