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临床试验/NCT01140633
NCT01140633已完成不适用

Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Distribution of adherence

研究概览

简要总结

Current measures of adherence detect problems weeks to months after they occur. Because the HIV virus rapidly begins replicating and mutating in the absence of effective antiretroviral therapy, treatment failure may develop before an intervention can be deployed. Real-time objective adherence monitoring could redirect efforts from a reactive response to the proactive prevention of treatment failure. Because adherence is so closely associated with viral suppression, accurate adherence monitoring could also strategically limit viral monitoring only to those patients at a defined risk for viral rebound.

This observational study is assessing a wireless adherence monitoring device and mobile phone-based adherence data collection among caregivers of children under the age of ten years in Mbarara, Uganda. It involves both quantitative and qualitative measures of the feasibility and acceptability of these measures, as well as circumstances of adherence lapses and other individual and cultural factors affecting adherence. The qualitative data will be used to explore models of adherence behavior, which will likely include the child-caregiver dynamic, the child's mental and physical health, and social support mechanism.

详细描述

See above.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age 1 to 10 years
  • HIV-infected, meeting Ugandan criteria for antiretroviral therapy
  • living within 30 km of Mbarara, Uganda

排除标准

  • lack of mobile-phone reception

结局指标

主要结局

Distribution of adherence

时间窗: Monthly adherence levels will be determined over the six-month study period.

Distribution of adherence based on wireless adherence monitoring devices and interactive voice response (IVR) or short message service (SMS) self report by caregivers of HIV-infected children under ten years old in Mbarara, Uganda.

次要结局

  • Feasibility and acceptability of wireless adherence measures(Assessments will be made a the one-month time point.)
  • Model of adherence behavior(Data collected at baseline and during adherence interruptions will be analyzed at the end of the six-month study period.)

研究者

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

Jessica Haberer, MD

Assistant in Medicine

Massachusetts General Hospital

研究点 (1)

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