Randomized Controlled Trial Using Patient Reported Outcomes and Care Managers to Improve HIV Medication Adherence in Routine Clinical Care
试验速览
- 阶段
- 不适用
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Self-reported adherence
研究概览
简要总结
Among HIV-infected patients, adherence to antiretroviral medications is one of the most important determinants of clinical outcomes including viral suppression, viral resistance, disease progression, and death. Unfortunately poor adherence among patients with HIV is very common, mean levels of adherence in clinical cohorts are 60-75% or less. Alcohol, drug abuse, and mental illness particularly depression symptoms are key predictors of poor adherence, common among HIV-infected individuals, and important to identify and treat among nonadherent patients. This study will examine the ability of patient reported outcomes (PROs) and a targeted care management approach to improve clinical outcomes with a randomized controlled trial (RCT) in routine clinical care of patients with HIV. The investigators will determine whether healthcare delivery team notification of PROs including antiretroviral medication adherence and barriers of adherence such as depression and substance abuse along with tailored intervention recommendations and targeted care management leads to improvement in both process and clinical outcomes including patient-reported outcomes. The investigators will examine process outcomes such as use of clinic support services, and patient outcomes such as improvement in adherence, substance use, depression, and HIV-1 RNA levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
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-infected individuals
- •English speaking
- •18 years of age or older
- •Access to either a home phone or cell phone at enrollment
- •In care at least 6 months.
- •Self-reported inadequate adherence based on routine clinic assessment
排除标准
- •Do not speak English
- •Not receiving antiretroviral medications
结局指标
主要结局
Self-reported adherence
时间窗: up to 1 year after enrollment
次要结局
- HIV-1 RNA level(up to 1 year after enrollment)
- Self-reported depression(Up to 1 year)
- Self-reported substance use(Up to 1 year after enrollment)
- Physical activity levels(up to 1 year after enrollment)
- Health related quality of life(Up to 1 year after enrollment)
研究者
Heidi Crane
Assistant Professor
University of Washington
