New study aims to make HIV prevention easier for black women
NCT ID NCT05514509
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed phase 4 study looked at how to best offer cabotegravir PrEP (a long-acting injection and tablets) to Black cisgender and transgender women in the US who do not have HIV. About 370 women took part, and researchers measured how well different delivery strategies worked in real clinics. The goal was to find ways to make HIV prevention more accessible and acceptable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cabotegravir (injection and tablet)
- What this could lead to
- If successful, this study could show that offering cabotegravir PrEP in different ways helps more Black women at risk of HIV get and stay on prevention.
- What could go wrong
- This is a completed implementation study, not a test of whether the drug works. The results may not apply to all settings or populations.
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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370 people
The number who actually took part.
- Started
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Oct 2022
- Finished
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Sep 2025
- 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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Female 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, at the time of signing the informed consent. * HIV negative at screening. Type of HIV-1 test is per standard of care. * No prior history of receiving oral CAB or CAB LA injections. * PrEP provider deems CAB PrEP use to be appropriate per the applicable CAB PrEP prescribing information prior to enrollment in the study. * Female at birth or self-identified Transgender Female. * Self-identified as African American/Black * Capable of giving signed informed consent Exclusion criteria: * HIV indeterminate or positive test result during screening. * A participant of concurrent interventional clinical or implementation science study at any time during the study. * Cis-gender or Transgender male
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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
Washington D.C., District of Columbia, 20005, United States
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GSK Investigational Site
Washington D.C., District of Columbia, 20010, United States
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GSK Investigational Site
Washington D.C., District of Columbia, 20017, United States
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GSK Investigational Site
Miami, Florida, 33137, United States
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GSK Investigational Site
Orlando, Florida, 32808, United States
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GSK Investigational Site
Tampa, Florida, 33611, United States
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GSK Investigational Site
West Palm Beach, Florida, 33401, United States
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GSK Investigational Site
Atlanta, Georgia, 30303, United States
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GSK Investigational Site
Atlanta, Georgia, 30309, United States
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GSK Investigational Site
Atlanta, Georgia, 30312, United States
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GSK Investigational Site
Bridgeport, Kansas, 06605, United States
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GSK Investigational Site
Detroit, Michigan, 48201, United States
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GSK Investigational Site
Las Vegas, Nevada, 89104, United States
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GSK Investigational Site
Brooklyn, New York, 10001, United States
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GSK Investigational Site
New York, New York, 10029, United States
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GSK Investigational Site
Philadelphia, Pennsylvania, 19114, United States
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GSK Investigational Site
Philadelphia, Pennsylvania, 19147, United States
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GSK Investigational Site
Memphis, Tennessee, 38104, United States
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GSK Investigational Site
Dallas, Texas, 75201, United States
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GSK Investigational Site
Houston, Texas, 77006, United States
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GSK Investigational Site
Houston, Texas, 77021, United States
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GSK Investigational Site
Norfolk, Virginia, 23510, United States
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Other studies related to the condition(s) this trial covers.
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- Can testing together again keep male couples HIV-Free?
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- New injectable HIV prevention drug tested in healthy volunteers