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临床试验/NCT03834779
NCT03834779已完成不适用

A Community-Clinic Collaboration to Improve Outcomes in HIV+ Substance Users Released From Jail

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2019年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
Number of Participants With Undetectable HIV Viral Load

研究概览

简要总结

The long-term goal of this project is to improve HIV and substance use outcomes and reduce recidivism for HIV+ substance users released from jail. The overall objective of the proposed R34 project is to develop and pilot test a multi-sector community-clinic collaborative intervention that can subsequently be implemented on a larger scale (as part of a future R01) to achieve this goal. Our central hypothesis is that HIV+ substance users released from jail can successfully overcome obstacles to re-entry and continuity of HIV care with individualized, culturally competent assistance in navigating both social and medical services.

Aim 1: Develop and refine a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees.

Aim 2: Conduct a pilot randomized controlled trial comparing the collaborative intervention (n=40) compared to treatment as usual (n=40) in HIV+ substance users released from jail.

详细描述

Aim 1 Introduction: This first aim will be critical to successful implementation of the CHW-DOORS intervention. Employing a formerly incarcerated CHW to assist individuals leaving prison in order to connect to healthcare has been successfully implemented in different settings, but it has not been applied specifically to HIV patients or those leaving jail (v. prison), nor has it been integrated into a community based organization. The objective of this aim is to adapt the evidence-based CHW intervention to the HIV population and to the jail setting and to integrate the CHW into existing processes at DOORS and the outpatient HIV clinic system.

Research Design. Aim 1.1: The first step of Aim 1 will be to train the CHW using the transitions clinic approach, add modules on HIV and substance use and familiarize the CHW with DOORS processes and HIV clinic workflow.

Aim 1.2: The second step will be to complete qualitative interviews with stakeholders in three different settings- the jail, the HIV clinic and DOORS. All interviews will be semi-structured, one-on-one interviews, with an estimated 4-7 interviews in each setting.

The structured component of the interview guide will prompt interviewee input on study design (e.g. recruitment, intervention, follow-up visits), content of the intervention (e.g. high demand services) and an open-ended component eliciting possible barriers to study implementation.

Aim 1.3: The final step in Aim 1 will be to complete pilot testing with 5 subjects, which will focus on refining recruitment/enrollment protocols, streamlining study assessments and evaluating the intervention.

研究设计

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

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HIV-infected AND
  • ≥18 years old AND
  • report or have medical records documenting any opioid (illicit or prescription misuse), stimulant (cocaine, ecstasy, or amphetamines), or heavy alcohol use (as determined by the 3-item Alcohol Use Disorders Identification Test (AUDIT-C) within the past 12 months
  • Provide two forms of contact information (address, phone number, email, other locator info) AND
  • HIV VL >200 copies/mL within past 90 days OR
  • No HIV visit in 6 months OR Self-reported non-adherence to medications

排除标准

  • Unwilling to participate
  • Unable to consent
  • Does not speak English
  • Unwilling to participate
  • Unable to consent
  • Does not plan to remain in greater Dallas area after release Sentenced to prison or other court-mandated program for ≥6 months
  • Does not speak English
  • Have an acute medical or psychiatric disorder that would, in the judgment of the PI, make participation difficult or unsafe.

结局指标

主要结局

Number of Participants With Undetectable HIV Viral Load

时间窗: At 6 months after enrollment

Number of participants with an undetectable HIV viral load (\<200 copies/mL) is assessed via blood work.

次要结局

  • Number of Participants Who Are Positive/Negative for Substance Use as Assessed Via Urine Drug Screen(At 6 months after enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ank Nijhawan

Associate Professor

University of Texas Southwestern Medical Center

研究点 (2)

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