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New study aims to tackle social barriers for those on HIV prevention shots

NCT ID NCT07116629

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a program to help people on long-acting injectable HIV prevention (LAI-PrEP) with social needs like food, housing, and transportation. Researchers will screen participants every 4 months and connect them with community organizations for support. The goal is to see if this approach improves screening and referral completion.

What this could mean

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

What this could lead to
If successful, this could show that connecting patients with community resources improves their overall health and ability to stay on HIV prevention medication.
What could go wrong
This is an early-stage study focused on feasibility, not on proving health outcomes. The results may not apply to all populations or settings.

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 343 people

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

Started

Oct 2025

Expected to finish

May 2028

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

There are multiple participant groups: * Patients on or initiating LAI-PrEP as part of standard of care * Medical Staff who work with patients on LAI-PrEP * CBO Partner who work with patients on LAI-PrEP * Patients who decline LAI-PrEP as part of standard of care

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: For Patient participant group: In order to be eligible for participation in this study, an individual must meet all of the following criteria: * 18 years of age or older * Does not have HIV AND vulnerable for HIV infection per WHO, NHS, and CDC recommendations * On or initiating LAI-PrEP as part of standard of care prior to study participation * Identify as either a Black/Latine cisgender woman OR Black/Latine MSM OR Transgender or Nonbinary Individual * Capacity and willingness to provide consent For Medical Staff participant group: In order to be eligible for participation in this study, an individual must meet all of the following criteria: * 18 years of age or older * Works with patients who go to the Bellevue Pride Center * Be employed at NYU Langone Health or NYC H+H/Bellevue as one of the following occupations * Physician * Clinical Pharmacist * Nurse * Medical Phlebotomist * Social Worker/Navigator * Community Health Worker * Medical Leader (i.e., director of services) For CBO Partner participant group: In order to be eligible for participation in this study, an individual must meet all of the following criteria: * 18 years of age or older * Works with patients who go to the Bellevue Pride Center * Be employed at one of the established CBOs * Capacity and willingness to provide consent For Patient Who Declines LAI-PrEP participant group: In order to be eligible for participation in this study, an individual must meet all of the following criteria: * 18 years of age or older * Declines LAI-PrEP as part of standard of care * Capacity and willingness to provide consent Exclusion Criteria: For Patient participant group: An individual who meets any of the following criteria will be excluded from participation in this study: * Less than 18 years old * Known HIV seropositive status or test positive at screening * Does not identify as one of the listed priority populations * Not fluent in either English or Spanish * Not interested in HIV PrEP * Not willing to consent for study participation * Does not reside within New York State * Pregnant or planning to become pregnant at the time of consent. * Without capacity to consent to participate in the study For Medical Staff participant group: An individual who meets any of the following criteria will be excluded from participation in this study: * Do not work with patients who go to the Bellevue Pride Center * Is not employed at NYU Langone Health or NYC/H+H Bellevue as one of the following occupations * Physician * Clinical Pharmacist * Nurse * Medical Phlebotomist * Social Worker * Community Health Worker * Medical Leader (i.e., directors of services) For CBO Partner participant group: An individual who meets any of the following criteria will be excluded from participation in this study: • Does not work with patients who go to the Bellevue Pride Center For Patient Who Declines LAI-PrEP participant group: An individual who meets any of the following criteria will be excluded from participation in this study: * Less than 18 years old * Interested in initiating LAI-PrEP as part of standard of care or on LAI-PrEP

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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.

How to take part

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

  1. The places running it

    2 sites. 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

  • NYC Health + Hospitals/Bellevue

    RECRUITING

    New York, New York, 10016, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

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