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

描述（由申请人提供）：由于需要极高水平的治疗依从性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，艾滋病毒疾病自我管理变得复杂。据评价，提高自我管理技能和坚持抗逆转录病毒疗法的战略取得了一定的成功，但由于其中一些战略增加了时间、成本和人员，可持续性可能存在问题，特别是在资源有限的情况下。本申请是对PA-07-340的回应，旨在开发和评估一种易于管理、教育合理、便携式音乐增强音频自我管理依从性计划在提高抗逆转录病毒依从性和抗逆转录病毒相关症状管理方面的可行性和有效性。这种方法将采用自我管理的模块，设置为文字和音乐，旨在提高患者在抗逆转录病毒自我管理和依从性以及药物相关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，并将包括坚持和解决问题的战略和建议，以识别和管理与抗逆转录病毒相关的症状和副作用。在已知的音乐能力的基础上，提高听力吸引力，动机，学习和回忆信息，这些模块将包括歌曲和口语单词设置为音乐。将在两次初始临床访视期间向参与者介绍并演示这些编程到MP3播放器中的模块，每位参与者将收到其自己的预编程MP3播放器，其中包含整个70分钟的程序和供在家使用的参考手册。将设立一个800号码供与会者提问。该干预措施将在72名首次开始抗逆转录病毒治疗的艾滋病毒阳性男性和女性样本中进行试点测试。将在研究中心将干预（2：1分配）与常规护理（由经过培训的ART护士教育者进行至少2次访视）进行比较。这种方法是创新的，相对便宜，实用，便携式和可持续的，即使在最基本的临床环境。它可以补充和维持临床工作人员的努力，并提高低识字率或文盲人口的理解能力。有四个目标。1)开发一个音乐增强型音频自我管理坚持程序，该程序将是便携式的，并附有用户友好的参考手册。2)收集形成性信息，以便进一步完善项目和研究方法和程序，以便在未来的对照临床试验中进行严格的测试。3）对该方案进行初步评价，以评估与常规治疗相比，该方案对依从性、治疗性血浆ARV谷浓度、病毒载量、CD 4计数、症状和生活质量（QoL）的影响（12周时）。（4）检验自我效能、结果期望和个人目标设定的中介变量对课程效果的影响。 公共卫生相关性：我们建议开发和试点测试音频音乐增强自我管理坚持程序，可下载到MP3播放器，并有一个附带的手册。便携式，用户友好的程序，旨在教育和激励艾滋病毒+的人坚持他们的药物治疗和管理药物相关的症状，并可能是特别有用的人识字率低。如果成功，由此产生的更高水平的依从性将降低病毒载量，从而降低传染性，促进健康，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.