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。在 超过50%的艾滋病新诊断病例都发生在那里。迫切需要创新和 艾滋病毒治疗和预防的合作新方法，在青少年和年轻人（AYA）， 休斯顿这项研究的长期目标是使美国和休斯顿地区更接近于结束艾滋病毒 通过解决在AYA成功预防和治疗艾滋病毒所涉及的问题来预防这一流行病。这些目标 与青少年试验网络（ATN）的研究目标保持一致，休斯顿联盟的伙伴关系将 允许在AYA进行ATN所有五个优先领域的研究：改善艾滋病毒检测，预防 新的感染，让青年参与护理，改善治疗和治疗效果， 2019冠状病毒病导致的艾滋病毒健康不良后果。我们计划实现以下具体目标，作为一个网站， 艾滋病护理，研究和预防在AYA。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（贝勒医学院） ATN网站有一个长期的研究单位与工作人员多年的经验与AYA，无论是在一个 临床试验环境和社区中的艾滋病毒感染者（LWH）或有感染艾滋病毒风险的人。目标2 - 参与试验的开发：TMF的ATN项目负责人和工作人员在以下方面拥有多年的经验： 在AYA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）开发和实施在ATN中进行的试验。此外， 青年社区咨询委员会（YCAB），该委员会的成员一直活跃在ATN青年中 咨询理事会（YAC）和国家CAB、青年专家和健康倡导者（ATN-YEAH）将评估 并就发展研究提供意见，以及为日后的研究提供和加强构思。目标3 -提供 关于成功招募和招募参与者的创新：作为ATN研究中心联盟，我们 有结构，经验和推广，以实现这一目标，在多个层次上与推广难以- 接触AYA，包括种族和性别少数群体以及无家可归的青年。目标4 -提供网站（德克萨斯州儿童 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，以便开展ATN试验 与OCC合作。目标5 -继续评价和调整休斯顿协作组织 ATN中反映的有意义和持续社区参与的联盟领导模式 AYA参与研究有LWH风险。我们预计改进的预期结果 沿着艾滋病毒感染和预防的连续性，在每个ATN优先领域。这个项目影响力很大 因为它将在一个高度优先的地区， 美国与OCC合作，在实现ATN目标方面取得可持续进展。