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

实施循证多层次干预措施，促进 HIV 阳性成年人接种 HPV 疫苗

• 批准号: 10326568
• 负责人: Jessica Wells
• 金额: $ 39.09万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-29 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10326568
• 关键词: Address; Adult; Advisory Committees; Age; Aging; Anus; Awareness; Caring; Centers for Disease Control and Prevention (U.S.); Clinic; Clinical; Diagnosis; Disease; Dose; Effectiveness; Enrollment; Evidence based intervention; Exposure to; FDA approved; Future; General Population; Geography; Guidelines; HIV; HIV Seropositivity; HIV diagnosis; Human Papilloma Virus Vaccination; Human Papilloma Virus Vaccine; Human Papilloma Virus-Related Malignant Neoplasm; Human Papillomavirus; Human papillomavirus 16; Immunization; Immunocompromised Host; Incidence; Individual; Intervention; Investigation; Knowledge; Lesion; Level of Evidence; Life Expectancy; Malignant Neoplasms; Malignant Vaginal Neoplasm; Malignant neoplasm of anus; Malignant neoplasm of cervix uteri; Malignant neoplasm of penis; Measures; Mediator of activation protein; Modeling; Morbidity - disease rate; Oncogenic; Outcome; Patients; Pilot Projects; Population; Positioning Attribute; Prevention approach; Primary Cancer Prevention; Prospective cohort; Provider; Public Health; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Research; Research Personnel; Research Proposals; Risk; Rural; Rural Population; Safety; Screening for cancer; Series; Site; Survival Rate; Target Populations; Testing; Time; Vaccinated; Vaccination; Vaccine Research; Vaccines; Vulnerable Populations; Woman; Work; anal pap smear; antiretroviral therapy; cancer health disparity; cancer prevention; cancer survival; career; chemoradiation; comorbidity; design; effectiveness testing; efficacious intervention; evidence base; follow-up; high risk; high risk population; immunogenic; improved; intervention effect; malignant mouth neoplasm; men; mortality; novel strategies; post intervention; premalignant; prevent; primary endpoint; programs; public health priorities; rural area; rural health disparities; screening; secondary endpoint; sexual debut; tumor; uptake; vaccine acceptance

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.

项目摘要 HIV 感染者 (PLWH) 被诊断出患有肛门癌的可能性是普通人的 28 倍 人口。人乳头瘤病毒 (HPV) 与 >90% 的肛门癌相关，也是一种重要的 该人群中出现宫颈癌、阴道癌、阴茎癌和口腔癌的原因。 HPV 疫苗是一种有效且 预防和降低 PLWH 中 HPV 相关疾病风险的安全方法。然而，HPV疫苗接种 尽管疾病预防控制中心免疫咨询委员会提出正式建议，艾滋病病毒感染者的感染率仍然很低 最近为 26 岁以下免疫功能低下的个体接种 3 剂系列疫苗的做法 FDA 批准 45 岁以下人士接种疫苗。 PI 的 K01 是本研究的基本原理。 PI 发现 肛门巴氏检查异常后，后续护理明显延迟。肛门巴氏涂片检查后随访延迟 缺乏支持艾滋病毒感染者筛查的国家指南意味着肛门癌的发病率将 艾滋病病毒感染者和艾滋病患者的感染率继续上升，特别是随着人口老龄化。因此，HPV疫苗的推广 对这一人群进行初​​级癌症预防是公共卫生的优先事项。然而，PI 的工作意义重大 对 HPV 疫苗的了解和认识存在差距，以及 HPV 疫苗的使用率较低（13.5%） 农村艾滋病病毒感染者人数。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 PLWH 中推广 HPV 疫苗接种，作为成功的一部分，进一步推进 PI 的职业轨迹 癌症预防计划。然而，针对 HIV 人群量身定制和实施的 HPV 疫苗计划是 对于这个高风险群体来说是滞后的。 CDC 的 4 Pillars™ 转型计划是一个多层次、基于证据的计划 该干预措施已成功用于增加一般人群的 HPV 疫苗接种，并且 准备在高危艾滋病毒人群中进行测试，特别是南方农村的艾滋病毒感染者。以 RE-AIM 为指导 框架，我们将在乔治亚州的三个艾滋病毒诊所实施该项目，并招募 n=365 名年龄在 18-45 岁，来自这些诊所。目标 1) 定制和完善 4 PillarsTM 计划，以在农村和农村地区实施 格鲁吉亚的城市艾滋病毒诊所；目标 2) 测试 4 PillarsTM 计划的有效性（通过增加来衡量） HPV 疫苗初始接种率（主要终点）和疫苗完成接种率（次要终点） 与感染者的历史基线疫苗接种率（对照）相比；目标 2.1) 确定调解者和 HPV 疫苗接种干预效果的潜在调节因素；目标 3) 评估可持续性 干预后对疫苗接种的干预；目标 3.1) 评估程序的可扩展性 通过未来的国家随机对照试验实施。作为早期研究人员，PI（Wells）已经组建了一个 优秀的研究团队带来了互补的专业知识，成功地实现了这项研究的目标 提议。拟议的研究是解决严重且可预防的公共卫生问题的一种新方法 通过对新的目标人群使用有效的、基于证据的干预措施。研究结果预计 在改善高危和老龄化艾滋病毒人群的癌症结果领域具有重大影响。