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

NCT05934305 | Recruiting DMC

• 2 other identifiers: H-44770R01DA057298
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Viral Suppression at 12 month follow-up

  Compare the proportion of participants randomized to the intervention to the proportion of those randomized to the time-matched control condition who are virally suppressed at the 12 months follow up visit.

  12 month follow up

Secondary Outcomes (5)

• Viral Suppression at 6 month follow-up

  6 month follow up

• Viral Suppression at 6 and 12 months

  6 and 12 months

• Internalized HIV Stigma Scale at 6 and 12

  6 and 12 months

• Substance Use Severity based on clinical diagnostic interview

  12 months

• Visual Analogue Scale for Antiretroviral Adherence

  12 months

Study Arms (2)

Matter Intervention

EXPERIMENTAL

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.

Behavioral: Matter Intervention

Control Condition

ACTIVE COMPARATOR

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).

Behavioral: Control Condition

Interventions

Matter Intervention BEHAVIORAL

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.

Matter Intervention

Control Condition BEHAVIORAL

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).

Control Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \- HIV-

Sponsors & Collaborators

• Florida International University: collaborator
• Boston University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Florida International University

Miami, Florida, 33199, United States

RECRUITING

Fenway Health

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Substance-Related Disorders

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Abigail Batchelder, PhD, MPH

  CABU School of Medicine, Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail Batchelder, PhD, MPH

CONTACT

6173587640; abatchel@bu.edu

Alexandria Miller, PhD

CONTACT

anmille1@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 6, 2023
• Study Start: March 12, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)