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临床试验/NCT05786027
NCT05786027已完成不适用

Exploring the Feasibility of a Peer-Driven Intervention to Improve HIV Prevention Among Prisoners Who Inject Drugs

Yale University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月1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
100
试验地点
2
主要终点
Number of participants enrolled in MMT or Atlantis 12-step addiction recovery program

研究概览

简要总结

The purpose of this study is to develop, conduct, and assess the feasibility of a) a pilot peer-driven intervention (PDI) to reduce HIV risk and increase the uptake of primary HIV prevention services (i.e. prison addiction treatment programs), and b) explore the PDI's usefulness from the perspective of both prisoners and prison staff to make recommendations for the PDI future improvement and adaptation.

详细描述

The investigators will develop and pilot a 12-week in-prison peer-driven intervention to increase the uptake of primary HIV prevention strategies (readiness to initiate addiction treatment (MMT or Atlantis), initiation of MMT/Atlantis, retention in MMT/Atlantis; or the use of SSP), and reduce the use of opioids and HIV risk behaviors, in HIV-negative PWID in prison.

Aim 1: To develop, conduct, and assess the feasibility and the immediate and durable effects of a 12-week within-prison PDI to reduce HIV risk and increase uptake of primary HIV prevention among prisoners who abuse drugs and are ≥1 year prior to release at baseline. The quasi-experimental design where two prisons will be assigned to experiment and two comparable prisons will be assigned to control, will strive to account for the potential threats to internal validity (e.g. history and maturation), and to external validity (e.g. various interaction effects between characteristics of selected participants and their engagement in HIV prevention). The focus of this registration is Aim 1.

Aim 2: Using the data from structured ethnographic observation of PDI sessions, and qualitative interviews immediately after the PDI with prisoner participants, staff of prison addiction treatment programs, and researchers who implemented the PDI, to explore why the PDI is successful (or not), and optimize the PDI manual.

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
Male
接受健康志愿者

入选标准

  • HIV negative by self-report before the study confirmed by HIV rapid test
  • Has ever injected drugs
  • ≥1 year before prison release (release dates are fixed and accurate)
  • currently not enrolled in MMT/Atlantis
  • Capable of providing informed consent.

排除标准

  • 未提供

结局指标

主要结局

Number of participants enrolled in MMT or Atlantis 12-step addiction recovery program

时间窗: Month 9

Number of participants that enrolled in MMT or Atlantis 12-step addiction recovery program at month 9.

次要结局

  • Number of times participants relapsed(Month 9)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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