Development of CART for HIV adherence and cocaine abuse

说明（由申请人提供）：必须减少艾滋病毒感染者的药物依从性和可卡因使用，以最大限度地提高他们的健康。虽然不依从性并不是可卡因滥用者所独有的，但这些患者有很高的偶发性不依从性的风险。间歇性不遵医嘱使患者处于产生耐药艾滋病毒株的最高风险。我们迫切需要创新的行为治疗方法来解决这两个问题。特别需要可以纳入艾滋病毒护理提供系统或药物滥用治疗方案的简短干预措施。有两个目标的干预是对动机访谈（MI）的一种有希望的适应，这是一种对药物滥用有良好疗效的简短干预。要求提供资金，以支持为感染艾滋病毒的非依从性可卡因滥用者制定和试点测试4期双重重点的心梗干预、可卡因和依从性准备培训。本1期研究的主要目的是确定最终干预措施是否有必要进行更大规模的疗效试验。我们建议实现以下具体目标来提供证据。1)开发CART，这是一种针对HIV+可卡因滥用者的新型基于mi的联合干预措施，通过开展预试点会议，迭代调整干预措施，并为试点试验制定治疗手册，提高药物依从性并减少可卡因使用。CART将包括a)与改变相关的依从性和物质使用、态度和目标的评估，以及决策平衡练习；b)风险的个性化反馈，准备程度的探索和目标设定；c)改变计划，引出改变的潜在障碍，更新准备程度评级，并采取改变的初步步骤；d)最终确定改变计划，引出持续的承诺，并建立自我效能感。2)制定并验证治疗师干预能力的评定量表3)为提供实验性干预的治疗师制定培训协议，并制定治疗师能力和干预依从性的评分。4)在一项随机试点研究（n=50）中测试最终的CART干预与最低注意控制条件，以估计主要结果的效应大小；依从率和可卡因使用严重程度。5)研究潜在的中介变量，包括基线可卡因和依从水平和模式、每个领域的问题严重程度、精神共病和跨理论模型变量（自我效能、阶段和变化过程）对干预完成、研究保留和主要结果的影响。这项研究将产生重要的临床创新，以改善艾滋病毒感染者可卡因滥用者的健康状况，为第二阶段试验提供所需的材料，并为今后改善艾滋病毒感染者依从性和减少可卡因使用的研究提供方向和方法。

DESCRIPTION (provided by applicant): Medication non-adherence and cocaine use must be reduced among people with HIV to maximize their health. Although non-adherence is not unique to cocaine abusers, these patients are at very high risk of sporadic non-adherence. Intermittent non-adherence puts patients at the highest risk for developing medication-resistant strains of HIV. There is an urgent need for innovative behavioral treatments to address these two problems in a combined approach. Brief interventions are especially needed that could be incorporated into HIV care delivery systems or substance abuse treatment programs. Interventions with two targets are a promising adaptation of motivational interviewing (MI), a brief intervention with good evidence of efficacy in substance abuse. Funds are requested to support the development and pilot testing of a 4 session, dual-focused MI intervention, Cocaine and Adherence Readiness Training (CART) for non-adherent cocaine abusers with HIV. The primary aim of this Stage 1 study is to determine if a larger efficacy trial with the finalized intervention is warranted. We propose to accomplish the following specific aims to provide that evidence. 1) Develop CART, a novel MI-based combination intervention for HIV+ cocaine abusers that increases medication adherence and reduces cocaine use, through conducting pre-pilot sessions, adapting the intervention iteratively, and developing a therapy manual for a pilot trial. CART will include a) assessment of adherence and substance use, attitudes and goals related to change, and a decisional balance exercise, b) personalized feedback of risks, explorations of readiness, and goal setting, c) change planning, eliciting potential barriers to change, updating readiness ratings, and taking initial steps to change, and d) finalizing the change plan, eliciting continued commitment, and building self-efficacy. 2) Develop and validate rating scales of therapist competence to the intervention 3) Develop a training protocol for therapists delivering the experimental intervention and develop ratings of therapist competence and adherence to the intervention. 4) Test the finalized CART intervention vs. a minimal attention control condition in a randomized pilot study (n=50) to estimate effect sizes for primary outcomes; adherence rate and cocaine use severity. 5) Investigate the impact of potential mediator variables including baseline cocaine and adherence levels and patterns, problem severity in each domain, psychiatric comorbidity, and transtheoretical model variables (self-efficacy, stages and processes of change) on intervention completion, research retention, and primary outcomes. This study will yield important clinical innovations to improve the health of cocaine abusers with HIV, provide materials needed for a Stage 2 trial, and provide directions and methods for future research on improving adherence and reducing cocaine use in people with HIV.