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: 5

Duration: 12 weeks

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

English speaking

Able to provide informed consent

Exclusion Criteria

Do not identify as gay, bisexual, or MSM

I do not identify as a cisgender man.

I am a woman.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the intervention group with 5 therapy sessions and text queries or the E-TAU group with a single session and counseling

12 weeks

5 therapy sessions (in-person) for intervention group

Follow-up

Participants are monitored for engagement in HIV care and intervention acceptability

12 weeks

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+