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临床试验/NCT02444403
NCT02444403已完成不适用

Proyecto ESCUDO: Police Training to Reduce Occupational Needlesticks and HIV Among Substance Users

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
2
主要终点
Incidence of Occupational Needle Stick Injuries

研究概览

简要总结

Background: Policing practices are key drivers of HIV among people who inject drugs (PWID). This study prospectively examines the impact of a police education program (PEP) to align law enforcement and HIV prevention. PEPs incorporating HIV prevention, (including harm reduction programs like syringe exchange) have been successfully piloted in several countries but were limited to brief pre-post assessments; the impact of PEPs on policing behaviors and occupational safety is unknown. Objectives: Proyecto ESCUDO (Project SHIELD) aims to evaluate the efficacy of the PEP on uptake of occupational safety procedures, as assessed through the incidence of needle stick injuries (NSIs) (primary outcome) and changes in knowledge of transmission, prevention and treatment of HIV and viral hepatitis; attitudes towards PWID, adverse behaviors that interfere with HIV prevention, and protective behaviors (secondary outcomes). The investigators hypothesize that, over the course of the 24-month follow-up, the PEP will be associated with significant declines in NSI incidence, improved knowledge of HIV and related infections, uptake of occupational safety measures, and decreases in behaviors that undermine HIV prevention (e.g. syringe confiscation, police harassment of PWID at opioid substitution therapy and syringe exchange programs). Methods/Design: ESCUDO is a Hybrid Type 2 design that simultaneously tests an intervention and an implementation strategy. Using a modified stepped-wedge design involving all active duty street-level police officers in Tijuana (N= ~1200), the investigators will administer one 3-hour PEP course to groups of 20-50 officers until the entire force is trained. NSI incidence and geo-coded arrest data will be assessed from department-wide de-identified data. Of consenting police officers, a sub-cohort (N=500) will be randomly sampled from each class to undergo pre- and post-PEP surveys with semi-annual follow-up for 2 years to assess self-reported NSIs, attitudes and behavior changes. Impact on PWIDs will be externally validated through a parallel cohort of Tijuana PWIDs. Discussion: This is the first trial to assess efficacy of a PEP on policing behaviors that place PWID and police at elevated risk of HIV and blood-borne infections. Findings may help bring PEPs to scale in the growing number of countries where policing is a documented driver of HIV acquisition.

详细描述

The Police Education Program (PEP) and its evaluation component, has been titled Proyecto ESCUDO (Project SHIELD). This project has the following aims: 1) To evaluate the efficacy of the PEP on uptake of occupational safety procedures, as assessed through the incidence of occupational needle-stick injury (NSI) (primary outcome), monitored by a department-wide NSI surveillance program, and self-reported NSI; 2) To evaluate the efficacy of the PEP on changes in the following secondary outcomes: i) knowledge of transmission, prevention and treatment of HIV and related infections (sexually transmitted infections (STIs) and viral hepatitis); ii) attitudes towards people who inject drugs (PWID); iii) adverse behaviors that interfere with HIV prevention (i.e., arrests near syringe exchange programs (SEP) and drug treatment locations); iv) protective behaviors (e.g., use of barrier protection, self-reported reductions in syringe confiscation). 3) To assess potential mediating and moderating factors that influence PEP efficacy, including changes in knowledge and attitudinal factors and occupational constructs. The investigators hypothesize that, over the course of the 24-month follow-up, the PEP will be associated with significant declines in NSI incidence, improved knowledge of HIV and related infections, uptake of occupational safety measures, and decreases in behaviors that undermine HIV prevention (e.g. syringe confiscation, police harassment of PWID at opioid substitution therapy (OST) and SEPs).

Hypotheses:

H1. The PEP will be associated with a significant decline in NSI incidence among the force during follow-up.

H2.1. The PEP will be associated with significantly increased knowledge of transmission, prevention and treatment of HIV and HCV among Tijuana police officers participating in the sub-cohort.

H2.2. The PEP will be associated with significant improvements in attitudes towards PWID, sex workers and HIV-infected persons.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Age >18 years old
  • Active-duty police officer
  • Completion of 3-hour PEP course
  • Completion of the pre- and post-PEP surveys
  • Follow-up consent
  • For level 2: report encountering syringes within the last 6 months comprise the follow-up sampling frame

排除标准

  • Did not complete 3-hour PEP course
  • Did not complete pre- and post-PEP surveys

结局指标

主要结局

Incidence of Occupational Needle Stick Injuries

时间窗: 3 years

• The number of incident NSIs reported by each police officer, under the surveillance system. Cumulative NSI incidence will be measured over a three year period to accommodate the implementation of the step-wedge design intervention framework.

次要结局

  • HIV Knowledge(0, 3, 6, 12, 18 and 24 months)
  • Attitudinal and behavior changes(0, 3, 6, 12, 18 and 24 months)
  • Adverse behaviors that interfere with HIV prevention(0, 3, 6, 12, 18 and 24 months)
  • Protective behaviors(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steffanie Strathdee

Associate Dean of Global Health Sciences, Harold Simon Professor, Chief, Division of Global Public Health, University of California San Diego, Department of Medicine

University of California, San Diego

研究点 (2)

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