Improving Adherence to Antiretroviral Therapy

描述（由申请人提供）：坚持抗逆转录病毒药物对艾滋病毒感染者（PWHIV）至关重要。这项基于社会认知和自我效能理论的5年研究的主要目的是比较两个干预组（结构化[ITs]和个体化[Tl]）相对于常规护理对抗逆转录病毒治疗依从性的影响。300名接受抗逆转录病毒治疗且没有艾滋病毒痴呆的pwhv患者（外加51名消耗者）的样本将被随机分配到三个研究组中的一个。患者将接受为期12周的结构化电话干预和为期3个月的维护计划；其中一半将在接下来的6个月内随机接受3次增强剂。TI将根据他们自己确定的需求接受为期12周的个性化电话干预，并接受为期3个月的维护计划；其中一半将在未来6个月内随机接受3次增强剂。常规护理组将接受常规护理。数据将在基线、治疗后（3个月）、维持后（6个月）、强化后（12个月）和强化后6个月（18个月）收集。依从性将通过电子事件监视器（主要测量方法）、日记、4天回忆、自我报告服药量表和错过的预约来评估。次要目的是检查依从性对临床反应和生活质量的影响。探索目的将检验：1)自我效能感对依从性的中介作用；2)依从性对自我效能感与临床反应和生活质量之间关系的中介作用；3)生理反馈（症状、用药方案负担感知、药物滥用）和心理反馈（情绪、人格特征、人际关系、污名感知）可能是自我效能感的预测因子。具有特定对比的重复测量分析将用于检验所陈述的假设（p也小于或等于）。05年,双尾)。纵向数据分析技术将用于检查协议分配和依从性之间的关系。类似的方法将用于次要目的，检查干预对临床反应和生活质量的影响。探索目标将使用结构方程模型进行检查。

DESCRIPTION (provided by applicant): Adherence to antiretroviral medications is critically important for persons with HIV (PWHIV). The primary aim of this 5-year study based on social cognitive and self-efficacy theory proposes to compare the effect of two intervention groups (structured [ITs] and individualized [Tl]) relative to usual care on adherence to antiretroviral therapy over time. A sample of 300 PWHIV (plus 51 for attrition), taking antiretroviral therapy and without HIV dementia will be randomly assigned to one of three study arms. Ts will receive a 12 week structured telephone delivered intervention and a 3-month maintenance program; half will then be randomized to receive 3 boosters over the next 6 months. TI will receive a 12 week individualized telephone delivered intervention based on their self identified needs and a 3-month maintenance program; half will be randomized to receive 3 boosters over the next 6 months. The usual care group will receive their regular care. Data will be collected at baseline, post-treatment (3 months), post-maintenance (6 months), post-booster (12 months), and 6 months post-booster (18 months). Adherence will be assessed using electronic event monitors (primary measure), diaries, 4-day recall, the Self reported Medication-taking Scale, and missed appointments. Secondary aims will examine the effect of adherence on clinical response and quality of life. Exploratory aims will examine: 1) the mediating effect of self-efficacy on adherence, 2) the mediating effect of adherence on the relationship between self-efficacy and outcomes: clinical response and quality of life; 3) physiologic feedback (symptoms, perceived burden of medication regimen, substance abuse) and psychologic feedback (mood, personality characteristics, interpersonal relations, perceived stigma) as possible predictors of self-efficacy. Repeated measures analyses with specified contrasts will be used to test stated hypotheses (p less than or equal too .05, two-tailed). Longitudinal data analytic techniques will be used to examine the relationship between protocol assignment and adherence over time. A similar approach will be used for the secondary aims examining intervention effect on clinical response and quality of life. Exploratory aims will be examined using structural equation modeling.