Improving Measurement of Antiretroviral Adherence in Current and Former Drug User

描述（由申请人提供）：艾滋病毒感染的当前和以前的吸毒者从抗逆转录病毒治疗中获得的益处比非吸毒者少得多，部分原因是依从性不佳。尽管依从性评估的临床重要性和大量的抗逆转录病毒治疗依从性的最新文献，有没有一个单一的依从性措施，是普遍接受的临床或研究环境。在干预试验中，依从性测量缺乏严格的方法学，这一点尤其重要，并可能导致研究者得出错误的结论。复合依从性指标可能成为评估研究中药物依从性的复杂和动态行为的金标准，但此类指标才刚刚开始评估。在临床环境中，不精确的依从性估计可能导致干预措施的不准确目标和不良临床结局。自我报告是最可行、最灵活、最广泛使用的测量方法，但不同自我报告测量方法的相对有效性尚不清楚。为了解决这些问题，我建议研究目前和以前的吸毒者的依从性测量。本建议的具体目标是：（1）开发一个综合抗逆转录病毒治疗依从性测量模型，其中包括四种测量方法（自我报告、药丸计数、药房续药记录和MEMS），并比较复合模型与HIV病毒载量的相关性与各单一方法的相关性;（2）检查常见抗逆转录病毒治疗依从性自我报告措施之间的一致性，并通过评估其与新的依从性测量金标准的相关性来确定每个测量的有效性（复合抗逆转录病毒依从性模型）和依从性替代物（HIV病毒载量）;（3）描述当前和既往吸毒者回答自我报告抗逆转录病毒依从性问题的认知过程，包括问题解释、记住服药的能力和答案编辑。我的主要目标是成为一名独立的临床调查员，在行为药物滥用研究方面具有专业知识。我提出的职业发展计划包括在抗逆转录病毒治疗依从性、行为研究方法和药物滥用研究方面的指导，以及正式的课程和参加当地的互动研讨会和国家科学会议。

DESCRIPTION (provided by applicant): HIV-infected current and former drug users have received disproportionately less benefit from antiretroviral therapy than non-drug users, in part because of sub-optimal adherence. Despite the clinical importance of adherence assessments and a large body of recent literature on antiretroviral adherence, there is no single adherence measure that is universally accepted in clinical or research settings. The lack of methodogical rigor in adherence measurement is particularly significant in intervention trials and may lead investigators to draw erroneous conclusions. Composite adherence measures may become the gold standard for assessing the complex and dynamic behavior of medication adherence in research studies, but such measures are only beginning to be evaluated. In clinical settings, imprecise adherence estimates can result in inaccurate targeting of interventions and poor clinical outcomes. Self-report is the most feasible, flexible, and widely used measure, but the relative validity of different self-report measures is unknown. To address these issues, I propose to study adherence measurement in current and former drug users. The specific aims of this proposal are: (1) to develop a composite antiretroviral adherence measurement model that incorporates four methods of measurement (self-report, pill count, pharmacy refill records, and MEMS), and to compare the correlation with HIV viral load of the composite model with the correlation of each single method; (2) to examine the agreement between common antiretroviral adherence self-report measures, and to determine the validity of each measure by assessing its correlation with a new adherence measurement gold standard (composite antiretroviral adherence model) and an adherence surrogate (HIV viral load); and (3) to describe the cognitive processes undertaken by current and former drug users to answer self-report antiretroviral adherence questions, including question interpretation, ability to remember medication taking, and answer editing. My major goal is to become an independent clinical investigator with expertise in behavioral substance abuse research. The career development plan I have proposed includes mentorship in antiretroviral adherence, behavioral research methods, and substance abuse research, coupled with formal coursework and participation in local interactive seminars and national scientific meetings.