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A new strategy aims to close the HIV prevention gap for black gay men

NCT ID NCT06785376

Prevention Sponsor: Columbia University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This study tests a combination of programs to help Black gay, bisexual, and same-gender-loving men in the New York City area get tested for HIV and start taking PrEP, a daily pill that prevents HIV. Participants receive one or more of the following: a 3-session empowerment workshop, a single-session HIV self-testing training, and standard peer navigation to PrEP. A social media and print campaign also runs during the study. Researchers follow 480 men for 18 months to see if these tools increase HIV testing and PrEP use.

What this could mean

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

Active substance
A combination of a 3-session empowerment program (DIY), a single-session HIV self-testing training (TRUST), and standard-of-care peer navigation to PrEP, plus a social media and print campaign.
What this could lead to
If effective, this approach could increase HIV testing and PrEP use among Black gay and bisexual men, reducing new HIV infections in a heavily affected community.
What could go wrong
The trial is early-stage and relies on self-reported behavior, which may not reflect real-world impact. The social media campaign's effect is hard to isolate, and results may not generalize beyond NYC.

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 480 people

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

Started

Dec 2024

Expected to finish

Feb 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

18 to 65 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: * Assigned biological male sex at birth * 18-65 years of age * Self-identify as: Black, African-American, Afro-Caribbean, Black African, Afro-Latino or multiethnic Black * Reside in the NYC metro area * Not HIV-positive (tested before randomization) * Report insertive or receptive anal intercourse with another man in the past six months * Not currently on PEP or PrEP * Can communicate in English or Spanish * Provide informed consent for the study * Any sexual identity Exclusion Criteria: * Unable to conduct a rapid HIV-self test to confirm self-reported HIV-negative status

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Conditions

The condition(s) this trial relates to.

Homosexuality HIV infectious disease prevention target

As listed by the trial registrant

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

HIV testing Prep uptake

How to take part

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  1. The places running it

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  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

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Contacts and locations

Locations

  • Columbia University

    RECRUITING

    New York, New York, 10027, United States

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