Wagner Glenn J, Linnemayr Sebastien, Ghosh-Dastidar Bonnie, Currier Judith S, Hoffman Risa, Schneider Stefan
RAND Corporation, 1776 Main Street, Santa Monica, CA, 90407, USA.
Department of Medicine, UCLA, Los Angeles, CA, USA.
Trials. 2016 Mar 24;17:162. doi: 10.1186/s13063-016-1287-3.
Few HIV antiretroviral adherence interventions target patients before they start treatment, assess adherence readiness to determine the timing of treatment initiation, or tailor the amount of adherence support. The Supporting Treatment Adherence Readiness through Training (START) intervention, based on the information-motivation-behavioral skills model of behavior change, is designed to address these gaps with the inclusion of (1) brief pill-taking practice trials for enhancing pretreatment adherence counseling and providing a behavioral criterion for determining adherence readiness and the timing of treatment initiation and (2) a performance-driven dose regulation mechanism to tailor the amount of counseling to the individual needs of the patient and conserve resources. The primary aim of this randomized controlled trial is to examine the effects of START on antiretroviral adherence and HIV virologic suppression.
METHODS/DESIGN: A sample of 240 patients will be randomized to receive START or usual care at one of two HIV clinics. Primary outcomes will be optimal dose-taking adherence (>85 % prescribed doses taken), as measured with electronic monitoring caps, and undetectable HIV viral load. Secondary outcomes will include dose-timing adherence (>85 % prescribed doses taken on time) and CD4 count. Primary endpoints will be month 6 (short-term effect) and month 24 (to test durability of effect), though electronic monitoring will be continuous and a fully battery of assessments will be administered every 6 months for 24 months.
If efficacious and cost-effective, START will provide clinicians with a model for assessing patient adherence readiness and helping patients to achieve and sustain readiness and optimal treatment benefits.
ClinicalTrials.gov identifier NCT02329782 . Registered on 22 December 2014.
很少有HIV抗逆转录病毒治疗依从性干预措施在患者开始治疗前针对他们，评估其依从性准备情况以确定治疗开始时间，或调整依从性支持的量。通过培训支持治疗依从性准备（START）干预措施基于行为改变的信息-动机-行为技能模型设计，旨在通过纳入以下内容来弥补这些差距：（1）简短的服药实践试验，以加强治疗前依从性咨询，并提供确定依从性准备情况和治疗开始时间的行为标准；（2）一种基于表现的剂量调节机制，根据患者的个体需求调整咨询量并节省资源。这项随机对照试验的主要目的是研究START对抗逆转录病毒治疗依从性和HIV病毒学抑制的影响。
方法/设计：240名患者的样本将被随机分配到两家HIV诊所之一接受START或常规护理。主要结局将是通过电子监测帽测量的最佳剂量服用依从性（服用规定剂量的>85%）和无法检测到的HIV病毒载量。次要结局将包括剂量时间依从性（按时服用规定剂量的>85%）和CD4细胞计数。主要终点将是第6个月（短期效果）和第24个月（测试效果的持久性），不过电子监测将持续进行，并且每6个月进行一次全面评估，为期24个月。
如果START有效且具有成本效益，它将为临床医生提供一个评估患者依从性准备情况的模型，并帮助患者实现并维持准备状态以及获得最佳治疗效果。
ClinicalTrials.gov标识符NCT02329782。于2014年12月22日注册。
