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

 描述(由申请人提供)：青年艾滋病毒携带者的服药依从率不足以有效控制疾病。在年轻人中测试的遵守干预措施很少，而且由于课程强度高或出席率低，那些已经测试过的干预措施很难在现实环境中实施。因此，存在针对依从性的创新、可行和参与性行为干预的需求，特别是在最大的抗逆转录病毒治疗(ART)发起者YLH中。普遍的初级预防方案是一种新的方法，通过为所有新开始接受抗逆转录病毒治疗的青年提供预防干预，在依从性问题开始之前针对这些问题。作为对PA-14-127的回应，这项提案计划测试一种简短的、两个疗程的、计算机提供的动机干预，以防止新开出的青少年ART的坚持困难。该方案的所有要素(评估、干预、控制条件)都在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)的一项小型多点随机对照试验中进行了试验。结果表明研究方案的可行性和可接受性，以及在比较干预和积极控制条件时改善依从性的趋势。在拟议的多地点随机临床试验中，新开始抗逆转录病毒治疗的青年(来自美国4个ATN地点的N=300人)将被随机分配到坚持动机增强系统(MESA)或对照条件(由相同平台提供的营养和运动信息，剂量匹配)。在基线、1个月、3个月、6个月、9个月和12个月时，将收集抗逆转录病毒治疗依从性(视觉模拟和头发标本分析)和生物医学测量(病毒载量和CD4计数)，以及潜在的中介因素(艾滋病毒知识、坚持的动机和坚持的自我效能)和调节因素(物质滥用、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，随机进入MESA的年轻人将比随机进入对照条件的年轻人表现出更大的依从性和健康结果。此外，我们将确定MESA治疗对主要结果影响的机制(中介)，并评估不同干预反应的预测因素，包括药物滥用、精神健康症状、执行功能和结构性障碍。

 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.