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临床试验/NCT02106702
NCT02106702已完成不适用

Navigator-Enhanced Case Management for HIV-Infected Jail Inmates Reentering the Community

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 271 人开始时间: 2010年2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
271
试验地点
1
主要终点
substance use

研究概览

简要总结

Each year, there are over 600 unduplicated HIV-infected persons incarcerated in the San Francisco jail. Two thirds of those released with HIV-focused discharge planning are reincarcerated within one year. More than half of HIV-infected jail inmates are diagnosed with mental health conditions severe enough to require medication and a similar proportion report substance use disorders at the time of detention. While some community-based services exist, there remains a critical need to improve linkages to care and adherence to care plans for HIV-infected adults as they move between community and jail. The Navigator Project is a five-year randomized study that will test the effectiveness of an intensive enhanced case management intervention to reduce sex and drug-related HIV transmission risk; increase HIV medication adherence; reduce drug dependence; and reduce reincarceration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Detention in the San Francisco jail system
  • •Confirmed HIV infection
  • •Lifetime history of ever having met standardized criteria for drug or alcohol addiction
  • •Likely release back into San Francisco without transfer to another facility
  • •Agreement to work with Forensic AIDS Project to plan post-release care
  • •Able and willing to provide informed consent
  • •Not scheduled for release within 36 hours

排除标准

  • •Undocumented HIV status
  • •Inability to speak English or Spanish
  • •Unable or unwilling to provide informed consent
  • •Not under routine level of jail security

研究组 & 干预措施

FAP counseling

Active Comparator

Control arm utilizing the standard of care: access to services provided by the Forensic AIDS Project for up to 90 days after release

干预措施: Forensic AIDS Project (Behavioral)

Navigator enhanced case-management

Experimental

Experimental arm: access to Navigator enhanced case-management services for one year after release

干预措施: Navigator enhanced case-management (Behavioral)

结局指标

主要结局

substance use

时间窗: 2 months, 6 months, 12 months

change from baseline in self-reported drug and alcohol use, measured by a survey tool, and actual use of five drugs (methamphetamine, cocaine, tetrahydrocannabinol, opiates, and benzodiazepines), measured by a urine screen, at three time points each

recidivism

时间窗: 12 months

number of times re-detained during the twelve-month study period, collected from jail records

次要结局

  • adherence to HIV medications(2 months, 6 months, 12 months)
  • sexual risk behavior(2 months, 6 months, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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