๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-18

Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention (NCT07473778)

Pioneering Research to Optimize Pre-exposure Prophylaxis (PrEP) Expansion With Lenacapavir (LEN)

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Gilead Sciences

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGOยฎ, (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 join: Review the eligibility criteria below.

Location: UAB 1917 Research Clinic โ€” Birmingham, Alabama

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (34 Sites)

Showing the first 25 of 34 sites.

  • UAB 1917 Research Clinic โ€” Birmingham, Alabama
  • Pacific Oaks Medical Group โ€” Beverly Hills, California
  • Ruane Clinical Research Group Inc. โ€” Los Angeles, California
  • Family Health Centers of San Diego โ€” San Diego, California
  • UC San Diego (UCSD) AntiViral Research Center (AVRC) โ€” San Diego, California
  • Mills Clinical Research โ€” West Hollywood, California
  • Vivent Health โ€” Denver, Colorado
  • Bliss Health โ€” Orlando, Florida
  • Pineapple Healthcare Orlando โ€” Orlando, Florida
  • AHF - Pensacola โ€” Pensacola, Florida
  • Faebris Medical & Community Education โ€” Atlanta, Georgia
  • Grady Memorial Hospital โ€” Atlanta, Georgia
  • DOM/Project WISH Research Clinic โ€” Chicago, Illinois
  • Rush University Medical Center/Division of Infectious Diseases โ€” Chicago, Illinois
  • Howard Brown Health โ€” Chicago, Illinois
  • The Clinic NOLA โ€” New Orleans, Louisiana
  • Chase Brexton Health Care โ€” Baltimore, Maryland
  • Fenway Health โ€” Boston, Massachusetts
  • Be Well Medical Center โ€” Berkley, Michigan
  • Henry Ford Health โ€” Detroit, Michigan
  • The Aliveness Project โ€” Minneapolis, Minnesota
  • KC Care Health Center โ€” Kansas City, Missouri
  • Washington University School of Medicine Infectious Disease Clinical Research Unit โ€” St Louis, Missouri
  • University of Nebraska Medical Center/Nebraska Medicine Specialty Care Center โ€” Omaha, Nebraska
  • NYC Health + Hospitals / Bellevue โ€” New York, New York

๐Ÿ“ž Contact the Study Coordinator

Phone: 1-833-445-3230 (GILEAD-0)

Email: GileadClinicalTrials@gilead.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All HIV Infections clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—