Baylor College of Medicine Site Consortium - Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Operations and Collaborations Center (UM2 Clinical Trial Optional)

贝勒医学院站点联盟 - 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: 10709602
• 负责人: MARY E PAUL
• 金额: $ 31.22万
• 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/10709602
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Adherence; Adolescent Medicine Trials Network; Adolescent and Young Adult; Advisory Committees; Advocate; Affect; African American population; Area; Black race; COVID-19; COVID-19 pandemic; Caring; Cities; Clinical Trials; Collaborations; Communities; Conduct Clinical Trials; County; Development; Discipline of Nursing; Drug Kinetics; Epidemic; Evaluation; Failure; Feedback; Future; Goals; HIV; HIV Infections; HIV diagnosis; HIV/AIDS; Health; Healthcare; Heterosexuals; Hispanic; Homeless Youth; Human Resources; Human immunodeficiency virus test; Individual; Infection; Intervention; Laboratories; Latino; Latinx; Lead; Leadership; Low income; Medicaid; Medical; Medicine; Minority Groups; Modality; Modeling; Newly Diagnosed; Online Systems; Outcome; Pediatric Hospitals; Pharmacy facility; Prevention; Reporting; Research; Risk; Services; Site; Structure; Technology; Texas; Treatment Effectiveness; Uninsured; United States; Work; Youth; age group; case-based; college; community engagement; community organizations; design; ethnic minority population; experience; gender minority youth; health inequalities; high risk; human old age (65+); improved; improved outcome; innovation; male; marginalized community; meetings; member; motivational enhancement therapy; novel strategies; operation; outreach; participant enrollment; pre-exposure prophylaxis; prevent; prevention service; programs; racial minority; recruit; research study; sexual minority group; testing services; transmission process; treatment services; uptake

ABSTRACT Baylor College of Medicine Harris County, which includes the City of Houston, is among the 48 counties in the United States (U.S.) in which more than 50 percent of new HIV diagnoses occur. There is an urgent need for innovative and collaborative new approaches to HIV treatment and prevention in adolescents and young adults (AYA) in Houston. The long-term goal of this research is to move the U.S. and Houston area closer to ending the HIV epidemic by addressing the issues involved in successful prevention and treatment of HIV in AYA. These goals align with Adolescent Trials Network (ATN) research objectives and Houston Consortium partnerships will allow research to be conducted in AYA in all five priority areas of the ATN: improving HIV testing, preventing new infections, engaging youth in care, improving treatment and treatment effectiveness, and reducing adverse HIV health outcomes due to COVID-19. We plan to accomplish the following specific aims as a site for HIV care, research, and prevention in AYA. Aim 1 – Conduct the Trials of the ATN as identified by the ATN Executive Committee (EC) and Scientific Leadership Committee (SLC): Baylor College of Medicine (BCM) ATN site has a longstanding research unit with staff with years of experience working with AYA, both in a clinical trials settings and in the community, who are living with HIV (LWH) or are at risk for HIV. Aim 2 – Participate in the Development of Trials: BCM's ATN Project Lead and staff have years of experience in development and conducting of clinical trials in AYA and so will work in collaboration with the ATN Operations and Collaborations Center (OCC) to develop and conduct the trials performed in the ATN. In addition, the BCM Youth Community Advisory Board, (YCAB), which has had members who have been active in the ATN Youth Advisory Council (YAC) and National CAB, Youth Experts and Advocates for Health (ATN-YEAH), will evaluate and provide input on developing studies and provide and enhance ideas for future studies. Aim 3 – Provide Innovation Regarding Successful Recruitment and Enrollment of Participants: As an ATN Site Consortium, we have the structure, experience, and outreach to approach this aim at multiple levels with outreach in hard-to- reach AYA including racial and gender minority and homeless youth. Aim 4 – Provide Sites (Texas Children's Hospital and Harris Health Northwest and Thomas Street Health Center) as well as outreach within the Houston ATN Consortium, local laboratory capacity, and pharmacy support in order to conduct the ATN trials in collaboration with the OCC. Aim 5 – Continued evaluation and adjustment of Houston collaborative consortium leadership model for meaningful and continued community engagement as reflected in ATN research study participation of AYA at risk for or LWH. We anticipate the expected outcomes of improvements in each ATN priority area along the continuums of HIV infection and prevention. This project is high impact because it will provide the necessary consortium in impacted communities of AYA in a high-priority region of the U.S. to collaborate with the OCC to make sustainable progress in reaching the ATN goals.

摘要 贝勒医学院 哈里斯县（包括休斯顿市）是美国 48 个县之一 超过 50% 的艾滋病毒新诊断迫切需要创新和解决方案。 青少年和年轻人（AYA）艾滋病毒治疗和预防的合作新方法 这项研究的长期目标是让美国和休斯顿地区更接近终结艾滋病毒。 通过解决 AYA 成功预防和治疗艾滋病毒所涉及的问题来实现这些目标。 与青少年试验网络（ATN）的研究目标保持一致，休斯顿联盟的合作伙伴关系将 允许 AYA 在 ATN 的所有五个优先领域进行研究：改进 HIV 检测、预防 新感染、青年参与护理、改善治疗和治疗效果，以及减少 由于 COVID-19，我们计划实现以下具体目标： AYA 中的 HIV 护理、研究和预防 目标 1 – 进行 ATN 确定的 ATN 试验。 执行委员会 (EC) 和科学领导委员会 (SLC)：贝勒医学院 (BCM) ATN 站点拥有一个长期研究部门，其工作人员均具有多年与 AYA 合作的经验 临床试验环境和社区中感染艾滋病毒 (LWH) 或有感染艾滋病毒风险的人 目标 2 –。 参与试验的开发：BCM 的 ATN 项目负责人和员工拥有多年的经验 在 AYA 中开发和开展临床试验，因此将与 ATN 运营部门合作 和合作中心（OCC）开发并进行在 ATN 中进行的试验此外，BCM。 青年社区咨询委员会 (YCAB)，其成员一直活跃于 ATN Youth 咨询委员会 (YAC) 和国家 CAB、青年专家和健康倡导者 (ATN-YEAH) 将评估 为开展研究提供意见，并为未来的研究提供和加强想法 3 – 提供。 关于成功招募和注册参与者的创新：作为 ATN 站点联盟，我们 拥有在多个层面上实现这一目标的结构、经验和外展活动，并在难以实现的领域进行外展活动 覆盖 AYA，包括种族和性别少数群体以及无家可归的青少年。 目标 4 – 提供站点（德克萨斯州儿童基金会）。 医院和哈里斯健康西北和托马斯街健康中心）以及在 休斯顿 ATN 联盟、当地实验室能力和药房支持，以进行 ATN 试验 与 OCC 合作目标 5 – 继续评估和调整休斯顿合作。 ATN 中反映的有意义且持续的社区参与的联盟领导模型 AYA 或 LWH 风险的研究参与我们预计改进的预期结果。 在艾滋病毒感染和预防连续体的每个 ATN 优先领域，该项目影响很大。 因为它将在 AYA 高优先级地区的受影响社区中提供必要的联盟 美国与 OCC 合作，在实现 ATN 目标方面取得可持续进展。