Development of CART for HIV adherence and cocaine abuse

描述(由申请人提供)：艾滋病毒携带者必须减少用药不遵守和可卡因使用，以最大限度地提高他们的健康。虽然不遵守规定并不是可卡因滥用者独有的，但这些患者有非常高的风险出现零星不遵守规定。间歇性的不遵守使患者处于发展成耐药艾滋病毒毒株的最高风险。迫切需要创新的行为疗法，以综合方法解决这两个问题。特别需要简短的干预措施，可以纳入艾滋病毒护理提供系统或药物滥用治疗方案。有两个目标的干预是对动机访谈(MI)的一种有希望的适应，这是一种简短的干预，有很好的证据表明对药物滥用有效。要求提供资金，以支持为携带艾滋病毒的非依从性可卡因滥用者制定和试行4期、双重点的MI干预、可卡因和依从性准备培训(CART)。这一阶段1研究的主要目的是确定是否有必要对最终干预措施进行更大规模的疗效试验。我们建议实现以下具体目标，以提供该证据。1)开发CART，这是一种针对HIV+可卡因滥用者的基于MI的新型组合干预措施，通过开展试点前会议、反复调整干预措施并为试点试验编写治疗手册，提高了服药依从性并减少了可卡因的使用。CART将包括a)遵守情况和物质使用情况的评估，与变革相关的态度和目标，以及决策平衡练习；b)风险的个性化反馈、准备情况的探索和目标设定；c)变革规划，引出潜在的变革障碍，更新准备程度评级，并采取变革的初步步骤；d)最终确定变革计划，引发持续承诺，并建立自我效能。2)制定和验证治疗师对干预的能力评定量表；3)为实施实验干预的治疗师制定培训方案，并对治疗师的能力和对干预的依从性进行评级。4)在随机先导研究(n=50)中测试最终的CART干预与最小注意力控制条件，以估计主要结果、依从率和可卡因使用严重程度的影响大小。5)调查潜在中介变量对干预完成、研究保留和初步结果的影响，包括基线可卡因和依从性水平和模式、每个领域的问题严重性、精神病学共病和跨理论模型变量(自我效能、阶段和变化过程)。这项研究将产生重要的临床创新，以改善艾滋病毒携带者的可卡因滥用者的健康，提供第二阶段试验所需的材料，并为未来提高艾滋病毒携带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.