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: 10174219
• 负责人: MARIA ISABEL FERNANDEZ
• 金额: $ 93.16万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-30 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10174219
• 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; Homelessness; Human immunodeficiency virus test; Incidence; Infection; Intervention; Leadership; Life; Link; Literature; Los Angeles; Medical; Modeling; Monitor; Neighborhoods; Outcome; Perinatal transmission; Prevention; Prophylactic treatment; Quality of life; Randomized; Randomized Controlled Trials; Recording of previous events; Research; Research Personnel; Sampling; Scientist; Secure; Sexually Transmitted Diseases; Shelter facility; 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; improved; neonatal 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; 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.

项目总结/摘要 美国12-24岁的年轻人中艾滋病毒流行病的增加以及我们同时未能识别，联系到 护理，并在感染艾滋病毒的青少年中实现病毒抑制（YLH）表明有必要识别新的 以社区为基础的战略，利用高风险和受感染青年可能接触的通道和环境 从事艾滋病的预防和治疗。科学成功减少急性感染者中的艾滋病毒储存库 受感染的婴儿，阻止病毒载量检测不到的艾滋病毒感染成人传播艾滋病毒， 记录治疗即预防（TASP）的有效性，提出了减少 增加青少年艾滋病毒感染。这一U19将评估这些进步对青年的有用性。 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）和无家可归青年（HY） - 以及两个艾滋病毒中心（洛杉矶和新奥尔良）的青年艾滋病毒感染者（YLH）。 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将被 筛选了18个月。从这些筛查中，220名YLH和1，500名最高风险血清阴性的队列 GBTY和HY将形成。在24个月内，该队列将每隔4个月重复检测 性传播感染（STI）和严重吸毒，如果血清阴性，则进行第四代HIV检测， 确定急性感染的青年，让青年参与医疗保健，并监测结果。青年被分类为： 研究1：急性感染。使用60例确诊感染的未接受过抗逆转录病毒治疗的YLH作为对照，我们希望 鉴定出36例急性感染YLH。所有患有急性感染的青少年将积极接受至少四种 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 减少了病毒库，从而有可能实现无抗逆转录病毒的艾滋病缓解。 研究2：YLH的阶梯式护理。调整策略以管理慢性病，我们将进行RCT 比较标准治疗组（每四个月重复评估一次，自动消息传递， 监测干预[AMMI]）到阶梯式护理。在分级护理组中， 如果可检测到病毒载量，则进行干预：a）标准治疗组; B）定制的AMMI， 特定YLH的合并症;或c）在危机期间提供支持的教练，进行治疗转诊，并简要介绍 干预措施。干血斑将监测病毒载量，并在一个小样本，随着时间的推移，抗逆转录病毒药物的坚持。 研究3：让血清反应阴性青年参与艾滋病毒预防连续体。青少年将被随机分配至： a）AMMI组; B）同伴支持加AMMI组; c）eNavigator和AMMI组;或d）同伴支持加 eNavigator + AMMI臂。每种条件都旨在优化HIV预防连续体。 一个由基础、临床和应用研究人员组成的跨学科团队，他们在艾滋病毒、性传播感染、行为 干预措施，生物医学干预措施，CURE研究，围产期艾滋病毒，以及参与和 协调多站点RCT参与了来自六所大学的U19。