A Pilot Test of an Online HIV Medication Adherence Intervention

描述(由申请人提供)：艾滋病毒流行在美国仍然是一个重大的公共卫生威胁，特别是由于艾滋病毒阳性(HIV+)患者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疗法(HAART)的依从性差是很常见的，而且与不理想的依从性相关的医疗费用具有很高的社会成本。这项由一位新的研究人员提出的建议的长期目标是提高美国HIV+患者的服药依从性。为实现这一目标，具体目标是：1)在互联网使用HIV+人群中开展药物依从性及其危险因素的形成性研究；2)基于信息-动机-行为技能理论设计基于同伴支持的互联网艾滋病毒用药依从性干预；以及3)试点在线干预，以评估干预的可行性和程序，以及获得人群参数，以计算更精确的功率，并为未来的随机对照试验设计估计。我们建议开发核心干预组件，包括用户驱动的个人配置文件，使参与者能够彼此交流并获得同行支持，药物自我监控和电子邮件和短信提醒，以及解决常见坚持问题的定制IMB相关反馈。所有干预功能都将具有高度的移动性，以便在出现坚持问题的情况下使用。该项目的创新包括使用基于理论和经验的基于互联网的干预措施来解决遵守HAART的问题，并纳入了尚未在艾滋病毒相关在线干预措施中广泛使用的同行互动和自我监测特征。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健康、心理学、计算机科学和药剂学-以开发第一种此类干预措施。HIPS计划环境在在线艾滋病毒预防研究中享有全国声誉，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，这是有效的基于互联网的研究的公认障碍。这项建议对艾滋病毒治疗依从性研究的意义包括制定一种全面的方法，制定和实施有理论基础的在线干预措施，以经验为基础的形成性研究，以了解使用互联网的艾滋病毒+患者的风险和需求，以及为未来的依从性努力使用技术标准。该项目对公共卫生的重要意义包括为使用互联网的HIV+患者开发和试点第一个在线HAART药物依从性干预措施，如果成功，可以很容易地适应更明确的后续随机对照试验。 公共卫生相关性：拟议的项目是：a)对互联网使用艾滋病毒阳性者的服药依从性及其风险因素进行形成性研究，以及b)设计和试点理论上有根据的、同伴支持的在线艾滋病毒服药依从性干预措施。拟议的干预措施在个人一级的影响是减少艾滋病毒病毒载量，从而在社会一级通过减少由于遵守情况不佳而导致的医疗费用来遏制向艾滋病的进展。利用互联网提供干预措施将使其能够广泛传播，并适用于各种人群。

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.