CHANGING ART ADHERENCE BEHAVIOR

改变艺术依从行为

• 批准号: 7719124
• 负责人: JEFFREY D FISHER
• 金额: $ 24.03万
• 依托单位: UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7719124
• 关键词: Adherence; Adverse effects; Alcohol or Other Drugs use; Behavior; Behavioral; Caring; Clinic; Clinical; Complex; Computer Assisted; Computer Retrieval of Information on Scientific Projects Database; Condition; Control Groups; Counseling; Depressed mood; Development; Drug resistance; Educational process of instructing; Effectiveness of Interventions; Event; Funding; Grant; HIV; Health Status; Health behavior change; Immune; Individual; Institution; Intervention; Life; Link; Maintenance; Measures; Mediating; Mental Health; Modeling; Morbidity - disease rate; Motivation; Multi-Drug Resistance; Natural History; Numbers; Outcome; Outcomes Research; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Pharmacy facility; Population; Procedures; Public Health; Rate; Records; Research; Research Personnel; Resources; Source; Standards of Weights and Measures; Structure; System; Techniques; Testing; Time; Training; Treatment Failure; Treatment Protocols; United States National Institutes of Health; Upper arm; Viral Load result; Visit; antiretroviral therapy; base; cohort; cost; design; experience; interest; mortality; motivational enhancement therapy; skills; success; theories; therapy adherence; therapy development; transmission process; trend

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Antiretroviral therapy (ART) has enormous promise for reducing Human Immunodeficiency Virus (HIV)-related morbidity and mortality, but ART regimens are often complex, prone to side effects, and expensive, and ART adherence is often extremely poor. The individual and public health consequences of suboptimal ART adherence are significant and include treatment failure, viral load increase, immune compromise, development of multidrug resistant (MDR) HIV, and potential transmission of drug resistant HIV to uninfected others. Although the consequences of suboptimal ART adherence are well-recognized, ART adherence promotion efforts in clinical settings are typically intermittent and ad hoc. When adherence promotion interventions are systematically implemented in clinical care settings, they almost always involve exceedingly time-, cost-, and labor-intensive one-on-one counseling procedures that cannot be widely deployed to assist substantial numbers of HIV+ patients to adhere to ART over time. Moreover, to date, relatively few theoryART adherence promotion interventions have been conducted, rigorously evaluated, and found to be effective in increasing ART adherence. The present research employs a well-validated conceptualization of health behavior change, the Information-Motivation-Behavioral Skills (IMB) model (J. Fisher & Fisher, 1992, 2000, 2002; W. Fisher & Fisher, 1993, 1999; W. Fisher et al., in press), as a basis for the design and implementation of a cost-, time- and labor-efficient, completely individualized and engaging, computer-assisted ART adherence promotion intervention. The intervention we propose will be employed on an ongoing basis in the context of routine clinical care, to teach adherence enhancement strategies to HIV+ patients about to begin ART, and to increase adherence and maintenance of adherence among HIV+ patients currently on ART. The proposed research has four specific aims: 1. We will conduct elicitation research with HIV+ patients in clinical care and with HIV care clinicians, to explore the dynamics of ART nonadherence in the HIV+ clinical population, and to identify the optimal structure and content of a theory-based, computer-assisted ART adherence intervention linked to clinical care visits. Elicitation research findings will be systematically integrated to guide the development of the intervention and to increase its ecological validity by adapting it to the dynamics of ART nonadherence among clinic patients, and to the realities of real-life clinical settings. 2. Based on elicitation research findings, guided by the IMB model, and employing motivational interviewing (MI) techniques as an intervention delivery system, we will design, pilot test, refine, and fully implement a theory-based, computer-assisted ART adherence intervention that is linked to naturally occurring HIV clinical care. 3. We will conduct rigorous intervention outcome research comparing the effects of the ART adherence intervention with an appropriate standard-of-care control group with respect to multiple measures of adherence collected over 18 months. Rates of adherence, estimated by three types of indicators (self-reports of adherence to medication, pharmacy refill records, and viral load assessments) will be collected over an 18 month period and will serve as the major outcomes of interest. We hypothesize that participants in the intervention condition will demonstrate better adherence, as defined by greater gains in absolute values of the adherence indicators noted above and by a larger proportion of participants who experience success in achieving and sustaining clinically optimal levels of adherence (e.g., ¿¿ 95%), compared to those in the control condition. Additionally, we predict that individuals who use the intervention¿ training arm component before beginning ART will demonstrate better initial degrees of adherence, compared to controls. Finally, we predict that changes in adherence as a result of the intervention will be mediated by intervention effects on ART adherence information, motivation, and behavioral skills. 4. We will use the standard-of-care control group from the intervention outcome research as a no-cost cohort for a longitudinal natural history study of ART adherence in HIV+ patients. We will test putative proximal determinants of adherence to therapy, including levels of adherence-related information, motivation, and behavioral skills. We will also test the influence on adherence of subjective and objective health status, substance use, depressed mental health functioning, changing ART regimens, development of new drugs, and other historical events that may occur over the course of the study. We hypothesize that ART adherence will be predicted longitudinally by ART adherence related information, motivation, and behavioral skills. We also hypothesize that longitudinal trends in adherence will be influenced by factors such as substance use, mental health functioning, and historical events.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 抗逆转录病毒疗法(ART)在降低人类免疫缺陷病毒(HIV)相关发病率和死亡率方面有着巨大的希望，但ART方案往往复杂、容易产生副作用、费用昂贵，而且ART的依从性往往非常差。坚持非最佳抗逆转录病毒疗法的个人和公共健康后果是重大的，包括治疗失败、病毒载量增加、免疫损害、多药耐药(MDR)艾滋病毒的发展，以及将耐药艾滋病毒潜在地传播给未感染的其他人。尽管不良ART依从性的后果是众所周知的，但在临床环境中促进ART依从性的努力通常是间歇性的和临时的。当在临床护理环境中系统地实施依从性促进干预措施时，它们几乎总是涉及过多的时间、成本和劳动力密集型一对一咨询程序，这些程序无法广泛部署来帮助大量HIV+患者随着时间的推移坚持抗逆转录病毒疗法。此外，到目前为止，开展的促进ART依从性的理论干预相对较少，并进行了严格的评估，发现它们在增加ART依从性方面是有效的。本研究采用了一个经过验证的健康行为改变的概念，即信息动机行为技能(IMB)模型(J.Fisher&Fisher，1992,2000,2002；W.Fisher&Fisher，1993,1999；W.Fisher et al，in Press)，作为设计和实施一种成本、时间和劳动力效率的、完全个性化和参与式的计算机辅助艺术依从性促进干预的基础。我们建议的干预措施将在常规临床护理的基础上持续进行，向即将开始抗逆转录病毒治疗的艾滋病毒阳性患者传授提高依从性的策略，并提高目前正在接受抗逆转录病毒疗法的艾滋病毒阳性患者的依从性和保持依从性。 拟议的研究有四个具体目标： 1.我们将对临床护理中的HIV+患者和HIV护理临床医生进行启发性研究，探索HIV+临床人群中ART不依从性的动态变化，并确定与临床护理访问相关的基于理论的、计算机辅助的ART依从性干预的最佳结构和内容。启发研究结果将被系统地整合，以指导干预措施的发展，并通过使其适应临床患者中ART不依从性的动态变化，以及现实生活中临床环境的现实，来增加其生态有效性。 2.基于启发式研究结果，在IMB模式的指导下，采用动机访谈(MI)技术作为干预交付系统，我们将设计、中试、改进并全面实施基于理论的、计算机辅助的ART依从性干预，该干预与自然发生的HIV临床护理有关。 3.我们将进行严格的干预结果研究，比较ART依从性干预和适当的护理标准对照组在18个月内收集的多项依从性指标的效果。通过三种类型的指标(服药依从性自我报告、药房再灌装记录和病毒载量评估)估计的依从率将在18个月内收集，并将作为感兴趣的主要结果。我们假设，与对照组相比，干预条件下的参与者将表现出更好的依从性，如上述依从性指标绝对值的更大收益，以及成功实现并维持临床最佳依从性水平(例如，95%)的参与者的比例更大。此外，我们预测，与对照组相比，在开始抗逆转录病毒治疗前使用干预训练手臂组件的个体将表现出更好的初始依从度。最后，我们预测，作为干预结果的依从性变化将通过干预对ART依从性信息、动机和行为技能的影响来中介。 4.我们将使用干预结果研究中的护理标准对照组作为一个免费队列，对HIV+患者的抗逆转录病毒治疗依从性进行纵向自然历史研究。我们将测试坚持治疗的假定近端决定因素，包括坚持相关信息、动机和行为技能的水平。我们还将测试在研究过程中可能发生的主观和客观健康状况、物质使用、抑郁的精神健康功能、改变的艺术养生法、新药开发和其他历史事件对坚持的影响。我们假设，艺术坚持将通过与艺术坚持相关的信息、动机和行为技能来纵向预测。我们还假设，依从性的纵向趋势将受到诸如物质使用、心理健康功能和历史事件等因素的影响。