CHANGING ART ADHERENCE BEHAVIOR

改变艺术依从行为

• 批准号: 7607628
• 负责人: JEFFREY D FISHER
• 金额: $ 21.71万
• 依托单位: UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7607628
• 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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 抗逆转录病毒疗法（ART）对于降低人类免疫缺陷病毒（HIV）相关的发病率和死亡率具有巨大的希望，但是ART方案通常是复杂的，易于产生副作用，并且昂贵，并且ART依从性通常非常差。次优ART依从性的个人和公共健康后果是显著的，包括治疗失败、病毒载量增加、免疫损害、多药耐药（MDR）HIV的发展以及耐药HIV向未感染者的潜在传播。虽然次优的ART依从性的后果是公认的，但在临床环境中的ART依从性促进工作通常是间歇性的和特设的。当在临床护理环境中系统地实施依从性促进干预措施时，它们几乎总是涉及非常时间、成本和劳动密集型的一对一咨询程序，这些程序不能广泛部署以帮助大量HIV+患者随着时间的推移坚持ART。此外，到目前为止，相对较少的理论ART坚持促进干预措施进行了严格的评估，并发现是有效的增加ART坚持。目前的研究采用了一个经过充分验证的健康行为改变的概念化，信息动机行为技能（IMB）模型（J. Fisher & Fisher，1992，2000，2002; W。Fisher & Fisher，1993，1999; W. Fisher等人，出版），作为设计和实施成本、时间和劳动效率高、完全个性化和吸引人的计算机辅助ART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背景下持续使用，以向即将开始开始ART的HIV+患者教授依从性增强策略，并增加目前正在接受ART的HIV+患者的依从性和维持依从性。 拟议的研究有四个具体目标： 1. 我们将与临床护理中的HIV+患者和HIV护理临床医生进行启发研究，以探索HIV+临床人群中ART不依从性的动态，并确定基于理论的计算机辅助ART依从性干预的最佳结构和内容。将系统地整合启发研究结果，以指导干预措施的发展，并通过使其适应临床患者中ART不依从性的动态以及现实临床环境的现实来提高其生态有效性。 2. 基于启发式研究结果，IMB模型的指导下，并采用动机访谈（MI）技术作为干预提供系统，我们将设计，试点测试，完善，并充分实施一个基于理论的，计算机辅助的ART依从性干预，与自然发生的HIV临床护理。 3. 我们将进行严格的干预结果研究，比较ART依从性干预与适当的标准治疗对照组在18个月内收集的多项依从性指标方面的效果。将在18个月内收集通过三种类型的指标（药物依从性自我报告、药房续药记录和病毒载量评估）估计的依从率，并将其作为主要关注结局。我们假设，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增益和更大比例的成功实现和维持临床最佳依从性水平的参与者所定义的（例如，95%），与对照组相比。此外，我们预测，与对照组相比，在开始ART之前使用干预训练臂组件的个体将表现出更好的初始依从性。最后，我们预测，作为干预的结果，依从性的变化将介导的干预效果对ART依从性的信息，动机和行为技能。 4. 我们将使用来自干预结果研究的标准治疗对照组作为HIV+患者ART依从性纵向自然史研究的无成本队列。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。我们还将测试主观和客观健康状况、物质使用、抑郁的心理健康功能、改变ART方案、新药开发以及研究过程中可能发生的其他历史事件对依从性的影响。我们假设ART依从性将通过ART依从性相关信息、动机和行为技能进行纵向预测。我们还假设，依从性的纵向趋势将受到物质使用、心理健康功能和历史事件等因素的影响。