PROTECT-ED Care Coordination for Overdose and HIV Prevention

(PROTECT-ED Trial)

BH
CH
Overseen ByChris Hoffmann, MD, MSc, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to support individuals visiting the emergency department who need help with opioid use disorder or are at risk of HIV. The goal is to enhance overdose and HIV prevention services for those returning to the community after a correctional setting. Participants will receive comprehensive care, including peer support, medications for opioid use disorder, and access to HIV prevention services if needed. Suitable candidates include individuals recently released from a correctional facility who face opioid use issues or are at risk for HIV.

As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions for critical health challenges.

What prior data suggests that the PROTECT-ED Care Coordination is safe for overdose and HIV prevention?

Research has shown that the PROTECT-ED Care Coordination approach, which includes strategies like harm reduction and peer support, is generally safe. Harm reduction methods have reduced the use of nonprescribed opioids and lowered related risks. This suggests that the PROTECT-ED methods are likely safe for participants.

Although controlled studies have not directly proven the safety of the PROTECT-ED approach, its components have succeeded in other settings. For example, programs focusing on harm reduction and connecting people to community care have demonstrated positive results, such as fewer overdoses and better access to healthcare.

In summary, while specific safety data for PROTECT-ED is lacking, the success of its strategies in other programs suggests it is likely safe.12345

Why are researchers excited about this trial?

Researchers are excited about the PROTECT-ED Care Coordination because it combines several innovative approaches to prevent overdose and HIV. Unlike traditional methods that might focus only on prescribing medications like MOUD (Medications for Opioid Use Disorder) and PrEP (Pre-exposure Prophylaxis) separately, this approach offers a comprehensive package delivered right in the emergency department. It includes peer-delivered prevention services, same-day medication initiation when appropriate, and a strong emphasis on harm reduction and seamless transition to community care. This integrated strategy aims to streamline and enhance the effectiveness of care, addressing multiple health concerns simultaneously and potentially improving patient outcomes dramatically.

What evidence suggests that the PROTECT-ED Care Coordination is effective for overdose and HIV prevention?

Research has shown that combining HIV prevention with care for opioid use disorder (OUD) can help reduce new HIV infections. Evidence indicates that most overdose deaths occur after individuals have started HIV care, highlighting the need for improved prevention services. This trial will evaluate the PROTECT-ED intervention, which includes peer-delivered prevention services and same-day initiation of medication for opioid use disorder (MOUD) and pre-exposure prophylaxis (PrEP) during emergency room visits. Studies suggest that effective strategies can improve outcomes for people with HIV by ensuring they receive appropriate care and support. A coordinated approach in emergency settings, as tested in this trial, could strengthen efforts to prevent both overdoses and HIV.678910

Who Is on the Research Team?

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Bhakti Hansoti, MBChB, PhD, MPH

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for people who visit the emergency department and may be at risk of opioid overdose or HIV, especially those re-entering the community. Specific inclusion and exclusion criteria are not listed, but it targets individuals needing support with overdose prevention and HIV care.

Inclusion Criteria

Present to the Johns Hopkins Hospital Emergency Department
Meet criteria for opioid use disorder or hazardous opioid use and are appropriate for evaluation for medications for opioid use disorder (MOUD) or are at risk for HIV acquisition
Have a reliable telephone number for study follow-up
See 4 more

Exclusion Criteria

Prior enrollment in the PROTECT-ED study
I was unable to give consent during my emergency room visit.
Lack of a reliable telephone number for study follow-up

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Refinement

Participatory prototyping and intervention refinement through stakeholder engagement

12 months

Intervention Delivery

Participants receive the PROTECT-ED intervention during the emergency department encounter, including peer-delivered prevention services and initiation of MOUD and PrEP

24 months

Follow-up

Participants are monitored for repeat emergency department utilization, opioid overdose events, and linkage to care

26 weeks

Data Analysis and Dissemination

Data analysis, dissemination of findings, and development of a future multicenter effectiveness-implementation trial

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • PROTECT-ED Care Coordination

Trial Overview

The study is testing a program called PROTECT-ED Care Coordination, which helps connect patients in the emergency department to services that prevent overdoses and HIV. The goal is to improve follow-up care after leaving the hospital.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Aim 2 Study ParticipantsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Citations

Study Details | NCT07868393 | Prevention and Rapid ...

Emergency Department (PROTECT-ED) study evaluates an emergency department-based implementation strategy designed to improve delivery of evidence-based overdose ...

Integrating HIV prevention services into care settings ... - PMC

Integrating HIV prevention into routine OUD care could reduce new infections, but scalable, evidence-based strategies are lacking.

We Should Leverage the Successes of HIV Care to Prevent ...

Nearly all (98%) of those who died of overdose had been linked to HIV care after their HIV diagnosis, and more than three quarters had been ...

National HIV Prevention and Care Objectives | HIV Data

Only 76% had received some care, 54% were retained in care, and 65% had achieved viral suppression in 2022. These data highlight the need for ...

Outcome Evaluation of Expanding Capacity to Address the ...

Anticipated outcomes include strengthened capacity in OD2A-funded jurisdictions for conducting overdose prevention and surveillance activities, ...

Prevention Education and Overdose Emergency Response ...

Reduce the risks and harmful consequences. Harm Reduction that can reduce the rate of nonprescribed opioid use by youth and lower the risks of ...

CDC Resources for Treatment Center Operators

CDC tracks overdose data, The agency's overdose Vital Statistics System provides the underlying mortality data. These resources are essential ...

Coordinating Systems of Care for HIV and Opioid Use ...

Recent data from the Centers for Disease Control and Prevention (CDC) report that there were greater than 92,000 deaths from opioid overdose in ...

The PROTECT Initiative: Advancing Children's Medication ...

This Web site offers resources related … developing strategies and recommendations to prevent accidental medication overdoses in children.

Overdose Prevention Centers in the United States

OPCs are associated with a range of positive outcomes, including (among others): • Reductions in community-level overdose and crime • Reductions in HIV and ...