Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
Recruiting · NCT07473778 · Observational (researchers observe without assigning treatment) · Lead sponsor: Gilead Sciences
View the official record on ClinicalTrials.gov →Interventions studied
Cabotegravir (CAB)Emtricitabine/tenofovir alafenamide (F/TAF)Emtricitabine/tenofovir disoproxil fumarate (F/TDF)Lenacapavir InjectionLenacapavir Tablet
What this trial is about
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. 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
- Key
Exclusion criteria
- 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 it is running
34 locations listed across 18 US states.
- UAB 1917 Research Clinic - Birmingham, Alabama, United States
- Pacific Oaks Medical Group - Beverly Hills, California, United States
- Ruane Clinical Research Group Inc. - Los Angeles, California, United States
- Family Health Centers of San Diego - San Diego, California, United States
- UC San Diego (UCSD) AntiViral Research Center (AVRC) - San Diego, California, United States
- Mills Clinical Research - West Hollywood, California, United States
- Vivent Health - Denver, Colorado, United States
- Bliss Health - Orlando, Florida, United States
- Pineapple Healthcare Orlando - Orlando, Florida, United States
- AHF - Pensacola - Pensacola, Florida, United States
- Faebris Medical & Community Education - Atlanta, Georgia, United States
- Grady Memorial Hospital - Atlanta, Georgia, United States
- DOM/Project WISH Research Clinic - Chicago, Illinois, United States
- Rush University Medical Center/Division of Infectious Diseases - Chicago, Illinois, United States
- Howard Brown Health - Chicago, Illinois, United States
- The Clinic NOLA - New Orleans, Louisiana, United States
- Chase Brexton Health Care - Baltimore, Maryland, United States
- Fenway Health - Boston, Massachusetts, United States
- Be Well Medical Center - Berkley, Michigan, United States
- Henry Ford Health - Detroit, Michigan, United States
- The Aliveness Project - Minneapolis, Minnesota, United States
- KC Care Health Center - Kansas City, Missouri, United States
- Washington University School of Medicine Infectious Disease Clinical Research Unit - St Louis, Missouri, United States
- University of Nebraska Medical Center/Nebraska Medicine Specialty Care Center - Omaha, Nebraska, United States
- NYC Health + Hospitals / Bellevue - New York, New York, United States
- Colombia University Irving Medical Center - New York, New York, United States
- University of Cincinnati College of Medicine - Cincinnati, Ohio, United States
- Ohio State University Infectious Diseases Clinical Trials Unit - Columbus, Ohio, United States
- Perelman Center for Advanced Medicine - Philadelphia, Pennsylvania, United States
- Abounding Prosperity Inc. - Dallas, Texas, United States
- Prism Health - Dallas, Texas, United States
- UT Health - Houston, Texas, United States
- Thomas Street at Quentin Mease Health Center - Houston, Texas, United States
- West Virginia Health Right, Inc. - Charleston, West Virginia, United States