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HIV prevention shot studied in real-world women

NCT ID NCT06145854

Prevention Sponsor: Midway Specialty Care Center Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 100 cisgender women in the southern U.S. who are already prescribed long-acting cabotegravir injections (Apretude) for HIV prevention. Over two years, researchers will track how many women stick with the shots, how satisfied they are, and rates of other sexually transmitted infections. The goal is to see how this newer option works outside of clinical trials.

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 (Apretude)
What this could lead to
If successful, this study could show that long-acting injections are a practical and effective HIV prevention option for cisgender women in real-world settings.
What could go wrong
This is an observational study with no control group, so it cannot prove cause and effect. Results may not apply to other populations or regions.

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 100 people

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

Started

Jan 2024

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

100 cisgender females (including 15 cisgender females with history of substance use and 15 cisgender females with unstable housing)

Ages

18 years and older

Sex

Female participants only

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: 1. Cisgender females, ages 18 years and older 2. Negative HIV test at baseline 3. Negative Pregnancy test at baseline 4. Weigh at least 35 kilograms 5. Already Prescribed CAB-LA (Apretude) Exclusion Criteria: 1. Transgender females or males 2. Cisgender males 3. Cisgender female who is actively breastfeeding 4. Severe hepatotoxicity 5. Evidence of Hepatitis B Infection 6. History or presence of allergies to cabotegravir or its components

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease prevention target

As listed by the trial registrant

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

HIV

Contacts and locations

Locations

  • Midway Specialty Care Center

    Orlando, Florida, 32819, United States

  • Midway Specialty Care Center

    Temple Terrace, Florida, 33617, United States

  • Midway Specialty Care Center

    West Palm Beach, Florida, 33401, United States

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