Project-002

项目-002

• 批准号: 10601393
• 负责人: Robinson Cabello
• 金额: $ 21.59万
• 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 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10601393
• 关键词: Project; 002

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原因； 80%颈椎 癌症的发生和 87% 的宫颈癌死亡发生在低收入和中低收入国家。在秘鲁， 每年每 100,000 名女性中有 17 例被诊断出宫颈癌，而在刚果民主共和国，每 100,000 名女性中有 23 例被诊断出宫颈癌 每年在总人口中的妇女中进行一次。宫颈癌负担大幅增加 感染艾滋病毒的女性 (WLWH) 中，尽管确切的比率尚未得到很好的描述。虽然HPV 疫苗作为一级预防是安全有效的，但在资源匮乏的地区其可用性有限 在这种情况下，艾滋病毒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国家中提供宫颈癌预防和 WLWH 前兆治疗 各国所采取的方法往往成本高昂、需要多次访问和广泛的提供者 训练。此外，其中许多不适合在艾滋病毒初级保健模式中提供。 宫颈癌预防合作伙伴 (C2P2) 中心涉及两个临床试验中心，分别位于秘鲁和 多米尼加共和国，三个核心（行政和协调核心、统计和数据管理 核心和中央实验室核心）位于西雅图。 C2P2中心的研究人员将共同设计、进行和 分析三项临床试验，目标是在高危人群中消除宫颈癌 拉丁美洲和加勒比地区 (LAC) 资源匮乏地区的艾滋病毒易感人群。我们寻求 使用新方法提高预防战略的质量和效率，以增强预防能力 秘鲁和多米尼加共和国 (DR) 当地艾滋病毒诊所的现有基础设施。该组织的目标 拟议的临床试验中心涵盖了从疫苗接种到宫颈癌预防的整个过程 通过治疗。我们建议的试验将解决这些技术问题并提供更直接的管道 用于预防。在这个 C2P2 中心，我们的首要目标是：  具体目标 1：测试高负担人群中预防宫颈癌的新方法的有效性 通过在秘鲁和刚果民主共和国的艾滋病毒感染人群中进行三项临床试验。一会评估 HPV 疫苗接种方案引发持久 B 细胞反应的能力，两人将评估新的 筛查、分诊和治疗方法将提高预防的质量和范围 整个拉美和加勒比地区资源匮乏。  具体目标 2：在所有研究中心的研究人员之间建立强有力的多向合作 满足照顾感染艾滋病毒的妇女的提供者的需求。该中心将与 该地区领导人将加强旨在未来消除宫颈癌的努力的可持续性 通过多种高影响力的预防和治疗策略来预防癌症。