Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Helping MSM with HIV and substance use disorders overcome stigma and shame

Official title: Mitigating the Impact of Stigma and Shame as a Barrier to Viral Suppression Among People Living With HIV and Substance Use Disorders

Run by Boston University · NCT05934305 · Data updated 2026-11-12

This study is testing a new program to help men who have sex with men and gender minorities living with HIV and substance use issues feel better about themselves and manage their health by reducing stigma and shame.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment256 (estimated)
SponsorBoston University
Academic / other
Locations2 sites (Miami, Florida and 1 other locations)
StatusRecruiting
StartedMarch 12, 2025
Main results expectedJune 30, 2028
Study endsJune 30, 2028
Registry record updatedJune 23, 2026
Trial IDNCT05934305 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include HIV-positive MSM or gender minority individuals with substance use disorders who experience internalized stigma and have an unsuppressed viral load.

Probably not a fit

Patients who are cisgender women or cisgender heterosexual men will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This intervention focuses on men who have sex with men (MSM) and gender minority individuals living with HIV and substance use disorders (SUDs). It aims to improve viral suppression by addressing internalized stigma and shame through a 5-session text-enhanced psychobehavioral intervention called MATTER. The study will assess the efficacy and implementation of this intervention in two different locations, Boston and Miami, to understand the facilitators and barriers to engaging in HIV care. Participants will receive support in developing self-care goals and increasing their self-efficacy to manage their health better.

Why it matters

Potential benefit: If successful, this intervention could significantly improve health outcomes for MSM and gender minority individuals living with HIV and SUDs by enhancing their engagement in HIV care.

How similar studies have gone: Other studies have shown success in addressing stigma and shame in similar populations, indicating that this approach has potential for positive outcomes.

Who can join: the full rules

Show full inclusion / exclusion criteria
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-

Where it's running

  • Florida International University
    Miami, Florida, United States
    Recruiting
  • Fenway Health
    Boston, Massachusetts, United States
    Recruiting

Study contacts

  • Principal investigator: Abigail Batchelder, PhD, MPH — CABU School of Medicine, Psychiatry
  • Study coordinator: Abigail Batchelder, PhD, MPH
  • Email: abatchel@bu.edu
  • Phone: 6173587640

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.