Project Matter for HIV and Substance Use Disorder

Overseen By Abigail W Batchelder, M.P.H., Ph.D.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Women, Non-cisgender men, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will implement a pilot randomized controlled trial (RCT, N=60) to assess the feasibility and acceptability a refined emotion regulation intervention designed to improve engagement in HIV-care among substance using HIV+ MSM sub-optimally engaged in HIV care.

Eligibility Criteria

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.

Inclusion Criteria

Elevated levels of internalized stigma related to HIV, substance use, or homophobia

I am 18 years old or older.

English speaking

Exclusion Criteria

Do not identify as gay, bisexual, or MSM

I do not identify as a cisgender man.

I am a woman.

Treatment Details

Interventions

• Project Matter

Trial Overview 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.

Participant Groups

Group I: Intervention Experimental Treatment 1 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 Control 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+