Health TrialsbyHealthPanel

Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department

ConditionsOpioid Overdose PreventionHIV Prevention and CareHarm Reduction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

The Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition from the Emergency Department (PROTECT-ED) study evaluates an emergency department-based implementation strategy designed to improve delivery of evidence-based overdose and HIV prevention services during community re-entry.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Are 18 years of age or older.

Present to the Johns Hopkins Hospital Emergency Department.

Have been released within the previous 180 days from a prison, jail, juvenile detention facility, immigration detention facility, halfway house, residential reentry center, or other correctional setting. Recent incarceration may be confirmed through participant self-report, electronic medical record documentation, the Victim Information and Notification Everyday (VINE) system, or other available documentation. Participant self-report alone is sufficient to establish eligibility.

Meet criteria for opioid use disorder or hazardous opioid use and are considered appropriate for evaluation for medications for opioid use disorder (MOUD) or are at risk for HIV acquisition.

Disqualifiers

Inability to provide informed consent during the index emergency department encounter.

Lack of a reliable telephone number for study follow-up.

Prior enrollment in the PROTECT-ED study.

Trial design

Design model

Single group

Treatments tested in this trial

  • PROTECT-ED Care Coordination

    Behavioral

    Participants will receive the PROTECT-ED intervention during the index emergency department encounter. The intervention consists of systematic identification; peer-delivered prevention services; same-day offer and initiation of MOUD and PrEP, when clinically appropriate; harm reduction services; and facilitated linkage to ongoing community care. Clinical decisions regarding medication initiation remain the responsibility of the treating emergency department clinician. The ED clinician would prescribe medication as part of ED care delivery, this would include reviewing eligibility and dosing with the ED pharmacist.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Aim 2 Study ParticipantsOther 1 intervention

Trial outcomes

Primary outcomes

1

MOUD uptake

Proportion of participants initiating MOUD

Time frame
0-26 Weeks
2

MOUD and PrEP Uptake

Proportion of participants initiating MOUD and PrEP

Time frame
0-26 Weeks
3

PrEP Uptake

Proportion of participants initiating PrEP

Time frame
0-26 Weeks

Secondary outcomes

1

MOUD persistence at 6 months

Proportion of participants on MOUD at 6 months among those who initiated

Time frame
26 Weeks
2

PrEP persistence at 6 months

Proportion of participants on PrEP at 6 months among those who initiated

Time frame
26 Weeks
3

Participants with Repeat emergency department utilization

Repeat emergency department utilization across Baltimore City

Time frame
0-26 Weeks
4

Opioid overdose events

Proportion of participants with 1+ opioid overdose events

Time frame
0-26 Weeks

Other outcomes

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: