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临床试验/NCT01721226
NCT01721226已完成不适用

CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC)

George Washington University1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2013年8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
112
试验地点
1
主要终点
Plasma Viral Load Suppression

研究概览

简要总结

The purpose of this study is to determine whether an intervention (CARE+ Corrections) delivered to HIV-infected detainees within the DC Department of Corrections (DOC) and recently -released ex-detainees in the community can improve linkage to community HIV care and adherence to HIV medications after release, and ultimately achieve or maintain HIV viral suppression following community re-entry.

详细描述

The intervention is modeled after CARE, a technology based HIV-counseling tool used in other settings. The investigators have adapted CARE to create CARE+ Corrections, a tool designed specifically for incarcerated and recently-released populations. New and innovative information communication tools (ICT), including a cell phone/text messaging component delivered in the community after release from jail, will be included in the intervention.

The study is a randomized controlled trial. One half of the participants will receive the intervention either inside the jail, in addition to standard discharge planning services, or in the community right after release. The other half of the participants will view an educational video related to the prevention of drug overdose following release, in addition to standard discharge planning services, or in the community right after release. The investigators will follow all participants for 6 months post release/study enrollment and determine if the linkage to community care and adherence to HIV medications was higher in the intervention arm.

The study also has an evaluation component to it. The evaluation component consists in a series of qualitative interviews with the goal of gaining a better understanding of the barriers and facilitators involved in implementing the CARE+ Corrections intervention and to better assess the usability and participants' experiences with the CARE+ Corrections intervention. The semi-structured interviews are being conducted among the following groups: 1) managers and staff at local correctional facilities and agencies which have interaction with HIV+ individuals transitioning to the community; 2) leadership and selected staff at relevant and targeted community-based organizations; and 3) selected study participants from the intervention group of the RCT. the interviews elicit perspectives on the foreseen facilitators and challenges in implementing the CARE+ Corrections tool at their respective organizations as well as their perception on the acceptability of the tool. We also ask their views about the intervention and the post-release experiences of HIV-positive individuals who complete the CARE+ Corrections Tool and receive the text message plan.

No prisoners will be involved in this subsection of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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
否

入选标准

  • •Currently detained in jail or released from the jail/prison 6 months ago or less
  • •18 years of age or older
  • •English speaking
  • •Able to provide informed consent for research participation
  • •Anticipated release from the DOC to the community (or living in the community if recently released ex-detainee)
  • •Confirmed to be HIV-infected by self-report
  • •Live in metropolitan Washington, DC area
  • •Able to read at 8th grade level as assessed by brief literacy screen

排除标准

  • •Expected release to restricted setting (or currently living in a restricted setting if recruited in the community), including residential drug treatment, sober house, half-way house, or similar

研究组 & 干预措施

Control Arm

Sham Comparator

Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.

干预措施: Educational video on opiate overdose prevention (Other)

CARE tool and cell phone/text messaging

Experimental

The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.

干预措施: Intervention Arm (computer-based CARE+ Corrections tool) (Device)

结局指标

主要结局

Plasma Viral Load Suppression

时间窗: 24 weeks

Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction

次要结局

  • Linkage to Community Care(24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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