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Behavioral Intervention

Project Matter for Substance Use Disorder

N/A

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

18 years or older

Cisgender male

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 12 weeks after intervention completion

Awards & highlights

Study Summary

This trial will test a new intervention to improve HIV care engagement among substance-using MSM.

Who is the study for?

This trial is for HIV-positive, cisgender men who have sex with men (MSM), are at least 18 years old, speak English, and feel internal stigma about their HIV status, substance use, or sexual orientation. Participants should be poorly engaged in their HIV care. Women, non-cisgender men, and those not identifying as gay or bisexual cannot join.Check my eligibility

What is being tested?

The study is testing 'Project Matter,' an emotion regulation intervention aimed to improve engagement in HIV-care among MSM with substance use disorders. It's a small-scale randomized controlled trial to see if the approach is workable and acceptable.See study design

What are the potential side effects?

Since this trial focuses on behavioral intervention rather than medication, traditional physical side effects are not applicable. However, participants may experience emotional discomfort when discussing sensitive topics related to their condition.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am a cisgender male.

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I am a man who has sex with men.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 12 weeks after intervention completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 12 weeks after intervention completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 12 weeks after intervention completion for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Acceptability of Intervention

Feasibility of Intervention

Secondary outcome measures

Engagement in HIV Care

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

This intervention includes 5 face-to-face therapy sessions with a trained clinician plus a bidirectional text component that queries mood, substance use, and medication adherence.

Group II: Enhanced Treatment as Usual (E-TAU)Active Control1 Intervention

Enhanced treatment as usual includes a one session behavioral engagement in care intervention as well as substance use treatment counseling.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,305 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,464 Previous Clinical Trials

2,618,543 Total Patients Enrolled

Frequently Asked Questions

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

Are new participants being recruited for this trial at this time?

"The online database clinicaltrials.gov states that this clinical trial is still looking for participants. The study was first advertised on April 24th, 2019 and updated most recently on December 22nd, 2021."

Answered by AI

How many individuals are currently enrolled in this experiment?

"Active recruitment is underway for this clinical trial, which was originally posted on April 24th, 2019. The most recent update to the posting occurred on December 22nd, 2021. Up to 60 patients can be enrolled at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Project Matter: Intervention to Improve HIV Self-care Among Men Who Have Sex With Men (MSM) With Substance Use Disorders

Abigail Batchelder, Ph.D., M.P.H. 2019. "Project Matter: Intervention to Improve HIV Self-care Among Men Who Have Sex With Men (MSM) With Substance Use Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03899220.