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临床试验/NCT01505660
NCT01505660Unknown不适用

Randomized Controlled Trial Using Patient Reported Outcomes and Care Managers to Improve HIV Medication Adherence in Routine Clinical Care

University of Washington2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2012年1月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heidi Crane

Assistant Professor

University of Washington

研究点 (2)

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