An Audio Music Self-Management Program to Improve ART Adherence in Rural GA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Change in Antiretroviral Therapy (ART) Adherence Rates
研究概览
简要总结
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.
详细描述
The project has two primary aims and one exploratory aim. 1.0 Revise and adapt the Live Network (LN) program and manual for rural persons living with HIV/AIDS (PLWHA) and develop into a mobile application.
2.0 Conduct a randomized controlled trial to test the efficacy of the program. When compared with an educational music control condition at 3, 6, and 9 months post-baseline, those randomized to the LN will have: H1: Significantly higher mean antiretroviral therapy (ART) adherence rates (measured by pill counts, self report).
H2: Significantly higher mean levels of ART drug levels in hair sample analyses.
H3: Significantly better clinical indicators: higher mean CD4 lymphocyte counts and percents, a larger proportion achieving virologic suppression (proportion with HIV RNA PCR <50 copies/ml), and smaller proportion with evidence of drug resistance, all as measured by medical record review.
3.0 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV+ individuals initiating ART for the first time (except women who may have had ART during pregnancy); or HIV+ individuals changing ART regimen within the past 3 months due to side effects or virologic resistance; or HIV+ individuals with a detectable viral load ≥ 40copies/ml; or HIV+ individuals on ART medication
- •English speaking
- •Willing to complete 4 assessments
- •Willing to complete monthly, unannounced pill counts
- •Willing to allow collection of hair samples
- •Willing to be randomly assigned to either condition
- •Willing to participate in study activities that include using smart phone and mobile app
排除标准
- •Have a history of bilateral hearing loss (health care provider diagnosed or self-identified)
- •Have a cognitive impairment (inability to comprehend the informed consent)
- •Display psychotic symptoms, as determined by the Brief Symptom Inventory (BSI)
结局指标
主要结局
Change in Antiretroviral Therapy (ART) Adherence Rates
时间窗: Baseline, 3 months post-baseline, 6 months post-baseline and 9 months post-baseline
Adherence rate was measured with the Antiretroviral General Adherence Scale (AGAS) which measures the general ease and ability to take one's medication as prescribed in the past 30 days. It includes 5 items scored 1 to 6, with the possible scores for this instrument ranging from 5 to 30, and higher scores reflect better adherence.
次要结局
- Change in Antiretroviral (ART) Drug Levels in Hair Sample Analyses.(3, 6, and 9 months post-baseline)
- Clinical Indicator: Change in Mean CD4 Percentage(Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention)
- Clinical Indicator: Number of Participants With Non-detectable Viral Load(Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention)
研究者
Marcia McDonnell Holstad, DSN, FNP-BC
Associate Professor
Emory University