HIVNCT07804121
Project SHIELD 2.0: Police Education to Support Public Health in Kentucky
A study testing SHIELD 2.0 in people with HIV and Substance Use Disorder (SUD), run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Substance Use Disorder (SUD)
- What is being tested?
- SHIELD 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2026to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
Carol White, MPH, 859-562-2684, crwhit3@uky.edu
Jennifer Havens, PhD, 859-323-6553, Jennifer.Havens@uky.edu
About this study
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.
- Conditions
- HIV, Substance Use Disorder (SUD)
- Being tested
- SHIELD 2.0
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHIELD 2.0Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SHIELD 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Law enforcement officer self-reported referrals to MOUD
Measured: From baseline up to 12 months post SHIELD training
Frequency of Law enforcement officer self-reported drug-related arrests
Measured: From baseline up to 12 months post SHIELD training
Secondary outcomes (3)
Law enforcement officer self-reported stress as assessed by survey
Survey scores range from 0-12, with lower scores indicating a lower level of stress
Measured: From baseline up to 12 months post SHIELD training
Law enforcement officer self-reported burnout as assessed by survey
Survey scores range from 0-24, with lower scores indicating a lower level of burnout
Measured: From baseline up to 12 months post SHIELD training
Law enforcement officer self-reported job satisfaction as assessed by survey
Survey scores range from 0-6, with lower scores indicating a lower level of job satisfaction
Measured: From baseline up to 12 months post SHIELD training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start25 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky, Northeastern University, San Diego State University, National Institute on Drug Abuse (NIDA), Brown University, University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Javier Cepeda, PhD, MPH, Principal investigator, Johns Hopkins Bloomberg School of Public Health, Department of EpidemiologyEileen Pitpitan, PhD, MA, Principal investigator, San Diego State University School of Social WorkLeo Beletsky, JD, MPH, Principal investigator, Northeastern University School of Law, Bouvé College of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804121
- Sponsor's protocol ID
- IRB00541902
- Other IDs
- R33DA060622
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 42090841
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project SHIELD 2.0: Police Education to Support Public Health in Kentucky
- ClinicalTrials.gov ID
- NCT07804121
- Acronym / sponsor ID
- IRB00541902
- Conditions
- HIV, Substance Use Disorder (SUD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- University of Kentucky, Northeastern University, San Diego State University, National Institute on Drug Abuse (NIDA), Brown University, University of California, San Diego
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHIELD 2.0 | Experimental | Behavioral: SHIELD 2.0SHIELD is an evidence-based police education training program. Participants in this study are law enforcement officers who will receive the SHIELD training modules. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHIELD 2.0SHIELD 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. | Behavioural | SHIELD 2.0 |
Primary outcome
Frequency of Law enforcement officer self-reported referrals to MOUD
Time frame: From baseline up to 12 months post SHIELD training
Frequency of Law enforcement officer self-reported drug-related arrests
Time frame: From baseline up to 12 months post SHIELD training
3 secondary outcomes
Law enforcement officer self-reported stress as assessed by survey
Time frame: From baseline up to 12 months post SHIELD training
Law enforcement officer self-reported burnout as assessed by survey
Time frame: From baseline up to 12 months post SHIELD training
Law enforcement officer self-reported job satisfaction as assessed by survey
Time frame: From baseline up to 12 months post SHIELD training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 42090841Cepeda 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.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Javier Cepeda, PhD, MPH principal investigator
Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology
Eileen Pitpitan, PhD, MA principal investigator
San Diego State University School of Social Work
Leo Beletsky, JD, MPH principal investigator
Northeastern University School of Law, Bouvé College of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHIELD 2.0 in people with HIV and Substance Use Disorder (SUD), run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zach R Salazar, MPH (8132307741, zachrsalazar@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Law enforcement officer self-reported referrals to MOUD (time frame: From baseline up to 12 months post SHIELD training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07804121, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.