Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
Public ClinicalTrials.gov record NCT07473778. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pioneering Research to Optimize Pre-exposure Prophylaxis (PrEP) Expansion With Lenacapavir (LEN)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07473778
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 3,000 participants
Conditions and interventions
Conditions
Interventions
- Lenacapavir Injection Drug
- Emtricitabine/tenofovir disoproxil fumarate (F/TDF) Drug
- Emtricitabine/tenofovir alafenamide (F/TAF) Drug
- Cabotegravir (CAB) Drug
- Lenacapavir Tablet Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 16, 2026
- Primary completion
- Mar 31, 2028
- Completion
- Mar 31, 2029
- Last update posted
- Aug 18, 2026
2026 – 2029
United States locations
- U.S. sites
- 34
- U.S. states
- 18
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB 1917 Research Clinic | Birmingham | Alabama | 35222 | Recruiting |
| Pacific Oaks Medical Group | Beverly Hills | California | 90211 | Recruiting |
| Ruane Clinical Research Group Inc. | Los Angeles | California | 90036 | Recruiting |
| Family Health Centers of San Diego | San Diego | California | 92102 | Recruiting |
| UC San Diego (UCSD) AntiViral Research Center (AVRC) | San Diego | California | 92103 | Recruiting |
| Mills Clinical Research | West Hollywood | California | 90046 | Recruiting |
| Vivent Health | Denver | Colorado | 80246 | Recruiting |
| Bliss Health | Orlando | Florida | 32803 | Recruiting |
| Pineapple Healthcare Orlando | Orlando | Florida | 32829 | Recruiting |
| AHF - Pensacola | Pensacola | Florida | 32503 | Recruiting |
| Faebris Medical & Community Education | Atlanta | Georgia | 01111 | Recruiting |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | Recruiting |
| DOM/Project WISH Research Clinic | Chicago | Illinois | 60612 | Recruiting |
| Rush University Medical Center/Division of Infectious Diseases | Chicago | Illinois | 60612 | Recruiting |
| Howard Brown Health | Chicago | Illinois | 60613 | Recruiting |
| The Clinic NOLA | New Orleans | Louisiana | 70115 | Recruiting |
| Chase Brexton Health Care | Baltimore | Maryland | 21201 | Recruiting |
| Fenway Health | Boston | Massachusetts | 02215 | Recruiting |
| Be Well Medical Center | Berkley | Michigan | 48072 | Recruiting |
| Henry Ford Health | Detroit | Michigan | 48202 | Recruiting |
| The Aliveness Project | Minneapolis | Minnesota | 55409 | Recruiting |
| KC Care Health Center | Kansas City | Missouri | 64111 | Recruiting |
| Washington University School of Medicine Infectious Disease Clinical Research Unit | St Louis | Missouri | 63110 | Recruiting |
| University of Nebraska Medical Center/Nebraska Medicine Specialty Care Center | Omaha | Nebraska | 68198 | Recruiting |
| NYC Health + Hospitals / Bellevue | New York | New York | 10016 | Recruiting |
| Colombia University Irving Medical Center | New York | New York | 10032 | Recruiting |
| University of Cincinnati College of Medicine | Cincinnati | Ohio | 45267 | Recruiting |
| Ohio State University Infectious Diseases Clinical Trials Unit | Columbus | Ohio | 43210 | Recruiting |
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19107 | Recruiting |
| Abounding Prosperity Inc. | Dallas | Texas | 75215 | Recruiting |
| Prism Health | Dallas | Texas | 75246 | Recruiting |
| UT Health | Houston | Texas | 77009 | Recruiting |
| Thomas Street at Quentin Mease Health Center | Houston | Texas | 77030 | Recruiting |
| West Virginia Health Right, Inc. | Charleston | West Virginia | 25302 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07473778, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 18, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07473778 live on ClinicalTrials.gov.