An Audio Music Self-management Program to Improve ART Adherence in Rural GA

描述(由申请人提供)：本申请建议修改和评估LIVE Network(LN)的有效性，LIVE Network(LN)是一种易于管理、具有教育意义的便携式音乐增强的音频自我管理坚持计划，用于提高佐治亚州农村地区艾滋病毒+患者的抗逆转录病毒治疗依从性。佐治亚州的艾滋病诊断比例在美国每10万人中排名第六，在农村居民艾滋病毒感染者数量中排名第二。LN计划在一家城市诊所(R21 NR010862)的77名HIV+患者中进行了为期12周的试点测试(由于样本量较小，设定为0.1)。与标准护理相比，LN-ARM组的患者自我效能感显著提高(p=0.08)，无法检测到的病毒载量比例更高 虽然没有统计学意义，但LN-ARM在12周时的平均药片计数(77.8%比70.6%)和治疗范围内的血浆ART水平(80.5%比72%)更高。参与者对该计划持压倒性的积极态度。在这个项目中，LN和随附的手册将被开发成一个交互式移动应用程序(APP)，加载到智能手机上，并在首次考察访问时介绍给参与者。新歌将会 在后续访问和简短访问期间添加到应用程序(30秒)励志歌曲和教育歌曲将定期通过短信发送。智能手机将用于学习活动，包括通过应用程序计算药片数量。该计划的有效性将在4年内在佐治亚州不同农村县的5个艾滋病毒服务机构的240名艾滋病毒+患者中进行测试。参与者将被随机(1：1)分配到LN或教育音乐计划应用程序(EP)。评估将在基线和3、6、9个月的随访中进行。作为遵守措施，将在研究时间点收集用于治疗药物监测的头发样本。该节目采用预先录制的电台脱口秀节目格式，音乐节目主持人接受来电者关于艾滋病毒药物和相关问题的问题和评论，向专家提出问题和评论，并播放歌曲，阐明阻碍坚持自我管理的问题。它是自我给药，旨在提高患者在ART坚持自我管理方面的知识、动机和自我效能。它建立在已知的音乐能力的基础上，以增强倾听的吸引力、动机、学习和对信息的回忆。如果成功，对艾滋病毒护理的影响将 这将是巨大的，并可通过克服这一弱势群体中的隔离、交通、保密和耻辱障碍，改变提供遵守艾滋病毒的自我管理教育的方式。在信息-动机-行为模型的指导下，有三个目标：1)修改和修改LN程序和手册，使其成为适合农村HIV+患者的移动应用程序。2)与对照条件相比，评估该计划在依从性(药片计数、头发样本中的药物水平、自我报告)、病毒载量、CD4计数、耐药性方面的效果。3)探讨：a)LN对症状和症状管理的影响；b)自我效能感、结果期望和个人目标设置作为中介变量的作用，以及抑郁和健康素养作为坚持调节变量的作用。

DESCRIPTION (provided by applicant): This application proposes to revise and evaluate the efficacy of The LIVE Network (LN), an easy to administer, educationally sound portable music-enhanced audio self-management adherence program, for improving ART adherence in HIV+ persons in rural Georgia, a state that ranks 6th in the proportion of AIDS diagnoses per 100,000 in the US and 2nd in the number of rural dwelling HIV infected persons. The LN program was pilot tested in 77 HIV+ persons at an urban clinic (R21 NR010862) over a 12-week period (¿ set at 0.1 due to small sample size). Compared to standard care, those in the LN-arm had significantly improved self-efficacy (p=0.08), higher proportion of undetectable viral loads at all time points (p=.067), and while not statistically significant the LN-arm had higher mean pill counts at 12 weeks (77.8% vs. 70.6%), and higher therapeutic range plasma ART trough levels (80.5% vs. 72%). Participants were overwhelmingly positive about the program. For this project, the LN and accompanying manual will be developed into an interactive mobile application (app), loaded onto smart phones, and introduced to participants at the initial study visit. New songs will be added to the app during follow up visits and brief (30 sec.) motivational and educational song jingles will be sent regularly via text messaging. Smart phones will be used for study activities including pill counts via an app. The program's effectiveness will be tested over 4-years in 240 HIV+ persons starting or changing ART at 5 HIV service agencies in different rural counties in GA. Participants will be randomized (1:1) to LN or to an educational music program app (EP). Assessments will be conducted at baseline and 3, 6, 9 months follow-up. Hair samples for therapeutic drug monitoring will be collected at the study time points as an adherence measure. The program is in a pre-recorded radio talk show format where a disc jockey takes questions and comments from callers about HIV medications and related issues, poses them to experts, and plays songs that shed light on issues that impede adherence self-management. It is self-administered and designed to enhance patients' knowledge, motivation, and self-efficacy in ART adherence self-management. It is built on the known capacity of music to enhance listening appeal, motivation, learning, and recall of information. If successful, the impact on HIV care will be immense and could transform the delivery of HIV adherence self-management education by overcoming barriers of isolation, transportation, confidentiality and stigma in this vulnerable group. Guided by the Information-Motivation-Behavior Model, there are three aims: 1) Revise and adapt the LN program and manual into a mobile app appropriate for rural HIV+ persons. 2) Evaluate the efficacy of the program, compared to the control condition, on the outcomes of adherence (pill counts, drug levels in hair samples, self report), viral load, CD4 counts, drug resistance. 3) Explore: a) the effects of LN on symptoms and symptom management; b) the roles of self-efficacy, outcome expectancies, and personal goal setting as mediators, and depression and health literacy as moderators of adherence.