Addressing Internalized Stigma and Shame as Barriers to Engagement in HIV Care Among Men Who Have Sex With Men (MSM) With Substance Use Disorders (Project Matter)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Feasibility of Intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
- •Non-cisgender men
- •Do not identify as gay, bisexual, or MSM
Arms & Interventions
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.
Intervention: Project Matter (Behavioral)
Enhanced Treatment as Usual (E-TAU)
Enhanced treatment as usual includes a one session behavioral engagement in care intervention as well as substance use treatment counseling.
Intervention: Project Matter (Behavioral)
Outcomes
Primary Outcomes
Feasibility of Intervention
Time Frame: 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
Time Frame: 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 Outcomes
- Engagement in HIV Care(change from baseline to 12 weeks after intervention completion)
Investigators
Abigail Batchelder, Ph.D., M.P.H.
Assistant Professor and Staff Psychologist
Massachusetts General Hospital