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

Study acronym: MATTER
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Primary and study completion dates: Jun 2028 to Jun 30, 2028v10
  2. Notable Primary completion pushed from Jul 2027 to Jun 2028
    • Study completion moved earlier from Jul 2028 to Jun 2028
    v9
  3. Minor Eligibility criteria expanded, about 89 wordsv8
  4. Minor Start date: Mar 20, 2025 to Mar 12, 2025v7
  5. Notable Lead sponsor: Massachusetts General Hospital to Boston Universityv6 Show 5 more changesShow less
    • Eligibility criteria shortened, about 11 words
    • Study description shortened, about 38 words
    • Site details revised at 2 of 2 sites
    • Collaborators: 1 to 2
    • Study title revised
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2024 to Mar 20, 2025
    • Site details revised at 2 of 2 sites
    v5
  2. Notable Phase: Phase 2 to Not applicable
    • Start date: Dec 18, 2023 to Dec 2024
    v4
  3. Minor Study sites: 1 to 2v3
  4. Notable Start date: Aug 2023 to Dec 18, 2023
    • Collaborators expanded, about 6 words
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05934305
Lead Sponsor Boston University
Collaborators: National Institute on Drug Abuse (NIDA), Florida International University
Conditions
(from sponsor)
Hiv, Substance Use Disorders
Related terms Acquired Immunodeficiency Syndrome, Substance-Related Disorders
Enrollment 256 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov