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New therapy aims to lift depression in HIV-Positive teens

NCT ID NCT07211087

Symptom relief 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an enhanced version of depression treatment (COMBEX) for youth aged 15-24 with HIV. It combines therapy, medication management, and extra support strategies to improve mood and HIV care. Researchers will compare it to standard combination therapy over 72 weeks in 130 participants.

What this could mean

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

Active substance
behavioral therapy (cognitive behavioral therapy and medication management)
What this could lead to
If successful, this could provide a more effective, sustainable way to treat depression in youth with HIV, improving both mental health and HIV outcomes.
What could go wrong
This is an early-stage behavioral trial with 130 participants, so results may not apply broadly. The enhanced therapy may not significantly outperform the standard approach.

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 130 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

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

15 to 24 years

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: * aged 15- 24 years * engaged in care at a participating HIV care site * have documented HIV-1 confirmed by medical records * a diagnosis as determined by a site clinician of nonpsychotic depression requiring treatment \[either Major Depressive Disorder (MDD), Depression not otherwise specified, or Dysthymia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) * significant symptomatology at Entry (as defined by the PHQ-9) * aware of their HIV status as determined by site staff * English-speaking * able and willing to provide written informed assent/consent and written parental or guardian permission Exclusion Criteria: * by site review, have a history of any psychotic disorders and/or Bipolar I or II Disorder * have of a severe alcohol or substance dependence according to DSM-V or had moderate symptoms and are experiencing withdrawal or dependence symptoms within the month prior to enrollment * have depression and/or suicidal ideation requiring more intensive services * intend to relocate from the study site; 5) are in therapy with a non-study therapist (unless willing to switch to a study-trained therapist) * if they are in imminent danger to themselves or others. If wards of the state meet all eligibility requirements, they will be eligible if the state allows them to participate in research. Otherwise, they will be excluded.

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Conditions

The condition(s) this trial relates to.

AIDS depressive disorder dysthymic disorder HIV infectious disease major depressive disorder

As listed by the trial registrant

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

Depression disorders HIV (human immunodeficiency virus)

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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