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New study aims to help At-Risk youth prevent HIV and get substance use support

NCT ID NCT06585631

Disease control Sponsor: Children's Hospital of Philadelphia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a program called PrTNER that helps young people aged 15-29 who are at risk for HIV or already living with it, and who also have substance use issues. The program provides prevention, treatment, and support to help them start HIV prevention medication (PrEP) or lower their viral load. The goal is to see if this approach improves health outcomes and reduces substance use.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 275 people

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

Started

Jan 2025

Expected to finish

Jun 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.

Ages

15 to 29 years

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: Aim 1: * 15-24 years old; * Cisgender male; * History of condomless sex; * Moderate-to-high risk SU behaviors based upon a Car, Relax, Alone, Forget, Friends, Trouble (CRAFFT) score ≥2, * Living in Philadelphia, PA or Baltimore, MD, and surrounding areas; * Able to read and write in English Aim 2: * 15-29 years old; * Cisgender male; * Living with a diagnosis of HIV; * CRAFFT score ≥2, * Living in Philadelphia, PA or Baltimore, MD, and surrounding areas; * Able to read and write in English Aim 3 • All randomized study participants will be included in Aim 3. Exclusion Criteria: Aim 2: * Participants will be excluded if they are: * Assigned female sex at birth * Identify as transgender * Outside the age criteria (\<15 or \>29 years old) * Cognitively unable to complete study requirements * Living outside of the two geographic areas * Do not screen positive for SU * No prior substance use history * No prior condomless sex; * Unable to read or write in English, * Plan to move in the next 12 months.

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Conditions

The condition(s) this trial relates to.

AIDS Alcohol Drinking HIV infectious disease substance abuse substance-related disorder

As listed by the trial registrant

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

AIDS HIV Substance use Substance use disorders

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

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19146, United States

  • Johns Hopkins Center for Adolescent and Young Adult Health

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21205, United States

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