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临床试验/NCT05776316
NCT05776316招募中不适用

Culturally Response Integrated Harm Reduction Services for Black and Latinx People Who Use Drugs

NYU Langone Health5 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年11月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
5
主要终点
Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session

研究概览

简要总结

The purpose of this study is to assess whether an integrated harm reduction intervention (IHRI), compared to harm reduction (HR) services as usual, will improve harm reduction service utilization among Black and Latinx people who use drugs (PWUD).

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

  • at least 18 years of age
  • self-identified as misusing opioids +/- other substances (stimulants) in the past 30 days, confirmed by interview using DSM-5 criteria
  • English or Spanish speaking
  • able to provide informed consent.

排除标准

  • inability to provide informed consent or participate in the study procedures as proposed in the consent
  • active suicidal or homicidal ideation or an unstable psychotic disorder (schizophrenia, schizoaffective disorder) or mood disorder (bipolar disorder, severe major depressive disorder)
  • an unwillingness to be randomized.
  • are prisoners

研究组 & 干预措施

IHRI

Experimental

Integrated harm reduction intervention (IHRI) program tailored specifically for highly marginalized Black and Latinx people who use drugs (PWUDs). The IHRI lasts 8 weeks in duration, with the first 4 weeks consisting of weekly education lessons provided by the IHRI care coordinator. The subsequent 4 weeks will involve individualized identification of vulnerabilities in the social determinants of health (SDOH) for the purposes of making informed referrals to relevant partnering social service organizations. Participants will also be exposed to service encounters through mobile vans in which staff offer information to PWUD on syringe exchange, clean user kits, naloxone use, and fentanyl strip distribution.

干预措施: Integrated Harm Reduction Intervention (IHRI) (Behavioral)

HR SAU

No Intervention

Harm reduction services as usual (HR SAU). Participants will be exposed to service encounters through the mobile vans in which staff offer information to PWUD on syringe exchange, clean user kits, naloxone use, and fentanyl strip distribution.

结局指标

主要结局

Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session

时间窗: Up to Week 8

Measure of engagement.

Percentage of Participants who Attend at least 3 HR Sessions in Total

时间窗: Up to Week 8

Measure of engagement.

次要结局

  • Change from Baseline in Brief Quality of Life Scale Score(Baseline, Week 8)
  • Change from Baseline in Number of Days of Opioid/Other Stimulant Use(Baseline, Week 8)
  • Change from Baseline in Overdose Risk Assessment Tool Score(Baseline, Week 8)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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