Project-002

项目-002

• 批准号: 10689747
• 负责人: Robinson Cabello
• 金额: $ 47.6万
• 依托单位: FRED HUTCHINSON CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-18 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10689747
• 关键词: Acceleration; Address; Algorithms; B-Lymphocytes; Biological Assay; Cancer Burden; Cancer Etiology; Caribbean region; Caring; Cessation of life; Child; Clinic; Clinical; Clinical Trials; Collaborations; Collection; Communication; Country; Dedications; Diagnosis; Dominican Republic; Dose; Ensure; Future; Future Generations; General Population; Goals; HIV; Human Papilloma Virus Vaccination; Human Papilloma Virus Vaccine; Human Papilloma Virus-Related Malignant Neoplasm; Immunotherapy; Incidence; Infrastructure; Interruption; Laboratories; Latin America; Lesion; Malignant neoplasm of cervix uteri; Minority; Modeling; Monitor; National Cancer Institute; Persons; Peru; Population; Prevention; Prevention approach; Prevention strategy; Primary Care; Primary Prevention; Productivity; Protocols documentation; Provider; Quality Control; Regimen; Research Personnel; Resource-limited setting; Resources; Safety; Sampling; Schedule; Site; Statistical Data Interpretation; Time; Training; Triage; Vaccination; Vaccines; Visit; Vulnerable Populations; Woman; Work; cancer prevention; cancer therapy; cervical cancer prevention; cost; data management; design; effectiveness testing; experience; immunogenicity; improved; low and middle-income countries; mortality; new technology; novel; novel strategies; premalignant; programs; recruit; response; screening; statistics; success; treatment strategy

Worldwide, cervical cancer is the fourth leading cause of cancer incidence and mortality; 80% of cervical cancers arise and 87% of cervical cancer deaths occur in low and lower-middle income countries. In Peru, cervical cancer is diagnosed at a rate of 17 per 100,000 women per year, and in the DR at 23 per 100,000 annually among women in the general population. The burden of cervical cancer is substantially increased among women living with HIV (WLWH), although the exact rates are not well described. Although HPV vaccines are safe and effective as primary prevention, they have limited availability in low resource settings and the optimal regimen of vaccine doses for HIV-infected persons in such settings has not been defined. Furthermore, delivery of cervical cancer prevention and treatment of precursors for WLWH in low- and middle-income countries is impeded by approaches that are often costly, require multiple visits and extensive provider training. Moreover, many of these are not suitable for delivery within an HIV primary care model. The Cervical Cancer Prevention Partnership (C2P2) Center involves two clinical trial sites, in Peru and the Dominican Republic, and three cores (Administrative and Coordinating Core, Statistics and Data Management Core and Central Laboratory Core) in Seattle. Investigators in the C2P2 Center will jointly design, conduct and analyze three clinical trials with the goal of moving toward elimination of cervical cancer among highly vulnerable populations with HIV in low resource settings in Latin America and the Caribbean (LAC). We seek to improve the quality and efficiency of prevention strategies using new approaches that will augment the existing infrastructure at local HIV clinics in Peru and the Dominican Republic (DR). The aims of the proposed Clinical Trials Center span the continuum of cervical cancer prevention from vaccination through treatment. The trials we propose will address these technical issues and provide a more direct pipeline for prevention. In this C2P2 Center, our overarching aims are:  Specific Aim 1: To test the effectiveness of novel approaches to cervical cancer prevention in high-burden HIV-infected populations in Peru and the DR by performing three clinical trials. One will assess the ability of HPV vaccination regimens to elicit long-lasting B cell responses, and two will assess novel screening, triage, and treatment approaches that will improve the quality and reach of prevention in low-resource settings throughout the LAC region.  Specific Aim 2: To build a robust multidirectional collaboration between study investigators at all sites that serves the needs of providers who care for women living with HIV. The Center will engage with leaders in the region to enhance the sustainability of efforts that target future elimination of cervical cancer through multiple high-impact prevention and treatment strategies.

在世界范围内，宫颈癌是癌症发病率和死亡率的第四大主要原因; 80%的宫颈癌患者 宫颈癌的发病率和87%的宫颈癌死亡发生在低收入和中低收入国家。在秘鲁， 宫颈癌的诊断率为每年每10万名妇女中有17人，DR为每10万名妇女中有23人 每年在总人口中的妇女中。宫颈癌的负担大幅增加 妇女艾滋病毒感染者中的艾滋病毒/艾滋病感染率（WLWH），尽管确切的感染率没有得到很好的描述。虽然HPV 疫苗作为一级预防是安全有效的，但在资源匮乏的情况下， 在这种情况下，HIV感染者的最佳疫苗剂量方案尚未确定。 此外，在低收入和中等收入妇女中提供宫颈癌预防和WLWH前体治疗， 这些方法往往费用昂贵，需要多次访问，需要大量的供应商， 训练此外，其中许多不适合在艾滋病毒初级保健模式下提供。 宫颈癌预防合作（C2 P2）中心涉及两个临床试验地点，分别位于秘鲁和 多米尼加共和国和三个核心（行政和协调核心、统计和数据管理 核心和中心实验室核心）在西雅图。C2 P2中心的研究者将共同设计、实施和 分析三项临床试验，其目标是在高风险人群中消除宫颈癌。 在拉丁美洲和加勒比地区（LAC），在资源匮乏的环境中，艾滋病毒感染的弱势群体。我们寻求 提高预防战略的质量和效率， 在秘鲁和多米尼加共和国（多米尼加共和国），艾滋病毒诊所的现有基础设施。的目标 拟议的临床试验中心跨越了从接种疫苗预防宫颈癌的连续性 通过治疗。我们提议的试验将解决这些技术问题，并提供一个更直接的管道 为了预防。在这个C2 P2中心，我们的首要目标是： 具体目标1：在高负担人群中测试预防宫颈癌的新方法的有效性 艾滋病毒感染人群在秘鲁和DR通过执行三项临床试验。一个将评估 HPV疫苗接种方案引发持久B细胞应答的能力，其中两项将评估新的 筛查，分类和治疗方法，将提高预防的质量和范围， 在整个拉丁美洲和加勒比区域， 具体目标2：在所有研究中心的研究者之间建立强大的多向合作 这是一个服务于照顾感染艾滋病毒的妇女的提供者的需求的项目。中心将与 * 该区域领导人加强今后消除宫颈癌的努力的可持续性 通过多种高效的预防和治疗策略来治疗癌症。