Improving Measurement of Antiretroviral Adherence in Current and Former Drug User

描述（由申请人提供）：与非吸毒者相比，感染艾滋病毒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不成比例地少，部分原因是依从性不够理想。尽管依从性评估具有临床重要性，并且最近有大量关于抗逆转录病毒依从性的文献，但在临床或研究环境中没有一种普遍接受的依从性措施。在干预试验中，依从性测量缺乏方法学上的严谨性尤其重要，并可能导致研究者得出错误的结论。在研究中，复合依从性措施可能成为评估药物依从性复杂动态行为的金标准，但这类措施的评估才刚刚开始。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靶向和不良的临床结果。自我报告是最可行、最灵活、最广泛使用的测量方法，但不同的自我报告测量方法的相对效度尚不清楚。为了解决这些问题，我建议研究当前和以前的吸毒者的依从性测量。本研究的具体目的是：(1)建立一个包含四种测量方法（自我报告、药片计数、药房补充记录和MEMS）的复合抗逆转录病毒依从性测量模型，并比较复合模型与HIV病毒载量的相关性以及各单一方法的相关性；(2)检查常见抗逆转录病毒依从性自我报告测量之间的一致性，并通过评估其与新的依从性测量金标准（复合抗逆转录病毒依从模型）和依从性替代指标（HIV病毒载量）的相关性来确定每种测量的有效性；(3)描述当前和以前的吸毒者在回答自我报告的抗逆转录病毒依从性问题时所承担的认知过程，包括问题解释、记住药物服用的能力和回答编辑。我的主要目标是成为一名具有行为药物滥用研究专业知识的独立临床调查员。我提出的职业发展计划包括抗逆转录病毒依从性、行为研究方法和药物滥用研究方面的指导，再加上正式课程和参加当地互动式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.