Improving Adherence to Antiretroviral Therapy

提高抗逆转录病毒治疗的依从性

• 批准号: 7082150
• 负责人: Judith A Erlen
• 金额: $ 58.12万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-30 至 2008-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7082150
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; antiviral agents; behavioral /social science research tag; clinical research; cognitive behavior therapy; combination chemotherapy; human subject; human therapy evaluation; immunologic assay /test; longitudinal human study; mental health; nursing intervention; outcomes research; patient monitoring device; patient oriented research; personal log /diary; quality of life; self help; telemedicine; therapy compliance

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.

描述（由申请人提供）：坚持抗逆转录病毒药物治疗对于艾滋病毒感染者 (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] 和个体化 [Tl]）相对于常规护理对长期坚持抗逆转录病毒治疗的影响。 300 名接受抗逆转录病毒治疗且未患 HIV 痴呆的 PWHIV 样本（加上 51 名自然减员）将被随机分配到三个研究组之一。 Ts 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，一半的人将在接下来的 6 个月内随机接受 3 次加强剂。 TI 将根据他们的自我确定需求接受为期 12 周的个性化电话干预以及为期 3 个月的维护计划；一半的人将在接下来的 6 个月内随机接受 3 次加强剂。常规护理组将接受常规护理。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（主要措施）、日记、4 天回忆、自我报告服药量表和错过的预约来评估依从性。次要目标将检查依从性对临床反应和生活质量的影响。探索性目标将检查：1）自我效能对依从性的中介作用，2）依从性对自我效能与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、药物治疗的感知负担、药物滥用）和心理反馈（情绪、人格特征、人际关系、感知耻辱）作为自我效能的可能预测因素。具有指定对比的重复测量分析将用于检验所述假设（p 小于或等于 0.05，双尾）。纵向数据分析技术将用于检查协议分配和遵守时间之间的关系。类似的方法将用于检查干预对临床反应和生活质量的影响的次要目标。将使用结构方程模型来检查探索性目标。