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

描述（由申请人提供）：本申请旨在修订和评估the LIVE Network （LN）的有效性，这是一个易于管理，具有教育意义的便携式音乐增强音频自我管理依从性程序，用于改善佐治亚州农村艾滋病毒感染者的抗逆转录病毒治疗依从性。佐治亚州在美国每10万人中艾滋病诊断比例排名第六，在农村居住艾滋病毒感染者人数中排名第二。LN项目在一家城市诊所（R21 NR010862）对77名HIV阳性患者进行了为期12周的试点测试（由于样本量小，设置为0.1）。与标准治疗相比，ln组患者的自我效能显著提高（p=0.08），无法检测到的病毒载量比例更高

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.