New study aims to tackle social barriers for those on HIV prevention shots
NCT ID NCT07116629
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
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About 343 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 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: 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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NYC Health + Hospitals/Bellevue
RECRUITINGNew York, New York, 10016, United States
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
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