Helping MSM with HIV and substance use disorders overcome stigma and shame
Mitigating the Impact of Stigma and Shame as a Barrier to Viral Suppression Among People Living With HIV and Substance Use Disorders
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston University Academic / other |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT05934305 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are cisgender women or cisgender heterosexual men will not benefit from this study.
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 performed: Other studies have shown success in addressing stigma and shame in similar populations, indicating that this approach has potential for positive outcomes.
Eligibility criteria
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 this trial is running
Miami, Florida and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.