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New injectable HIV prevention program aims to protect latine communities

NCT ID NCT07218211

Prevention Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Updated 2 times

Summary

This study tests a long-acting injectable PrEP (lenacapavir) program designed specifically for Latine gay, bisexual men and transgender women. Researchers want to see if offering the shots at community organizations helps more people stay on HIV prevention compared to standard clinic care. The study involves 100 HIV-negative participants in the southern U.S. and focuses on identifying barriers and facilitators to PrEP use.

What this could mean

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

Active substance
lenacapavir (long-acting injectable PrEP)
What this could lead to
If successful, this program could make it easier for Latine gay, bisexual men and transgender women to stay on HIV prevention, reducing new infections in these communities.
What could go wrong
This is a small, early-phase study (100 participants) comparing to historical data, not a randomized trial. Results may not apply broadly, and long-term adherence remains uncertain.

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

About 100 people

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

Started

Jan 2026

Expected to finish

Jul 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.

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: * Participants must be assigned male sex at birth. * Report sexual activity with a someone assigned male at birth OR identify as GBM or TGW; be HIV-negative. * Identify as Hispanic and/or Latine . * Be able to provide informed consent in English or Spanish . * Be 18 years or older . * Weigh at least 77 lbs (35 kg) by self-reported weight. * Interested in PrEP and willing to undergo the study procedures. Exclusion Criteria: * Individuals living with HIV. * Individuals assigned female sex at birth will be excluded. * Individuals who are currently taking oral PrEP from another source and are not willing to switch to lenacapavir for PrEP for the duration of the study will also be excluded. * Individuals who report a history of severe renal or hepatic disease or with clinical stigmata of either disease on physical exam as assessed by a study clinician will be excluded. * Individuals taking a medication with a significant interaction with lenacapavir will be excluded from the study.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

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

HIV pre-exposure prophylaxis HIV pre-exposure prophylaxis use HIV prevention HIV prevention and care HIV prevention program

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • El Centro Hispano

    RECRUITING

    Durham, North Carolina, 27701, United States

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