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

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：开发改变患者和提供者行为以提高依从性的新技术。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个体活得更长、更健康（O’cleirigh和Safren， 2008年；Safren等人，2001年；2009年）。HAART通常涉及联合用药，可降低病毒载量，增强免疫系统功能，减少HIV感染患者临床免疫缺陷的可能性（Carpenter et al., 1997; Flexner, 1998; Goebel, 1995）。然而，高效抗逆转录病毒疗法的有效性完全取决于完全遵守处方药物治疗方案，这通常涉及不同的给药方案和食物摄入条件，需要在无限期的治疗过程中坚持复杂且经常令人困惑的药物组合。药物使用已被证明会严重侵蚀依从性（Hinkin et al., 2007），而且由于依从性会受到压力和消极情绪状态的进一步威胁，最近的建议强调了开发依从性干预措施的重要性，这些干预措施也可以解决压力、情绪状态和药物使用问题（Scott-Sheldon, 2008； O'Cleirigh and Safren, 2008; Safren et al., 2009）。一项针对艾滋病毒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有效的证据（Scott-Sheldon et al., 2008）。最近，为了进一步认识到情绪状态和药物依从性之间的联系，Safren和同事（2009）对hiv阳性诊断为抑郁症的个体进行了一项药物依从性干预的随机对照试验，发现对药物依从性和抑郁症都有积极的影响。因此，很明显，改善HIV药物依从性的有效干预措施是可用的，并且在压力和情绪管理的框架内提供药物依从性策略的培训可能是改善情绪状态和药物依从性的有效方法。然而，迄今为止创建的所有艾滋病毒药物依从性项目都需要专业人员，在依从性程序方面经过专门培训，在多个疗程的过程中亲自与患者互动。在与惠特曼沃克诊所的合作中，我们建议在压力和情绪管理项目的框架内对艾滋病毒阳性个体进行基于网络的药物依从性项目的随机对照试验。这项随机试验将在为期两年的时间里对惠特曼沃克诊所（Whitman Walker Clinic）的200名患者进行抽样，主要通过电子药物事件监测系统（MEMS）评估依从性，同时对压力、情绪和药物使用进行多重自我报告评估。惠特曼沃克诊所位于华盛顿特区，那里有很大一部分艾滋病毒阳性人口是由最近或目前的吸毒者组成的。如果证明有效，基于网络的SMM-AD项目将向所有能上网的艾滋病毒阳性患者开放，从而大大扩大药物依从性项目的覆盖范围。Drs。Cook和Billings （PI和合作研究者）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（其中包括一个关于物质使用的部分），最近在一个随机对照试验中显示有效（Cook等人，2007；Billings等人，2008）。他们目前正在进行一项基于网络的妇女艾滋病预防项目的随机试验。史蒂文·萨夫伦（Steven Safren）开发并测试了多个艾滋病药物依从性项目，大卫·默里（David Murray）是随机试验设计和分析方面的公认专家，他们将担任该项目的顾问。

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.