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

项目概要/摘要 美国 12 至 24 岁青少年中艾滋病毒流行率不断上升，而我们同时未能识别、联系到 护理，并在感染艾滋病毒的青少年（YLH）中实现病毒抑制，这表明需要确定新的 基于社区的战略，利用高风险和受感染青少年可能接触的门户和环境 从事艾滋病预防和治疗工作。科学上的成功大大减少了艾滋病病毒储存库 受感染的婴儿，阻止病毒载量无法检测到的艾滋病毒感染成人的艾滋病毒传播，以及 记录“治疗即预防”（TASP）的功效，提出了减少这种趋势的策略 青少年艾滋病毒感染增加。这位 U19 将评估这些进步对青少年的有用性 12-24岁感染艾滋病毒的风险最高——同性恋、双性恋、变性青年（GBTY）和无家可归的青年（HY） – 以及两个艾滋病毒中心（洛杉矶和新奥尔良）的艾滋病毒感染者 (YLH) 青少年。 五个同性恋社区组织 (CBO) 和无家可归者收容所的所有 GBTY 和 HY 都将 筛选时间超过 18 个月。从这些筛查中，我们得到了 220 名 YLH 和 1,500 名最高风险血清阴性人群的队列 GBTY和HY将成立。在 24 个月内，该队列将每隔 4 个月进行一次重复测试 性传播感染 (STI) 和严重吸毒，如果血清呈阴性，则进行第四代 HIV 检测，以便 识别严重感染的青少年、让青少年接受医疗护理并监测结果。青少年被分类为： 研究1：急性感染。使用 60 个未感染 ARV 并已确诊感染的 YLH 作为对照，我们期望 确定 36 名 YLH 患有急性感染。所有患有急性感染的青少年都将接受至少四种治疗 高效抗逆转录病毒疗法（ARV）并反复评估以检查是否延长病毒抑制 已实现，病毒库减少，有可能实现无抗逆转录病毒（ARV）的艾滋病毒缓解。 研究 2：YLH 的分级护理。调整策略来管理慢性病，我们将进行随机对照试验 比较标准护理组（每四个月重复一次评估以及自动消息传递和 监测干预[AMMI]）到分级护理。在阶梯护理臂中，越来越强烈 如果检测到病毒载量，则提供干预措施： a) 标准护理组； b) AMMI 专门针对 特定 YLH 的合并症； c) 一名教练在危机期间提供支持、转介治疗并简要说明 干预措施。干血斑将监测病毒载量，并在小样本上监测抗逆转录病毒药物随时间的变化情况。 研究 3：让血清阴性青少年参与艾滋病毒预防连续体。青少年将被随机分配到： a) AMMI 臂； b) 同伴支持加 AMMI 部门； c) eNavigator 和 AMMI 臂；或 d) 同伴支持加 eNavigator 加上 AMMI 臂。每种情况都旨在优化艾滋病毒预防连续体。 由基础、临床和应用研究人员组成的跨学科团队，具有艾滋病毒、性传播感染、行为学方面的专业知识 干预措施、生物医学干预措施、CURE 研究、围产期 HIV 以及参与和参与的历史 协调多地点 RCT 的六所大学参与了这一 U19 项目。

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.