A Randomized Controlled Trial and Cohort Study of HIV Testing and Linkage to Care Corrections
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
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
Off-site referral for rapid HIV testing at a community health center or HIV testing clinic
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.
干预措施: Project Bridge (Behavioral)
Treatment as Usual
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)
