An Audio Music Self-Management Adherence Program to Improve ART Adherence

描述(由申请人提供)：艾滋病毒疾病的自我管理因需要非常高的坚持治疗水平以及处理短期和长期抗逆转录病毒(ARV)相关症状和副作用的能力而变得复杂。加强自我管理技能和坚持艺术的战略已被评估为相当成功，但由于其中一些战略增加了时间、成本和人员，可持续性可能会有问题，特别是在资源有限的情况下。本申请响应PA-07-340，建议开发和评估一种易于管理、具有教育意义的便携式音乐增强的音频自我管理遵守计划在改善ARV依从性和ARV相关症状管理方面的可行性和有效性。这一方法将使用设置为文字和音乐的自我管理模块，旨在提高患者在抗逆转录病毒自我管理和依从性以及与药物相关的症状管理方面的知识和自我效能；这些模块将附有参考手册。内容将强调坚持的重要性，并将包括坚持和问题解决战略和建议，以识别和管理与抗逆转录病毒相关的症状和副作用。在已知音乐能力的基础上，增强聆听吸引力、动机、学习和回忆信息的能力，这些模块将由歌曲和为音乐设置的口语单词组成。这些模块被编程到MP3播放器中，将在最初的两次诊所访问中向参与者介绍和演示，每个参与者都将收到自己的预先编程的MP3播放器，其中包含整个70分钟的程序和参考手册，供在家使用。将设立一个800号码，供与会者来电提问。这项干预措施将在72名HIV+男性和女性样本中进行试点测试，他们将首次开始抗逆转录病毒治疗。将在研究现场将干预措施(2：1分配)与常规护理(至少由训练有素的艺术护士教育人员进行2次探视)进行比较。即使在最基本的临床环境中，这种方法也是创新的、相对便宜的、实用的、便携的和可持续的。它可以补充和维持临床工作人员的努力，并提高低文盲或不识字人群的理解能力。有四个目标。1)开发一个音乐增强的音频自我管理遵守计划，该计划将是可携带的，并伴随着一本用户友好的参考手册。2)收集形成信息，以便进一步完善计划以及研究方法和程序，以便在未来的对照临床试验中进行严格的测试。3)对该计划进行初步评估，该计划旨在评估与常规护理相比对坚持治疗的结果、治疗性血浆ARV谷值、病毒载量、CD4计数、症状和生活质量(QOL)的影响(12周)。4)考察项目对自我效能感、结果期望和个人目标设定的中介变量的影响。 与公共健康相关：我们建议开发和试行一项音频音乐增强的自我管理遵守计划，该计划可下载到MP3播放器上，并附带一份手册。这个便携的、用户友好的程序旨在教育和激励HIV+患者坚持他们的药物治疗并管理与药物相关的症状，对低识字率的人可能特别有用。如果成功，由此产生的更高水平的依从性将减少病毒载量，从而减少传染性，促进健康，并提高生活质量。

DESCRIPTION (provided by applicant): HIV disease self-management is complicated by the need for exceedingly high levels of adherence to therapy and the ability to deal with the short and long term antiretroviral (ARV) related symptoms and side- effects. Strategies to enhance self-management skills and ART adherence have been evaluated to be moderately successful, but because of the added time, cost and personnel associated with some of these strategies, sustainability can be problematic, particularly in resource-limited settings. This application, in response to PA-07-340, proposes to develop and evaluate the feasibility and effectiveness of an easy to administer, educationally sound, portable music-enhanced audio self-management adherence program in improving ARV adherence and ARV-related symptom management. This approach will employ self- administered modules set to words and music that are designed to enhance patients' knowledge and self- efficacy in ARV self-management and adherence and medication-related symptom management; the modules will be accompanied by a reference manual. Content will emphasize the importance of adherence and will include adherence and problem solving strategies and suggestions for recognizing and managing ARV-related symptoms and side effects. Building on the known capacity of music to enhance listening appeal, motivation, learning, and recall of information, the modules will consist of songs and spoken words set to music. These modules, programmed into MP3 players, will be introduced and demonstrated to participants during two initial clinic visits, and each participant will receive his/her own pre-programmed MP3 player containing the entire 70 minute program and reference manual for use at home. An 800 number will be established for participants to call with questions. The intervention will be pilot tested in a sample of 72 HIV+ men and women who will be starting ART for the first time. The intervention will be compared (2:1 allocation) to the usual care (at least 2 visits with a trained ART nurse educator) at the study site. This approach is innovative, relatively inexpensive, practical, portable, and sustainable even in the most basic clinical setting. It could supplement and sustain the efforts of clinical staff and enhance comprehension in low or non-literate populations. There are four aims. 1) To develop a music-enhanced audio self-management adherence program that will be portable and accompanied by a user-friendly reference manual. 2) To gather formative information to enable further refinement of the program and research methods and procedures in order to conduct rigorous testing in a controlled clinical trial in the future. 3)To conduct a preliminary evaluation of the program designed to assess the impact (at 12 weeks) when compared to the usual care on the outcomes of adherence, therapeutic plasma ARV trough concentrations, viral load, CD4 counts, symptoms, and quality of life (QoL). 4)To examine the effects of the program on the mediators of self-efficacy, outcome expectancy, and personal goal setting. PUBLIC HEALTH RELEVANCE: We propose to develop and pilot test an audio music enhanced self-management adherence program that is downloadable to an MP3 player and has an accompanying manual. The portable, user friendly program is designed to educate and motivate HIV+ persons to adhere to their medications and manage medication related symptoms and may be particularly useful in persons with low literacy. If successful, the resultant higher levels of adherence will reduce viral load, thus reducing infectiousness, promoting health, and increasing quality of life.