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: 9353195
• 负责人: Mary Jane Rotheram-Borus
• 金额: $ 373.86万
• 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/9353195
• 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; Comorbidity; 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; Infant; Infection; Intervention; Leadership; Life; Link; Literature; Los Angeles; Medical; Modeling; Monitor; Neighborhoods; Outcome; Perinatal; Prevention; Prophylactic treatment; Quality of life; Randomized; Randomized Controlled Trials; Recording of previous events; Recruitment Activity; 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; adolescent health outcomes; aged; antiretroviral therapy; arm; base; brief intervention; care seeking; cohort; community center; comparison group; design; disorder prevention; evidence base; high risk; improved; novel; peer support; policy implication; pre-exposure prophylaxis; prevent; screening; skills; social media; standard care; success; therapy adherence; transgender; transmission process; 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 美国艾滋病毒在12-24岁青年中的流行日益增加，而我们同时未能识别、联系 在青年艾滋病毒携带者中护理和实现病毒抑制(青年会)表明有必要确定新的 以社区为基础的战略，以利用高危和受感染青年可能存在的网关和环境 从事艾滋病毒预防和治疗工作。科学成就显著减少了HIV病毒的蓄积量 受感染的婴儿，阻止艾滋病毒感染的成年人在无法检测到的病毒载量下传播艾滋病毒，以及 记录治疗作为预防的有效性(TasP)建议减少以下趋势的策略 青少年艾滋病毒感染增加。这份U19将评估这些进步对年青人的用处 12-24岁-感染艾滋病毒的风险最高-男同性恋、双性恋、变性人青年(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)的艾滋病毒携带者青年(青年会)。 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将是 经过18个月的筛选。从这些筛查中，220名青年黄体生成素和1500名最高风险血清阴性 GBTY和HY将成立。在24个月内，这一队列将每隔4个月重复测试一次 性传播感染(STI)和严重药物使用，以及第四代艾滋病毒检测如果血清阴性，依次为 识别受急性感染的青年，让青年参与医疗护理，并监测结果。青年被分流到： 研究1：急性感染。以60例确诊感染的初治ARV患者为对照，我们预计 确诊36例青壮年急性感染。所有患有急性感染的青少年都将接受至少四种药物的积极治疗 高效抗逆转录病毒疗法(ARV)，并反复评估以检查是否延长了病毒抑制 实现了这一目标，减少了病毒库，有可能实现无ARV的艾滋病毒缓解。 研究2：对青年会的阶梯式护理。调整管理慢性病的策略，我们将进行随机对照试验 比较标准护理臂(每四个月重复评估一次)和自动化消息传递和 监测干预[AMMI])到分级护理。在阶梯式护理的手臂上，越来越强烈 如果可以检测到病毒载量，则提供干预：a)标准护理臂；b)量身定做的AMMI 共病；或c)一名教练在危机期间提供支持，进行治疗转介，并简要介绍 干预措施。干血斑点将监测病毒载量，并在小样本上监测随着时间的推移ARV的粘附性。 研究3：让血清阴性的年轻人参与艾滋病毒预防的连续体。青年将随机分为以下两组： A)AMMI臂；b)对等支持加AMMI臂；c)eNavigator和AMMI臂；或d)对等支持加 ENavigator加上AMMI ARM。每一种情况都旨在优化艾滋病毒预防连续体。 一个由基础、临床和应用研究人员组成的跨学科团队，他们拥有艾滋病毒、性传播感染、行为学等方面的专业知识 干预措施，生物医学干预，治愈研究，围产期艾滋病毒，以及参与和 协调多站点RCT将参加来自六所大学的U19。