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: 7938693
• 负责人: ROYER F COOK
• 金额: $ 49.49万
• 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 2012-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7938693
• 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 Depression; Mental Health; Meta-Analysis; Monitor; Moods; Online Systems; Outcomes Research; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Population; Prevention program; Procedures; Provider; Randomized Controlled Trials; Recommendation; Regimen; Relative (related person); Research Personnel; Research Project Grants; Sampling; Schedule; Self Efficacy; Stress; System; Technology; Testing; Training; Viral Load result; Walkers; Woman; behavioral health; cooking; cost; design; efficacy testing; improved; innovation; medication compliance; negative mood; new technology; programs; public health relevance; randomized trial; 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-和特定的挑战主题06-DA-104：开发新技术以改变患者和提供者的行为，从而提高依从性。自从高活性抗逆转录病毒疗法（HAART）出现以来，大量HIV阳性个体正在延长和更健康地生活（O 'Cleiigh和Safren，2008; Safren等人，2001; 2009）。HAART通常涉及药物组合，导致HIV感染患者中病毒载量减少、免疫系统功能增强和临床免疫缺陷的可能性降低（Carpenter et al.，1997; Flexner，1998; Goebel，1995）。然而，HAART的有效性完全取决于对处方药物治疗方案的完全遵守，这通常涉及不同的给药方案和食物摄入条件，需要在整个无限期的治疗过程中遵守复杂且经常混淆的药物组合。药物使用已被证明会严重侵蚀依从性（Hinkin等人，2007），并且由于坚持可能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也解决压力、情绪状态和物质使用的坚持干预的重要性（Scott-Sheldon，2008; O 'Cleiigh和Safren，2008; Safren等人，2009年）。对HIV阳性人群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年）。最近，在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）进行了一项随机对照试验，对诊断为抑郁症的HIV阳性个体进行药物依从性干预，发现药物依从性和抑郁症都有积极的影响。因此，似乎很明显，有效的干预措施，以提高艾滋病毒药物的依从性是可用的，并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一种有效的方法，以改善情绪状态和药物依从性。然而，迄今为止创建的所有艾滋病毒药物依从性计划都需要经过依从性程序专门培训的专业人员在多个会话过程中与患者进行亲自互动。在与惠特曼步行者诊所的合作伙伴关系，我们建议进行一项随机对照试验，基于网络的药物依从性计划的艾滋病毒阳性的个人提出的框架内的压力和情绪管理计划。这项随机试验将在为期两年的时间内进行，样本为惠特曼步行者诊所的200名患者，主要使用电子药物事件监测系统（MEMS）评估依从性，沿着压力、情绪和药物使用的多项自我报告评估。惠特曼步行者诊所位于华盛顿，那里的艾滋病毒阳性人群中有很大一部分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计划将提供给所有能够访问互联网的艾滋病毒阳性者，大大扩大药物依从性计划的范围。Cook博士和Billings博士（PI和共同研究者）成功地创建并测试了几个基于网络的行为健康计划，包括压力和情绪管理（其中包括药物使用部分），最近在一项随机对照试验中显示有效（Cook等人，2007; Billings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预防计划的随机试验。史蒂文·萨夫伦（Steven Safren）开发并测试了多种艾滋病药物依从性计划，大卫·默里（David Murray）是随机试验设计和分析方面的公认专家，他将担任该项目的顾问。 公共卫生关系：自从高效抗逆转录病毒疗法出现以来，大量艾滋病毒抗体阳性者的寿命延长，生活更加健康。然而，HAART的有效性完全取决于在整个无限期的治疗过程中完全坚持复杂且经常混淆的药物组合。吸毒、压力和消极情绪状态会进一步降低艾滋病毒药物治疗的依从性。然而，最近的数据表明，面对面的抑郁症和药物依从性治疗可以改善情绪，提高药物依从性。不幸的是，面对面干预的范围受到其成本和相对难以获得的限制。这项研究项目的成果将是一个全面的，创新的，基于网络的药物依从性计划，为艾滋病毒阳性的个人提出的压力和情绪管理计划的框架内。这将大大扩大有效药物依从性计划的覆盖范围，从而改善艾滋病毒感染者的身心健康。