A Comprehensive Community-based Strategy to Optimize the HIV Prevention and Treatment Continuum for Youth At HIV Risk, Acutely Infected and with Established HIV Infection

一项以社区为基础的综合战略，旨在优化处于艾滋病毒风险、急性感染和已确诊艾滋病毒感染的青少年的艾滋病毒预防和治疗连续性

• 批准号: 10397368
• 负责人: MARIA ISABEL FERNANDEZ
• 金额: $ 242.98万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10397368
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Acute; Address; Adolescent; Adopted; Adult; Age; Americas; Behavior; Behavior Therapy; Behavioral; Bisexual; Blood; Caring; Centers for Disease Control and Prevention (U.S.); Chronic Disease; Clinical; Collaborations; Communication; Communities; Consult; Data; Data Analyses; Data Collection; Development; Diffuse; Disease Progression; Disease remission; Drug usage; Economics; Epidemic; Evidence based intervention; Failure; Gays; HIV; HIV Infections; HIV Seronegativity; HIV risk; Health; High Prevalence; Homeless Youth; Human immunodeficiency virus test; Incidence; Infection; Intervention; Leadership; Life; Link; Literature; Los Angeles; Medical; Modeling; Monitor; Neighborhoods; Outcome; Perinatal transmission; Prophylactic treatment; Quality of life; Randomized; Randomized Controlled Trials; Recording of previous events; Research; Research Personnel; Sampling; Scientist; Secure; Sexually Transmitted Diseases; Site; Spottings; Structure; Subgroup; Technology; Testing; Time; Training; Treatment Efficacy; Triage; Universities; Viral; Viral Load result; Viral reservoir; Youth; acute infection; adolescent health outcomes; aged; antiretroviral therapy; arm; base; brief intervention; care seeking; cohort; community center; comorbidity; comparison group; data standards; design; evidence base; high risk; homeless shelters; improved; infant infection; novel; peer support; perinatal HIV; policy implication; pre-exposure prophylaxis; prevent; recruit; screening; skills; social media; standard care; success; therapy adherence; transgender; transmission process; treatment arm; treatment as prevention; trend; trial comparing; trial design

Project Summary/Abstract America's increasing HIV epidemic among youth aged 12-24 and our concurrent failure to identify, link to care, and achieve viral suppression among youth living with HIV (YLH) suggests the need to identify novel community-based strategies to leverage gateways and settings where high risk and infected youth can be engaged in HIV prevention and treatment. Scientific successes reducing HIV viral reservoirs among acutely infected infants, stopping HIV transmission from HIV-infected adults with undetectable viral loads, and documenting the efficacy of Treatment as Prevention (TASP) suggest strategies to reduce the trend of increasing adolescent HIV infections. This U19 will evaluate the usefulness of these advances for youth aged 12-24 at the highest risk of acquiring HIV- gay, bisexual, transgender youth (GBTY) and homeless youth (HY) – as well as youth living with HIV (YLH) in two HIV epicenters (Los Angeles and New Orleans). All GBTY and HY at five gay-identified community-based organizations (CBO) and homeless shelters will be screened over 18 months. From these screenings, a cohort of 220 YLH and 1,500 highest risk seronegative GBTY and HY will be formed. Over 24 months, this cohort will be repeatedly tested at four month intervals for sexually transmitted infections (STI) and serious drug use, and with 4th Gen HIV tests if seronegative, in order to identify acutely infected youth, engage youth in medical care, and monitor outcomes. Youth are triaged to: Study 1: Acute infection. Using 60 ARV-naive YLH with established infection as controls, we expect to identify 36 YLH with acute infection. All youth with acute infections will be aggressively treated with at least four highly potent antiretroviral therapies (ARV) and repeatedly assessed to examine if prolonged viral suppression is achieved, with reduced viral reservoirs to potentially allow ARV- free HIV remission. Study 2: Stepped care for YLH. Adapting strategies to manage chronic illnesses, we will conduct a RCT comparing a Standard Care Arm (repeated assessments every four month and an Automated Messaging and Monitoring Intervention [AMMI]) to Stepped Care. In the Stepped Care Arm, increasingly more intense interventions are delivered if viral load is detectable: a) the Standard Care Arm; b) an AMMI that is tailored to comorbidities of the specific YLH; or c) a Coach to support during crises, make treatment referrals, and brief interventions. Dried blood spots will monitor viral load and, on a small sample, ARV adherence over time. Study 3: Engaging seronegative youth in the HIV Prevention Continuum. Youth will be randomized to either: a) an AMMI Arm; b) Peer-Support plus AMMI Arm; c) eNavigator and an AMMI arm; or d) Peer-Support plus eNavigator plus AMMI Arm. Each condition aims to optimize the HIV Prevention Continuum. An interdisciplinary team of basic, clinical, and applied researchers with expertise in HIV, STI, behavioral interventions, biomedical interventions, CURE research, perinatal HIV, and a history of participating and coordinating multi-site RCT is participating on this U19 from six universities.

项目摘要/摘要 美国12-24岁的年轻人的艾滋病毒流行日益增加，我们同时未能识别，与 护理并在艾滋病毒（YLH）的青年中实现病毒抑制表明需要识别新颖 基于社区的策略来利用高风险和受感染青年的门户和环境 从事艾滋病毒预防和治疗。科学成功降低了敏锐的艾滋病毒病毒储量 受感染的婴儿，阻止感染了无法检测到病毒载荷的HIV感染的成年人的HIV传播，并且 记录治疗效率作为预防效率（TASP）提出了降低趋势的策略 增加青少年HIV感染。该U19将评估这些进步的有用性 12-24处于获得艾滋病毒，双性恋，变性青年（GBTY）和无家可归青年（HY）的最高风险 - 以及在两个艾滋病毒震中（洛杉矶和新奥尔良）中患有艾滋病毒（YLH）的青年。 五个基于同性恋社区的组织（CBO）和无家可归者庇护所的所有GBTY和HY将是 筛选了18个月以上。从这些筛选中，共有220 YLH和1,500最高风险血清负格的队列 GBTY和HY将形成。在24个月的时间里，该队列将在四个月间的间隔中重复测试 性传播感染（STI）和严重的药物使用，以及第四代HIV测试（如果血清染色） 确定急性感染的年轻人，让青年参与医疗保健并监测结果。青年人被分为： 研究1：急性感染。使用已建立感染作为对照的60个ARV-NOIVE YLH，我们希望 鉴定出36 YLH，急性感染。所有患有急性感染的年轻人将至少进行至少四个 高潜在的抗逆转录病毒疗法（ARV），并反复评估以检查是否长期抑制病毒 实现了降低的病毒储存剂，可以潜在地允许无抗HIV的缓解。 研究2：对YLH的阶梯护理。适应管理慢性病的策略，我们将进行RCT 比较标准护理部门（每四个月重复评估，以及自动消息传递和 监测干预[AMMI]）以逐步护理。在阶梯式护理臂中，越来越强烈 如果可以检测到病毒负荷，则提供干预措施：a）标准护理臂； b）量身定制的AMMI 特定YLH的合并症；或C）在危机期间支持的教练，进行治疗和简短 干预措施。干血点会监测病毒载荷，并且在一小部分样本上，随着时间的推移遵守。 研究3：吸引血清神经青年在HIV预防连续体中。年轻人将被随机分配给： a）AMMI手臂； b）同伴支持加上AMMI臂； c）Enavigator和AMMI臂；或d）同伴支持Plus Enavigator Plus Ammi Arm。每种疾病旨在优化HIV预防连续体。 一个基本，临床和应用研究人员的跨学科团队 干预措施，生物医学干预措施，治疗研究，围产期艾滋病毒以及参与和 坐标多站点RCT正在六所大学参加该U19。