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临床试验/NCT03567174
NCT03567174已完成不适用

Building on Needle Exchange to Optimize Prevention & Treatment

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2018年6月22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
720
试验地点
1
主要终点
Composite PWID Score (Service Access, Risk Behaviors, Adverse Outcomes)

研究概览

简要总结

There are several biomedical interventions that can help people who inject drugs (particularly those with or at risk for HIV), but these services often do not get to the people most in need. In this project investigators propose to determine if delivery of these services to PWID by an integrated care van that is linked to a mobile syringe service program improves clinical outcomes, is feasible and sustainable, and is cost-effective.

详细描述

Biomedical interventions that have direct applicability to people who inject drugs (PWID) have flourished over the past 15 years (HIV treatment as prevention, pre-exposure prophylaxis, office-based medication-assisted treatment (MAT) with buprenorphine, and hepatitis C virus (HCV) treatment with direct acting agents). However, penetration of these interventions among PWID is low relative to the potential benefits. Syringe service programs (SSP) are an essential risk reduction service for PWID, and represent the outermost reach of public health services for this population. The Baltimore City Health Department (BCHD) and investigators at Johns Hopkins University are developing a dedicated integrated care van (ICV) to complement the city's mobile SSP, with the goals of optimizing the HIV care cascade in HIV-positive clients and extending needed biomedical interventions to PWID. A nurse practitioner, case worker, and peer navigators will engage HIV-positive clients (known and newly diagnosed) and collaborate closely with local HIV clinics to promote progress toward durable viral suppression. To support the ICV's role in HIV care facilitation, investigators propose an innovative application of the Center for Disease Control (CDC)-sponsored "Data to Care" initiative - a multi-source health service database designed to assist health departments track the HIV care cascade in real time. Additionally, the ICV will provide rapid HIV testing, PrEP screening and initiation, buprenorphine-based MAT, HCV testing and referrals to treatment, and wound care. Using a cluster-randomized trial design, investigators propose to determine whether the ICV intervention advances the HIV care cascade among HIV-positive PWID, improves the Pre-Exposure Prophylaxis (PrEP) continuum, and increases uptake of MAT and HCV treatment (Aim 1). Additionally, investigators will examine the implementation of the ICV intervention using a mixed methods approach among PWID, local/state public health stakeholders, and medical providers to examine the intervention's feasibility, acceptability, coverage, fidelity, and sustainability (Aim 2). Finally, investigators will determine the incremental cost-effectiveness of the ICV intervention (Aim 3). Investigators have assembled a multi-disciplinary team with methodological expertise in PWID interventions and cost-effectiveness evaluations, and longstanding collaboration with investigators' partners at the BCHD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

入选标准

  • If HIV-positive: report history of injection drug use
  • If HIV-negative: injected drugs ≥ 4 days in the last 30 days or shared a needle or syringe in the last 6 months

排除标准

  • Not competent to provide written informed consent
  • Not willing or able to provide a blood specimen

研究组 & 干预措施

Integrated care van (ICV)

Experimental

ICV visits neighborhoods served by the mobile syringe service program weekly. ICV provides a range of services targeted to people who inject drugs - HIV testing, HCV testing, PrEP, MAT, wound care, case work services, on-site medical management and linkage.

干预措施: Integrated care van (ICV) (Other)

Control

No Intervention

No additional services provided.

结局指标

主要结局

Composite PWID Score (Service Access, Risk Behaviors, Adverse Outcomes)

时间窗: Between baseline visit and the V7 follow-up visit at 7 months

To capture the multifaceted nature of the ICV intervention and the array of health issues relevant to PWID, we developed a scoring rubric based on World Health Organization (WHO) guidelines for evidence-based PWID services, a predictive risk model for HIV seroconversion among PWID developed by the Baltimore-based ALIVE study, the HCV care continuum, and the overdose epidemic. In the scoring rubric, points are allocated on the basis of failure to access evidence-based services, riskier behaviors, and adverse outcomes. This outcome will be assessed in all participants at all time points. The score is based on self-report, biomarker testing, and medical record review, and ranges from 0 to 15, with higher scores indicating worse overall status.

次要结局

  • HIV Testing(Between 6 months prior to and the V7 follow-up visit at 7 months)
  • HIV Care Continuum(Between 6 months prior to and the V7 follow-up visit at 7 months)
  • Pre-exposure Prophylaxis (PrEP) Continuum(Between 6 months prior to and the V7 follow-up visit at 7 months)
  • HCV Testing(Between 6 months prior to and the V7 follow-up visit at 7 months)
  • HCV Care Continuum(Between 6 months prior to and the V7 follow-up visit at 7 months)
  • Medication for Opioid Use Disorder (MOUD) Use(Between 6 months prior to and the V7 follow-up visit at 7 months)
  • Naloxone Overdose Kit(Between 6 months prior to and the V7 follow-up visit at 7 months)
  • Recent Drug Use(Between 6 months prior to and the V7 follow-up visit at 7 months)
  • Syringe Service Program (SSP) Use(Between 6 months prior to and the V7 follow-up visit at 7 months)
  • Non-fatal Overdose(Between 6 months prior to and the V7 follow-up visit at 7 months)
  • Mortality Rate(Between baseline visit and the V7 follow-up visit at 7 months)
  • Injection Drug Use(Between 6 months prior to and the V7 follow-up visit at 7 months)
  • Sharing Injection Equipment(Between 6 months prior to and the V7 follow-up visit at 7 months)
  • Emergency Department (ED) Use(Between 6 months prior to and the V7 follow-up visit at 7 months)
  • HIV Seroconversion(Between baseline visit and the V7 follow-up visit at 7 months)
  • HCV Seroconversion(Between baseline visit and the V7 follow-up visit at 7 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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