[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628513":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":25,"responsibleParty":49,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":20,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":28,"whyStopped":20,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Participants who decide to receive PrEP (rapid start)","Rapid start of PrEP in the Emergency Department (ED)",[12,13],"Behavioral: PrEP Uptake with Rapid Start","Behavioral: Pre-Exposure Prophylaxis (PrEP) Persistence",[15,21],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BEHAVIORAL","PrEP Uptake with Rapid Start","For participants who test negative for HIV and are interested in PrEP, the navigator will notify the ED clinician who will discuss starting PrEP with the subject in shared decision making as per standard care. If they decide to initiate PrEP, the ED clinician will complete standard care testing for someone starting PrEP, prescribe a 30-day supply of oral tenofovir disoproxil fumarate \u002F emtricitabine (TDF\u002FFTC), and place a referral to Parkland ID clinic. The rapid-start TDF\u002FFTC can be immediately filled at the co-located Parkland Anderson pharmacy where it is on formulary or other retail pharmacy of subject's choice. The participants will complete a brief survey assessing facilitators\u002Fbarriers to PrEP initiation.",[9],null,{"type":16,"name":22,"description":23,"armGroupLabels":24,"otherNames":20},"Pre-Exposure Prophylaxis (PrEP) Persistence","After rapid start PrEP initiation in the ED, the subject will continue on the PrEP modality of their choice in ID clinic with options to include long-acting injectables. Participants will be followed for 12 months with a final survey assessing facilitators\u002Fbarriers to PrEP persistence to be administered in the final clinic visit. After study completion, participants can continue to receive PrEP through standard care.",[9],[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Parkland Health","RECRUITING","Dallas","Texas","75390","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-96.80667,32.78306,{"lat":38,"lon":37},[41,46],{"name":42,"role":43,"phone":44,"phoneExt":20,"email":45},"Hayden Andrews, MD","CONTACT","214-645-7863","Hayden.Andrews@UTSouthwestern.edu",{"name":47,"role":43,"phone":20,"phoneExt":20,"email":48},"Stephanie Reyes, MA","stephanie.reyes@utsouthwestern.edu",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Hayden Andrews","Assistant Professor-Internal Medicine",[54],{"name":55,"class":56},"Gilead Sciences","INDUSTRY","100628513","hiv-pre-exposure-prophylaxis-prep-linkage-with-immediate-medications-in-the-emergency-department-study-100628513",false,"NCT07462611","HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department Study","HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department (PrEP-ED) Study","PrEP ED","Primary study (ED patients):\n\nInclusion Criteria:\n\n* Able to comprehend and provide signed, written informed consent prior to initiation of study procedures.\n* Negative HIV rapid test\n* At least one of the following criteria:\n\n  * Requesting PrEP from their ED clinician\n  * Score \\>75% on the PCCI HIV Prediction Tool\n  * Prior bacterial STI diagnosis\n  * Seeking STI testing\n  * Referred by their ED clinician as someone who otherwise meets a CDC PrEP indication\n\nExclusion Criteria:\n\n* Known diagnosis of HIV\n* Positive HIV rapid test\n* Current use of PrEP, which is defined for purposes of this study as use of PrEP in the last 4 weeks\n* Known hypersensitivity or allergy to any PrEP modality\n* People who do not want to follow with Parkland ID clinic for ongoing PrEP care\n* Adults unable to consent, people under the age of 18, women who are known to be pregnant or breast feeding at time of study enrollment, or prisoners\n\nSub-study subjects (ED clinicians):\n\nInclusion criteria:\n\n• Clinician in the Parkland ED\n\nExclusion criteria:\n\n• People under the age of 18 or prisoners.",true,"ALL","18 Years",{"count":69,"type":70},250,"ESTIMATED","INTERVENTIONAL",[73],"NA","Our primary objective is to increase HIV pre-exposure prophylaxis (PrEP) awareness and uptake among people who want, need, or would benefit from PrEP in Dallas, TX through a pilot program of immediate PrEP prescribing in the Parkland Memorial Hospital Emergency Department (ED) with linkage to PrEP clinic. Leveraging the previous work of the Parkland Center for Clinical Innovation (PCCI) which created an automated electronic health record (EHR) based HIV prediction tool and prior success with a robust ED HIV navigation program, a PrEP navigator would approach patients in the Parkland ED for PrEP initiation. Through standard care prescribing by their ED clinician, subjects would leave the ED with a prescription for rapid-start oral PrEP and a clinic appointment to persist on the PrEP modality of their choice which will include long-acting injectable options.",[76,77],"HIV Pre-exposure Prophylaxis","PrEP",[77,79,80],"HIV pre-exposure prophylaxis","Emergency department","2026-05-29",{"date":83,"type":84},"2026-06-02","ACTUAL",{"date":86,"type":84},"2026-04-08",{"date":88,"type":70},"2028-04-01",{"name":5,"class":6},1]