A Pilot Test of an Online HIV Medication Adherence Intervention

描述（由申请人提供）：在美国，艾滋病毒流行病仍然是一个重大的公共卫生威胁，特别是因为艾滋病毒阳性（艾滋病毒+）个体由于治疗方法的改进而寿命更长。然而，对高效抗逆转录病毒治疗（HAART）的依从性差是很常见的，并且在与次优依从性相关的医疗支出方面具有很高的社会成本。一名新研究者提出的这项建议的长期目标是增加美国HIV+个体的药物依从性。为此，本研究的具体目标是：1)对互联网使用HIV+人群的药物依从性及其风险因素进行形成性研究；2)基于信息-动机-行为技能理论设计基于互联网的同伴支持HIV药物依从性干预；3)在线干预试点，评估干预的可行性和程序，并获得群体参数，为未来的随机对照试验计算更精确的功率和设计估计。我们建议开发核心干预组件，其中包括用户驱动的个人档案，使参与者能够相互交流并获得同伴支持，药物自我监控和电子邮件和短信提醒，以及定制的与imb相关的反馈，以解决依从性的常见问题。所有干预措施的特点都是高度可移动的，以便在出现依从性问题的情况下加以利用。该项目的创新包括采用基于理论和经验的基于互联网的干预措施来解决HAART治疗依从性问题，并结合同伴互动和自我监测的特点，这些特点在与艾滋病毒相关的在线干预措施中尚未广泛使用。PI在基于互联网的艾滋病毒相关干预研究方面经验丰富，并组建了一支强大的多学科团队——代表流行病学和社区卫生、心理学、计算机科学和药剂学——来开发首个此类干预。HIPS项目环境在在线艾滋病毒预防研究方面享有全国声誉，并为人类受试者的考虑制定了广泛的协议，包括数据安全和交叉验证协议，这些协议被确定为有效的基于互联网的研究的障碍。本提案对艾滋病毒治疗依从性研究的意义包括开发一种基于理论的综合方法，以在线干预的开发和实施为基础，基于经验的形成性研究，以了解使用互联网的艾滋病毒+个体的风险和需求，以及使用技术标准为未来的依从性努力。该项目对公共卫生的重要意义包括为使用互联网的艾滋病毒+个体开发和试点第一个在线HAART药物依从性干预措施，如果成功，可以很容易地适用于随后更明确的随机对照试验。

DESCRIPTION (provided by applicant): The HIV epidemic continues to be a significant public health threat in the United States (US), particularly as HIV-positive (HIV+) individuals live longer as a result of improved treatments. However, poor adherence to highly active antiretroviral therapy (HAART) is common, and has a high societal cost in terms of medical expenditures associated with suboptimal adherence. The long-term objective of this proposal by a new investigator is to increase medication adherence among HIV+ individuals in the US. To achieve this, the specific aims are to: 1) conduct formative research on medication adherence and its risk factors among Internet-using HIV+ persons, 2) design a peer support Internet-based HIV medication adherence intervention grounded in the Information-Motivation-Behavioral Skills theory; and 3) pilot the online intervention to assess intervention feasibility and procedures, as well as to obtain population parameters to calculate more precise power and design estimates for a future randomized controlled trial. We propose to develop core intervention components that include user-driven personal profiles that enable participants to communicate with one another and receive peer support, medication self-monitoring and e-mail and text message reminders, and tailored IMB-related feedback that address common problems of adherence. All intervention features will be highly mobile to allow for utilization in contexts in which adherence problems arise. Innovation in this project includes the use of a theoretically-grounded and empirically-derived Internet- based intervention to address HAART adherence, with incorporation of peer interaction and self-monitoring features that have not been widely used in HIV-related online interventions. The PI is experienced in Internet-based HIV-related intervention research, and has assembled a strong multidisciplinary team - representing Epidemiology and Community Health, Psychology, Computer Science, and Pharmacy - to develop the first of its kind intervention. The HIPS Program environment has a national reputation in online HIV prevention studies, and has developed extensive protocols for human subjects' considerations, including data security and cross-validation protocols, which are identified barriers to effective Internet- based research. The significance to HIV treatment adherence research of this proposal includes the development of a comprehensive approach to theoretically-grounded online intervention development and implementation, empirically-based in formative research to understand the risks and needs of Internet-using HIV+ individuals and the use of technology standards for future adherence efforts. The significance of this project to public health involves the development and pilot testing of the first online HAART medication adherence intervention for Internet-using HIV+ individuals that, if successful, can be easily adapted for a more definitive subsequent randomized controlled trial. PUBLIC HEALTH RELEVANCE: The proposed project is to a) conduct formative research on medication adherence and its risk factors among Internet-using HIV-positive individuals and b) design and pilot a theoretically grounded, peer support online HIV medication adherence intervention. The impact of the proposed intervention at the individual level is the reduction of HIV viral load, thereby curtailing progression to AIDS, and at the societal level, by reducing health care costs that result from poor adherence. Using the Internet to deliver the intervention will allow it to be distributed widely and adapted for use with a variety of populations.