Project Matter: Intervention to Improve HIV Self-care Among Men Who Have Sex With Men (MSM) With Substance Use Disorders
- Conditions
- Substance Use DisordersHIV/AIDSHomosexuality, Male
- Interventions
- Behavioral: Project Matter
- Registration Number
- NCT03899220
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 50
- 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
- Women
- Non-cisgender men
- Do not identify as gay, bisexual, or MSM
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Project Matter 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. Enhanced Treatment as Usual (E-TAU) Project Matter Enhanced treatment as usual includes a one session behavioral engagement in care intervention as well as substance use treatment counseling.
- Primary Outcome Measures
Name Time Method Feasibility of Intervention change from baseline to 12 weeks after intervention completion Percent of sessions completed (≥70% considered indicative of feasibility) and percent of text messages responded to by participants (≥70% considered indicative of feasibility).
Acceptability of Intervention change from baseline to 12 weeks after intervention completion The summary score of the Client Satisfaction Questionnaire (CSQ-8) (Sum of 8 questions with response options ranging from 1-4).
- Secondary Outcome Measures
Name Time Method Engagement in HIV Care change from baseline to 12 weeks after intervention completion Summary Score of 6 indicators of HIV treatment engagement: no missed and not rescheduled HIV-related appointments in the past 3 months, no missed and not rescheduled HIV-related lab tests in the past 3 months, maintaining ART prescriptions over the past 3 months, maintaining \>=80% ART adherence in the past 30 days, no period of 4 days where ART was stopped in the past 3 months (without guidance from an HIV care provider), and undetectable viral load at the study visit.
Trial Locations
- Locations (1)
Fenway Community Health
🇺🇸Boston, Massachusetts, United States