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临床试验/NCT01366495
NCT01366495已完成不适用

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

Friends Research Institute, Inc.1 个研究点 分布在 1 个国家目标入组 797 人开始时间: 2011年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
797
试验地点
1
主要终点
Number of Participants Willing to Undergo Rapid HIV Testing

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

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

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

On-site Rapid HIV Testing

Experimental

On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office.

干预措施: Project Bridge (Behavioral)

Off-site Referral for HIV Testing

No Intervention

Off-site referral for rapid HIV testing at a community health center or HIV testing clinic

Project Bridge

Experimental

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.

干预措施: Project Bridge (Behavioral)

Treatment as Usual

No Intervention

Passive referral to HIV community treatment provider.

结局指标

主要结局

Number of Participants Willing to Undergo Rapid HIV Testing

时间窗: 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).

Number of Participants That Entered Community HIV Treatment

时间窗: 3-months

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

次要结局

  • Retention in Community HIV Treatment(18 months)
  • Proportion of Those Prescribed Highly Active Antiretroviral Therapy (HAART) Who Are Undetectable(6,12,18-months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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