跳至主要内容
临床试验/NCT01596322
NCT01596322已完成不适用

Novel Approaches to Monitoring and Utilizing Adherence to HIV Therapy in Uganda

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2004年9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
750
试验地点
1
主要终点
Adherence to antiretroviral therapy

研究概览

简要总结

Real-time Wireless Adherence Monitoring to HIV Antiretroviral Therapy in Rural Uganda.

详细描述

The investigators will study use a novel method of real-time wireless adherence monitoring in one of the best established multi-disciplinary HIV antiretroviral treatment cohorts in rural Africa. The investigators will advance our theoretical understanding of HIV antiretroviral adherence behavior, HIV pathogenesis, and to address the monitoring and prevention of HIV antiretroviral treatment failure. Based on a successful pilot study in rural Uganda and favorable cost-effective estimates, the investigators will deploy the Wisepill real-time wireless adherence monitoring system to objectively monitor adherence in real time. The investigators will determine to what extent social capital mitigates economic barriers to long-term adherence and determine if the pervasive impact of stigma on adherence operates through social capital (Aim 1). The investigators will determine the relationship between missed doses, low-level viremia (between 1 and 50 copies RNA/mL), inflammation, bacterial translocation, suboptimal CD4 response, and mortality (Aim 2). Finally, The investigators will examine the relationship between complex adherence patterns and viral failure to both inform selective viral load monitoring and to lay the foundation for the first-of-kind intervention to prevent viral failure after missed doses, but before viral rebound (Aim 3). The investigators will secure behavioral and biologic data over nine years of potential treatment by recruiting 500 additional people to our existing cohort in Mbarara, Uganda for a total of 750 participants.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HIV positive patients over 18 years
  • ART naive and initiating therapy at the Mbarara Immune Suppression Syndrome (ISS) Clinic
  • Live within 60 kilometers of the clinic
  • Women who have received a single dose of nevirapine for prevention of mother to child transmission, but have not received other ART, will be included

排除标准

  • Patients who do initiate therapy during the course of the study recruitment
  • Patients who decline or are unable to give consent

结局指标

主要结局

Adherence to antiretroviral therapy

时间窗: real time (up to 7 years)

Adherence is assessed through a medication event monitoring system which records every time the device is opened (e.g. for pill taking). Before June 2012, this data was stored on the device and downloaded monthly. After June 2012, this data is transmitted through cellular networks to a central server in real time.

次要结局

  • Adherence to antiretroviral therapy by self report(every four months)
  • Correlates of adherence to antiretroviral therapy(every four months)
  • Biological consequences of adherence (or incomplete adherence)(every four months and during adherence interruptions)

研究者

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

Jessica Haberer, MD

Associate Professor

Massachusetts General Hospital

研究点 (1)

Loading locations...

相似试验