Fighting stigma to stop HIV: a new counseling approach put to the test

NCT ID NCT04832477

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This study tests whether a single counseling session aimed at reducing stigma can help Black men who have sex with men and use substances stay on PrEP, a daily pill that prevents HIV. Participants receive the counseling and are monitored for PrEP adherence through biological tests. The goal is to see if addressing emotional barriers can improve HIV prevention in this high-risk group.

What this could mean

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

Active substance
Stigma counseling for PrEP use
What this could lead to
If effective, this counseling approach could improve PrEP adherence and reduce HIV rates among Black sexual minority men who use substances.
What could go wrong
The trial is early-stage and relies on self-reported and biological measures; results may not generalize to other 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.

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

500 people

The number who actually took part.

Started

Sep 2021

Finished

Feb 2026

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: * Men (based on male sex assignment at birth) * Age 18 or older * Identify as Black, African-American, Afro-Brazilian, Afro-Carribean, or African diaspora, * Report condomless anal sex with man in past six months * Test HIV negative * Report recent (\<3 months) substance use * Positive drug toxicology for substance use Exclusion Criteria: \-

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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.

Contacts and locations

Locations

  • SHARE Project

    Atlanta, Georgia, 30303, United States

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