[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hiv-pre-exposure-prophylaxis-use\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hiv-pre-exposure-prophylaxis-use":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":19,"type":20},400,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"HIV Pre-exposure Prophylaxis Use",[28,29,30],"HIV PrEP","Injectable PrEP","Lenacapavir","NOT_YET_RECRUITING","2026-06-24",{"date":34,"type":35},"2026-06-25","ACTUAL",{"date":37,"type":20},"2026-06-30",{"date":39,"type":20},"2027-02-01",{"name":41,"class":42},"Massachusetts General Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":15,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":43},"100609717","phase-4-enhancing-prep-uptake-and-retention-among-latine-tgw-and-gbm-in-the-south-using-long-acting-injectable-prep-100609717","NCT07218211","Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP","INCLUSION - Enhancing PrEP Uptake and Retention Among Latine Transgender Women and Gay, Bisexual, and Other Men Who Have Sex With Men in the South Using Long-Acting Injectable PrEP","INCLUSION","Inclusion Criteria:\n\n* Participants must be assigned male sex at birth.\n* Report sexual activity with a someone assigned male at birth OR identify as GBM or TGW; be HIV-negative.\n* Identify as Hispanic and\u002For Latine .\n* Be able to provide informed consent in English or Spanish .\n* Be 18 years or older .\n* Weigh at least 77 lbs (35 kg) by self-reported weight.\n* Interested in PrEP and willing to undergo the study procedures.\n\nExclusion Criteria:\n\n* Individuals living with HIV.\n* Individuals assigned female sex at birth will be excluded.\n* Individuals who are currently taking oral PrEP from another source and are not willing to switch to lenacapavir for PrEP for the duration of the study will also be excluded.\n* Individuals who report a history of severe renal or hepatic disease or with clinical stigmata of either disease on physical exam as assessed by a study clinician will be excluded.\n* Individuals taking a medication with a significant interaction with lenacapavir will be excluded from the study.","MALE",{"count":54,"type":20},100,[56],"PHASE4","The purpose of this project is to test a culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW). The objective is to evaluate whether this intervention demonstrates greater persistence on lenacapavir for Latine GBM and TGW compared with what has been observed historically at the Duke PrEP Clinic.",[59,60,61,62,26],"HIV Prevention","HIV Pre-exposure Prophylaxis","HIV Prevention Program","HIV Prevention and Care",[64,30,65,66],"Long-acting Injectable PrEP","PrEP","PrEP injections","RECRUITING","2026-01-29",{"date":70,"type":35},"2026-02-02",{"date":72,"type":35},"2026-01-13",{"date":74,"type":20},"2028-01-05",{"name":76,"class":42},"Duke University"]