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

旨在提高 GA 农村地区 ART 依从性的音频音乐自我管理计划

• 批准号: 8327458
• 负责人: MARCIA McDonnell Holstad
• 金额: $ 65.7万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8327458
• 关键词: AIDS diagnosis; AIDS prevention; AIDS/HIV problem; Address; Adherence; Adverse effects; Behavior; CD4 Lymphocyte Count; Car Phone; Caring; Chronic; Chronic Disease; Clinic; Clinical; Complex; Confidentiality; County; Data; Disabled Persons; Disease Management; Dose; Drug Monitoring; Drug resistance; Education; Expectancy; Fright; Funding; Goals; HIV; HIV Infections; Hair; Health; Health Services Accessibility; Human Resources; Intervention; Knowledge; Learning; Life; Light; Logistics; Manuals; Measures; Mediator of activation protein; Medical Records; Mental Depression; Modeling; Motivation; Music; Outcome; Participant; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Plasma; Play; Program Effectiveness; Provider; Published Comment; RNA; Radio; Randomized; Randomized Controlled Trials; Regimen; Reporting; Resources; Role; Rural; Rural Community; Rural Population; Sample Size; Sampling; Self Administration; Self Efficacy; Self Management; Self-Administered; Services; Stigmata; Symptoms; Technology; Telephone; Testing; Text; Therapeutic; Time; Time Study; Training; Transportation; Treatment outcome; Viral Load result; Visit; Vulnerable Populations; Work; antiretroviral therapy; arm; cost; design; efficacy testing; experience; follow-up; handicapping condition; health literacy; improved; medication compliance; pill; programs; psychologic; response; rural area; skills; social stigma; sound; standard care; standard of care; success; symptom management; therapy adherence; trend

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. PUBLIC HEALTH RELEVANCE: An Audio Music Self-Management Program to Improve ART Adherence in Rural GA Project Narrative The overall goal of this project is to use technology to improve adherence to antiretroviral therapy (ART) and increase access to ART adherence care for those HIV+ persons living in rural areas. The LIVE Network audio music program mobile application (app) is innovative, practical, portable, and could be rapidly scaled up to address the adherence self-management needs of rural groups nationwide. If successful, the impact on HIV care will be immense and could transform the delivery of HIV self-management and adherence education by overcoming barriers of geographic isolation, transportation, stigma and confidentiality in this vulnerable group.

描述（申请人提供）：本申请建议修改和评估LIVE网络（LN）的有效性，这是一种易于管理、教育合理的便携式音乐增强音频自我管理依从性计划，用于改善格鲁吉亚农村艾滋病毒阳性者的ART依从性，格鲁吉亚是一个在每100人中艾滋病诊断比例排名第6的州，在美国，艾滋病毒感染者的数量在农村地区排名第二。LN方案在一家城市诊所（R21 NR 010862）的77名HIV+患者中进行了为期12周的试点测试（由于样本量小，因此设置为0.1）。与标准治疗相比，LN组患者的自我效能显著改善（p=0.08）， 在两个时间点，LN组的平均药物计数（77.8% vs. 70.6%）和治疗范围血浆ART谷水平（80.5% vs. 72%）较高，但无统计学显著性。与会者对该计划持压倒性的积极态度。对于本项目，LN和随附手册将被开发为交互式移动的应用程序（app），加载到智能手机上，并在首次研究访视时介绍给受试者。新歌将 在随访访视和简短（30秒）期间添加到应用程序中将定期通过短信发送激励和教育歌曲广告歌。智能手机将用于研究活动，包括通过应用程序进行药丸计数。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对240名开始或改变抗逆转录病毒疗法的艾滋病毒阳性者进行测试。受试者将被随机（1：1）分配至LN或教育音乐程序应用程序（EP）。将在基线和3、6、9个月随访时进行评估。将在研究时间点采集用于治疗药物监测的毛发样本，作为依从性指标。该节目采用预先录制的电台脱口秀形式，节目主持人回答来电者关于艾滋病毒药物和相关问题的问题和评论，将其提交给专家，并播放歌曲，阐明阻碍坚持自我管理的问题。它是自我管理的，旨在提高患者在ART依从性自我管理方面的知识，动机和自我效能。它是建立在音乐的已知能力，以提高聆听的吸引力，动机，学习和回忆的信息。如果成功，对艾滋病护理的影响将 这将是巨大的，可以通过克服这一弱势群体中的隔离、交通、保密和耻辱等障碍，改变艾滋病毒依从性自我管理教育的提供。在信息-动机-行为模式的指导下，有三个目标：1）修订和调整LN方案和手册，使其成为适合农村艾滋病毒阳性者的移动的应用程序。2)与对照条件相比，评价该计划对依从性（药丸计数、头发样本中的药物水平、自我报告）、病毒载量、CD 4计数、耐药性结果的有效性。3)探索：a）LN对症状和症状管理的影响; B）自我效能、结果预期和个人目标设定作为中介的作用，以及抑郁和健康素养作为调节剂的依从性。 公共卫生关系：一个音频音乐自我管理计划，以提高抗逆转录病毒治疗的坚持在农村GA项目叙述该项目的总体目标是利用技术，以提高坚持抗逆转录病毒治疗（ART），并增加获得ART坚持照顾那些艾滋病毒阳性的人生活在农村地区。LIVE网络音频音乐程序移动的应用程序（app）是创新的、实用的、便携的，并且可以快速扩展以解决 坚持全国农村群体自我管理的需要。如果成功，对艾滋病毒护理的影响将是巨大的，并可能通过克服这一弱势群体的地理隔离，交通，耻辱和保密等障碍，改变艾滋病毒自我管理和坚持教育的提供。