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Talking it out: new study tests counseling to boost HIV treatment success

NCT ID NCT05352061

Disease control Sponsor: University of Miami 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a counseling program for people living with HIV who also face mental health challenges or substance use. The program uses one-on-one sessions to help with medication adherence, stress, and other life issues. Researchers will see if participants complete the program and improve their HIV viral control. The goal is to find better ways to support overall health in this group.

What this could mean

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

Active substance
CBT (cognitive behavioral therapy) counseling
What this could lead to
If successful, this could point toward a practical counseling approach to help people with HIV stay on treatment and manage mental health challenges.
What could go wrong
This is a small, early feasibility study with only 75 participants, so results may not apply broadly. The intervention is behavioral, not a medical treatment, and may not work for everyone.

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 75 people

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

Started

Aug 2022

Expected to finish

May 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. Age: 18 years or older 2. HIV positive 3. Evidence of uncontrolled virus (e.g., \> 20 copies/ml) within the past 12 months as verified by medical record 4. Group 1: (Men who have sex with men (MSM) who have used stimulants within the past 4 months (approximately 10 participants))OR Group 2: transgender women (approximately 10 participants) OR Group 3: Emerging adults between the ages of 18 and 26 (inclusive; approximately 10 participants) Exclusion Criteria: 1. Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview 2. Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania) that would interfere with study participation 3. Opinion of the PI that the participant would be at risk for harm to self or others 4. Currently receiving CBT for a psychiatric disorder, or received a course of CBT in the past year.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease Medication Adherence Psychological Well-Being

As listed by the trial registrant

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

Medication adherence Mental health issue

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • University of Miami

    Miami, Florida, 33136, United States

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