Improving Adherence to Antiretroviral Therapy

描述(由申请人提供)：坚持使用抗逆转录病毒药物对艾滋病毒携带者(PWHIV)至关重要。这项基于社会认知和自我效能理论的为期5年的研究的主要目的是比较两个干预组(结构化[ITS]和个性化[TL])相对于常规护理随着时间的推移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PWHIV样本(加上51名自然减少性样本)将被随机分配到三个研究小组中的一个。TS将接受12周的结构化电话干预和3个月的维护计划；然后随机选择一半的患者在接下来的6个月内接受3次强化治疗。TI将根据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；一半将随机接受未来6个月的3次强化治疗。常规护理组将接受常规护理。数据将在基线、治疗后(3个月)、维护后(6个月)、加强后(12个月)和加强后6个月(18个月)收集。将使用电子事件监视器(主要衡量标准)、日记、4天召回、自我报告服药量表和错过约会来评估依从性。二级目标将检查坚持对临床反应和生活质量的影响。探索性目标将检验：1)自我效能感对坚持的中介作用，2)坚持对自我效能感和结果之间关系的中介作用：临床反应和生活质量；3)生理反馈(症状、感觉到的用药负担、药物滥用)和心理反馈(情绪、人格特征、人际关系、感觉到的耻辱)作为自我效能的可能预测因素。具有特定对比的重复测量分析将用于检验陈述的假设(p小于或等于0.05，双尾)。将使用纵向数据分析技术来检查随时间推移协议分配和遵守之间的关系。类似的方法将用于次要目标，检查干预对临床反应和生活质量的影响。将使用结构方程模型来检验探索性目标。

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.