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Linking Infectious and Narcology Care in Russia (LINC)

2018年6月20日 更新者：Jeffrey Samet、Boston Medical Center

Linking Russian Narcology & HIV Care to Enhance Treatment, Retention, & Outcomes

The purpose of this study is to implement and assess a behavioral and structural intervention in Russia designed to support and motivate HIV-infected narcology heroin dependent patients (i.e., IDUs) to engage (i.e., initiate and retain) in HIV medical care and ultimately improve their HIV outcomes. The central hypothesis is that an intervention that involves coordination between the narcology and HIV systems via HIV case management delivered by a peer to help motivate and reduce barriers to HIV care will lead to engagement in HIV care.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The objective of this study "Linking Infectious and Narcology Care (LINC)" is to improve upon the treat and retain dimensions of the "seek, test, treat, and retain" paradigm in Eastern Europe. We will implement and assess a behavioral and structural intervention in Russia designed to support and motivate HIV-infected narcology heroin dependent patients (i.e., IDUs) to engage (i.e., initiate and retain) in HIV medical care and ultimately improve their HIV outcomes.

LINC is a clinical model designed to coordinate narcology and HIV systems of care using elements shown to facilitate engagement in medical care: HIV case management and point-of-care CD4 testing. The central hypothesis is that an intervention that involves coordination between the narcology and HIV systems via HIV case management delivered by a peer to help motivate and reduce barriers to HIV care will lead to engagement in HIV care.

Implementation research recognizes that effective interventions may not translate successfully across different contexts and systems. Hence, we will assess the organizational and operational issues that drive engagement in HIV care in Russia.

The project will be undertaken by an international research team experienced in addressing HIV, substance use, and clinical interventions in Russia. This proposal's Specific Aims are to assess the effectiveness of the LINC intervention compared to standard of care on 4 distinct outcomes: 1) initiation of HIV care (> 1 visit to HIV medical care) within 6 months of enrollment; 2) retention in HIV care (> 1 visit to medical care in 2 consecutive 6 month periods) within 12 months; 3) appropriate HIV care (prescribed ART if CD4 cell count is <350 or having a second CD4 count if CD4 ≥350 within 12 months; and 4) improved HIV health outcomes (CD4 cell count at 12 months). The final Specific Aim is to establish the contextual factors that influence adoption and sustainability of the LINC intervention in Russia. If LINC can embed effectively within Eastern European medical systems, then it has the potential to be widely implemented in this region of the world and have a major impact on the HIV epidemic among IDUs.

研究类型

介入性

注册 (实际的)

349

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

  • 俄罗斯联邦
      • St. Petersburg、俄罗斯联邦
        • City Addiction Hospital
      • St. Petersburg、俄罗斯联邦
        • Pavlov State Medical University
      • St. Petersburg、俄罗斯联邦
        • Botkin Infectious Disease Hospital

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 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • age 18 - 70 years
  • HIV-infected
  • hospitalized at a narcology hospital
  • history of injection drug use
  • available for CD4 testing
  • has 2 contacts to assist with follow-up
  • lives within 100 km of St. Petersburg, Russia
  • has telephone
  • willing to receive care at Botkin Infectious Disease Hospital

Exclusion Criteria:

  • currently on ART
  • not fluent in Russian
  • cognitive impairment precluding informed consent

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：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
无干预：Standard of Care
Control participants will receive the narcology hospital's standard of care. With regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care - the outpatient clinic that is involved in the intervention. Control patients will be referred to outpatient narcology care as part of standard of care. If control participants are newly diagnosed with HIV infection at the addiction hospital, they will receive HIV post test counseling consistent with CDC recommendations (this represents an enhancement of the current standard of care in Russia).
实验性的：LINC Case Management (Intervention)
LINC Case Management (study Intervention) - see Intervention description
行为的：LINC Case Management
The 1st case management (CM) session will be at the Narcology Hospital and will follow a modified strengths-based case management curriculum. As part of this first session, the CM will show a 10 minute video clip produced by a Russian NGO of HIV-infected patients talking about accessing HIV care. The CM will also tell the patient what his/her CD4 cell count is and discuss what it means with the patient. The case manager will help the client identify the outpatient HIV clinic on a map and will discuss basic drug harm reduction ideas with the client. The remaining 4 CM sessions will happen over the following 6 months. Sessions may happen at the HIV clinic, NGOs, or in the community. The HIV CM helps the client understand the importance of HIV care, identify barriers to care acquisition and recognize one's own strengths, abilities and assets to reduce self-identified barriers to care. The HIV CM's primary aim is to have the client attend an appointment at the HIV outpatient clinic.

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
1) initiation of HIV care
大体时间：6 months
Greater than or equal to 1 visit to HIV medical care within 6 months of enrollment
6 months
2) retention in HIV care
大体时间：12 months
Greater than or equal 1 visit to medical care in 2 consecutive 6 month periods within 12 months
12 months
3) appropriate HIV care
大体时间：12 months
prescribed ART if CD4 cell count is less than 350 or having a second CD4 count if CD4 is greater than or equal to 350 within 12 months (Note: As guidelines change over time, this outcome may be updated accordingly.)
12 months
4) improved HIV health outcomes
大体时间：12 months
CD4 cell count at 12 months (compared to CD4 cell count at baseline)
12 months
5) Establish the contextual factors that influence adoption and sustainability of the LINC intervention in Russia
大体时间：4 years
Qualitative implementation science analysis, including pre-implementation focus groups, interviews, and surveys in Russia; post-implementation qualitative interviews in Russia.
4 years

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。

赞助

Boston Medical Center

合作者

National Institute on Drug Abuse (NIDA)

调查人员

  • 首席研究员：Jeffrey Samet, MD, MA, MPH、Boston Medical Center

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

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 (实际的)

2012年7月1日

初级完成 (实际的)

2016年1月1日

研究完成 (实际的)

2016年1月1日

研究注册日期

首次提交

2012年6月1日

首先提交符合 QC 标准的

2012年6月1日

首次发布 (估计)

2012年6月5日

研究记录更新

最后更新发布 (实际的)

2018年6月21日

上次提交的符合 QC 标准的更新

2018年6月20日

最后验证

2018年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • H-30414
  • R01DA032082 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

爱滋病毒感染的临床试验

LINC Case Management的临床试验

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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