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Evaluation of Behavioral Intervention for HIV Positive Prisoners in NC and TX (imPACT)

2015年6月9日 更新者:David A Wohl, MD、University of North Carolina, Chapel Hill

CID 1007 - Randomized Controlled Trial of an Augmented Test, Treat, Link & Retain Model for NC and TX Prisoners (imPACT Study)

Purpose: The purpose of this study is to determine if a comprehensive intervention supporting seek-test-and-treat results in a significant reduction in the potential for HIV-infected prisoners to transmit their virus after release from prison.

Aim 2: Compare the effect of standard prison test-and-treat (sTNT) with the TNT-imPACT (imPACT) intervention on viral load 24 weeks following prison release.

Aim 3: Describe and model secondary outcomes, comparing them between sTNT and TNT-imPACT study arms. These outcomes include post-release HIV transmission risk behaviors, incident STIs, adherence to ART, medical care appointments, emergence of ART resistance mutations, and predicted HIV transmission events.

研究概览

详细说明

For Aims 2 and 3:

Participants:

We will enroll 400 HIV-infected men and women, age 18 years and older who are incarcerated in the NC Department of Correction (NCDOC) or the Texas Department of Criminal Justice (TDCJ) and scheduled for prison release in approximately 12 weeks, who are receiving ART and have an HIV RNA level that is below 400 copies/mL.

Procedures (methods): Participants will be consented, enrolled, and then randomized 1:1 to one of two conditions:

  1. standard test-and-treat (sTNT), which is the current standard of care, wherein following HIV testing, the DOC provides to HIV-infected inmates ART during incarceration and referral to community-based care and services by prison staff as well as a supply of antiretroviral medication (30 days in NC, 10 in TX) upon release, or
  2. TNT-imPACT (imPACT),which includes the sTNT plus our integrated, multi-component intervention targeting multiple levels to enhance adherence to HIV therapy and linkage to and engagement in clinical care, to maintain viral suppression after release.

All participants will be followed for up to 24 weeks post-release.

研究类型

介入性

注册 (实际的)

381

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • North Carolina
      • Chapel Hill、North Carolina、美国、27514
        • University of North Carolina at Chapel Hill
    • Texas
      • Fort Worth、Texas、美国、76129
        • Texas Christian University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Documented HIV infection
  • Incarcerated in the NCDOC at a facility within a 3 hour drive from Chapel Hill OR incarcerated in the TDCJ at a facility within a 3 hour drive from Ft. Worth
  • Age 18 years or older
  • Receiving ART for at least 30 days
  • Last recorded viral load (must be within 90 days of entry) <400 copies/mL
  • English speaking
  • Able and willing to provide informed consent
  • Willing to participate in post-release study activities
  • For NC - planning to remain in state after release and returning to a community within a 3 hour drive of Chapel Hill
  • For TX - returning to one of the following areas: Houston, Dallas, and Ft. Worth (including their suburbs)
  • Scheduled for release from prison

Exclusion Criteria:

  • Conviction for offenses that includes sexual assault or death or serious injury to a victim or is otherwise found, in the opinion of the investigators, to be at high risk for injury to staff (this criterion is designed to minimize risk to study personnel who will conduct study-related visits with participants in the communities to which they return and may be informed by input from correctional staff)
  • Pending charges that would likely lead to transfer of custody or other condition which would otherwise prevent or significantly delay release from custody.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Text reminders, counseling, link coordinator
Text reminders, counseling, link coordination
This is an intervention with text reminders, counseling that involves motivational interviewing, and link coordination
有源比较器:Standard of care - control arm
The control arm is standard of care for each subject.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
HIV RNA level (Viral Load)
大体时间:Week 24 post-release from prison
Week 24 post-release from prison

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:David A Wohl, MD、University of North Carolina, Chapel Hill
  • 首席研究员:Carol Golin, MD、University of North Carolina, Chapel Hill

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年3月1日

初级完成 (实际的)

2015年5月1日

研究完成 (实际的)

2015年5月1日

研究注册日期

首次提交

2012年6月4日

首先提交符合 QC 标准的

2012年6月25日

首次发布 (估计)

2012年6月27日

研究记录更新

最后更新发布 (估计)

2015年6月11日

上次提交的符合 QC 标准的更新

2015年6月9日

最后验证

2015年6月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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