Pilot of an ART Adherence Readiness Intervention

描述（由申请人提供）：推荐的治疗指南强调患者需要在开始抗逆转录病毒治疗之前做好坚持治疗的准备。然而，我们并不知道有任何干预措施不仅可以帮助患者达到并保持依从性准备，而且还包括调节所提供的依从性培训数量的机制，并在患者准备好开始治疗时通知提供者。为此，本研究将试点测试依从性准备计划，这是一个基于IMB健康行为模型和学习理论的依从性训练的密集和全面计划。根据第一阶段的形成性评估工作，ARP将在第二阶段的试点RCT中进行评估。ARP采用传统的依从性咨询组件，但在以下方面具有创新性：(1)纳入治疗前、治疗早期和持续维持培训阶段；(2)使用简短的安慰剂实践试验来增强治疗前依从性准备并确定治疗开始的时间；(3)纳入剂量调节机制，根据患者的依从性表现调整提供的治疗前和维持培训的数量。(4)在患者家中实施干预，训练患者识别和控制依从性检索线索的过程可以得到加强。参与者将随机接受家庭ARP培训、诊所ARP培训或常规护理（无干预）。初步评估将在筛查和第8周和第24周进行，电子监测依从性是主要结果。如果有效，ARP可以为临床医生提供(1)在整个治疗过程中增强患者的依从性准备，从而改善临床结果；(2)根据患者的需要和表现量身定制提供的培训数量，从而促进更有效地利用临床资源，并促进提供者和患者更好地接受。如果有必要，该试验项目的结果将为R01应用中更大、更严格的评估提供关键设计参数的信息。

DESCRIPTION (provided by applicant): Recommended treatment guidelines emphasize the need for patients to be ready to adhere well prior to starting ART. Yet we are unaware of any intervention that is designed to not only help patients achieve and maintain adherence readiness, but also includes mechanisms for regulating the amount of adherence training provided and informing the provider when the patient is ready to start treatment. In response, the proposed study will pilot test the Adherence Readiness Program, an intensive and comprehensive program of adherence training based on the IMB model of health behavior and learning theory. Informed by formative evaluation work in Phase 1, the ARP will be evaluated in a pilot RCT in Phase 2. The ARP utilizes conventional adherence counseling components, but is innovative in its (1) inclusion of pre-treatment, early-treatment and ongoing maintenance training phases, (2) use of brief placebo practice trials for enhancing pre-treatment adherence readiness and determining the timing of treatment initiation, (3) inclusion of a dose regulation mechanism that adjusts the amount of pre-treatment and maintenance training provided based on the patient's adherence performance, and (4) administration of the intervention in the patient's home where the process of training patients to identify and control retrieval cues for adherence can be enhanced. Participants will be randomized to receive the ARP training at home, ARP training at the clinic, or usual care (no intervention). Primary assessments will be administered at screening and Weeks 8 and 24, with electronic monitored adherence being the primary outcome. If effective, the ARP may provide clinicians with an intervention that (1) enhances patient's adherence readiness throughout the course of therapy, thereby improving clinical outcomes, and (2) tailors the amount of training provided based on patient need and performance, thus facilitating a more efficient use of clinic resources, and fostering better acceptance from both providers and patients. Findings from this pilot project will provide information on critical design parameters for a larger, more rigorous evaluation in an R01 application, if warranted. PUBLIC HEALTH RELEVANCE: This study is important to public health as its findings could provide critical information for the evaluation of an intervention aimed at enhancing patient adherence readiness over the entire course of treatment, facilitating optimal clinical outcomes of treatment, and informing efficient use of clinic resources for enhancing adherence.