Centralized Off-Site Adherence Enhancement Program

描述(由申请人提供)：使用药物或酒精的患者，如果没有充分坚持抗逆转录病毒药物，结果不佳，但缺乏有效的干预措施。在这一R34应用中，我们寻求开发和试点一个通过电话提供并得到信息技术支持的干预计划，该计划结合了对服药依从性的应急管理以及对坚持抗逆转录病毒治疗和戒除滥用物质的认知行为方法。这项名为CARE(集中式异地依从性增强计划)的干预基于已发表的发现，即在接受现金强化以打开MEMS盖子的瓶子以按时服用处方药的患者中，依从性得到了显著改善，病毒载量显著降低。CARE包括将具有实时操作的开瓶数据从SimPill瓶子传输到网站系统，该网站系统向患者生成消息，表明如果在指定的时间窗口内服用药物，则获得多少现金强化，或者如果错过药物，则放弃。对服药的加固将被连接到借记卡上，患者将被给予这些借记卡以获得付款。这一临时加强的药物服用将与通过电话进行的12次认知行为治疗(CBT)相结合，该网站也将帮助从患者和治疗师谈判的选择菜单中生成与CBT相关的短信、提醒和日程安排信息。护理的发展将分三个阶段进行，每个阶段都会修订干预措施。首先，将开发网络系统和治疗手册。其次，12周的护理将预先在10名依从性不佳、最近有风险使用酒精和/或滥用兴奋剂的患者中进行。将收集有关护理组成部分的可接受性、可用性和感知效果的定性和定量数据；将对程序和后勤进行评估，并在必要时进行修改。第三，护理将在为期12周的随机对照试验中进行试点测试，在该试验中，控制组只涉及基于电话的咨询，首先关注依从性，然后关注禁欲。将在12周的随访期内检查效果的保留情况。CARE有可能成为首批同时提供远程强化和咨询的干预措施之一，可以在不提供阿片类药物替代或其他极端密集干预的情况下改善药物使用者的结果，并利用针对不遵守和药物滥用的认知行为方法。由于护理是由不在患者诊所现场的治疗师提供的，因此可以从任何距离有效地提供护理，对于坚持服药至关重要的患者来说，这是一种可扩展的治疗方法。

DESCRIPTION (provided by applicant): Patients who use drugs or alcohol who do not adequately adhere to antiretroviral medication have sub-optimal outcomes, but effective interventions for them are lacking. In this R34 application, we seek to develop and pilot an intervention program delivered by phone and supported by information technology that combines contingency management for medication adherence and a cognitive-behavioral approach to both adherence to antiretroviral therapy and abstinence from substances of abuse. The intervention, CARE (Centralized Off-site AdheRence Enhancement Program), builds on the published finding that adherence was robustly improved and viral load was significantly reduced among patients who received cash-reinforcement for opening MEMS- capped bottles to take prescribed medication on time. CARE involves transmission of bottle-opening data with real time operation from SimPill bottles to a website system which generates messages to patients indicating the amount of cash-reinforcement earned if medication was taken within a specified time window or forsaken if medication was missed. Reinforcement for medication-taking will be wired to debit cards that patients will be given to receive the payments. This contingent reinforcement of medication-taking will be coupled with twelve sessions of cognitive-behavioral therapy (CBT) conducted by phone, also assisted by the website which will generate CBT-related text messages, reminders and scheduling information from a menu of choices negotiated by the patient and therapist. Development of CARE will proceed in three stages, with revisions of the intervention at each stage. First, the web system and therapy manuals will be developed. Second, twelve weeks of CARE will be pre-piloted in 10 patients with sub-optimal adherence and recent risky alcohol use and/or stimulant misuse. Qualitative and quantitative data will be collected concerning acceptability, usability and perceived efficacy of components of CARE; Procedures and logistics will be evaluated, and modified, if necessary. Third, CARE will be pilot-tested in a twelve-week randomized controlled trial in which the control arm only involves phone-based counseling focusing first on adherence and then on abstinence. Retention of effects will be examined during a twelve-week follow-up period. CARE has the potential to be among the first interventions that delivers both reinforcement and counseling remotely, that improves outcomes among substance users without providing opioid substitution or other extremely intensive interventions, and that utilizes a cognitive-behavioral approach targeting both non-adherence and substance abuse. Because CARE is delivered by a therapist who is off-site from the patient's clinic, CARE can be effectively delivered from any distance and is a scalable treatment for patients in whom medication adherence is crucial.