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

NCT03899220 | Completed DMC

• 2 other identifiers: 2019p001118K23DA043418
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance Use Disorders; Homosexuality, Male; HIV/AIDS

Outcome Measures

Primary Outcomes (2)

• Acceptability of Intervention

  The summary score of the Client Satisfaction Questionnaire (CSQ-8) (Sum of 8 questions with response options ranging from 1-4).

  change from baseline to 12 weeks after intervention completion

• Feasibility of Intervention

  Percent of sessions completed (≥70% considered indicative of feasibility) and percent of text messages responded to by participants (≥70% considered indicative of feasibility).

  change from baseline to 12 weeks after intervention completion

Secondary Outcomes (1)

• Engagement in HIV Care

  change from baseline to 12 weeks after intervention completion

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Project Matter

Enhanced Treatment as Usual (E-TAU)

ACTIVE COMPARATOR

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

Behavioral: Project Matter

Interventions

Project Matter BEHAVIORAL

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. Both the intervention group and the enhanced treatment as usual (E-TAU) involve a one-session behavioral engagement in care intervention as well as substance use treatment counseling.

Enhanced Treatment as Usual (E-TAU); Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender men who have sex with men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older
• English speaking

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Fenway Community Health

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Acquired Immunodeficiency Syndrome; Homosexuality, Male

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Homosexuality; Sexuality; Sexual Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Staff Psychologist

Model Details: Pilot Randomized Controlled Trial

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 2, 2019
• Study Start: April 24, 2019
• Primary Completion: May 30, 2023
• Study Completion: December 1, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)