The Supporting Adolescent Adherence in Vietnam (SAAV) Study

 描述(由申请人提供)：支持越南青少年坚持抗逆转录病毒治疗(SAAV)越南迫切需要1)了解艾滋病毒感染青少年在保持高度坚持抗逆转录病毒治疗(ART)方面面临的挑战，包括在资源匮乏的情况下；2)在这些情况下严格衡量青少年对抗逆转录病毒治疗的坚持；以及3)确定和测试旨在帮助青少年实现并保持较高抗逆转录病毒治疗坚持水平的干预措施。包括电子药物监测器(EDM)在内的新兴技术已显示出在成人中作为依从性支持的潜力；我们建议将其扩展到青少年。在越南，目前有4300多名艾滋病毒阳性的儿童和青少年正在接受抗逆转录病毒治疗，首批幸存的接受抗逆转录病毒治疗的儿童正在过渡到成人护理。其中超过10%的患者已经在接受二线治疗，这引发了人们对越南艾滋病毒治疗计划的依从性、耐药性和最终有效性的担忧。SAAV的总体目标是增加对支持青少年抗逆转录病毒治疗患者高依从性的可行和有效的干预措施的理解。具体目的是：1)检查青少年抗逆转录病毒治疗患者及其照顾者中坚持治疗的促进者和挑战；2)为青少年患者量身定做基于EDM的实时坚持支持干预包，利用青少年在制定包中的意见；3)评估这种创新的、个性化的方法在青少年中改善坚持治疗的可行性和可接受性；以及4)通过实施小型随机对照试验(RCT)，在这一患者群体中产生关于坚持治疗和临床结果的个性化实时反馈包的有效性的初步数据。SAAV将通过RCT的形成性研究和实施，在两年内实现这些目标。在形成性工作中，我们将质疑坚持的挑战，讨论提高坚持的策略，并改进向随机对照试验参与者提供的干预方案的选项；我们还将与临床医生探讨他们照顾青少年和管理向成人护理过渡的经验。在随机对照试验中，80名青少年患者将在河内的一家艾滋病毒诊所登记。核心干预将利用无线药丸容器(WPC)在6个月内提供2层量身定制的依从性反馈：1)通过电话或瓶子提醒错过剂量时的持续反馈；以及2)通过咨询会议与获得实时数据的临床医生进行每月反馈。干预对象可以定制他们的个人干预方案。对照受试者将通过WPC提供依从性数据，并在每月的诊所就诊时接受常规护理和咨询。除了依从性和临床数据外，还将使用调查工具和深入访谈收集定量和定性数据。对这些数据的分析将有助于实现具体目标，并有助于为青少年抗逆转录病毒治疗依从性支持策略提供科学证据。该研究的波士顿-河内团队由经验丰富的研究人员组成，具有进行这项研究的非凡能力。在越南官员和临床医生的大力支持下，我们的结果具有很高的政策和项目影响潜力。

 DESCRIPTION (provided by applicant): Supporting Adolescent Adherence in Vietnam (SAAV) There an urgent need to 1) gain understanding of challenges faced by HIV-infected adolescents in maintaining high adherence to antiretroviral treatment (ART), including in low-resource settings; 2) measure ART adherence rigorously among youth in these contexts; and 3) identify and test interventions designed to help adolescents achieve and maintain high ART adherence levels. Emerging technologies, including electronic drug monitors (EDM), have demonstrated potential as adherence supports in adults; we propose to extend this to adolescents. In Vietnam, more than 4300 HIV-positive children and adolescents are currently on ART, and the first surviving cohorts of pediatric ART recipients are transitioning to adult care. Over 10% of these patients are already on second line therapy, raising concerns regarding adherence, drug resistance, and the ultimate effectiveness of Vietnam's HIV treatment program. SAAV's overall goal is to increase understanding of interventions that are feasible and effective in supporting high adherence among adolescent ART patients. The specific aims are to: 1) Examine facilitators of and challenges to adherence among adolescent ART patients and their caregivers; 2) Tailor an EDM-based real-time adherence support intervention package for adolescent patients, using input from adolescents in development of the package; 3) Assess feasibility and acceptability of this innovative, personalized approach to improving adherence among adolescents; and 4) Generate preliminary data regarding efficacy of the personalized real-time feedback package on adherence and clinical outcomes in this patient population by implementing a small randomized controlled trial (RCT). SAAV will achieve these aims over 2 years via formative research and implementation of the RCT. In formative work, we will query challenges to adherence, discuss strategies for improving adherence, and refine options for the intervention package offered to RCT participants; we will also explore with clinicians their experiences caring for youth and managing the transition to adult care. For the RCT, 80 adolescent patients will be enrolled in a HIV clinic in Hanoi. The core intervention will make use of wireless pill containers (WPCs) to provide, over 6- months, 2 layers of tailored adherence feedback: 1) continuous feedback via phone or bottle-based reminders when doses are missed; and 2) monthly feedback via counseling sessions with a clinician informed by the real- time data. Intervention subjects may tailor their individual intervention package. Comparison subjects will provide adherence data via WPC and receive usual care and an offer of counseling at monthly clinic visits. In addition to adherence and clinical data, quantitative and qualitative dat will be collected using survey instruments and in-depth interviews. Analysis of these data will enable achievement of the specific aims and contribute to the scientific evidence base on ART adherence-support strategies in adolescents. The study's Boston-Hanoi team of experienced researchers has exceptional capacity to conduct the study. With strong support from Vietnamese officials and clinicians, our results have high potential for policy and program impact.