Development of CART for HIV adherence and cocaine abuse

描述（由申请人提供）：必须减少艾滋病毒感染者的药物不依从性和可卡因使用，以最大限度地提高他们的健康。尽管不依从性并非可卡因滥用者所独有，但这些患者发生偶发性不依从性的风险非常高。间歇性的不依从性使患者处于发展耐药性艾滋病毒菌株的最高风险。迫切需要创新的行为治疗方法来解决这两个问题。特别需要的是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。有两个目标的干预措施是一个有前途的适应动机访谈（MI），一个简短的干预与良好的证据，在药物滥用的疗效。请求提供资金，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、双重点MI干预、依从性和依从性准备培训（CART）。第1阶段研究的主要目的是确定是否需要进行更大规模的最终干预有效性试验。我们建议实现以下具体目标，以提供这一证据。1)开发CART，这是一种针对艾滋病毒+可卡因滥用者的新型基于MI的组合干预措施，通过进行预试点会议，迭代调整干预措施，并为试点试验开发治疗手册，增加药物依从性并减少可卡因使用。CART将包括：a）评估依从性和药物使用、与变更相关的态度和目标，以及决策平衡练习; B）个性化风险反馈、准备情况探索和目标设定; c）变更计划，发现变更的潜在障碍，更新准备情况评级，并采取初步变更步骤; d）最终确定变更计划，激发持续承诺，并建立自我效能。2)3）为提供实验性干预的治疗师制定培训方案，并制定治疗师能力和对干预的依从性的评级。4)在一项随机初步研究（n=50）中测试最终的CART干预与最小注意力控制条件，以估计主要结局的效应量;依从率和可卡因使用严重程度。5)调查潜在中介变量的影响，包括基线可卡因和坚持水平和模式，问题的严重程度，在每个领域，精神科共病，和transtheoretical模型变量（自我效能，阶段和过程的变化）对干预完成，研究保留，和主要成果。这项研究将产生重要的临床创新，以改善艾滋病毒可卡因滥用者的健康，提供第二阶段试验所需的材料，并为未来关于改善艾滋病毒感染者的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.