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

HIV/艾滋病干预青少年医学试验网络 (ATN) 运营和合作中心（UM2 临床试验可选）

• 批准号: 10599556
• 负责人: Barbara Driver
• 金额: $ 738.95万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-22 至 2029-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10599556
• 关键词: AIDS prevention; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adherence; Adolescent; Adolescent Medicine Trials Network; Adolescent and Young Adult; Affect; Age; Alaska Native; American Indians; Behavioral; Black race; Budgets; Clinical Trials; Collaborations; Communication; Communities; Continuity of Patient Care; Dropout; Enrollment; Ensure; Epidemiology; Gender; Geographic Locations; Geography; HIV; HIV Infections; HIV diagnosis; Health; Infection; Infrastructure; Intervention; Intervention Studies; Latino; Leadership; Logistics; Maintenance; Manuals; Measures; Medical; Midwestern United States; Minor; Mission; Monitor; Office of Administrative Management; Outcome; Participant; Performance; Pharmacologic Substance; Population; Positioning Attribute; Procedures; Protocols documentation; Quality Control; Regimen; Reporting; Research; Research Personnel; Resources; Risk; Safety; Science; Site; Specimen; System; Therapeutic; TimeLine; Training; United States; United States National Institutes of Health; Vendor; Work; Youth; adolescent health outcomes; adolescent substance abuse; antiretroviral therapy; base; design; diversity and equity; ethnic minority; experience; improved; innovation; medically underserved; meetings; men who have sex with men; microbicide; multi-racial; operation; pediatric human immunodeficiency virus; performance site; pre-exposure prophylaxis; programs; quality assurance; racial and ethnic; recruit; screening; success; symposium; translational therapeutics; transmission process; vaccine trial; web site

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).

摘要 – 总体 在美国，13-24 岁的青少年和年轻人 (AYA) 占新诊断艾滋病毒的 21% 2019 年各州。AYA 中的新感染对黑人、拉丁裔、多种族和美国人影响尤为严重 与男性发生性关系的印第安/阿拉斯加原住民男性也属于美国地理区域。 受新感染影响不成比例：东北部>南部>西部，其次是中西部。 申请人的目标是充当青少年试验的运营和合作中心（OCC） 网络 (ATN) 处于专业执行 ATN OCC 工作范围 (SOW) 的理想位置。 RFA-HD-23-021 中概述了我们之前和当前支持 HIV 儿科和艾滋病毒的成功经验。 新设计的 ATN 网络将由科学领导层组成。 中心 (SLC) 和 OCC 作为 OCC，Westat 将与 ATN SLC 合作并提供服务。 支持 ATN 执行委员会 (EC) 的运营和后勤基础设施这对于 ATN 至关重要。 EC 在实现其科学领导议程以及与 ATN 外部合作方面取得的成功 科学小组 (ESP)、美国国立卫生研究院 (NIH) 项目工作人员以及外部研究网络和 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、协作提供运营支持； 和其他项目（例如，进行培训、制定操作手册、网络公共支持关系、 提供网络网站维护、支持沟通和电话会议、召集委员会 (3) 对网络参与者进行广泛的研究相关主题培训； (4) 管理资源； 并与现场联盟、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、协作和新兴项目的监管基础设施（例如，站点 (6) 提供机制和 监测受试者筛选、招募、保留和退出的指标，以及调整程序 (7) 提供详细的学习进度跟踪系统 现场联盟的绩效并向 EC 报告（例如，支持研究进展和绩效 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，以确保研究按计划进行并在预算之内。 相关性：Westat 将提供相关信息。 适当的技术、组织、管理专业知识和资源，以有效地设计、实施、 同时管理广泛的治疗、行为和社区研究结果。 将用于制定干预措施，以减少 AYA 中艾滋病毒的传播和感染，安全且可靠 长效 HIV 暴露前预防 (PrEP) 和长效抗逆转录病毒疗法的有效形​​式 (ART)，以提高艾滋病毒感染者 (LHIV) 的 AYA 依从性和长期健康结果。