HIV prevention shot delivery methods put to the test
NCT ID NCT05374525
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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287 people
The number who actually took part.
- Started
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May 2022
- Finished
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Aug 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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GSK Investigational Site
Los Angeles, California, 90036, United States
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GSK Investigational Site
San Francisco, California, 94102, United States
-
GSK Investigational Site
Washington D.C., District of Columbia, 20005, United States
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GSK Investigational Site
Miami, Florida, 33140, United States
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GSK Investigational Site
Orlando, Florida, 32806, United States
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GSK Investigational Site
Pensacola, Florida, 32503, United States
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GSK Investigational Site
Sarasota, Florida, 34237, United States
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GSK Investigational Site
Bridgeport, Kansas, 06605, United States
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GSK Investigational Site
Boston, Massachusetts, 02215, United States
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GSK Investigational Site
Columbia, Missouri, 65212, United States
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GSK Investigational Site
St Louis, Missouri, 63117, United States
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GSK Investigational Site
Rochester, New York, 14607, United States
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GSK Investigational Site
The Bronx, New York, 10467, United States
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GSK Investigational Site
Philadelphia, Pennsylvania, 19123, United States
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GSK Investigational Site
Charleston, South Carolina, 29407, United States
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GSK Investigational Site
Harlingen, Texas, 78550, United States
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GSK Investigational Site
Seattle, Washington, 98104, United States
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Other studies related to the condition(s) this trial covers.
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- New injectable HIV prevention drug tested in healthy volunteers