NCT07868393

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
23mo left

Started Nov 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

October 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

11 months

First QC Date

October 5, 2026

Last Update Submit

October 5, 2026

Conditions

Opioid Overdose PreventionHIV Prevention and CareHarm Reduction

Keywords

Harm reductionOUDJustice-Involved IndividualsHealthcare Engagement

Outcome Measures

Primary Outcomes (3)

  • MOUD uptake

    Proportion of participants initiating MOUD

    0-26 Weeks

  • MOUD and PrEP Uptake

    Proportion of participants initiating MOUD and PrEP

    0-26 Weeks

  • PrEP Uptake

    Proportion of participants initiating PrEP

    0-26 Weeks

Secondary Outcomes (5)

  • MOUD persistence at 6 months

    26 Weeks

  • PrEP persistence at 6 months

    26 Weeks

  • Participants with Repeat emergency department utilization

    0-26 Weeks

  • Opioid overdose events

    0-26 Weeks

  • Linkage and engagement in longitudinal care

    0-26 Weeks

Study Arms (1)

Aim 2 Study Participants

OTHER

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.

Behavioral: PROTECT-ED Care Coordination

Interventions

PROTECT-ED Care CoordinationBEHAVIORAL

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.

Aim 2 Study Participants

Eligibility Criteria

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

You may qualify if:

  • 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.
  • Able to speak and understand communicate in English sufficiently to provide informed consent and complete study assessments.
  • Provide informed consent.
  • Have a reliable telephone number for study follow-up.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Johns Hopkins Hospital Emergency Department

Baltimore, Maryland, 21287, United States

Location

Related Publications (14)

  • Vargas C, Zorbas C, Longworth GR, Ugalde A, Needham C, Sunil A, Venegas Hargous C, Bennett R, Forrester-Bowling T, Cardoso Richter AP, Allender S. Exploring co-design: a systematic review of concepts, processes, models, and frameworks used in public health research. J Public Health (Oxf). 2025 Dec 1;47(4):e616-e639. doi: 10.1093/pubmed/fdaf084.

    PMID: 40796276BACKGROUND

  • Rousham E, Pareja RG, Creed-Kanashiro HM, Bartolini R, Pradeilles R, Ortega-Roman D, Holdsworth M, Griffiths P, Verdezoto N. Designing intervention prototypes to improve infant and young child nutrition in Peru: a participatory design study protocol. BMJ Open. 2023 Dec 9;13(12):e071280. doi: 10.1136/bmjopen-2022-071280.

    PMID: 38070935BACKGROUND

  • Goldfarb DA. Surgical adrenal disorders. Semin Nephrol. 1994 Nov;14(6):570-9. No abstract available.

    PMID: 7855463BACKGROUND

  • Gelberg L, Andersen RM, Leake BD. The Behavioral Model for Vulnerable Populations: application to medical care use and outcomes for homeless people. Health Serv Res. 2000 Feb;34(6):1273-302.

    PMID: 10654830BACKGROUND

  • Eswaran V, Raven MC, Wang RC, Cawley C, Izenberg JM, Kanzaria HK. Understanding the association between frequent emergency department use and jail incarceration: A cross-sectional analysis. Acad Emerg Med. 2022 May;29(5):606-614. doi: 10.1111/acem.14437. Epub 2022 Feb 10.

    PMID: 35064709BACKGROUND

  • Easter MM, Schramm-Sapyta NL, Tackett MA, Larsen IG, Tang B, Ralph MA, Huynh LN. Reliance on Community Emergency Departments by People Ever Detained in Jail: Retrospective Cross-Sectional Study. J Correct Health Care. 2023 Aug;29(4):282-292. doi: 10.1089/jchc.22.02.0011. Epub 2023 Jun 19.

    PMID: 37335965BACKGROUND

  • Bazin H. Is antiinfectious defence thymus-dependent? Ann Inst Pasteur Immunol. 1988 Mar-Apr;139(2):187-9. doi: 10.1016/0769-2625(88)90040-2. No abstract available.

    PMID: 3259426BACKGROUND

  • Humphreys J, Ahalt C, Stijacic-Cenzer I, Widera E, Williams B. Six-Month Emergency Department Use among Older Adults Following Jail Incarceration. J Urban Health. 2018 Aug;95(4):523-533. doi: 10.1007/s11524-017-0208-4.

    PMID: 29204845BACKGROUND

  • Meyer JP, Qiu J, Chen NE, Larkin GL, Altice FL. Frequent emergency department use among released prisoners with human immunodeficiency virus: characterization including a novel multimorbidity index. Acad Emerg Med. 2013 Jan;20(1):79-88. doi: 10.1111/acem.12054.

    PMID: 23570481BACKGROUND

  • Westergaard RP, Spaulding AC, Flanigan TP. HIV among persons incarcerated in the USA: a review of evolving concepts in testing, treatment, and linkage to community care. Curr Opin Infect Dis. 2013 Feb;26(1):10-6. doi: 10.1097/QCO.0b013e32835c1dd0.

    PMID: 23221766BACKGROUND

  • Iroh PA, Mayo H, Nijhawan AE. The HIV Care Cascade Before, During, and After Incarceration: A Systematic Review and Data Synthesis. Am J Public Health. 2015 Jul;105(7):e5-16. doi: 10.2105/AJPH.2015.302635. Epub 2015 May 14.

    PMID: 25973818BACKGROUND

  • Spittal MJ, Forsyth S, Pirkis J, Alati R, Kinner SA. Suicide in adults released from prison in Queensland, Australia: a cohort study. J Epidemiol Community Health. 2014 Oct;68(10):993-8. doi: 10.1136/jech-2014-204295. Epub 2014 Jul 9.

    PMID: 25009152BACKGROUND

  • Wang EA, Wang Y, Krumholz HM. A high risk of hospitalization following release from correctional facilities in Medicare beneficiaries: a retrospective matched cohort study, 2002 to 2010. JAMA Intern Med. 2013 Sep 23;173(17):1621-8. doi: 10.1001/jamainternmed.2013.9008.

    PMID: 23877707BACKGROUND

  • Hartung DM, McCracken CM, Nguyen T, Kempany K, Waddell EN. Fatal and nonfatal opioid overdose risk following release from prison: A retrospective cohort study using linked administrative data. J Subst Use Addict Treat. 2023 Apr;147:208971. doi: 10.1016/j.josat.2023.208971. Epub 2023 Feb 10.

    PMID: 36821990BACKGROUND

MeSH Terms

Conditions

Harm Reduction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Bhakti Hansoti, MBChB, PhD, MPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bhakti Hansoti, MBChB, PhD, MPH

CONTACT

410-955-5000bhansot1@jh.edu

Chris Hoffmann, MD, MSc, MPH

CONTACT

choffmann@jhmi.edu

Study Design

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

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 9, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Last Updated

October 9, 2026

Record last verified: 2026-10

Locations

US(1)