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New counseling approach aims to boost HIV prevention in young black men who have sex with men

NCT ID NCT05087680

Prevention Sponsor: Rhode Island Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests a counseling program called ACTPrEP, designed to help young Black men who have sex with men (ages 18-34) start and continue taking PrEP, a daily pill that prevents HIV. The program uses acceptance and commitment therapy to address thoughts and feelings that might get in the way of using PrEP. Participants are randomly assigned to either the ACTPrEP program or a standard PrEP education session, and researchers measure how many people stay in the study and how satisfied they are with the program.

What this could mean

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

Active substance
Acceptance and Commitment Therapy (ACT)-based counseling program
What this could lead to
If successful, this counseling approach could help more young Black men who have sex with men consistently use PrEP, reducing HIV transmission in a high-risk group.
What could go wrong
This is a small, early-stage feasibility study, so results may not apply broadly. The intervention may not improve PrEP use more than standard education.

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

66 people

The number who actually took part.

Started

Sep 2023

Finished

Jun 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 to 34 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: * English speaking * Between 18-34 years old * Male sex assigned at birth * Identify as African American/Black * Not enrolled in another PrEP related study * Able to give consent * Not taken PrEP in past 3 months * Report having sex with a man in the past 3 months * PrEP-eligible according to CDC guidelines Exclusion Criteria: * Participating in another PrEP study * Unable to provide consent

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

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

HIV prevention

Contacts and locations

Locations

  • Univeristy of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

More trials for these conditions

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