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

Mass General Brigham

Status: Completed

Conditions: Homosexuality, Male; Substance Use Disorders; HIV/AIDS

Treatments: Behavioral: Project Matter

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03899220

2019p001118

K23DA043418 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Eligible study participants will be screened and enrolled at Fenway Health (Boston, MA). Participants will be randomized to an enhanced treatment as usual (E-TAU) arm or the intervention arm. All participants (in both the E-TAU and intervention groups) will receive a one-session behavioral engagement in care intervention, substance use treatment referral information, and the opportunity to discuss and problem solve barriers to substance use treatment with an interventionist, informed by motivational interviewing principles. After randomization, participants in the intervention group will attend 5 therapy sessions focused on behavioral strategies for improving HIV self-care, meta-cognitive awareness of emotions and thoughts, and cognitive restructuring. All participants will receive texts queries about antiretroviral therapy (ART) adherence and substance use, and participants in the intervention group will also receive text queries about mood. All participants will be compensated for every research visit and completed text message blocks.

Enrollment: 50 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV positive
• Cisgender male
• Man who has sex with men (MSM)
• Elevated levels of internalized stigma related to HIV, substance use, or homophobia
• Poorly engaged in HIV care
• Able to provide informed consent
• 18 years or older
• English speaking

Exclusion criteria

• Women
• Non-cisgender men
• Do not identify as gay, bisexual, or MSM

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Project Matter

Enhanced Treatment as Usual (E-TAU)

Active Comparator group

Description:

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

Treatment:

Behavioral: Project Matter