Frontlight ResearchEarly access
Taking people in United StatesNo phase
Real-life use of lenacapavir to prevent HIV in US clinics
Observes how people use lenacapavir to prevent HIV in routine care.
Key facts
- Who runs it
- Gilead Sciences
- Where
- Atlanta, Baltimore, Berkley, Beverly Hills, Birmingham, Boston, Charleston, Chicago, Cincinnati, Columbus, Dallas, Denver, Detroit, Houston, Kansas City, Los Angeles, Miami, Minneapolis, Nashville, New Orleans, New York, Oakland, Omaha, Orlando, Pensacola, Philadelphia, San Diego, Seattle, St Louis, The Bronx, and West Hollywood, United StatesSee the 44 sites
- Trial code
- Registry title
- Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
- Status
- Recruiting
- People taking part
- 3,000 people, planned
- Started
- 17 Mar 2026
- Expected to end
- Apr 2029
- Type of study
- Observational, 2 groups
- Treatments tested
- Lenacapavir Injection
- Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
- Emtricitabine/tenofovir alafenamide (F/TAF)
- Cabotegravir (CAB)
- Lenacapavir Tablet
- Record updated
- 21 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who want or need medicine to prevent HIV (PrEP) and who test HIV-negative. It follows how people use lenacapavir PrEP in routine care in the United States.
- Age
- 18 years or older
- Sex
- All sexes can join
- Earlier treatment
- New PrEP users and current or former users of oral or injectable PrEP can join.
- Biomarker or test result
- Must test HIV-1 negative at screening.
Main reasons for not taking part
- Any other reason that makes lenacapavir PrEP unsuitable at enrollment under local guidelines, protocols, the product label or CDC guidance
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of screening study procedures
- Willing and able to comply with all study requirements
- Presents at a study site needing or wanting PrEP for HIV prevention as determined by local clinical practice guidelines and institutional protocols, including new PrEP users (PrEP naïve) and current or former users of oral (emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®; F/TDF) or emtricitabine/tenofovir alafenamide (coformulated; Descovy®; F/TAF)) or injectable (LEN or cabotegravir (CAB)) PrEP who indicate interest in discussing PrEP methods that they are clinically eligible to receive
- Eligible for LEN PrEP per standard of care procedures, for example, being HIV-1 negative at screening using a Food and Drug Administration (FDA) approved/cleared test for diagnosis of acute or primary HIV-1 infection
- After PrEP counseling to learn about the advantages and disadvantages of various PrEP methods:; Selects LEN PrEP as their chosen PrEP method; OR,; Selects a different PrEP method or chooses not to start or continue PrEP
Who cannot take part
- Any other indication not already listed above that would make the participant ineligible for LEN PrEP at enrollment according to local guidelines, organizational protocols, US Prescribing Information (USPI) for the PrEP product, and/or Center for Disease and Control (CDC) guidance; Note: Other protocol defined Inclusion/Exclusion criteria may apply
Where in United States
- Faebris Medical & Community EducationAtlanta, United StatesTaking people
- Grady Memorial HospitalAtlanta, United StatesTaking people
- Chase Brexton Health CareBaltimore, United StatesTaking people
- Be Well Medical CenterBerkley, United StatesTaking people
- Pacific Oaks Medical GroupBeverly Hills, United StatesTaking people
- UAB, 1917 Research ClinicBirmingham, United StatesTaking people
- Fenway HealthBoston, United StatesTaking people
- Medical University of South CarolinaCharleston, United StatesTaking people
- West Virginia Health Right, Inc.Charleston, United StatesTaking people
- DOM/Project WISH Research ClinicChicago, United StatesTaking people
- Howard Brown HealthChicago, United StatesTaking people
- Northwestern MedicineChicago, United StatesTaking people
- Rush University Medical Center/Division of Infectious DiseasesChicago, United StatesTaking people
- Ruth M. Rothstein CORE CenterChicago, United StatesTaking people
- University of Cincinnati College of MedicineCincinnati, United StatesTaking people
- Ohio State University Infectious Diseases Clinical Trials UnitColumbus, United StatesTaking people
- Abounding Prosperity Inc.Dallas, United StatesTaking people
- Prism HealthDallas, United StatesTaking people
- Vivent HealthDenver, United StatesTaking people
- Henry Ford HealthDetroit, United StatesTaking people
- Thomas Street at Quentin Mease Health CenterHouston, United StatesTaking people
- UT HealthHouston, United StatesTaking people
- KC CARE Health CenterKansas City, United StatesTaking people
- Ruane Clinical Research Group Inc.Los Angeles, United StatesTaking people
- CAN Community HealthMiami, United StatesTaking people
- The Aliveness ProjectMinneapolis, United StatesTaking people
- Vanderbilt University Medical CenterNashville, United StatesTaking people
- Ochsner Baptist Medical CenterNew Orleans, United StatesTaking people
- The Clinic NOLANew Orleans, United StatesTaking people
- Colombia University Irving Medical CenterNew York, United StatesTaking people
- NYC Health + Hospitals / BellevueNew York, United StatesTaking people
- Sutter Health- East Bay Advanced CareOakland, United StatesTaking people
- University of Nebraska Medical Center/Nebraska Medicine Specialty Care CenterOmaha, United StatesTaking people
- Bliss HealthOrlando, United StatesTaking people
- Pineapple Healthcare OrlandoOrlando, United StatesTaking people
- AHF PensacolaPensacola, United StatesTaking people
- Perelman Center for Advanced MedicinePhiladelphia, United StatesTaking people
- Philadelphia FIGHTPhiladelphia, United StatesTaking people
- Family Health Centers of San DiegoSan Diego, United StatesTaking people
- UC San Diego (UCSD) AntiViral Research Center (AVRC)San Diego, United StatesTaking people
- Kelley-Ross PharmacySeattle, United StatesTaking people
- Washington University School of Medicine Infectious Disease Clinical Research UnitSt Louis, United StatesTaking people
- BronxCare Health SystemThe Bronx, United StatesTaking people
- Mills Clinical ResearchWest Hollywood, United StatesTaking people
About the trial
What the trial wants to find out
The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP.
Read full original descriptionShow less
The primary objective of this study is to evaluate real-life persistence on LEN PrEP at Week 52 in diverse clinical settings in the United States.
The 2 groups in the trial
- LEN PrEP
Participants in diverse clinical settings in the United States (US) who choose subcutaneous (SC) Lenacapavir (LEN) Pre-Exposure Prophylaxis for HIV Prevention (PrEP) at enrollment in the study or anytime during the follow-up period
Treatment: Lenacapavir Injection and Lenacapavir Tablet
- Other PrEP
Participants in diverse clinical settings in the United States (US) who choose other PrEP options ( F/TDF, F/TAF, CAB) or No PrEP.
Treatment: Emtricitabine/tenofovir disoproxil fumarate (F/TDF), Emtricitabine/tenofovir alafenamide (F/TAF), and Cabotegravir (CAB)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pioneering Research to Optimize Pre-exposure Prophylaxis (PrEP) Expansion With Lenacapavir (LEN)
- Plain-language title
- Real-life use of lenacapavir to prevent HIV in US clinicsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 21 October 2026