Implementing an evidence-based, multilevel intervention to promote HPV vaccination among HIV positive adults

项目摘要 艾滋病毒携带者(PLWH)被诊断为肛门癌的可能性是普通人群的28倍 人口。人乳头瘤病毒(HPV)与90%的肛门癌有关，也是一种重要的 宫颈癌、阴道癌、阴道癌和口腔癌的病因。人乳头瘤病毒疫苗是一种有效的 预防和降低PLWH中HPV相关疾病风险的安全方法。然而，接种HPV疫苗 尽管疾控中心免疫咨询委员会提出了正式建议，但PLWH仍处于较低水平 用3剂系列疫苗为26岁以下的免疫功能低下者接种疫苗的做法--最近 FDA批准45岁以下的人接种疫苗。PI的K01是本研究的理论基础。少年派找到了 在肛门巴氏试验异常后，随访护理明显延误。一项肛门巴氏试验后的随访延迟 缺乏国家指南来支持在PLWH中进行筛查意味着肛门癌的发病率将 在PLWH中继续上升，特别是随着这一人口老龄化。因此，在中国推广HPV疫苗 将这一人群作为癌症的一级预防是公共卫生的优先事项。然而，PI的工作发现了重要的意义 我们对HPV疫苗的知识和认识存在差距，对HPV疫苗的接受率较低(13.5%) 农村地区的人口数量。这些发现支持下一个合乎逻辑的步骤，即减少癌症差异以及 通过在公共卫生医院中推广HPV疫苗接种，进一步推动PI的职业发展轨迹，作为成功的 癌症预防计划。然而，在艾滋病毒人群中量身定做和实施的HPV疫苗计划是 对于这一高风险群体来说是滞后的。CDC的4支柱TM转型计划是一个多层次的、以证据为基础的 已成功用于在普通人群中增加HPV疫苗接种的干预措施 准备在艾滋病毒高危人群中进行测试，特别是在南部农村的PLWH。在RE-AIM的指导下 框架，我们将在佐治亚州的三家艾滋病毒诊所实施这一项目，并招募365名年龄较大的PLWH 距离这些诊所18-45年。目标1)调整和完善4个支柱TM方案，以便在农村和 佐治亚州的城市艾滋病毒诊所；目标2)测试4个支柱计划的有效性，以增加 开始接种HPV疫苗的接种率(主要终点)和疫苗完成率(次要终点) 与历史基线疫苗接种率(对照)相比；目标2.1)确定介体和 HPV疫苗接种干预效果的潜在调节因素；目的3)评估 干预后疫苗接种率的干预；目标3.1)评估该计划在更广泛的范围内的可扩展性 通过未来的国家区域合作伙伴关系实施。作为一名早期调查员，PI(Wells)已经组建了一个 优秀的研究团队，带来互补的专业知识，成功实现本研究的目标 求婚。拟议的研究是一种新的方法来解决一个严重的和可以预防的公共卫生问题 通过对新的目标人群进行有效的循证干预。这一发现预计将 在改善高危和老龄化艾滋病毒人群的癌症预后方面具有重大影响。

PROJECT ABSTRACT People living with HIV (PLWH) are 28 times more likely to be diagnosed with anal cancer than the general population. The Human Papillomavirus (HPV) is associated with >90% of anal cancers, and is also a significant cause of cervical, vaginal, penile, and oral cancers seen in this population. The HPV vaccine is an effective and safe approach to prevent and reduce the risk of HPV-related disease among PLWH. However, HPV vaccination remains low in PLWH despite formal recommendations from the CDC’s Advisory Committee on Immunization Practices to vaccinate immunocompromised individuals up to age 26 years with the 3-dose series-- and recently FDA approved to vaccinate up to age 45 years. The PI’s K01 serves as the rationale for this study. The PI found significant delays in follow up care after an abnormal anal Pap test. Delays in follow up after an anal Pap test in the absence of national guidelines to support screening in PLWH means the incidence of anal cancer will continue to rise among PLWH, especially as this population ages. Therefore, promotion of the HPV vaccine in this population as primary cancer prevention is a public health priority. However, the PI’s work found significant gaps in knowledge and awareness of the HPV vaccine as well as low uptake of the HPV vaccine (13.5%) in our population of rural PLWH. These findings support the next logical step to reduce cancer disparities as well as further the PI’s career trajectory through promotion of HPV vaccination among PLWH as part of a successful cancer prevention plan. However, HPV vaccine programs tailored and implemented in the HIV population is lagging for this high-risk group. The CDC’s 4 PillarsTM Transformation Program is a multi-level, evidence-based intervention that has been successfully utilized to increase HPV vaccination in the general population and is primed to be tested in the high-risk HIV population, particularly PLWH in the rural South. Guided by the RE-AIM framework, we will implement this project in three HIV clinics in Georgia and enroll n=365 PLWH who are age 18-45 years from those clinics. Aim 1) Tailor and refine the 4 PillarsTM program for implementation in rural and urban HIV clinics in Georgia; Aim 2) Test the effectiveness of the 4 PillarsTM program as measured by an increase in uptake rate in initiation of the HPV vaccine (primary endpoint) and vaccine completion (secondary endpoint) compared to historical baseline vaccination rate (control) among PLWH; Aim 2.1) Identify mediators and potential moderators of the intervention effects on HPV vaccination; Aim 3) Assess the sustainability of the intervention in vaccine uptake post-intervention; Aim 3.1) Assess scalability of the program for wider implementation via a future national RCT. As an Early-Stage Investigator, the PI (Wells) has assembled an outstanding research team that brings complementary expertise to successfully execute the aims of this research proposal. The proposed study is a novel approach to address a serious and preventable public health problem by using an efficacious, evidence-based intervention on a new target population. The findings are anticipated to have a significant impact in the field of improving cancer outcomes in a high-risk and aging HIV population.