Recruiting

Observational StudyMitigating the Impact of Stigma and Shame Among People Living With HIV and Substance Use Disorders

Sponsor:

Boston University

Code:

NCT05934305

Conditions

Hiv

Substance Use Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Matter Intervention

Control Condition

Study Details

Brief summary:

People living with HIV and substance use disorders (SUDs) are less likely to be virally suppressed, which can lead to HIV transmission and negative health outcomes. This hybrid type 1 study will assess the efficacy, mechanisms, as well as facilitators and barriers to implementing the MATTER intervention, a virtually delivered 5-session text-enhanced psychobehavioral intervention designed to facilitate viral suppression by addressing internalized stigma and shame as barriers to engagement in HIV care among individuals living with HIV and SUDs in two locations with different levels of HIV resources (i.e., the Boston, Massachusetts and Miami, Florida metro areas). MATTER aims to mitigate the negative behavioral consequences of internalized stigma and shame on viral suppression by a) developing behavioral self-care goal setting skills and related self-efficacy, b) increasing metacognitive awareness (i.e., non-judgmental awareness of emotions and cognitions), and c) teaching and reinforcing compassionate self-restructuring (i.e., self- compassion), in addition to providing access to phone-based resource navigation. Scalable interventions such as MATTER are essential to our efforts to end the HIV epidemic in high priority regions.

Conditions

Hiv

Substance Use Disorders

Study ID

NCT05934305

Start date

Mar 12, 2025

Status verified date

Jun, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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-

Study Design

Enrollment

256 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Matter Intervention

This 5-session text-enhanced intervention is designed to mitigate the negative behavioral consequences of internalized stigma and shame among individuals with SUDs that perpetuate sub-optimal engagement in HIV self-care and consequently inconsistent viral suppression. The intervention involves five virtually delivered one-on-one therapy sessions focused on behavioral goal setting skill development and related self-efficacy, increasing meta-cognitive awareness (i.e., non-judgmental awareness of emotions and cognitions), and teaching and reinforcing compassionate self-restructuring (i.e., self-compassion). Participants also receive daily text messages querying emotions during the one-on-one portion of the intervention. For eight weeks after the one-on-one portion, participants receive their compassionate self-statements via text in response to their indicated emotions. Participants will also receive phone-based resource navigation, as needed.

active comparator: Control Condition

The control condition will involve five sessions of prerecorded asynchronous content related to local resources (e.g., information related to substance use treatment and other ancillary services).

Interventions

Matter Intervention

Control Condition

The control condition will involve five sessions of prerecorded asynchronous content related to local resources (e.g., information related to substance use treatment and other ancillary services).

Primary outcome measure

Viral Suppression at 12 month follow-up [ Time Frame: 12 month follow up ]

Central Contacts and Locations

Central contacts

Abigail Batchelder, PhD, MPH

6173587640 abatchel@bu.edu

Alexandria Miller, PhD

anmille1@bu.edu

Locations

Florida International University

Recruiting

Miami, Florida, United States, 33199

Contacts

Adam Carrico, PhD

acarrico@fiu.edu

Fenway Health

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Abigail Batchelder, PhD, MPH

617-358-7640 abatchel@bu.edu

Kenneth Mayer, MD

mayer@fenwayhealth.org

More Information

Sponsor

Boston University

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Boston University on 2026-06-23.