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
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
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Maryland
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Baltimore、Maryland、美国
- Maryland Department of Public Safety and Correctional Services (DPSCS), Division of Parole and Probation
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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:
- Probation or Parole;
- 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.
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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.
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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
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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.
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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.
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无干预:Treatment as Usual
Passive referral to HIV community treatment provider.
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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
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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
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Number of Participants That Entered Community HIV Treatment
大体时间:3-months
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Number of Participants That Entered Community HIV Treatment (yes versus no) at the 3-month post baseline follow-up period.
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3-months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Retention in Community HIV Treatment
大体时间:18 months
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Number of Days with Retention in Community HIV Treatment
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18 months
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Proportion of Those Prescribed Highly Active Antiretroviral Therapy (HAART) Who Are Undetectable
大体时间:6,12,18-months
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To determine if a promising, theory driven, case management based strategy (Project Bridge), will be utilized by individuals with HIV recruited through community corrections.
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6,12,18-months
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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。
一般刊物
- Crable EL, Blue TR, McKenzie M, Rich JD, Gordon MS. Effect of Case Management on HIV Outcomes for Community Corrections Population: Results of an 18-Month Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2021 May 1;87(1):755-762. doi: 10.1097/QAI.0000000000002624.
- Gordon MS, Kinlock TW, McKenzie M, Wilson ME, Rich JD. Rapid HIV testing for individuals on probation/parole: outcomes of an intervention trial. AIDS Behav. 2013 Jul;17(6):2022-30. doi: 10.1007/s10461-013-0456-6.
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
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.