Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Coordinating Center

艾滋病毒/艾滋病干预青少年医学试验网络 (ATN) 协调中心

• 批准号: 9564517
• 负责人: Myra A. Carpenter
• 金额: $ 130.24万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-30 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9564517
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Administrative Coordination; Adolescent; Adolescent Medicine Trials Network; Adolescent Risk Behavior; Ancillary Study; Archives; Area; Awareness; Behavioral; Biometry; Calendar; Caring; Child; Clinical; Clinical Data; Clinical Trials Data Monitoring Committees; Coitus; Collaborations; Collection; Communicable Diseases; Communication; Communities; Computerized Medical Record; Consent Forms; Continuity of Patient Care; Data; Data Collection; Data Quality; Development; Elements; Ensure; Event; Foundations; Funding; Gills; Goals; HIV; HIV Infections; HIV diagnosis; Health Services Accessibility; High School Student; Human immunodeficiency virus test; Individual; Injectable; Institute of Medicine (U.S.); Intervention; Intervention Studies; Investigational New Drug Application; Label; Lead; Leadership; Manuals; Manuscripts; Mediation; Methodology; Methods; Minority; Monitor; National Institute of Child Health and Human Development; Newly Diagnosed; North Carolina; Office of Administrative Management; Online Systems; Operations Research; Outcome Measure; Parental Consent; Participant; Patients; Performance; Pharmaceutical Preparations; Phase; Preparation; Prevention trial; Privatization; Procedures; Productivity; Protocols documentation; Public Health; Publications; Quality Control; Questionnaires; Recruitment Activity; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Research Support; Resource Sharing; Resources; Risk; Risk Behaviors; Safety; Sample Size; Schools; Secure; Security; Services; Site; Solid; Standardization; Statistical Data Interpretation; Structure; Students; Surveys; System; Time; Training; United States National Institutes of Health; Universities; Vision; Vocabulary; Writing; Youth; aged; base; cohesion; condoms; data management; data sharing; design; experience; global health; handheld mobile device; innovation; medical schools; meetings; multidisciplinary; peer influence; programs; protocol development; quality assurance; repository; retention rate; self esteem; sexual encounter; social stigma; success; synergism; tool; user-friendly; web site; webinar; young adult; young men who have sex with men

ABSTRACT The goal of this U24 application is to establish a Coordinating Center (CC) for the next phase of the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) sponsored by the NIH. The objective of ATN is to increase awareness among at-risk youth of their HIV status and, for those with HIV, achieve linkage, engagement and retention in the care continuum. Many challenges are faced by adolescents during their transition to young adulthood, resulting from developmental changes, peer influences, identity, and self-esteem formation. Risky behaviors among adolescents, which include engaging in unprotected sexual encounters or sharing nonsterile injecting drug paraphernalia, increase their likelihood of acquiring HIV infection. In the 2013 US Youth Risk Behavior Surveillance Survey (YRBSS), 34% of US high school students reported sexual intercourse during the prior 3 months, of which only 59% indicated condom use during last sexual intercourse. The YRBSS also found that only 13% of students had ever been tested for HIV infection. Given the global burden of new HIV infections among young people, greater involvement of adolescents in biomedical and behavioral HIV research is essential. However, significant individual, operational, and community-level barriers have been recognized to engaging adolescents in clinical prevention trials, which include insufficient understanding of research, need for parental consent, lack of access, mistrust and stigma associated with research participation. The new ATN is poised to address these issues. Central to its success will be an innovative, forward-looking, and productive Coordinating Center that brings cohesion to the participating U19 investigators by sharing their visions and providing scientific leadership, organizational support and analytic results for ATN projects. Key elements that will enhance collaboration and research progress include experienced leadership, innovative design and analysis methodologies, comprehensive research operations support, a state-of-the-art data management system, and superior administrative support. Our infrastructure will provide both public and private websites which include ATN information pages for the public, participants, and investigators, frequently asked questions, study materials, project calendar, a communications hub, and other features. We will develop a secure, user-friendly advanced data management system that includes web-based access for surveys, data entry, research management (including comprehensive reporting, biosample tracking and performance-based reimbursement tools), integration with external applications, and quality control. Our research operations and administration teams will provide a solid foundation to ATN by facilitating communication including meeting arrangements and minutes, collaborative document preparation, tracking of regulatory compliance, and support for abstract and publication preparation across the ATN. Together, this integrated structure will set the stage for collaboration and extraordinary research productivity from protocol development through research data sharing.

抽象的 该 U24 申请的目标是为下一阶段的青少年教育建立协调中心 (CC) HIV/AIDS 干预药物试验网络 (ATN) 由 NIH 赞助。 ATN 的目标是 提高高危青少年对其艾滋病毒状况的认识，并为感染艾滋病毒的青少年建立联系， 护理连续体的参与度和保留度。青少年在成长过程中面临诸多挑战 由于发育变化、同伴影响、身份和自尊而向青年期过渡 形成。青少年中的危险行为，包括进行无保护的性接触或 共用未经消毒的注射吸毒用具，会增加感染艾滋病毒的可能性。 2013年 美国青少年危险行为监测调查（YRBSS），34%的美国高中生报告性行为 过去 3 个月内有过性行为，其中只有 59% 的人表示在最近一次性行为中使用了安全套。 YRBSS 还发现，只有 13% 的学生接受过 HIV 感染检测。鉴于全球 年轻人中新发艾滋病毒感染的负担，青少年更多地参与生物医学和 艾滋病毒行为研究至关重要。然而，个人、运营和社区层面的重大障碍 已认识到让青少年参与临床预防试验，其中包括不足的 对研究的理解、需要父母同意、缺乏接触机会、不信任和耻辱 研究参与。新的 ATN 已准备好解决这些问题。其成功的核心将是 创新、前瞻性和富有成效的协调中心，为参与的 U19 带来凝聚力 研究人员通过分享他们的愿景并提供科学领导、组织支持和分析 ATN 项目的结果。加强合作和研究进展的关键要素包括 经验丰富的领导、创新的设计和分析方法、全面的研究运作 支持、最先进的数据管理系统和卓越的管理支持。我们的基础设施 将提供公共和私人网站，其中包括供公众、参与者、 和调查人员、常见问题、学习材料、项目日历、通信中心，以及 其他功能。我们将开发一个安全、用户友好的高级数据管理系统，其中包括 基于网络的调查、数据输入、研究管理（包括综合报告、 生物样本跟踪和基于绩效的报销工具），与外部应用程序集成，以及 质量控制。我们的研究运营和管理团队将为 ATN 提供坚实的基础： 促进沟通，包括会议安排和会议记录、协作文件准备、 跟踪监管合规性，并支持整个 ATN 的摘要和出版物准备。 总之，这种综合结构将为协作和非凡的研究生产力奠定基础 从协议开发到研究数据共享。