The Supporting Adolescent Adherence in Vietnam (SAAV) Study

越南青少年依从性支持 (SAAV) 研究

• 批准号: 9336363
• 负责人: Mary Bachman DeSilva
• 金额: $ 17.3万
• 依托单位: UNIVERSITY OF NEW ENGLAND
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-24 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9336363
• 关键词: 19 year old; Achievement; Address; Adherence; Adolescence; Adolescent; Adult; Affect; Age; Anti-Retroviral Agents; Behavior; Boston; CD4 Lymphocyte Count; Caregivers; Caring; Child; Childhood; China; Chronic Disease; Clinic; Clinic Visits; Clinical; Clinical Data; Counseling; Country; Data; Data Analyses; Decision Making; Development; Dose; Drug resistance; Effectiveness; Electronic drug monitoring; Emerging Technologies; Enrollment; Epidemic; Feedback; General Population; Goals; HIV; HIV Seropositivity; HIV-infected adolescents; Health Personnel; Individual; Intervention; Interview; Literature; Measures; Monitor; Outcome; Participant; Patients; Pharmaceutical Preparations; Phase; Phonation; Policies; Policy Maker; Population; Populations at Risk; Randomized Controlled Trials; Recruitment Activity; Research; Research Personnel; Resources; Self Determination; Surveys; Telephone; Testing; Time; Vietnam; Viral Load result; Wireless Technology; Work; Youth; adolescent patient; antiretroviral therapy; base; clinical practice; cohort; effective intervention; effective therapy; evidence base; experience; improved; innovation; interest; medication compliance; mortality; multidisciplinary; new technology; novel; patient population; personalized approach; personalized intervention; pill; preference; programs; public health relevance; scale up; success; support tools; systematic review; theories; therapy design; tool; treatment adherence; treatment as usual; treatment program

 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.

 描述（由申请人提供）：支持越南青少年依从性 (SAAV) 迫切需要 1) 了解艾滋病毒感染青少年在维持抗逆转录病毒治疗 (ART) 的高依从性方面所面临的挑战，包括在资源匮乏的环境中； 2) 在这些背景下严格衡量青少年对 ART 的遵守情况； 3) 确定并测试旨在帮助青少年实现并保持高 ART 依从性水平的干预措施。包括电子药物监测仪 (EDM) 在内的新兴技术已显示出作为成人依从性支持的潜力；我们建议将此范围扩大到青少年。在越南，目前有超过 4300 名艾滋病毒呈阳性的儿童和青少年正在接受抗逆转录病毒治疗，第一批幸存的儿科抗逆转录病毒治疗接受者正在过渡到成人护理。其中超过 10% 的患者已经接受二线治疗，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 的总体目标是增进对支持青少年 ART 患者高依从性的可行且有效的干预措施的理解。具体目标是： 1) 检查青少年 ART 患者及其护理人员依从性的促进因素和挑战； 2) 利用青少年在制定该方案时的意见，为青少年患者量身定制基于 EDM 的实时依从性支持干预方案； 3) 评估这种创新、个性化方法的可行性和可接受性，以提高青少年的依从性； 4) 通过实施小型随机对照试验 (RCT)，生成有关个性化实时反馈包对该患者群体的依从性和临床结果的功效的初步数据。 SAAV 将通过形成性研究和 RCT 的实施，在两年内实现这些目标。在形成性工作中，我们将询问依从性方面的挑战，讨论提高依从性的策略，并完善为随机对照试验参与者提供的干预方案的选择；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。对于随机对照试验，河内一家艾滋病毒诊所将招募 80 名青少年患者。核心干预措施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) 在错过服药时通过电话或瓶子提醒进行持续反馈； 2) 通过与临床医生的咨询会议获得实时数据的每月反馈。干预对象可以定制他们的个人干预方案。比较对象将通过 WPC 提供依从性数据，并接受常规护理以及每月门诊就诊时提供的咨询服务。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，并有助于为青少年的 ART 依从性支持策略提供科学证据基础。该研究的波士顿-河内团队由经验丰富的研究人员组成，具有非凡的研究能力。在越南官员和临床医生的大力支持下，我们的结果具有很大的政策和项目影响潜力。