Test of a Web-Based Program to Improve Adherence to HIV/AIDS Medications

测试基于网络的计划，以提高对艾滋病毒/艾滋病药物的依从性

• 批准号: 7833076
• 负责人: ROYER F COOK
• 金额: $ 49.83万
• 依托单位: ISA ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7833076
• 关键词: AIDS prevention; AIDS/HIV problem; Address; Adherence; Alcohol or Other Drugs use; Area; Behavior; Clinic; Clinical; Combination Medication; Complex; Data; Development; Diagnosis; District of Columbia; Dose; Drug usage; Drug user; Eating; Effectiveness; Effectiveness of Interventions; Electronics; Emotional; Event; HIV; HIV Infections; HIV Seropositivity; Highly Active Antiretroviral Therapy; Immune; Immune system; Individual; Internet; Intervention; Life; Link; Mediating; Mental Health; Meta-Analysis; Monitor; Moods; Online Systems; Outcomes Research; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Population; Prevention program; Procedures; Provider; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Recommendation; Relative (related person); Research Personnel; Research Project Grants; Sampling; Schedule; Self Efficacy; Stress; System; Technology; Testing; Training; Treatment Protocols; Viral Load result; Walkers; Woman; behavioral health; cooking; cost; depression; design; efficacy testing; improved; innovation; medication compliance; negative mood; new technology; programs; public health relevance; stress management

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area 06 - Enabling Technologies - and specific Challenge Topic, 06-DA-104: Development of new technologies to change patient and provider behaviors to improve adherence. Since the advent of highly active antiretroviral therapy (HAART), significant numbers of HIV-positive individuals are living prolonged and healthier lives (O'Cleirigh and Safren, 2008; Safren et al., 2001; 2009). HAART, which typically involves a combination of medications, leads to reductions in viral load, greater immune system function, and less likelihood of clinical immune deficiency in patients with HIV infection (Carpenter et al., 1997; Flexner, 1998; Goebel, 1995). However, HAART effectiveness is wholly dependent on complete adherence to prescribed medication regimens, which often involve different dosing schedules and food intake conditions, requiring adherence to a complex and frequently confusing combination of medications throughout an indefinite course of treatment. Drug use has been shown to severely erode adherence (Hinkin et al., 2007), and because adherence can be further threatened by stress and negative mood states, recent recommendations have underscored the importance of developing adherence interventions that also address stress, mood states and substance use (Scott-Sheldon, 2008; O'Cleirigh and Safren, 2008; Safren et al., 2009). A meta-analysis of studies of stress management interventions for HIV-positive people found evidence for their effectiveness in reducing stress (Scott-Sheldon et al., 2008). Recently, in further recognition of the link between emotional states and medication adherence, Safren and associates (2009) conducted a randomized controlled trial of a medication adherence intervention for HIV-positive individuals diagnosed with depression and found positive effects on both medication adherence and depression. Therefore, it seems clear that efficacious interventions to improve adherence to HIV medications are available, and that providing training in medication adherence strategies within the framework of stress and mood management could be an effective approach for improving both mood states and medication adherence. However, all the HIV medication adherence programs created to date require professional staff, trained specifically in the adherence procedures, to interact in person with the patients over the course of multiple sessions. In partnership with the Whitman Walker Clinic, we propose to conduct a randomized controlled trial of a web-based medication adherence program for HIV-positive individuals presented within the framework of a stress and mood management program. The randomized trial will be conducted over a two-year period with a sample of 200 patients of the Whitman Walker Clinic, assessing adherence mainly with the electronic Medication Event Monitoring Systems (MEMS), along with multiple self-report assessments of stress, mood and drug use. The Whitman Walker Clinic is located in Washington, DC, where a large proportion of the HIV- positive population is comprised of recent or current drug users. If shown effective, the web-based SMM-AD program would be available to all HIV-positive people with access to the Internet, greatly expanding the reach of medication adherence programs. Drs. Cook and Billings (PI and Co-Investigator) have successfully created and tested several web- based behavioral health programs, including the Stress and Mood Management (which includes a segment on substance use), recently shown efficacious in a randomized controlled trial (Cook et al., 2007; Billings et al., 2008). They are currently conducting a randomized trial of a web-based HIV prevention program for women. Steven Safren, who has developed and tested multiple HIV medication adherence programs, and David Murray, a recognized expert on the design and analysis of randomized trials, will serve as consultants to the project. PUBLIC HEALTH RELEVANCE: Since the advent of highly active antiretroviral therapy (HAART), significant numbers of HIV-positive individuals are living prolonged and healthier lives. However, HAART effectiveness is wholly dependent on complete adherence to a complex and frequently confusing combination of medications throughout an indefinite course of treatment. Drug use, stress, and negative mood states can further lower rates of HIV medication compliance. Recent data suggests, however, that in-person depression and medication adherence treatment can improve mood and increase medication compliance. Unfortunately, the reach of in-person interventions is limited by their cost and relative inaccessibility. The outcome of this research project will be a comprehensive, innovative, web-based medication adherence program for HIV-positive individuals presented within the framework of a stress and mood management program. This will greatly expand access to an effective medication adherence program, thereby improving the physical and mental health of those infected with HIV.

描述(由申请人提供)：本申请涉及广泛的挑战领域06-使能技术-和具体的挑战主题06-DA-104：开发新技术以改变患者和提供者的行为，以提高依从性。自从出现了高效抗逆转录病毒疗法(HAART)以来，相当数量的艾滋病毒阳性患者的寿命更长、更健康(O‘Cleirigh和Safren，2008年；Safren等人，2001年；2009年)。HAART通常涉及多种药物的组合，可减少HIV感染患者的病毒载量，增强免疫系统功能，降低临床免疫缺陷的可能性(Carpenter等人，1997；Flexner，1998；Goebel，1995)。然而，HAART的有效性完全取决于完全遵守处方药物方案，这往往涉及不同的剂量计划和食物摄入条件，需要在不确定的治疗过程中坚持复杂且经常令人困惑的药物组合。药物使用已被证明严重侵蚀坚持(Hinkin等人，2007年)，由于坚持可进一步受到压力和消极情绪状态的威胁，最近的建议强调了制定遵守干预措施的重要性，该干预措施也针对压力、情绪状态和药物使用(Scott-Sheldon，2008；O‘Cleirigh and Safren，2008；Safren等人，2009)。一项针对HIV阳性患者的压力管理干预研究的荟萃分析发现了它们在减轻压力方面的有效性的证据(Scott-Sheldon等人，2008年)。最近，为了进一步认识情绪状态和服药依从性之间的联系，Safren和同事(2009)对被诊断为抑郁症的HIV阳性患者进行了一项服药依从性干预的随机对照试验，发现对服药依从性和抑郁症都有积极影响。因此，显然有有效的干预措施可以提高对艾滋病毒药物的依从性，在压力和情绪管理的框架内提供药物依从性策略培训可能是改善情绪状态和药物依从性的有效方法。然而，到目前为止创建的所有艾滋病毒药物依从性计划都需要经过专门培训的专业工作人员在多个疗程中与患者面对面互动。我们建议与惠特曼·沃克诊所合作，在压力和情绪管理计划的框架内，对HIV阳性患者进行一项基于网络的服药依从性计划的随机对照试验。这项随机试验将在两年内进行，惠特曼·沃克诊所的200名患者的样本主要使用电子药物事件监测系统(MEMS)来评估依从性，以及对压力、情绪和药物使用的多个自我报告评估。惠特曼·沃克诊所位于华盛顿特区，那里的艾滋病毒阳性人口中有很大一部分是最近或现在的吸毒者。如果被证明有效，基于网络的SMM-AD计划将适用于所有可以访问互联网的艾滋病毒阳性者，从而极大地扩大服药依从性计划的覆盖范围。库克博士和比林斯博士(PI和合作调查员)已经成功地创建并测试了几个基于网络的行为健康项目，包括压力和情绪管理(其中包括关于药物使用的部分)，最近在一项随机对照试验中显示出有效(库克等人，2007年；比林斯等人，2008年)。他们目前正在进行一项针对女性的基于网络的艾滋病毒预防计划的随机试验。曾开发和测试多个HIV药物依从性计划的Steven Safren和随机试验设计和分析方面的公认专家David Murray将担任该项目的顾问。 公共卫生相关性：自从高效抗逆转录病毒疗法(HAART)问世以来，相当数量的艾滋病毒阳性者正在延长和健康地活着。然而，HAART的有效性完全取决于在不确定的治疗过程中完全遵守复杂且经常令人困惑的药物组合。药物使用、压力和消极情绪状态会进一步降低HIV药物依从性。然而，最近的数据表明，面对面的抑郁和服药依从性治疗可以改善情绪，提高服药依从性。不幸的是，面对面干预的覆盖范围受到其成本和相对难以获得的限制。这一研究项目的结果将是一个全面的、创新的、基于网络的、针对艾滋病毒阳性患者的服药依从性计划，该计划在压力和情绪管理计划的框架内提出。这将极大地扩大获得有效用药依从性计划的机会，从而改善艾滋病毒感染者的身心健康。