NCT05934305 Mitigating the Impact of Stigma and Shame Among People Living With HIV and Substance Use Disorders
| NCT ID | NCT05934305 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston University |
| Condition | Hiv |
| Study Type | INTERVENTIONAL |
| Enrollment | 256 participants |
| Start Date | 2025-03-12 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 256 participants in total. It began in 2025-03-12 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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-
Contact & Investigator
Abigail Batchelder, PhD, MPH
PRINCIPAL INVESTIGATOR
CABU School of Medicine, Psychiatry
Frequently Asked Questions
Who can join the NCT05934305 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hiv. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05934305 currently recruiting?
Yes, NCT05934305 is actively recruiting participants. Contact the research team at abatchel@bu.edu for enrollment information.
Where is the NCT05934305 trial being conducted?
This trial is being conducted at Miami, United States, Boston, United States.
Who is sponsoring the NCT05934305 clinical trial?
NCT05934305 is sponsored by Boston University. The principal investigator is Abigail Batchelder, PhD, MPH at CABU School of Medicine, Psychiatry. The trial plans to enroll 256 participants.
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