Statistical Methods for Adherence and HIV Outcomes

描述（由申请人提供）：尽管人们越来越认识到坚持抗逆转录病毒药物治疗对成功治疗艾滋病毒至关重要，但衡量和统计方法的发展落后于有效艾滋病毒疗法的发展。研究表明，坚持抗逆转录病毒药物治疗对抑制病毒复制和增加CD 4计数至关重要，但确切的依从性-反应曲线以及依从性与HIV病毒学结局之间的关系尚未充分探讨。目前可用的遵守措施有几个主要问题。首先，存在与每种测量技术相关联的显著测量误差或偏差。其次，大多数指标仅测量处方药的服用百分比，忽略了依从性行为的其他方面，如给药间隔，这对于半衰期短的药物（如HIV蛋白酶抑制剂）尤为重要。目前使用的单一的依从性测量方法没有整合依从性行为的不同方面。第三，需要一个切实可行的遵守措施，为病人的护理设置。应用的简易性和低成本使自我报告最有吸引力的临床使用，但目前的调查方法无法收集信息的高敏感性不遵守。到目前为止，艾滋病毒药物治疗依从性和病毒学结果之间的关系主要是使用横断面分析的特点，坚持措施，是容易出错的，只有部分描述的依从性行为。利用两项纵向HIV研究收集的丰富的药物依从性和病毒学结局数据，我们建议开发改进的方法来收集和分析依从性数据，并对依从性和病毒学结局之间的关系进行建模。该研究将：1）创建能够全面准确描述药物依从性行为多方面特征的测量方法; 2）改进在临床护理背景下获得自我报告依从性信息的调查方法; 3）使用重复测量分析，调查药物依从性与RNA病毒载量和耐药性的HIV病毒学结果之间的潜在纵向关系。

DESCRIPTION (provided by applicant): Although adherence to antiretroviral medications is increasingly recognized as critical to successful HIV treatment, the development of measurement and statistical methods for adherence lags behind the advancement in development of effective HIV therapies. Studies have shown that adherence to antiretroviral medications is central to suppression of viral replication and to increases in CD4 count, but the exact compliance-response curve and the relationship between adherence and HIV virologic outcomes over time have been inadequately explored. Currently available adherence measures have several major problems. First, there are significant measurement errors or bias associated with each of the measurement techniques. Secondly, most of the measures only measure the percent of prescribed medication taken, ignoring the other aspects of adherence behavior such as dose-interval, which is particularly important for medications with a short half-life such as HIV protease inhibitors. No single adherence measure currently in use integrates the different aspects of adherence behavior. Third, a practical adherence measure feasible for patient care settings is needed. Ease of application and low cost make self-report most appealing for clinical use, but current survey methods fail to gather information with high sensitivity for non-adherence. To date, the relationship between HIV medication adherence and virologic outcomes has been characterized principally using cross sectional analyses with adherence measures that are error-prone and that only partially describe adherence behavior. Using available data from two longitudinal HIV studies that collected rich medication adherence and virologic outcome data, we propose to develop improved methods of collecting and analyzing adherence data, and modeling the relationship between adherence and virologic outcomes. The study will: 1) create measures that can fully and accurately describe the multifaceted character of medication adherence behavior; 2) improve survey methods for obtaining self-report adherence information in the context of clinical care; and 3) using repeated measures analyses, investigate the underlying longitudinal relationship between medication adherence and HIV virologic outcomes of RNA viral load and drug resistance.