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

项目摘要 艾滋病毒感染者（PLWH）被诊断为肛门癌的可能性是一般人的28倍。 人口人乳头瘤病毒（HPV）与>90%的肛门癌相关，并且也是一种重要的癌症。 宫颈癌、阴道癌、阴茎癌和口腔癌的病因。HPV疫苗是一种有效的， 安全的方法来预防和降低感染者中HPV相关疾病的风险。HPV疫苗接种 尽管疾病预防控制中心免疫咨询委员会提出了正式建议， 为26岁以下免疫功能低下的人接种3剂系列疫苗的做法-最近 FDA批准45岁以下的人接种疫苗。PI的K 01作为本研究的依据。PI发现 肛门巴氏试验异常后的随访护理显著延迟。肛门巴氏试验后延迟随访 缺乏国家指南来支持PLWH的筛查意味着肛门癌的发病率将 艾滋病毒/艾滋病感染者的死亡率继续上升，特别是随着这一人群的老龄化。因此，HPV疫苗的推广， 这一人群作为初级癌症预防是公共卫生的优先事项。然而，PI的工作发现， 在我们的国家中，对HPV疫苗的知识和认识存在差距，HPV疫苗的接种率较低（13.5%）， 农村艾滋病毒携带者。这些发现支持了减少癌症差异的下一个合乎逻辑的步骤， 通过在艾滋病毒感染者中推广HPV疫苗接种，进一步推动PI的职业轨迹， 癌症预防计划。然而，在艾滋病毒人群中量身定制和实施的HPV疫苗计划 对这个高危人群来说是落后的。疾病预防控制中心的4 PillarsTM转型计划是一项多层次、基于证据的计划 已成功用于增加普通人群HPV疫苗接种的干预措施， 在高危艾滋病毒人群中，特别是在南方农村的艾滋病毒携带者中进行检测。以RE-AIM为导向 在此框架下，我们将在格鲁吉亚的三个艾滋病毒诊所实施该项目，并招募n=365名年龄 18-45岁，这些诊所。目标1）调整和完善四个支柱TM方案，以便在农村和 格鲁吉亚的城市艾滋病诊所;目标2）测试4支柱TM计划的有效性， 启动HPV疫苗（主要终点）和完成疫苗接种（次要终点）的摄取率 与艾滋病毒携带者和艾滋病患者的历史基线疫苗接种率（对照组）相比;目标2.1）确定介导因子， HPV疫苗接种干预效果的潜在调节因素;目标3）评估 目标3.1）评估该方案的可扩展性， 通过未来的国家RCT实施。作为一名早期研究者，PI（威尔斯）已经组装了一个 优秀的研究团队，带来互补的专业知识，成功地执行这项研究的目标 提议这项拟议的研究是一种解决严重和可预防的公共卫生问题的新方法 对新的目标人群进行有效的循证干预。预计调查结果将 在改善高风险和老龄化HIV人群的癌症结局方面具有重大影响。

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.