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临床试验/NCT05363865
NCT05363865已完成不适用

Digital, Community-Led, Social Action Initiative to Reduce Opioid Vulnerability and HIV/HCV in Rural Areas of the Midwest and Appalachia

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 459 人开始时间: 2023年6月12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
459
试验地点
2
主要终点
Composite of Six Yes/No Behaviors Promoted by Intervention

研究概览

简要总结

The study is a cluster randomized controlled trial developed in counties located in Appalachia and the Midwest. We will prioritize counties from states with high risk for HIV and HCV infection associated with injection drug use.

详细描述

The study will randomize clusters with groups of participants to an intervention or a standard of care condition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The outcomes assessor will be unaware of the experimental condition.

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Lives in target zip codes
  • Half not using illicit substances (not including marijuana) currently or in the past
  • Half using illicit substances (not including marijuana) currently or in the past

排除标准

  • Under the age of 18
  • Not in target zip codes

结局指标

主要结局

Composite of Six Yes/No Behaviors Promoted by Intervention

时间窗: Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months

Measures: Sum of Yes to (a) self-testing for HIV, (b) self-testing for HCV, (c) HIV prevention, (d) requesting Naloxone, (e) carrying Naloxone, and (f) making at least one social connection (new or reestablished). Continuous (0 to 6)

次要结局

  • HIV and HCV Testing(Baseline [Control not offered testing at baseline], Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months)
  • HIV Prevention Behaviors(Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months)
  • Requesting Naloxone (Narcan)(Baseline[Control not offered Naloxone at baseline], Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months)
  • Carrying Naloxone (Narcan)(Baseline[Control not offered Naloxone at baseline], Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months)
  • Making Social Connections (New or Reestablished)(Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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