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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Men who have sex with men (MSM), and gender minority individuals who have sex with men, 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 MSM and gender minority 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• HIV+

• MSM or gender minority individuals who report having sex with men

• 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

• Unsuppressed HIV VL (\>20 copies/mL).

• Provide informed consent in English

• Verbally communicate in English 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).

Locations
United States
Florida
Florida International University
NOT_YET_RECRUITING
Miami
Massachusetts
Fenway Health
RECRUITING
Boston
Contact Information
Primary
Abigail Batchelder, PhD, MPH
abatchelder@mgh.harvard.edu
6172670900
Backup
Christopher Chiu, MA
cchiu3@partners.org
Time Frame
Start Date: 2025-03-20
Estimated Completion Date: 2028-07
Participants
Target number of participants: 256
Treatments
Experimental: Matter Intervention
This 5-session text-enhanced intervention is designed to mitigate the negative behavioral consequences of internalized stigma and shame among MSM and gender minority 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).
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov