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New HIV prevention shot tested in real-world clinics

NCT ID NCT07473778

Prevention Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 8 times

Summary

This study looks at how well people stick to a new HIV prevention shot called lenacapavir. About 3,000 people in the U.S. who want or need HIV prevention will take part. Researchers will track who stays on the shot and how it works in everyday clinic settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 3,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

People who need or want HIV prevention services identified and engaged through routine clinical practice

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key 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: 1. Selects LEN PrEP as their chosen PrEP method; OR, 2. 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.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    38 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AHF - Pensacola

    RECRUITING

    Pensacola, Florida, 32503, United States

  • Abounding Prosperity Inc.

    RECRUITING

    Dallas, Texas, 75215, United States

  • Be Well Medical Center

    RECRUITING

    Berkley, Michigan, 48072, United States

  • Bliss Health

    RECRUITING

    Orlando, Florida, 32803, United States

  • BronxCare Health System

    RECRUITING

    The Bronx, New York, 10457, United States

  • CAN Community Health

    RECRUITING

    Miami, Florida, 33055, United States

  • Chase Brexton Health Care

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Colombia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • DOM/Project WISH Research Clinic

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Faebris Medical & Community Education

    RECRUITING

    Atlanta, Georgia, 01111, United States

  • Family Health Centers of San Diego

    RECRUITING

    San Diego, California, 92102, United States

  • Fenway Health

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Grady Memorial Hospital

    RECRUITING

    Atlanta, Georgia, 30303, United States

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Howard Brown Health

    RECRUITING

    Chicago, Illinois, 60613, United States

  • KC Care Health Center

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Mills Clinical Research

    RECRUITING

    West Hollywood, California, 90046, United States

  • NYC Health + Hospitals / Bellevue

    RECRUITING

    New York, New York, 10016, United States

  • Ohio State University Infectious Diseases Clinical Trials Unit

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Pacific Oaks Medical Group

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Perelman Center for Advanced Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Pineapple Healthcare Orlando

    RECRUITING

    Orlando, Florida, 32829, United States

  • Prism Health

    RECRUITING

    Dallas, Texas, 75246, United States

  • Ruane Clinical Research Group Inc.

    RECRUITING

    Los Angeles, California, 90036, United States

  • Rush University Medical Center/Division of Infectious Diseases

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Ruth M. Rothstein CORE Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • The Aliveness Project

    RECRUITING

    Minneapolis, Minnesota, 55409, United States

  • The Clinic NOLA

    RECRUITING

    New Orleans, Louisiana, 70115, United States

  • Thomas Street at Quentin Mease Health Center

    RECRUITING

    Houston, Texas, 77030, United States

  • UAB 1917 Research Clinic

    RECRUITING

    Birmingham, Alabama, 35222, United States

  • UC San Diego (UCSD) AntiViral Research Center (AVRC)

    RECRUITING

    San Diego, California, 92103, United States

  • UT Health

    RECRUITING

    Houston, Texas, 77009, United States

  • University of Cincinnati College of Medicine

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Nebraska Medical Center/Nebraska Medicine Specialty Care Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37204, United States

  • Vivent Health

    RECRUITING

    Denver, Colorado, 80246, United States

  • Washington University School of Medicine Infectious Disease Clinical Research Unit

    RECRUITING

    St Louis, Missouri, 63110, United States

  • West Virginia Health Right, Inc.

    RECRUITING

    Charleston, West Virginia, 25302, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.