Children's Hospital Los Angeles Site Consortium - Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Operations and Collaborations Center (UM2 Clinical Trial Optional)

洛杉矶儿童医院站点联盟 - 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: 10709604
• 负责人: MARVIN E BELZER
• 金额: $ 39.78万
• 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/10709604
• 关键词: Address; Adolescent; Adolescent Medicine Trials Network; Adolescent and Young Adult; Adult; Advisory Committees; Advocacy; Area; CCL21 gene; California; Caring; Child; Cities; Clinic; Clinical; Clinical Research; Clinical Services; Clinical Trials; Clinical Trials Network; Cohort Studies; Collaborations; Communities; Complex; County; Databases; Development; Education; Family; Funding; Future; Gays; Goals; Government; HIV; HIV/AIDS; HIV/STD; Health; Homelessness; Hospitals; Intervention; Investigational Drugs; Laboratories; Laboratory Research; Latinx; Lead; Leadership; Lesbian; Lesbian Gay Bisexual Transgender Queer; Los Angeles; Medical; Medicine; Mental Health Services; Modeling; National Institute of Child Health and Human Development; National Institute of Drug Abuse; Pediatric Hospitals; Pharmaceutical Services; Pharmacy facility; Prevention; Protocols documentation; Public Health; Research; Research Project Grants; Risk; Secure; Services; Site; Structure; Universities; Work; adult of color; anti-racism; care systems; children of color; clinical research site; community based service; community engagement; community organizations; community partnership; design; epidemic preparedness; experience; gender diversity; innovation; lens; multidisciplinary; operation; participant enrollment; people of color; positive youth development; prevention service; programs; protocol development; recruit; research study; sex; substance use prevention; transgender; treatment services; young adult; young man

ABSTRACT Children's Hospital Los Angeles (CHLA) Children's Hospital Los Angeles (CHLA) is proposing to be the lead site for the Los Angeles Consortium. The primary aim is to collaborate with Westat as the Adolescent Trials Network (ATN) Operations and Collaborations Center (OCC) to successfully plan and implement ATN clinical research studies to meet the priority areas as outlined in SLC RFA-HD-23-020. CHLA will leverage the strength of the Connect to Protect Los Angeles (C2PLA) Coalition to lead a Research Advisory Committee of community, clinical, and academic partners to: 1. Conduct the Research Projects identified by the ATN Executive and Scientific Leadership Committees; 2. Participate in the development of trials using our community, academic, and clinical partners in conjunction with the ATN Scientific Core to meet the needs of adolescents and young adults (AYA) at- risk for or living with HIV; 3. Contribute to innovative strategies within ATN V regarding successful recruitment and enrollment of participants through established collaborations among clinics, academic universities, community-based organizations, health departments, and other partners; 4. Provide sites with local laboratory capacity and pharmacy support; and 5. Establish a leadership model with meaningful and sustained community engagement efforts to ensure that research studies reflect where AYA are accessing prevention and care services. Our proposed consortium will initially include nine partners who will bring their strength and diversity to a site consortium that will include clinical, academic, government, community, and other partnerships. We have four clinical sites that provide care to AYA living with HIV and at risk for HIV including mostly LGBTQ AYA of color and two partners that currently house large databases of AYA living with HIV and at risk for HIV: ATN CARES at UCLA and the NIDA UO1-funded Healthy Young Men/A Trans Youth of Color Study cohort at CHLA. We have initially targeted four community-based organizations and the County of Los Angeles Department of Public Health Division of HIV and STD Programs. Representatives of these groups and our AYA community advisory boards will form an innovative leadership structure that is representative of our communities and can provide leadership through protocol review, new protocol development, and guidance on recruitment and retention. Based on decades of experience with clinical services and research with AYA, our proposed Los Angeles ATN V Consortium is well suited to join the OCC and other city consortia. CHLA has exceptional access to AYA likely needed in future clinical trials, decades of ongoing community partnerships, and an outstanding track record for recruiting and retaining hard to reach AYA into clinical trials, including complex medical interventions requiring investigational new drugs (IND), research laboratories, and pharmacy services.

摘要 洛杉矶儿童医院 (CHLA) 洛杉矶儿童医院 (CHLA) 提议成为洛杉矶联盟的牵头地点。这 主要目标是与 Westat 合作，负责青少年试验网络 (ATN) 的运营和 合作中心 (OCC) 成功规划和实施 ATN 临床研究，以满足 SLC RFA-HD-23-020 中概述的优先领域。 CHLA 将利用 Connect to Protect 的力量 洛杉矶 (C2PLA) 联盟将领导一个由社区、临床和学术组成的研究咨询委员会 合作伙伴： 1. 开展 ATN 执行委员会和科学领导委员会确定的研究项目； 2. 与我们的社区、学术和临床合作伙伴一起参与试验的开发 与 ATN 科学核心相结合，满足青少年和年轻人 (AYA) 的需求： 有感染艾滋病毒或感染艾滋病毒的风险； 3. 为 ATN V 内成功招募和注册的创新战略做出贡献 参与者通过诊所、学术大学、社区之间建立的合作 组织、卫生部门和其他合作伙伴； 4. 为站点提供当地实验室能力和药房支持；和 5. 建立一个具有有意义和持续的社区参与努力的领导模型，以确保 研究反映了 AYA 在哪里获得预防和护理服务。 我们提议的联盟最初将包括九个合作伙伴，他们将把他们的力量和多样性带到一个网站上 该联盟将包括临床、学术、政府、社区和其他合作伙伴。我们有四个 为感染 HIV 和面临 HIV 风险的 AYA 提供护理的临床中心，其中大部分是 LGBTQ 有色人种 AYA 以及目前拥有感染艾滋病毒和面临艾滋病毒风险的 AYA 大型数据库的两个合作伙伴：ATN CARES 加州大学洛杉矶分校 (UCLA) 的研究和 NIDA UO1 资助的健康年轻人/有色人种跨性别青年研究队列 (CHLA)。我们 最初针对的是四个社区组织和洛杉矶县卫生局 艾滋病毒和性病项目公共卫生司。这些团体和我们 AYA 社区的代表 顾问委员会将形成一个创新的领导结构，该结构代表我们的社区，并且可以 通过方案审查、新方案制定以及招募和指导提供领导 保留。根据 AYA 数十年的临床服务和研究经验，我们建议的 Los 洛杉矶 ATN V 联盟非常适合加入 OCC 和其他城市联盟。 CHLA 拥有卓越的 未来临床试验可能需要获得 AYA、数十年持续的社区合作伙伴关系以及 在招募和保留难以接触的 AYA 进入临床试验（包括复杂的临床试验）方面拥有出色的记录 需要研究性新药 (IND)、研究实验室和药房服务的医疗干预措施。