[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618720":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":60,"collaborators":63,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":25,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":25,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":88,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PrEP Clinic","ACTIVE_COMPARATOR","The PrEP Clinic arm will be randomized to receive follow up at the clinic",[13],"Other: Follow up via standard clinic",{"label":15,"type":16,"description":17,"interventionNames":18},"PrEP Choice","EXPERIMENTAL","The PrEP Choice arm allows participants to choose where they receive their follow up",[19],"Other: Choice of follow up",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Choice of follow up","Randomization to either standard clinic follow up or choice of where follow up takes place",[15],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Follow up via standard clinic","Follow up will take place at the clinic where the first dose was administered.",[9],[31],{"name":32,"affiliation":5,"role":33},"Ruanne V Barnabas, MBChB, PhD","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Meighan Krows","CONTACT","617-726-2000","mkrows@mgb.org",[41],{"facility":42,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Massachusetts General Hospital Sexual Health Clinic","Boston","Massachusetts","02114","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-71.05977,42.35843,{"lat":52,"lon":51},[55,59],{"name":56,"role":37,"phone":57,"phoneExt":25,"email":58},"Kevin Ard, MD","617 726 2748","kard@mgh.harvard.edu",{"name":56,"role":33,"phone":25,"phoneExt":25,"email":25},{"type":33,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Ruanne Barnabas, MBChB, MSc, DPhil.","Chief, Division of Infectious Diseases",[64],{"name":65,"class":6},"Brigham and Women's Hospital","100618720","prep4u-assessing-the-effectiveness-of-integrated-same-day-lenacapavir-initiation-and-follow-up-choice-on-prep-persistence-100618720",false,"NCT07335289","PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence","Inclusion Criteria:\n\n* HIV negative\n* Eligible for HIV PrEP per CDC guidelines\n* Able and willing to provide informed consent\n* Willing to receive injectable lenacapavir and adhere to study procedures\n* Residing inMassachusetts with expected availability for 6-month follow-up\n\nExclusion Criteria:\n\n* Known HIV infection at baseline\n* Contraindication to lenacapavir injection (e.g., hypersensitivity, significant drug interactions)\n* Pregnancy at baseline (participants who become pregnant during the trial may remain enrolled if they choose)\n* Participation in another interventional HIV prevention study\n* Any condition judged by the investigator to compromise safety or study integrity",true,"ALL","18 Years",{"count":76,"type":77},400,"ESTIMATED","INTERVENTIONAL",[80],"NA","PrEP4U is designed as a pragmatic, randomized implementation trial to test strategies that could directly inform real-world roll-out of lenacapavir. By integrating:\n\n* Same-day initiation based on rapid HIV testing, and\n* Choice of follow-up delivery location (home, community, or clinic) the study addresses two of the most pressing implementation questions for long-acting injectable PrEP.\n\nThe primary hypothesis is that giving participants choice in follow-up location will improve PrEP persistence compared to a clinic-only model. Secondary analyses will evaluate safety of rapid testing, acceptability, and participant costs. Exploratory analyses will assess HIV incidence and resistance.\n\nFindings from PrEP4U will provide essential evidence to guide scalable, equitable, person-centered delivery models for lenacapavir PrEP in the U.S. and globally.",[83],"HIV Pre-exposure Prophylaxis Use",[85,86,87],"HIV PrEP","Injectable PrEP","Lenacapavir","NOT_YET_RECRUITING","2026-06-24",{"date":91,"type":92},"2026-06-25","ACTUAL",{"date":94,"type":77},"2026-06-30",{"date":96,"type":77},"2027-02-01",{"name":5,"class":6},1]