[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659622":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":43,"studyPopulation":36,"armGroups":44,"interventions":50,"overallOfficials":55,"centralContacts":59,"locations":67,"responsibleParty":81,"collaborators":83,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":36,"enrollmentInfo":98,"targetDuration":36,"studyType":101,"phases":102,"briefSummary":103,"conditions":104,"keywords":108,"overallStatus":113,"whyStopped":36,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":36},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"MOUD uptake","Proportion of participants initiating MOUD","0-26 Weeks",{"measure":14,"description":15,"timeFrame":12},"MOUD and PrEP Uptake","Proportion of participants initiating MOUD and PrEP",{"measure":17,"description":18,"timeFrame":12},"PrEP Uptake","Proportion of participants initiating PrEP",[20,24,27,30,33],{"measure":21,"description":22,"timeFrame":23},"MOUD persistence at 6 months","Proportion of participants on MOUD at 6 months among those who initiated","26 Weeks",{"measure":25,"description":26,"timeFrame":23},"PrEP persistence at 6 months","Proportion of participants on PrEP at 6 months among those who initiated",{"measure":28,"description":29,"timeFrame":12},"Participants with Repeat emergency department utilization","Repeat emergency department utilization across Baltimore City",{"measure":31,"description":32,"timeFrame":12},"Opioid overdose events","Proportion of participants with 1+ opioid overdose events",{"measure":34,"description":35,"timeFrame":12},"Linkage and engagement in longitudinal care","Proportion of participants linked to care",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"NA","SINGLE_GROUP","HEALTH_SERVICES_RESEARCH",{"masking":42,"maskingDescription":36,"whoMasked":36},"NONE","1. Background Individuals returning to the community following incarceration experience one of the highest periods of preventable morbidity and mortality observed in clinical medicine. During the weeks and months following release from correctional facilities, rates of fatal opioid overdose increase by as much as 10- to 100-fold, while the risk of HIV acquisition is estimated to be 6- to 20-fold higher than that of the general population. These risks reflect the convergence of opioid use disorder, disrupted healthcare access, unstable housing, poverty, stigma, untreated mental illness, and fragmented transitions between correctional and community healthcare systems. Although effective biomedical interventions exist--including medications for opioid use disorder (MOUD) and HIV pre-exposure prophylaxis (PrEP)--many recently incarcerated individuals do not successfully engage in or remain connected to these services during community re-entry.\n\n   Historically, efforts to improve continuity of care have focused on correctional health systems and community re-entry programs. These approaches have demonstrated important benefits but remain limited by incomplete implementation, inconsistent access across jurisdictions, and substantial loss to follow-up during the transition from incarceration to community living. Consequently, many individuals with ongoing opioid-related and HIV-related risks remain disconnected from preventive healthcare during the period of greatest vulnerability.\n\n   The emergency department represents an underutilized opportunity to address this implementation gap. Between one-quarter and one-half of individuals released from incarceration seek care in an emergency department within the first year following release, and for many, the emergency department serves as the only point of contact with the healthcare system. Contemporary emergency departments have increasingly expanded beyond episodic acute care to incorporate evidence-based public health interventions, including overdose prevention, medications for opioid use disorder, HIV screening, and initiation of HIV pre-exposure prophylaxis. These developments position the emergency department as a critical venue for delivering integrated preventive services to individuals who may otherwise remain unreached by traditional healthcare systems.\n\n   PROTECT-ED was developed to leverage this unique healthcare touchpoint by integrating peer-delivered prevention services, evidence-based biomedical prevention, harm reduction, and facilitated linkage to ongoing community care into a single emergency department encounter. Rather than evaluating the efficacy of MOUD or PrEP--which are already supported by extensive evidence--the study evaluates an implementation strategy designed to improve the reach, uptake, and continuity of these established interventions among recently incarcerated individuals. The intervention is informed by the Behavioral Model for Vulnerable Populations, which recognizes that healthcare utilization is shaped by predisposing characteristics, enabling resources, and perceived and evaluated need for care. By addressing barriers across each of these domains during an existing emergency department visit, PROTECT-ED seeks to improve engagement with preventive services during community re-entry.\n2. Study Objectives As a clinical trial planning study, the purpose of PROTECT-ED is to refine the intervention through participatory prototyping, evaluate the feasibility and preliminary clinical outcomes of implementation, and characterize implementation processes that will inform a future multicenter effectiveness-implementation trial. The knowledge generated through this study will provide the empirical and operational foundation necessary to scale emergency department-based overdose and HIV prevention strategies for individuals returning from incarceration nationally. The overarching objective of PROTECT-ED is to refine and evaluate an emergency department-based implementation strategy designed to improve uptake of evidence-based overdose and HIV prevention services among adults recently released from incarceration. Specifically, this study seeks to refine the intervention through stakeholder engagement, evaluate the feasibility and preliminary clinical outcomes of implementation, and characterize implementation processes to inform a future multi-center effectiveness-implementation trial.\n3. Aims The study consists of three integrated aims. Aim 1 focuses on refinement of the PROTECT-ED intervention through participatory prototyping involving individuals with lived experience, clinicians, correctional health partners, community-based organizations, and other stakeholders.\n\n   Aim 2 evaluates the feasibility and preliminary clinical outcomes of the refined PROTECT-ED intervention through a prospective implementation trial enrolling 120 adults recently released from incarceration.\n\n   Aim 3 evaluates implementation outcomes using mixed methods guided by the Practical, Robust, Implementation and Sustainability Model (PRISM). Quantitative and qualitative findings will characterize intervention reach, acceptability, contextual determinants, and implementation barriers and facilitators.\n4. Study Setting The study will be conducted within the Johns Hopkins Hospital Emergency Department, an urban, academic emergency department that evaluates approximately 60,000 adult patients annually. The emergency department has established clinical pathways for the identification and management of opioid use disorder, universal opt-out HIV screening, initiation of HIV pre-exposure prophylaxis, peer recovery services, and linkage to addiction medicine and infectious diseases care. The Johns Hopkins Hospital Emergency Department serves a large population of individuals affected by opioid use disorder, homelessness, structural vulnerability, and criminal-legal involvement.\n5. Conceptual Framework The PROTECT-ED intervention is informed by the Behavioral Model for Vulnerable Populations, which recognizes that healthcare utilization is influenced by predisposing characteristics, enabling resources, and perceived and evaluated need for care. The intervention seeks to improve engagement with overdose and HIV prevention services by addressing barriers across each of these domains during an emergency department encounter.\n\n   Evaluation of implementation outcomes is guided by the Practical, Robust, Implementation and Sustainability Model (PRISM). PRISM provides a framework for understanding the interaction between the intervention, recipients, organizational context, external environment, and implementation infrastructure, and will inform refinement of the intervention and planning for future scale-up.\n6. Study Timeline The anticipated duration of the study is 36 months. Year 1: Regulatory approvals, participatory prototyping (Aim 1), intervention refinement, and study start-up.\n\nYears 2-3: Participant enrollment, intervention delivery, follow-up assessments, and implementation evaluation (Aims 2 and 3).\n\nYear 3: Data analysis, dissemination of findings, and development of a future multicenter effectiveness-implementation trial.",[45],{"label":46,"type":6,"description":47,"interventionNames":48},"Aim 2 Study Participants","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.",[49],"Behavioral: PROTECT-ED Care Coordination",[51],{"type":52,"name":53,"description":47,"armGroupLabels":54,"otherNames":36},"BEHAVIORAL","PROTECT-ED Care Coordination",[46],[56],{"name":57,"affiliation":5,"role":58},"Bhakti Hansoti, MBChB, PhD, MPH","PRINCIPAL_INVESTIGATOR",[60,64],{"name":57,"role":61,"phone":62,"phoneExt":36,"email":63},"CONTACT","410-955-5000","bhansot1@jh.edu",{"name":65,"role":61,"phone":36,"phoneExt":36,"email":66},"Chris Hoffmann, MD, MSc, MPH","choffmann@jhmi.edu",[68],{"facility":69,"status":36,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":36},"The Johns Hopkins Hospital Emergency Department","Baltimore","Maryland","21287","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-76.61219,39.29038,{"lat":79,"lon":78},{"type":82,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[84],{"name":85,"class":86},"National Institute on Drug Abuse (NIDA)","NIH","100659622","prevention-and-rapid-outreach-for-treatment-engagement-and-care-transition-from-the-emergency-department-100659622",false,"NCT07868393","Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department","Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department (PROTECT-ED)","PROTECT-ED","Inclusion Criteria:\n\n* Are 18 years of age or older.\n* Present to the Johns Hopkins Hospital Emergency Department.\n* 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.\n* 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.\n* Able to speak and understand communicate in English sufficiently to provide informed consent and complete study assessments.\n* Provide informed consent.\n* Have a reliable telephone number for study follow-up.\n\nExclusion Criteria:\n\n* Inability to provide informed consent during the index emergency department encounter.\n* Lack of a reliable telephone number for study follow-up.\n* Prior enrollment in the PROTECT-ED study.",true,"ALL","18 Years",{"count":99,"type":100},120,"ESTIMATED","INTERVENTIONAL",[38],"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.",[105,106,107],"Opioid Overdose Prevention","HIV Prevention and Care","Harm Reduction",[109,110,111,112],"Harm reduction","OUD","Justice-Involved Individuals","Healthcare Engagement","NOT_YET_RECRUITING","2026-10-05",{"date":116,"type":117},"2026-10-09","ACTUAL",{"date":119,"type":100},"2026-11-01",{"date":121,"type":100},"2028-10-01",{"name":5,"class":6},1]