Project-001

项目-001

• 批准号: 10601392
• 负责人: Robinson Cabello
• 金额: $ 16.54万
• 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/10601392
• 关键词: Project; 001

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%的宫颈癌 癌症发生，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人被确诊，而在DR中，每年每10万人中有23人被诊断为宫颈癌 每年在一般人口中的妇女中。宫颈癌的负担大幅增加 在感染艾滋病毒(WLWH)的妇女中，尽管没有很好地描述确切的比率。虽然人乳头瘤病毒 疫苗作为一级预防是安全有效的，它们在资源匮乏的情况下可获得的机会有限 在这种情况下，艾滋病毒感染者的最佳疫苗剂量还没有确定。 此外，在中低收入人群中提供宫颈癌预防和治疗WLWH先兆 国家/地区往往受到成本高昂、需要多次访问和广泛提供服务的方法的阻碍 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。 宫颈癌预防伙伴关系(C2P2)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。C2P2中心的调查人员将联合设计、进行和 分析三项旨在消除高危人群宫颈癌的临床试验 拉丁美洲和加勒比(LAC)资源匮乏地区的艾滋病毒感染者弱势群体。我们在寻找 使用新的方法提高预防战略的质量和效率，以增强 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。该计划的目标是 拟议的临床试验中心跨越了接种疫苗预防宫颈癌的连续过程 通过治疗。我们提议的试验将解决这些技术问题，并提供更直接的渠道 用于预防。在这个C2P2中心，我们的首要目标是： 的具体目标1：测试新方法在高负担人群预防宫颈癌的有效性 秘鲁和DR的艾滋病毒感染人群进行了三项临床试验。其中一人将评估 HPV疫苗接种方案能否引发持久的B细胞反应，其中两种将评估新的 筛查、分类和治疗方法将提高预防的质量和覆盖面 整个LAC区域的低资源设置。 的具体目标2：在所有地点的研究人员之间建立强有力的多方向协作 这满足了护理艾滋病毒携带者妇女的提供者的需求。该中心将与 该地区领导人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癌症预防和治疗策略。