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New program aims to lower HIV risk for transgender women facing abuse

NCT ID NCT06001307

Knowledge-focused Sponsor: Brown University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new gender-affirming program called STARS for transgender women who have experienced intimate partner violence. The goal was to see if it could help reduce HIV risk and improve safety. Thirty-seven participants were randomly assigned to either the STARS program or a relaxation training group, and followed for 6 months. This is a small pilot study to gather initial data for a future larger trial.

What this could mean

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

Active substance
Program STARS (behavioral intervention)
What this could lead to
If successful, this could lead to a larger trial testing whether a gender-affirming program can reduce HIV risk and intimate partner violence among transgender women.
What could go wrong
This is a very small pilot study with only 37 participants, so results may not apply broadly. The intervention is behavioral and may not show clear benefits.

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

37 people

The number who actually took part.

Started

Jun 2023

Finished

May 2024

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: * 18+ years old; * Assigned male at birth but identify as female, transgender, or transfeminine; * Endorse at least one IPV incident during the previous 12 months based on the trans-specific IPV Scale (T-IPV Scale; Peitzmeier et al, in press); * Report at least one instance of condomless anal sex in the last 6 months. Exclusion Criteria: * Have been diagnosed with HIV or test positive for HIV.

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Conditions

The condition(s) this trial relates to.

Risk Reduction Behavior HIV infectious disease prevention target

As listed by the trial registrant

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

HIV Risk reduction behavior Violence, domestic Violence, gender-based

Contacts and locations

Locations

  • Brown University

    Providence, Rhode Island, 02912, United States

More trials for these conditions

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