Motivational Enhancement System for Adherence (MESA) for Youth Starting ART

青少年开始 ART 的依从性动机增强系统 (MESA)

• 批准号: 9116293
• 负责人: SYLVIE NAAR
• 金额: $ 66.61万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-01 至 2020-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9116293
• 关键词: AIDS/HIV problem; Address; Adherence; Adolescent Medicine; Adolescent Medicine Trials Network; Adult; Affect; Age; Anti-Retroviral Agents; Area; Behavior Therapy; Behavioral; Biological Assay; CD4 Lymphocyte Count; Computer software; Computers; Disease; Dose; Elements; Event; Exercise; Funding; HIV; Hair; Health; Individual; Intervention; Knowledge; Life; Measures; Mediator of activation protein; Medicine; Mental Health; Modeling; Motivation; Nature; Outcome; Perception; Persons; Prevention approach; Prevention program; Preventive Intervention; Primary Prevention; Protocols documentation; Public Health; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recruitment Activity; Sampling; Self Efficacy; Site; Specimen; Substance abuse problem; Symptoms; System; Technology; Testing; United States; United States National Institutes of Health; Update; Viral Load result; Virus; Visual; Youth; active control; analog; base; brief intervention; comparative efficacy; disease transmission; executive function; follow-up; improved; innovation; medication compliance; motivational enhancement therapy; motivational intervention; novel; novel strategies; nutrition; prevent; primary outcome; resistant strain; response; skills; standard care; theories; transmission process; treatment adherence; treatment effect; trend

 DESCRIPTION (provided by applicant): Medication adherence rates among youth living with HIV (YLH) are inadequate to effectively manage the disease. Very few adherence interventions have been tested with youth, and those that have are difficult to implement in real-world settings due to high intensity of sessions or low attendance rates. Thus, there is a demand for innovative, feasible, and engaging behavioral interventions targeting adherence, especially among YLH, the largest initiators of antiretroviral treatment (ART). A universal primary prevention program is a novel approach to target adherence problems before they begin by providing a prevention intervention to all youth newly initiating ART. In response to PA-14-127, this proposal plans to test a brief, 2-session, computer-delivered motivational intervention to prevent adherence difficulties among youth newly prescribed ART. All elements of the protocol (assessment, intervention, control condition) were piloted in a small multi-site randomized controlled trial in the NIH-funded Adolescent Medicine Trials Medicine Network for HIV/AIDS interventions (ATN). Results suggested feasibility and acceptability of the study protocol as well as trends for improved adherence when comparing the intervention to an active control condition. For the proposed multi-site randomized clinical trial, youth newly beginning ART (N=300 from 4 ATN sites in the United States) will be randomize to the Motivational Enhancement System for Adherence (MESA) or to the control condition (nutrition and exercise information delivered by the same platform matched for dose). ART adherence (visual analog and hair specimen assays) and biomedical measures (viral load and CD4 counts), in addition to potential mediators (HIV knowledge, motivation for adherence, and self-efficacy for adherence) and moderators (substance abuse, mental health symptoms, executive functioning, and stressful life events) will be collected at baseline, 1-month, and 3-, 6-, 9- and 12-months. It is hypothesized that youth randomized to MESA will show significantly greater adherence and health outcomes than youth randomized to the control condition over one year of follow-up. In addition, we will identify the mechanisms (mediators) of MESA treatment effects on primary outcomes and assess predictors of differential intervention response including substance abuse, mental health symptoms, executive functioning, and structural barriers.

 描述（由申请人提供）：艾滋病毒感染者（YLH）青年的药物依从率不足以有效管理这种疾病。很少有依从性干预措施在青少年中进行过测试，而且由于课程强度高或出勤率低，这些干预措施很难在现实世界中实施。因此，有一个创新的，可行的，并从事针对依从性的行为干预措施的需求，特别是在YLH，抗逆转录病毒治疗（ART）的最大发起者。普遍的一级预防计划是一种新的方法，通过向所有新开始接受ART的青少年提供预防干预，在依从性问题开始之前就针对这些问题。为了响应PA-14-127，该提案计划测试一种简短的、2次会议的、计算机提供的动机干预，以防止新接受ART的青少年出现依从性困难。（评估，干预，控制条件）在NIH资助的艾滋病毒/艾滋病干预青少年医学试验医学网络（ATN）的一项小型多中心随机对照试验中进行了试点。结果表明研究方案的可行性和可接受性，以及在将干预与活性对照条件进行比较时改善依从性的趋势。对于拟定的多中心随机临床试验，将新开始ART的年轻人（来自美国4个ATN中心的N=300）随机分配至依从性动机增强系统（梅萨）或对照条件（由与剂量匹配的相同平台提供营养和运动信息）。将在基线、1个月、3个月、6个月、9个月和12个月时收集ART依从性（视觉模拟和毛发标本测定）和生物医学指标（病毒载量和CD 4计数），以及潜在的介导因子（HIV知识、依从性动机和依从性自我效能）和调节因子（药物滥用、精神健康症状、执行功能和应激性生活事件）。据推测，在一年的随访中，随机分配到梅萨的青年将比随机分配到对照条件的青年显示出更大的依从性和健康结果。此外，我们将确定梅萨治疗对主要结局影响的机制（介质），并评估差异干预反应的预测因子，包括药物滥用、精神健康症状、执行功能和结构性障碍。