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在开始抗逆转录病毒治疗之前需要准备好很好地坚持。然而，我们不知道有任何干预措施不仅旨在帮助患者实现和保持依从性准备，还包括调节提供的依从性培训的数量并在患者准备开始治疗时通知提供者的机制。作为回应，这项拟议的研究将试行遵守准备计划，这是一个基于健康行为和学习理论的IMB模型的强化和全面的坚持训练计划。在第一阶段形成性评估工作的指导下，ARP将在第二阶段的试点RCT中进行评估。ARP利用传统的依从性咨询组件，但其创新之处在于：(1)包括治疗前、早期治疗和正在进行的维持训练阶段，(2)使用简短的安慰剂实践试验来提高治疗前的依从性并确定治疗开始的时间，(3)包括根据患者的依从性表现调整治疗前和维持训练量的剂量调节机制，以及(4)在患者家中实施干预，其中可以加强训练患者识别和控制用于依从性的检索线索的过程。参与者将被随机分配到家中接受ARP培训，在诊所接受ARP培训，或接受常规护理(不进行干预)。初步评估将在筛查和第8周和第24周进行，主要结果是电子监测的依从性。如果有效，ARP可以为临床医生提供干预措施，以(1)提高患者在整个治疗过程中的依从性，从而改善临床结果，以及(2)根据患者的需求和表现定制提供的培训量，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。该试验项目的结果将为R01应用程序中更大、更严格的评估提供关键设计参数的信息，如果有必要的话。 公共卫生相关性：这项研究对公共卫生很重要，因为它的研究结果可以为评估旨在提高患者在整个治疗过程中的依从性、促进最佳临床治疗结果以及有效利用临床资源以提高依从性的干预措施提供关键信息。

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.