RCT to Evaluate an Implementation Strategy to Increase Optimal Use of HPV Vaccine in Primary Care

项目摘要 HPV相关的泌尿生殖道癌和口咽癌的一级预防可以显著减少 与这些常见癌症相关的发病率、死亡率和医疗费用。疫苗 靶向人乳头瘤病毒致癌株(HPV)如果给予治疗，可以预防HPV相关癌症 在接触这些性传播病毒之前，女孩和男孩。然而，在美国，更多 在引入疫苗不到10年后，只有不到一半的目标人口接种了疫苗。 此应用程序的目标是评估实施战略( 干预)，以改进HPV疫苗的最佳使用。最佳使用需要完成两剂系列 在性生活首次亮相之前。为此，疾病控制和预防中心的国家建议 预防(CDC)是在13岁之前完成两剂HPV疫苗系列。 组成部分干预是与初级保健提供者合作开发的，包括：1) 教育视频，以增加提供者对指南建议和患者和 实践13岁接种疫苗的好处；2)对疫苗覆盖率进行审计和反馈，以增加动力 参与实践更改；3)沟通策略，以提高提供商的沟通技能 他们的自我效能感，以解决父母的犹豫；以及4)实践促进，以支持实践改变 开发可持续的HPV疫苗接种系统。干预将通过一系列简短的 在两年的时间里，每隔1-4周与辅导员一起练习拜访。在一项初步研究中，干预措施是 被广泛接受，疫苗接种率在临床上有意义的提高19个百分点 超过15个月。 这一有希望的干预措施将在20名初级保健儿科医生的整群随机试验中进行评估 在密苏里州的做法，一个低HPV疫苗覆盖率的州。研究目标是：1)确定 干预将增加两剂HPV的启动(主要结果)和完成(次要结果) 为13岁之前的青少年接种疫苗系列；2)确定提供者的动机和改进 沟通技能对干预的有效性起到中介作用；3)评估对扩展的重要因素 包括保真度、初级保健提供者和父母的接受度以及成本。青春期前使用的疫苗将是 在基线进行评估，24个月评估有效性，36个月评估变化是否 反对有效。对于初步分析，将使用患者级别数据的聚合来估计提供者 从执业者的电子病历中提取数据。

Project Summary Primary prevention of HPV-related urogenital and oropharyngeal cancers could significantly reduce morbidity, mortality, and healthcare costs associated with these commonly occurring cancers. The vaccine targeting oncogenic strains of the human papilloma virus (HPV) can prevent HPV-related cancers if given to girls and boys before exposure to these sexually transmitted viruses. Yet, in the United States (U.S.), more than 10 years after introduction of the vaccine, fewer than half of the target population is vaccinated. The objective of this application is to evaluate the effectiveness of an implementation strategy (the intervention) to improve optimal use of the HPV vaccine. Optimal use requires completion of the 2-dose series before sexual debut. To this end, national recommendations from the Centers for Disease Control and Prevention (CDC) are to complete the 2-dose HPV vaccine series by age 13. The theory-based, multi- component intervention was developed in collaboration with primary care providers and includes: 1) an educational video to increase the provider’s knowledge about guideline recommendations and patient and practice benefits of vaccination by age 13; 2) audit and feedback of vaccine coverage to increase motivation to engage in practice change; 3) a communication strategy to improve the provider’s communication skills and their self-efficacy to address parental hesitation; and 4) practice facilitation to support practice change to develop a sustainable HPV vaccine delivery system. The intervention will be delivered through a series of brief practice visits with the facilitator that occur every 1-4 weeks over 2 years. In a pilot study, the intervention was well-accepted and resulted in a clinically meaningful improvement in vaccine initiation of 19 percentage points over 15-months. This promising intervention will be evaluated in a cluster-randomized trial in 20 primary care pediatric practices in Missouri, a state with low HPV vaccine coverage. Study objectives are to 1) determine if the intervention will increase initiation (primary outcome) and completion (secondary outcome) of the 2-dose HPV vaccine series for preteens before their 13th birthday; 2) determine if provider motivation and improved communication skills mediate the effectiveness of the intervention; and 3) assess factors important for scaling including fidelity, acceptance by primary care providers and parents, and cost. Vaccine use in preteens will be assessed at baseline, at 24 months to assess effectiveness, and at 36 months to assess if change is sustained. For the primary analyses, aggregates of patient-level data will be used to estimate provider behavior, extracting data from the practices’ electronic medical record.