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A Randomized Controlled Trial of HIV Testing and Linkage to Care at Community Corrections

2019年8月14日 更新者:Friends Research Institute, Inc.

A Randomized Controlled Trial and Cohort Study of HIV Testing and Linkage to Care Corrections

The investigators propose to conduct both a randomized trial of HIV testing in community corrections, and a randomized trial of linkage to HIV care for people with HIV recruited through community corrections (probation and parole).

研究概览

地位

完全的

详细说明

The first study is a two-group randomized controlled trial in which 6,000 male and female probationers and parolees in Baltimore City, Maryland and Providence, Rhode Island will be randomly assigned to one of two treatment conditions: 1) On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office; or 2) Off-site referral for rapid HIV testing at a community health center or HIV testing clinic. Inclusion criteria will be: 1) Adult probationer/parolee; 2) not known to be HIV positive, and 3) resident of greater Baltimore or Providence throughout the study period. Exclusion criteria will be: 1) unable to give informed consent. The second study is a randomized trial, whereby all individuals identified at community corrections with HIV will be offered enrollment in a one-year intervention study to examine the ability to improve linkage into HIV care. Participants will be randomized to receive one of two conditions: 1) Project Bridge for one year, or 2) Treatment as Usual-referral to standard level of care. Moreover, those randomized to TAU will be given an opportunity to "crossover" to PB if they have failed to engage in treatment during the first three months. The rationale for choosing the two cities of Baltimore, MD and Providence, RI is due to the historically high rates of heroin addiction that is associated with multiple HIV-related risk behaviors in these two cities and a high likelihood of being on probation and/or parole. Furthermore, Maryland ranks 10th and Rhode Island ranks 4th in the nation in the number of probationers per 100,000 adult residents.

研究类型

介入性

注册 (实际的)

797

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

    • Maryland
      • Baltimore、Maryland、美国
        • Maryland Department of Public Safety and Correctional Services (DPSCS), Division of Parole and Probation

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

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Probation or Parole;
  2. Resident of Baltimore, MD or Providence, RI; 3) Willing to be tested for HIV

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:放映
  • 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:On-site Rapid HIV Testing
On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office.
Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.
无干预:Off-site Referral for HIV Testing
Off-site referral for rapid HIV testing at a community health center or HIV testing clinic
实验性的:Project Bridge
Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.
Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.
无干预:Treatment as Usual
Passive referral to HIV community treatment provider.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of Participants Willing to Undergo Rapid HIV Testing
大体时间:Baseline

Aim 1: To determine the willingness of the community corrections population to undergo HIV testing (Seek).

Aim 1a: To compare a strategy of rapid HIV testing on site in community corrections (probation and parole offices) to referral to an off site community HIV testing location with a randomized control study (Test).

Baseline
Number of Participants That Entered Community HIV Treatment
大体时间:3-months
Number of Participants That Entered Community HIV Treatment (yes versus no) at the 3-month post baseline follow-up period.
3-months

次要结果测量

结果测量
措施说明
大体时间
Retention in Community HIV Treatment
大体时间:18 months
Number of Days with Retention in Community HIV Treatment
18 months
Proportion of Those Prescribed Highly Active Antiretroviral Therapy (HAART) Who Are Undetectable
大体时间:6,12,18-months
To determine if a promising, theory driven, case management based strategy (Project Bridge), will be utilized by individuals with HIV recruited through community corrections.
6,12,18-months

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:Michael S Gordon, D.P.A.、Friends Research Institute, Inc.
  • 首席研究员:Josiah D Rich, M.D.、Brown University

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。

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

2011年4月1日

初级完成 (实际的)

2016年8月1日

研究完成 (实际的)

2016年8月1日

研究注册日期

首次提交

2011年6月1日

首先提交符合 QC 标准的

2011年6月2日

首次发布 (估计)

2011年6月6日

研究记录更新

最后更新发布 (实际的)

2019年8月21日

上次提交的符合 QC 标准的更新

2019年8月14日

最后验证

2019年8月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • R01DA030771-01 (美国 NIH 拨款/合同)

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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