[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626623":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":47,"locations":57,"responsibleParty":129,"collaborators":131,"id":145,"slug":25,"hasResults":146,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":22,"eligibilityCriteria":150,"healthyVolunteers":151,"sex":152,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":25,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":166,"overallStatus":170,"whyStopped":25,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"Westat","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LYPS Intervention","EXPERIMENTAL","PrEP and PrEP care will be delivered to youth in the communities where they live through a Community Health Professional (CHP) (e.g., a nurse or other qualified health care professional home, friend's home, community venue or clinic, mobile health clinic), supplemented by a mobile app to provide real-time intervention between CHP visits.",[13],"Other: LYPS",{"label":15,"type":16,"description":17,"interventionNames":18},"Enhanced Standard of Care (eSOC) Control Condition","ACTIVE_COMPARATOR","Usual standard of care clinic-based PrEP, enhanced with access to a limited number of LYPS app components, including basic PrEP adherence information and study visit reminders.",[19],"Other: Enhanced Standard of Care",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"LYPS","The LYPS intervention combines the use of a CHP to deliver PrEP services at a designated place in the community being offered by the SC where PrEP is not yet provided (e.g., participant's home, community partner location, or traveling mobile van) with an android-based smartphone or iphone app to support PrEP use between CHP visits.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Enhanced Standard of Care","Clinic-based PrEP services per usual standard of care (e.g., HIV and STI testing, clinical assessments for signs and symptoms of HIV and PrEP safety) with access to a limited number of LYPS app components, including basic PrEP adherence information and study visit reminders.",[15],[31,35,38,41,44],{"name":32,"affiliation":33,"role":34},"Kate Muessig","Florida State University","STUDY_CHAIR",{"name":36,"affiliation":37,"role":34},"Keith Horvath","San Diego State University",{"name":39,"affiliation":40,"role":34},"Audrey Pettifor","UNC Chapel Hill",{"name":42,"affiliation":33,"role":43},"Lisa Hightow-Weidman, MD, MPH","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":46,"role":43},"Sybil Hosek, PhD","University of Illinois at Chicago",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":25,"email":52},"Nancy Liu","CONTACT","718-980-3937","NancyLiu@westat.com",{"name":54,"role":50,"phone":55,"phoneExt":25,"email":56},"Erin Ricketts","240-453-2786","ErinRicketts@westat.com",[58,78,95,112],{"facility":59,"status":25,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"San Francisco Department of Public Health","San Francisco","California","94102","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-122.41942,37.77493,{"lat":69,"lon":68},[72,76],{"name":73,"role":50,"phone":74,"phoneExt":25,"email":75},"Emily Schaeffer","628-217-7456","emily.schaeffer@sfdph.org",{"name":77,"role":43,"phone":25,"phoneExt":25,"email":25},"Albert Liu",{"facility":79,"status":25,"city":80,"state":81,"zip":82,"country":63,"countryCode":64,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Emory Atlanta Adolescent Consortium","Atlanta","Georgia","30322",{"type":66,"coordinates":84},[85,86],-84.38798,33.749,{"lat":86,"lon":85},[89,93],{"name":90,"role":50,"phone":91,"phoneExt":25,"email":92},"Kaylin Dance","(404) 727-5642","kaylin.dance@emory.edu",{"name":94,"role":43,"phone":25,"phoneExt":25,"email":25},"Andres Camacho-Gonzalez",{"facility":96,"status":25,"city":97,"state":98,"zip":99,"country":63,"countryCode":64,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Johns Hopkins University","Baltimore","Maryland","21287",{"type":66,"coordinates":101},[102,103],-76.61219,39.29038,{"lat":103,"lon":102},[106,110],{"name":107,"role":50,"phone":108,"phoneExt":25,"email":109},"Jessica Coleman","301-385-4868","jcolem52@jh.edu",{"name":111,"role":43,"phone":25,"phoneExt":25,"email":25},"Allison Agwu",{"facility":113,"status":25,"city":114,"state":115,"zip":116,"country":63,"countryCode":64,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Baylor College of Medicine","Houston","Texas","77030",{"type":66,"coordinates":118},[119,120],-95.36327,29.76328,{"lat":120,"lon":119},[123,127],{"name":124,"role":50,"phone":125,"phoneExt":25,"email":126},"Litty Koshy","832-822-1038","Litty.Koshy@bcm.edu",{"name":128,"role":43,"phone":25,"phoneExt":25,"email":25},"Mary Paul",{"type":130,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[132,135,137,139,141,142],{"name":133,"class":134},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":136,"class":134},"National Institute on Drug Abuse (NIDA)",{"name":138,"class":134},"National Institute of Mental Health (NIMH)",{"name":140,"class":134},"National Institutes of Health (NIH)",{"name":33,"class":6},{"name":143,"class":144},"The Emmes Company, LLC","INDUSTRY","100626623",false,"NCT07438041","Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services","Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services (LYPS): An Innovative Mobile Delivery and Mobile Health (mHealth) Intervention to Optimize PrEP Adherence and Persistence","Inclusion Criteria:\n\n* Age 13-24 years, inclusive;\n* Reports anal or vaginal sex in the past year;\n* Is not living with HIV;\n* Weighs at least 35 kilograms (77 pounds);\n* Willing to receive PrEP care from a provider at a participating SC either in the clinic or at one of the designated places in the community being offered by the SC SC;\n* Has an Android-based smartphone or iPhone;\n* Has fluency in English (able to read, speak, and understand English); and\n* Willing to provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Has counter-indications for PrEP according to guidelines and approved local label;\n* Has any clinically significant systemic disease (including but not limited to significant or uncontrolled liver disease, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis, or bone disease) or diabetes;\n* Any other medical, behavioral, or other conditions that, in the opinion of the SC project lead or designee, could interfere with adherence to study procedures or compromise interpretation of study results;\n* Concurrent participation in ATN 166, ATN 170, or any other clinical trial providing HIV medications (PrEP, vaccine, etc.) or currently receiving any PrEP-adherence or persistence behavioral intervention; or\n* Is currently incarcerated or pending incarceration.",true,"ALL","13 Years","24 Years",{"count":156,"type":157},272,"ESTIMATED","INTERVENTIONAL",[160],"NA","The LYPS intervention is a multi-level intervention that combines: a) structural-level delivery of PrEP and PrEP services by a community health professional (CHP) at a designated place in the community being offered by the SC where PrEP is not yet provided (e.g., participant's home, community partner location, or traveling mobile van), with b) an individual-level mobile application (app) to support PrEP adherence and persistence between CHP visits.",[163,164,165],"HIV","PrEP","PrEP Adherence",[164,167,168,169],"Adherence","Oral PrEP","Injectable cabotegravir","NOT_YET_RECRUITING","2026-04-15",{"date":173,"type":174},"2026-04-16","ACTUAL",{"date":176,"type":157},"2026-05",{"date":178,"type":157},"2028-12",{"name":5,"class":6},4]