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New study aims to make HIV prevention easier for black women

NCT ID NCT05514509

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 4

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

Participants

370 people

The number who actually took part.

Started

Oct 2022

Finished

Sep 2025

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

Female 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, 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

  • GSK Investigational Site

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

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20010, United States

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20017, United States

  • GSK Investigational Site

    Miami, Florida, 33137, United States

  • GSK Investigational Site

    Orlando, Florida, 32808, United States

  • GSK Investigational Site

    Tampa, Florida, 33611, United States

  • GSK Investigational Site

    West Palm Beach, Florida, 33401, United States

  • GSK Investigational Site

    Atlanta, Georgia, 30303, United States

  • GSK Investigational Site

    Atlanta, Georgia, 30309, United States

  • GSK Investigational Site

    Atlanta, Georgia, 30312, United States

  • GSK Investigational Site

    Bridgeport, Kansas, 06605, United States

  • GSK Investigational Site

    Detroit, Michigan, 48201, United States

  • GSK Investigational Site

    Las Vegas, Nevada, 89104, United States

  • GSK Investigational Site

    Brooklyn, New York, 10001, United States

  • GSK Investigational Site

    New York, New York, 10029, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19114, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19147, United States

  • GSK Investigational Site

    Memphis, Tennessee, 38104, United States

  • GSK Investigational Site

    Dallas, Texas, 75201, United States

  • GSK Investigational Site

    Houston, Texas, 77006, United States

  • GSK Investigational Site

    Houston, Texas, 77021, United States

  • GSK Investigational Site

    Norfolk, Virginia, 23510, United States

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