[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614402":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":72,"collaborators":74,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":26,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":26,"enrollmentInfo":90,"targetDuration":26,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":104,"whyStopped":26,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"George Washington University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ED-PrEP","ACTIVE_COMPARATOR","In Phase 1 (Pre-DST) PrEP eligible patients who have agreed to PrEP will receive a PrEP prescription facilitated by a PrEP Champion; there will be no structured engagement intervention (i.e., the DST).",[13],"Behavioral: PrEP Delivery",{"label":15,"type":16,"description":17,"interventionNames":18},"ED-PrEP + DST","EXPERIMENTAL","In Phase 2 (Post-DST) PrEP Champions will integrate the DST into all patient encounters, facilitating the use of the DST as well as the provision of any identified resources.",[19,13],"Behavioral: Decision support tool",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Decision support tool","Participants enrolled during Phase 2 will engage in all the activities from Phase 1 and will receive the DST intervention. The DST will be designed and programmed to generate results if tablet-based (or to be easily manually scored if paper-based) to display the participant's PrEP knowledge and intention score, self-efficacy score, level of self-perceived risk, as well as generate a list of unmet needs. Upon completion of the DST, the Champion will review these results and discuss them with the participant. Referrals for needed resources will be proactively provided in the ED. After the DST delivery, participants will receive a PrEP prescription and follow-up appointment with a community PrEP provider.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"PrEP Delivery","Participants enrolled during Phase 1 will receive a 14-day prescription of TDF\u002FFTC or FTC\u002FTAF before leaving the ED and an appointment with a community PrEP provider. The Champion will provide brief HIV prevention and PrEP medication counseling including proper dosing, missed doses, review of medication side effects and efficacy, and risk reduction counseling including condom use. Participants will receive a PrEP information brochure. The Champion will also make the initial appointment with the PrEP community provider for within 7 days of the ED visit. Community PrEP providers will be identified using local resources, CDC PrEP locators, and insurance; appointments will be scheduled according to patient preference. All participants will receive a text message reminder two days prior, and a reminder call one day prior.",[9,15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Amanda D Castel","CONTACT","202-994-8325","acastel@gwu.edu",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Bhakti Hansoti","410-735-7077","bhansot1@jhmi.edu",[42,59],{"facility":43,"status":26,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"George Washington University Emergency Department","Washington D.C.","District of Columbia","20037","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-77.03637,38.89511,{"lat":53,"lon":52},[56,57],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"name":33,"role":58,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":60,"status":26,"city":61,"state":62,"zip":63,"country":47,"countryCode":48,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Johns Hopkins Hospital Emergency Department","Baltimore","Maryland","21287",{"type":50,"coordinates":65},[66,67],-76.61219,39.29038,{"lat":67,"lon":66},[70,71],{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},{"name":38,"role":58,"phone":26,"phoneExt":26,"email":26},{"type":73,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[75,78],{"name":76,"class":77},"National Institute of Mental Health (NIMH)","NIH",{"name":79,"class":6},"Johns Hopkins University","100614402","phase-1-decision-support-tool-to-integrate-prep-into-emergency-departments-100614402",false,"NCT07279129","Decision Support Tool to Integrate PrEP Into Emergency Departments","A Pilot Feasibility Study to Integrate PrEP Into Emergency Departments Using Decision Support Tools","Inclusion Criteria:\n\n* English-speaking\n* Self-report being HIV negative (GWU sites) or are found to be HIV rapid test negative (JHH ED)\n* Medically stable ED\u002FUC patients (defined as a triage category level 3, 4, 5 using Emergency Severity Index for ED patients only)\n\nExclusion Criteria:\n\n* Currently taking PEP, PrEP, or present with signs\u002Fsymptoms of acute HIV infection\n* Pregnant\n* Currently taking a nephrotoxic medication\n* Diagnosed with medical conditions that are contraindicated with use of TDF\u002FFTC or TAF\u002FFTC\n* Have a comorbid medical or psychiatric condition that would make PrEP adherence or ongoing follow-up care difficult\n* Admission to the hospital\n* Are in police custody\u002Fprisoner during the ED visit",true,"ALL","18 Years",{"count":91,"type":92},120,"ESTIMATED","INTERVENTIONAL",[95],"PHASE1","This project will explore the development of a personalized decision support tool to assist with pre-exposure prophylaxis (PrEP) initiation and persistence among patients identified in the emergency department (ED) and urgent care settings as PrEP eligible. First, the investigators will use a sequence of validated implementation science methodologies to develop and validate a decision support tool designed to optimize PrEP persistence by strengthening self-efficacy by addressing the multifaceted medical and social needs of the individual patient. The investigators will then test the preliminary effectiveness of this tool through a pilot stepped wedge implementation trial in two EDs and an urgent care in Baltimore, MD and Washington, DC among 120 PrEP eligible patients to determine PrEP initiation, linkage to care, persistence, and adherence rates.",[98],"HIV",[100,101,102,103],"PrEP","Emergency departments","Decision support tools","HIV prevention","NOT_YET_RECRUITING","2025-12-08",{"date":107,"type":108},"2025-12-12","ACTUAL",{"date":110,"type":92},"2027-01-15",{"date":112,"type":92},"2028-09-09",{"name":5,"class":6},2]