[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07728123":3,"trial-entities:NCT07728123":165,"trial-summary:NCT07728123":169},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":45,"secondary_outcomes":53,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":70,"locations":73,"central_contacts":153,"overall_officials":162,"references":163,"see_also_links":164},"NCT07728123","ATN164 (S2P)","Screen2Prevent (S2P)","Screen2Prevent (S2P): Using Digital Health to Improve HIV Screening and Prevention for Adolescents in the Emergency Department","RECRUITING","2028-10-31","2026-07","2026-07-27","2026-06-16","Westat","OTHER",false,"Screen2Prevent is a study intended to improve HIV prevention and detection through implementation and evaluation of three different broad-scale HIV screening approaches a) targeted, b) universally offered opt-in, and c) universally offered opt-out in Emergency Departments (EDs) by leveraging digital health to identify and link adolescents seeking care in the ED to HIV Pre-Exposure Prophylaxis (PrEP)\u002FAntiretroviral treatment (ART).","At each SC, each of the three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) will be employed, one at a time, for a period of 8 months and a total study period of 24 months.\n\nAll patients 14-24 years of age that are seeking care in participating EDs during the study period will be given the opportunity to complete the computerized sexual health survey (cSHS) on a tablet. The cSHS asks patients to decide whether they want to be tested for HIV and contains questions based on the 2021 update to the CDC PrEP eligibility guidelines that stratify risk for HIV exposure and acquisition. The patient will agree (or not) to completing the cSHS on the tablet. The cSHS is not mandatory, so a patient may decline to use the tablet, and their parent or guardian may decline as well.\n\nThroughout study activities (for all screening strategy phases), certain cSHS results will trigger real-time EHR-integrated decision support for clinicians on whether HIV testing should be ordered and whether counseling\u002Fprescription for PrEP should be provided. It also implements a text messaging platform with the patient for basic PrEP information and enrollment into a digital health PrEP linkage platform.\n\nAdditionally, all SCs will abstract baseline (plus 3 months) EHR data for all eligible patients to be used as a comparator in the analysis.",[19],"HIV Infections",[21,22,23,24,25,26],"HIV","adolescents","emergency department","preventive care","mHealth","PrEP","INTERVENTIONAL","SCREENING",[30],"NA",{"count":32,"type":33},84000,"ESTIMATED",[35],{"type":14,"name":36,"description":37,"armGroupLabels":38},"HIV screening strategies","The intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months.\n\nA targeted screening approach is defined as screening those who are at increased likelihood for acquiring HIV. Alternatively, a universally offered screening approach is defined as screening all, regardless of behavior informing risk. There are two types of universally offered screening, opt-in and opt-out. With opt-in screening, all patients are offered screening, which they may then agree to undergo. Opt-out screening consists of notifying patients that the test will be conducted unless they explicitly decline.\n\nEach screening strategy implements the cSHS, a text messaging platform, and Clinical Decision Support for identification of youth needing HIV treatment\u002Fprevention and linkage to services.",[39,40,41,42,43,44],"1. Universally offered opt-in > Universally offered opt-out > Targeted","2. Universally offered opt-out > Universally offered opt-in > Targeted","3. Universally offered opt-in > Targeted > Universally offered opt-out","4. Universally offered opt-out > Targeted > Universally offered opt-in","5. Targeted > Universally offered opt-out > Universally offered opt-in","6. Targeted > Universally offered opt-in > Universally offered opt-out",[46,50],{"measure":47,"description":48,"timeFrame":49},"Monthly HIV detection rates per 1,000 eligible patients","Compare the rate of HIV detection between each screening strategy (targeted, universal opt-in, universal opt-out) to baseline using the all patients analysis set.","36 months",{"measure":51,"description":52,"timeFrame":49},"Rapid PrEP\u002FART initiation (defined by prescription within 72 hours of ED discharge)","Compare the rates of rapid start of PrEP\u002FART, defined as PrEP\u002FART prescription within 72 hours of ED discharge, between adolescents and young adults who visit the ED prior to implementation of cSHS and those who visit after implementation of cSHS using the all patients analysis set.",[54,57],{"measure":55,"description":56,"timeFrame":49},"Cost per HIV case detected","Compare the cost per HIV case detected between each of the screening strategies and baseline using the all patients analysis set.",{"measure":51,"description":58,"timeFrame":49},"Compare the proportions of rapid start of PrEP\u002FART, defined as PrEP\u002FART prescription within 72 hours of ED discharge, among those who visit the ED during implementation of cSHS between those who engage in ScreenWell versus those who do not using the cSHS Analysis Set.","ALL","14 Years","24 Years",true,{"inclusion":64,"exclusion":67,"raw_text":69},[65,66],"Age 14-24 years, inclusive","Present to the participating ED, regardless of chief complaint during the study period",[68],"None","Inclusion Criteria:\n\n* Age 14-24 years, inclusive\n* Present to the participating ED, regardless of chief complaint during the study period\n\nExclusion Criteria:\n\n* None",[71,72],"CHILD","ADULT",[74,92,108,123,138],{"facility":75,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":89},"University of South Florida","Tampa","Florida","33612","United States",[81,86],{"name":82,"role":83,"phone":84,"email":85},"Elizabeth Enriquez-Bruce","CONTACT","813-250-2574","enriquezbruce@usf.edu",{"name":87,"role":88},"Carina Rodriguez, MD","PRINCIPAL_INVESTIGATOR",{"lat":90,"lon":91},27.94752,-82.45843,{"facility":93,"status":94,"city":95,"state":96,"zip":97,"country":79,"contacts":98,"geoPoint":105},"Emory Atlanta Adolescent Consortium","NOT_YET_RECRUITING","Atlanta","Georgia","30322",[99,103],{"name":100,"role":83,"phone":101,"email":102},"Kaylin Dance","404-727-5642","kaylin.dance@emory.edu",{"name":104,"role":88},"Andres Camacho-Gonzalez, MD",{"lat":106,"lon":107},33.749,-84.38798,{"facility":109,"status":94,"city":110,"state":111,"zip":112,"country":79,"contacts":113,"geoPoint":120},"Johns Hopkins University","Baltimore","Maryland","21287",[114,118],{"name":115,"role":83,"phone":116,"email":117},"Jessica Coleman-Lewis, MD","3013854868","jcolem52@jh.edu",{"name":119,"role":88},"Errol Fields, MD",{"lat":121,"lon":122},39.29038,-76.61219,{"facility":124,"status":8,"city":125,"state":126,"zip":127,"country":79,"contacts":128,"geoPoint":135},"St. Jude Children's Research Hospital","Memphis","Tennessee","38015",[129,133],{"name":130,"role":83,"phone":131,"email":132},"Jamie Russell","901-595-8300","jamie.russell@stjude.org",{"name":134,"role":88},"Aditya Gaur, MD",{"lat":136,"lon":137},35.14953,-90.04898,{"facility":139,"status":94,"city":140,"state":141,"zip":142,"country":79,"contacts":143,"geoPoint":150},"Baylor College of Medicine","Houston","Texas","77030",[144,148],{"name":145,"role":83,"phone":146,"email":147},"Litty Koshy","832-822-1038","Litty.Koshy@bcm.edu",{"name":149,"role":88},"Mary Paul, MD",{"lat":151,"lon":152},29.76328,-95.36327,[154,158],{"name":155,"role":83,"phone":156,"email":157},"Erin Ricketts","240-453-2786","erinricketts@westat.com",{"name":159,"role":83,"phone":160,"email":161},"Nancy Liu","718-980-3937","NancyLiu@westat.com",[],[],[],{"nct_id":4,"conditions":166,"biomarkers":168},[167],"HIV Infection",[],{"nct_id":4,"found":62,"summary":170,"prompt_version":180},{"design":171,"status":172,"heading":173,"summary":174,"follow_up":175,"word_count":176,"commitments":177,"compensation":178,"drugs_mentioned":179},"This interventional study will test three different HIV screening strategies, each for 8 months, over a total of 24 months. It plans to enroll 84,000 participants.","completed","Screen2Prevent (S2P) HIV Screening Study","This study, called Screen2Prevent (S2P), is looking at different ways to screen young people for HIV in emergency departments (EDs). It aims to find the best approach to identify HIV infections and quickly connect patients to HIV Pre-Exposure Prophylaxis (PrEP), a medicine to prevent HIV, or Antiretroviral Treatment (ART), medicines to treat HIV. The study will test three different screening strategies: targeted screening (for those at higher risk), universally offered opt-in screening (where everyone is offered a test and can choose to take it), and universally offered opt-out screening (where everyone is offered a test unless they say no). Researchers will measure how many new HIV cases are found each month and how quickly PrEP\u002FART is started after an ED visit. You can join if you are between 14 and 24 years old and visit a participating ED.","The study will measure outcomes related to HIV detection and PrEP\u002FART initiation at 36 months.",138,"You would be offered a computerized sexual health survey on a tablet during your ED visit. You can choose whether or not to complete the survey.","Not stated in the trial record.",[],"v2"]