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Police Training to Reduce Occupational Needlesticks and HIV Among Substance Users (ESCUDO)

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ClinicalTrials.gov Identifier: NCT02444403
Recruitment Status : Completed
First Posted : May 14, 2015
Last Update Posted : December 17, 2020
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Open Society Foundations
UCSD Center for AIDS Research (CFAR)
Mexico-U.S. Border Health Commission, Mexico section
Information provided by (Responsible Party):
Steffanie Strathdee, University of California, San Diego

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Occupational Needlestick Injuries Behavioral: Police Education Program designed to align law enforcement and HIV prevention in Tijuana Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Proyecto ESCUDO: Police Training to Reduce Occupational Needlesticks and HIV Among Substance Users
Study Start Date : June 2015
Actual Primary Completion Date : May 29, 2018
Actual Study Completion Date : May 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse HIV/AIDS

Arm Intervention/treatment
Police Education Program (PEP)
The entire police force mandated for periodic refresher training will be assigned to classes which receive one PEP course over 2 years.
Behavioral: Police Education Program designed to align law enforcement and HIV prevention in Tijuana

The 3.5-hour PEP course consists of 3 modules. Module I covers basic epidemiology, prevention and treatment of HIV, viral hepatitis and STIs, safe syringe disposal and fundamentals of addiction. Post-exposure protocols and appropriate follow-up procedures are outlined. Module II covers key provisions of Mexico's national drug policy (narcomenudeo, which defines amounts of drugs allowed for personal possession), as well as other legal provisions pertinent to HIV prevention, including the legality of syringe and condom possession. Module III covers public health-based interventions targeting PWID (SEPs, OST) and deconstructs myths typical among law enforcement (i.e., drug users do not care about their health, SEPs increase the risk of NSIs).

A sub-cohort sample will be invited to undergo pre- and post-PEP surveys with semi-annual follow-up for 2 years to assess self-reported NSIs (Aim 1), attitudinal and behavior changes (Aim 2) and mediators/moderators (Aim 3).

Other Name: Police Education Program (PEP)




Primary Outcome Measures :
  1. Incidence of Occupational Needle Stick Injuries [ Time Frame: 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.


Secondary Outcome Measures :
  1. HIV Knowledge [ Time Frame: 0, 3, 6, 12, 18 and 24 months ]
    Knowledge score: knowledge of transmission, prevention and treatment of HIV and related infections (STIs and viral hepatitis).

  2. Attitudinal and behavior changes [ Time Frame: 0, 3, 6, 12, 18 and 24 months ]
    Attitudes score: attitudes towards PWID, sex workers and HIV-infected persons.

  3. Adverse behaviors that interfere with HIV prevention [ Time Frame: 0, 3, 6, 12, 18 and 24 months ]
    Self-reporting of adverse behaviors that interfere with HIV prevention (i.e. syringe confiscation and syringe-related arrests) and Tijuana police department geo-coded arrest data will be used to determine the rate of arrests that occur near SEP and drug treatment programs, pre- and post-PEP.

  4. Protective behaviors [ Time Frame: 2 years ]
    Self-reporting of protective behaviors for HIV prevention (i.e. use of gloves as barrier protection during pat-downs and arrests, self-reported reductions in syringe confiscation) and Tijuana police department geo-coded arrest data will be used to determine the extent to which the PEP decreases the number of arrests near SEP and OST sites in Tijuana, pre- and post-PEP.


Other Outcome Measures:
  1. Mediating and moderating factors [ Time Frame: 2 years ]
    Potential mediating and moderating factors influencing PEP efficacy from SDT constructs (motivation, years spent in the police force and autonomous support from supervisors) within each model used to assess the effect of the intervention of the outcome (e.g., NSI incidence).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444403


Locations
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Mexico
Instituto de Capacitacion Y Adiestramiento Profesional
Tijuana, Baja California, Mexico, 22502
Sponsors and Collaborators
University of California, San Diego
National Institute on Drug Abuse (NIDA)
Open Society Foundations
UCSD Center for AIDS Research (CFAR)
Mexico-U.S. Border Health Commission, Mexico section
Investigators
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Principal Investigator: Steffanie A Strathdee, PhD Associate Dean of Global Health Sciences, Harold Simon Professor, Chief, Division of Global Public Health, University of California San Diego, Department of Medicine
Principal Investigator: Leo Beletsky, JD, MPH Associate Professor of Law and Health Sciences, School of Law & Bouvé College of Health Sciences, Northeastern University, Adjunct Professor, Division of Global Public Health, University of California San Diego Department of Medicine
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: 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
ClinicalTrials.gov Identifier: NCT02444403    
Other Study ID Numbers: R01DA039073 ( U.S. NIH Grant/Contract )
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Keywords provided by Steffanie Strathdee, University of California, San Diego:
HIV
Viral hepatitis
HCV
Needle-stick injury
Needle/syringes
Structural intervention
Stepped wedge
Police
Occupational safety
Police Training
Additional relevant MeSH terms:
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Needlestick Injuries
Wounds, Stab
Wounds, Penetrating
Wounds and Injuries