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New study tackles stigma and shame to help people with HIV and addiction get healthy

NCT ID NCT05934305

Disease control Sponsor: Boston 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a 5-session virtual program called MATTER for 256 people living with HIV and substance use disorders in Boston and Miami. The program uses text messages and coaching to help people manage shame and stigma, set health goals, and stay connected to HIV care. The goal is to see if it helps more people achieve an undetectable viral load, which keeps them healthy and prevents spreading HIV.

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 256 people

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

Started

Mar 2025

Expected to finish

Jun 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 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: * HIV+ * Meet criteria for an illicit (not solely including tobacco, cannabis, or alcohol) SUD * Endorse internalized stigma related to HIV, substance use, sexual orientation, or gender-identity * Either the participant reports a detectable viral load during past year OR if on oral ART, they report \<80% adherence in the past month OR if on oral ART, they report missing \>=7 days of ART in any month in the past year OR for those on long acting injectable (LAI) ART, they report a period of \>=14 days in the past year between LAI ART injections OR has a detectable HIV viral load (\>20 copies/ mL) in the past year confirmed by medical records or viral load test from blood drawn obtained as part of the baseline visit * Provide informed consent in English * Verbally communicate and read in English or Spanish * Be ≥18 years old * Provide evidence or documentation of HIV+ status * Release HIV-related health records * Have access to a cell phone with text capacity (study will supplement phones and plans as needed consistent with our pilot work). Exclusion Criteria: \- HIV-

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease substance-related disorder

As listed by the trial registrant

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

HIV Substance use disorders

How to take part

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

  1. The places running it

    2 sites. 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

  • Fenway Health

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Florida International University

    RECRUITING

    Miami, Florida, 33199, United States

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