Improving Adherence to Antiretroviral Therapy

描述（由申请人提供）：坚持抗逆转录病毒药物治疗对艾滋病毒感染者（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[IT]和个性化[TI]）相对于常规护理对抗逆转录病毒治疗依从性的影响。将300例接受抗逆转录病毒治疗且无HIV痴呆的PWHIV（加上51例自然减员）样本随机分配至三个研究组之一。受试者将接受为期12周的结构化电话干预和为期3个月的维护计划;然后将一半受试者随机分配，在接下来的6个月内接受3次加强剂。TI将根据其自我确定的需求接受为期12周的个性化电话干预和3个月的维持计划;一半将在接下来的6个月内随机接受3次加强剂。普通护理组将接受定期护理。将在基线、治疗后（3个月）、维持后（6个月）、加强后（12个月）和加强后6个月（18个月）收集数据。将使用电子事件监测器（主要指标）、日记、4天回忆、自我报告服药量表和错过预约来评估依从性。次要目的将检查依从性对临床反应和生活质量的影响。探索性目标将审查：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的关系的中介作用; 3）生理反馈（症状、药物治疗方案的感知负担、药物滥用）和心理反馈（情绪、人格特征、人际关系、感知耻辱）是自我效能感的可能预测因子。将使用具有指定对比的重复测量分析来检验所述假设（p小于或等于0.05，双尾）。将使用纵向数据分析技术来检查方案分配与随时间推移的依从性之间的关系。将使用类似的方法进行次要目的，检查干预对临床应答和生活质量的影响。探索性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.