Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Operations and Collaborations Center (UM2 Clinical Trial Optional)

摘要--总体 13-24岁的青少年和青壮年(Aya)占美国新增艾滋病毒诊断病例的21% 2019年美国。阿亚的新感染不成比例地影响了黑人、拉丁裔、多种族和美国人 与男性发生性关系的印第安人/阿拉斯加原住民。美国的地理区域也是 受新感染影响不成比例：东北部和南部及西部，其次是中西部。具体的 申请者的目标是充当青少年试验的操作和协作中心(OCC) 网络(ATN)。Westat是熟练执行ATN OCC工作范围(SOW)的理想人选 在RFA-HD-23-021中概述，这是由于我们以前和现在支持艾滋病毒儿科和 青少年研究项目。新设计的ATN网络将由科学领导组成 中心(SLC)和OCC。作为OCC，Westat将与ATN SLC合作并提供 业务和后勤基础设施，以支持ATN执行委员会(EC)。这对 欧共体在实现其科学领导议程以及与ATN外部合作方面的成功 科学小组(ESP)、国家卫生研究院(NIH)计划工作人员以及外部研究网络和 调查人员。ATN OCC的总体目标是：(1)提供行政管理和协调 网络外部协作；(2)为跨网络协议、协作、 和其他项目(例如，开展培训、编写操作手册、网络公共支持关系、 提供网络网站维护，支持通信和电话会议，召开委员会会议 和会议)；(3)就广泛的研究相关主题培训网络参与者；(4)管理资源 并与现场联合体、供应商和合作者执行基于绩效的分包合同；(5)提供 跨网络协议、协作和新兴项目(例如站点)的监管基础设施 性能监测、质量保证程序和协议登记)；(6)提供机制和 监控受试者筛选、招聘、留用和退学的指标，以及调整程序，如果 未达到招生目标；(7)提供详细的学习进度跟踪系统和 现场联合体的业绩和向欧共体的报告(例如，支持研究进展和业绩 监督委员会)。例行跟踪和报告将包括定义的指标、里程碑、时间表和 质量控制措施，以确保研究保持在正轨上并在预算之内。相关性：Westat将提供 适当的技术、组织、管理专业知识和资源，以高效地设计、实施 同时管理广泛的治疗、行为和社区研究组合。研究结果 将用于制定干预措施，以减少艾滋病毒在Aya、SAFE和 有效形式的长效艾滋病毒暴露前预防(PrEP)和长效抗逆转录病毒疗法 (ARTS)用于改善阿亚艾滋病毒携带者的依从性和长期健康结果。

ABSTRACT – OVERALL Adolescents and young adults (AYA) ages 13-24 accounted for 21% of new HIV diagnoses in the United States in 2019. New infections in AYA disproportionately affect Black, Latino, multiracial, and American Indian/Alaska Native men who have sex with men. Geographic areas of the United States are also disproportionately affected by new infections: Northeast > South > West followed by the Midwest. The specific aim of the applicant is to serve as the Operations and Collaborations Center (OCC) of the Adolescent Trials Network (ATN). Westat is in an ideal position to expertly perform the ATN OCC scope of work (SOW) as outlined in RFA-HD-23-021 due to our prior and current successful experience supporting HIV pediatric and adolescent research programs. The newly designed ATN network will be made up of a Scientific Leadership Center (SLC) and OCC. As the OCC, Westat will work collaboratively with the ATN SLC and provide operational and logistical infrastructure to support the ATN Executive Committee (EC). This is critical to the EC's success in achieving its scientific leadership agenda and in its collaborations with the ATN External Scientific Panel (ESP), National Institutes of Health (NIH) program staff, and external research networks and investigators. The overall aims of the ATN OCC are to: (1) Provide administrative management and coordinate Network external collaborations; (2) Provide operational support for cross-network protocols, collaborations, and other projects (e.g., conduct trainings, develop manuals of operation, Network public support relations, provide Network website maintenance, support communications and conference calls, convening committees and meetings); (3)Train Network participants on a breadth of research-related topics; (4) Manage resources and execute performance-based subcontracts with site consortiums, vendors, and collaborators; (5) Provide regulatory infrastructure for cross-network protocols, collaborations, and emerging projects (e.g., site performance monitoring, quality assurance procedures, and protocol registration); (6) Provide mechanisms and metrics to monitor subject screening, recruitment, retention, and dropout, and procedures for adjustment if enrollment targets are not being met; (7) Provide detailed systems for tracking study progress and performance of site consortia and reporting to the EC (e.g., support of a study progress and performance monitoring committee). Routine tracking and reporting will include defined metrics, milestones, timelines, and quality-control measures to ensure studies stay on track and within budget. Relevance: Westat will provide the appropriate technical, organizational, administrative expertise, and resources to efficiently design, implement, and simultaneously manage a broad portfolio of therapeutic, behavioral, and community studies. Study findings will be used to develop interventions for reducing HIV transmission and acquisition among AYA, safe and effective forms of long-acting HIV pre-exposure prophylaxis (PrEP), and long-acting antiretroviral therapies (ARTs) for improving adherence and long-term health outcomes of AYA living with HIV (LHIV).