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临床试验/NCT01402466
NCT01402466已完成2 期

Finding, Testing and Treating High-Risk Probationers and Parolees With HIV

RTI International2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
49
试验地点
2
主要终点
Log10 viral load

研究概览

简要总结

The study will test an intervention to help HIV-positive people achieve consistency of HIV care while transitioning in and out of jail.

详细描述

The study has two research objectives: (1) to expand access and options for HIV testing with individuals in the criminal justice system, by focusing on high-risk intravenous drug users (IDUs) and crack cocaine smokers in community settings; and (2) to improve access and maintenance of highly active antiretroviral treatment (HAART) among HIV-positive persons in this population, by implementing a promising intervention focused on continuity of HIV care, and evaluating it using a rigorous experimental design.

HIV-positive persons will be identified through the testing activities described in Objective 1. They will then be offered enrollment in a randomized controlled trial (RCT) of an intervention designed to engage and maintain HIV-positive people with criminal justice involvement in medical care. The intervention, Project Bridge, has shown great promise but has not yet been rigorously evaluated. The RCT will assess the efficacy of Project Bridge compared with a Usual Care arm. Our hypotheses are that, at quarterly data collection visits: (1) Intervention participants will have lower HIV viral load than usual care participants 2b: (2) Intervention participants will be more likely to be in HIV care than usual care participants (3) Intervention participants will be more likely to be on HAART than usual care participants.

The study design was changed from a randomized controlled trial to a quasi-experimental comparison group design. This change was approved by the NIMH Program Officer and the RTI IRB in June, 2012.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or older
  • HIV antibody positive
  • not currently receiving HIV care

排除标准

  • already in care
  • unable to provide informed consent

结局指标

主要结局

Log10 viral load

时间窗: Every 3 months for 2 years

Changes in viral load over time will be compared between the standard referral and Project Bridge Groups

次要结局

  • Engagement in HIV Care(Every 3 months for 2 years)
  • Initiation of Highly Active Antiretroviral Therapy (HAART)(Every 3 months for 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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