Centralized Off-Site Adherence Enhancement Program

描述（由申请人提供）：使用药物或酒精的患者没有充分坚持抗逆转录病毒药物治疗，结果不理想，但缺乏有效的干预措施。在这个R34应用程序中，我们寻求开发和试点一个通过电话提供并由信息技术支持的干预计划，该计划结合了药物依从性的应急管理和依从性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（集中异地依从性增强计划）的干预措施建立在已发表的研究结果的基础上，该研究发现，在打开MEMS瓶盖并按时服用处方药的患者中，依从性得到了显著提高，病毒载量显著降低。CARE涉及将开瓶数据通过实时操作从SimPill瓶传输到一个网站系统，该网站系统会向患者发送信息，表明如果在指定的时间窗口内服药，则可以获得多少现金奖励，如果错过服药，则可以放弃。加强服药的费用将被电汇到借记卡上，患者将获得借记卡来收取费用。这种药物服用的偶然强化将与12次通过电话进行的认知行为治疗（CBT）相结合，也由网站辅助，该网站将从患者和治疗师协商的选择菜单中生成与CBT相关的短信、提醒和日程安排信息。援外援助的发展将分三个阶段进行，每个阶段都对干预措施进行修订。首先，将开发网络系统和治疗手册。其次，12周的CARE将在10名依从性欠佳且近期有危险饮酒和/或滥用兴奋剂的患者中进行预试验。将收集有关援外援助组成部分的可接受性、可用性和感知功效的定性和定量数据；程序和物流将进行评估，并在必要时进行修改。第三，CARE将在一项为期12周的随机对照试验中进行试点测试，其中对照组只涉及基于电话的咨询，首先关注坚持，然后是戒断。将在为期12周的随访期间检查效果的保留情况。CARE有可能成为首批提供远程强化和咨询的干预措施之一，在不提供阿片类药物替代或其他极其密集的干预措施的情况下改善药物使用者的结果，并利用针对不依从性和药物滥用的认知行为方法。由于CARE是由不在患者诊所的治疗师提供的，因此CARE可以从任何距离有效地提供，并且对于药物依从性至关重要的患者来说，它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.