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HIV prevention shot delivery methods put to the test

NCT ID NCT05374525

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This completed study looked at how to best offer cabotegravir, an HIV prevention shot, in US clinics. About 287 men and transgender men at risk for HIV took part. Researchers compared two ways of rolling out the shot to see which worked better in busy and less busy clinics.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cabotegravir (injectable and oral tablets)
What this could lead to
If successful, this study could show the best way to offer cabotegravir PrEP in clinics, making HIV prevention easier and more accessible for at-risk groups.
What could go wrong
This is a completed Phase 4 implementation study, not a test of the drug itself. It focuses on clinic processes, not new efficacy or safety data, so results may not change current practice.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

287 people

The number who actually took part.

Started

May 2022

Finished

Aug 2024

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.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Inclusion Criteria: * Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent. * No prior history of receiving CAB PrEP * HIV negative test result at screening * Capable of giving signed informed consent form Exclusion Criteria: * HIV indeterminate or positive test result during screening and prior to initiation of CAB PrEP * A participant of concurrent interventional clinical or implementation science study at any time during the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • GSK Investigational Site

    Los Angeles, California, 90036, United States

  • GSK Investigational Site

    San Francisco, California, 94102, United States

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20005, United States

  • GSK Investigational Site

    Miami, Florida, 33140, United States

  • GSK Investigational Site

    Orlando, Florida, 32806, United States

  • GSK Investigational Site

    Pensacola, Florida, 32503, United States

  • GSK Investigational Site

    Sarasota, Florida, 34237, United States

  • GSK Investigational Site

    Bridgeport, Kansas, 06605, United States

  • GSK Investigational Site

    Boston, Massachusetts, 02215, United States

  • GSK Investigational Site

    Columbia, Missouri, 65212, United States

  • GSK Investigational Site

    St Louis, Missouri, 63117, United States

  • GSK Investigational Site

    Rochester, New York, 14607, United States

  • GSK Investigational Site

    The Bronx, New York, 10467, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19123, United States

  • GSK Investigational Site

    Charleston, South Carolina, 29407, United States

  • GSK Investigational Site

    Harlingen, Texas, 78550, United States

  • GSK Investigational Site

    Seattle, Washington, 98104, United States

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