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New program aims to boost mental health and cut substance use in HIV community

NCT ID NCT05700474

Symptom relief Sponsor: Duke 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a 6-month holistic behavioral health program called EASE for 200 adults with HIV or seeking HIV prevention who also use alcohol or drugs. Participants receive counseling, case management, peer support, and education. Researchers will measure changes in depression, anxiety, substance use, and HIV stigma at the start and after 6 months.

What this could mean

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

Active substance
comprehensive outpatient behavioral health care (counseling, case management, peer support, education)
What this could lead to
If it works, this could point toward an effective support program that improves mental health and reduces substance use in people affected by HIV.
What could go wrong
This is a small, early-stage study with no control group, so results may not be conclusive. Benefits may vary by individual.

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 200 people

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

Started

Feb 2023

Expected to finish

Jul 2027

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 years and older

Sex

Anyone

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: 1. HIV diagnosis or seeking HIV prevention services 2. Any alcohol or illicit substance use in the last 90 days 3. 18 or older 4. Residing in Mecklenburg County or surrounding areas. Exclusion Criteria: 1\) Inability to consent for services due to reduced mental or physical capacity

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Conditions

The condition(s) this trial relates to.

HIV infectious disease psychiatric disorder Psychological Well-Being substance abuse substance-related disorder

As listed by the trial registrant

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

HIV Mental health disorder Substance use

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Susan Reif

    RECRUITING

    Charlotte, North Carolina, 28207, United States

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