NCT07804121

Brief Summary

The project is a pragmatic, quasi-experimental hybrid type II effectiveness-implementation trial of a structural HIV prevention intervention to address police behavior (arrests and referrals) and ultimately improve health among people who use drugs. The study involves a novel implementation strategy that engages behavioral health workers as "local champions" in the delivery of an evidence-based police education program (SHIELD training intervention). In addition to examining implementation outcomes, primary outcomes focus on assessing effectiveness of the intervention among police (specifically in reducing drug-related arrests and promoting referrals to Medications for Opioid Use Disorder (MOUD) treatment. The investigator's overarching effectiveness hypothesis is that after law enforcement organizations receive the SHIELD training intervention, the organizations will be more likely to refer people who use drugs to MOUD treatment and other health and social services, rather than arresting for low level possession offenses. The study will be conducted across different counties in Appalachian Kentucky.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
32mo left

Started Jun 2026

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Jun 2026Apr 2029

Study Start

First participant enrolled

June 25, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2029

Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

1.5 years

First QC Date

September 1, 2026

Last Update Submit

September 8, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Frequency of Law enforcement officer self-reported referrals to MOUD

    From baseline up to 12 months post SHIELD training

  • Frequency of Law enforcement officer self-reported drug-related arrests

    From baseline up to 12 months post SHIELD training

Secondary Outcomes (3)

  • Law enforcement officer self-reported stress as assessed by survey

    From baseline up to 12 months post SHIELD training

  • Law enforcement officer self-reported burnout as assessed by survey

    From baseline up to 12 months post SHIELD training

  • Law enforcement officer self-reported job satisfaction as assessed by survey

    From baseline up to 12 months post SHIELD training

Study Arms (1)

SHIELD 2.0

EXPERIMENTAL

SHIELD is an evidence-based police education training program. Participants in this study are law enforcement officers who will receive the SHIELD training modules.

Behavioral: SHIELD 2.0

Interventions

SHIELD 2.0BEHAVIORAL

SHIELD is an evidence-based police education training program that has been demonstrated to change police behavior (arrest and referrals) and improve outcomes among police and people who use drugs in NIH-funded and other research studies. The original intervention delivery relied on academic teams, limiting sustainability and scalability. The investigator's novel "SHIELD 2.0" implementation strategy aims to address these limitations by capacitating the local behavioral health workforce to implement the steps of the SHIELD process, specifically to complete the delivery of the SHIELD intervention to local police officers.

SHIELD 2.0

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • An adult over the age of 18 years old
  • Currently employed in a law enforcement agency in one of the nine counties participating in the trial

You may not qualify if:

  • Only adult participants over the age of 18 will be recruited into the study, and the investigators will not restrict eligibility based on gender, race, or any other socio-demographic characteristics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

Related Publications (1)

  • Cepeda JA, Loeb T, Salazar ZR, Williams B, Hiltz B, Del Pozo B, Pitpitan EV, Beletsky L, Young AM, Havens JR. Frequent police contact and nonfatal overdose among people who use drugs in rural Appalachia. Drug Alcohol Depend. 2026 Jul 1;284:113188. doi: 10.1016/j.drugalcdep.2026.113188. Epub 2026 Apr 30.

    PMID: 42090841BACKGROUND

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Javier Cepeda, PhD, MPH

    Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology

    PRINCIPAL INVESTIGATOR
  • Eileen Pitpitan, PhD, MA

    San Diego State University School of Social Work

    PRINCIPAL INVESTIGATOR
  • Leo Beletsky, JD, MPH

    Northeastern University School of Law, Bouvé College of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zach R Salazar, MPH

CONTACT

Skylar M Chapdelaine, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2026

First Posted

September 4, 2026

Study Start

June 25, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

April 30, 2029

Last Updated

September 11, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

The counties in which this study will take place are small and, for the most part, demographically homogeneous. As such, to protect participant confidentiality individual participant data will not be shared.

Locations