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New approach aims to boost HIV prevention in LGBTQ+ individuals struggling with addiction

NCT ID NCT05934877

Prevention Sponsor: Friends Research Institute, Inc. 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 tested a program to help HIV-negative transgender women and men who have sex with men who also have a substance use disorder stick with PrEP, a daily pill or shot that prevents HIV. Participants received counseling and text support, with extra help for those who struggled. The goal was to see if this stepped-care approach improves PrEP use and is cost-effective.

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

152 people

The number who actually took part.

Started

May 2023

Finished

Mar 2025

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

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: * self-identified transgender woman or MSM * ≥18 years old * verified HIV negative * identified as high risk for HIV based on the Los Angeles County criteria * SUD (injection and non-injection; excluding cannabis (CUD) only For those who have already initiated PrEP there is an additional eligibility criterion: * non-protective prophylaxis defined as missed ≥4 doses of PrEP/week during any week in the previous 30 days * no PrEP care visits in the past 3 months * willing to provide informed consent; and * willing to comply with study requirements. Should a participant be identified as having kidney or liver dysfunction sufficient to contraindicate PrEP use (creatinine clearance \<60 mL/min), that individual will be withdrawn from study participation but may re-screen for eligibility once adequate renal and/or liver function has been established and medically documented (≥60 mL/min). Exclusion Criteria: * does not identify as a trans woman or male who has sex with men * under 18 years of age * HIV positive status * not identified as high risk for HIV based on the Los Angeles County criteria * no verified SUD or only CUD * if already initiated PrEP: PrEP adherent and PrEP care visits in the past 3 months * unwilling to provide informed consent * unwilling to comply with study requirements;

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Conditions

The condition(s) this trial relates to.

substance-related disorder HIV infectious disease prevention target

As listed by the trial registrant

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

HIV Substance use disorders

Contacts and locations

Locations

  • Friends Community Center

    Los Angeles, California, 90038, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.