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Behavioural Intervention

Text-Based Intervention for HIV and Substance Use Disorders (MATTER Trial)

Phase 2

Waitlist Available

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Provide informed consent in English

MSM or gender minority individuals who report having sex with men

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months

Awards & highlights

MATTER Trial Summary

This trial will test if a 5-session text-based intervention can help reduce HIV transmission & negative health outcomes by addressing stigma & shame among MSM & gender minority individuals w/ HIV & substance use issues.

Who is the study for?

This trial is for men and gender minority individuals who have sex with men, are HIV positive with unsuppressed viral loads, and suffer from substance use disorders excluding tobacco, cannabis, or alcohol. Participants must experience internalized stigma related to their HIV status, substance use, sexual orientation or gender identity. They need to be adults able to consent in English and communicate in either English or Spanish. Access to a text-capable cell phone is required.Check my eligibility

What is being tested?

The MATTER intervention is being tested against a control condition. It's a virtual program of five sessions designed to help participants manage internalized stigma and shame associated with HIV and substance use by setting self-care goals, increasing awareness of thoughts and feelings without judgment (metacognition), fostering self-compassion, plus offering phone-based resource navigation.See study design

What are the potential side effects?

Since the MATTER intervention involves psychological support through virtual sessions rather than medication or medical procedures, traditional physical side effects are not expected. However emotional discomfort may arise when addressing sensitive topics like stigma and shame.

MATTER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can read and understand English to give informed consent.

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I am a man who has sex with men or identify as a gender minority.

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I am 18 years old or older.

MATTER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Viral Suppression at 12 month follow-up

Secondary outcome measures

Internalized HIV Stigma Scale at 6 and 12

Substance Use Severity based on clinical diagnostic interview

Viral Suppression at 6 and 12 months

+2 more

MATTER Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Matter InterventionExperimental Treatment1 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.

Group II: Control ConditionActive Control1 Intervention

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).

0 / 3Eligibility criteria met

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Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH

2,464 Previous Clinical Trials

2,618,337 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,099 Total Patients Enrolled

Media Library

Control Condition (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05934305 — Phase 2

Substance Use Disorder Research Study Groups: Control Condition, Matter Intervention

Substance Use Disorder Clinical Trial 2023: Control Condition Highlights & Side Effects. Trial Name: NCT05934305 — Phase 2

Control Condition (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05934305 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any associated risks with Matter Intervention?

"Matter Intervention scored a 2 on our safety scale, as there is some data confirming its safety but no evidence of efficacy yet."

Answered by AI

Are participants being accepted for this research endeavor?

"According to clinicaltrials.gov, this trial is not actively recruiting participants at the moment; originally posted on August 1st 2023 and last updated June 28th of the same year. Despite this particular medical study being inactive for recruitment, 462 other opportunities are available currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Abigail Batchelder, Ph.D., M.P.H. 2023. "Mitigating the Impact of Stigma and Shame Among MSM Living With HIV and Substance Use Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05934305.