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临床试验/NCT04212364
NCT04212364已完成不适用

An Evaluation of a Social Network Intervention for Primary and Secondary Prevention of Opioid Overdoses

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 614 人开始时间: 2019年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
614
试验地点
1
主要终点
Network Enrollment

研究概览

简要总结

The purpose of this study is to pilot and implement a peer mentor intervention focused on overdose prevention and care.

The intervention consists of 3 sessions. During the first and second session, each participant will meet individually with a trained staff member. In the 3rd session, the participant will invite a social network member to attend the session, and these 2 participants will meet with a trained staff member.

详细描述

The specific aims of the study are:

  1. Conduct a pilot of an HIV/HCV/overdose prevention and care intervention for people who use opiates.
  2. Evaluate the feasibility of collecting donated drug preparation containers (i.e., cookers) to assess the presence of fentanyl, HCV, and HIV.
  3. Conduct a randomized controlled trial to assess efficacy of the experimental Peer Mentor condition on (a) overdose prevention and care education to drug network members, (b) naloxone availability, and (c) drug treatment readiness and entry.

There are two types of participants: Index participants and network participants. Both type of participant will currently used opiates. Participants will take part in a baseline visit and up to 3 follow-up visits. Index participants will be randomized into the intervention or control arm of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • 未提供

排除标准

  • Index participants may not take part in the study as a Network participant.
  • Network participants may not take part in the study as an Index participant.

研究组 & 干预措施

Peer Education

Experimental
  • During Session 1, participants will be trained in Peer Education and how to use Nasal Narcan. They will be given two Nasal Narcan kit that includes 2 doses. One kit if for their use and one kit is to give someone in their social network after they have trained them in how to use it.
  • A week after Session 1, participants will be scheduled for Session 2.
  • During session 1 and 2 participants, Index participants will be taught information and skills pertaining to overdose prevention and response and how to train network members in overdose prevention and response.
  • At the 2nd session, index participants will be given 1 coupon to give to 1 member from their social network to attend Session 3.
  • Session 3 will be a dyad session where Index participants will use their peer mentors' skills to train their network member in overdose prevention and response.
  • Index participants will also be invited to up to 3 Booster Session (monthly) after they complete Sessions 1-3.

干预措施: Peer Education (Behavioral)

Peer Education

Experimental
  • During Session 1, participants will be trained in Peer Education and how to use Nasal Narcan. They will be given two Nasal Narcan kit that includes 2 doses. One kit if for their use and one kit is to give someone in their social network after they have trained them in how to use it.
  • A week after Session 1, participants will be scheduled for Session 2.
  • During session 1 and 2 participants, Index participants will be taught information and skills pertaining to overdose prevention and response and how to train network members in overdose prevention and response.
  • At the 2nd session, index participants will be given 1 coupon to give to 1 member from their social network to attend Session 3.
  • Session 3 will be a dyad session where Index participants will use their peer mentors' skills to train their network member in overdose prevention and response.
  • Index participants will also be invited to up to 3 Booster Session (monthly) after they complete Sessions 1-3.

干预措施: Narcan Nasal Product (Drug)

Standard of care

Active Comparator
  • Participants randomized to this condition will participate in one 1-hour session. This session will be an individual session where the participant will meet with a trained staff member in a private room at the Lighthouse.
  • This session will be standard overdose prevention and response information. Participants will also be trained in Narcan administration. Participants will be given 1 nasal Narcan kit.
  • At the end of this session, participants will be asked to refer a network member to the study for survey visits

干预措施: Narcan Nasal Product (Drug)

结局指标

主要结局

Network Enrollment

时间窗: 6 months

The question will be: How many people in their social network did Index participants recruit to the study? Participants provide a number of 0 or higher.

次要结局

  • Drug treatment entry(12 months)
  • Overdose Risk(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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