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Clinical Trials/NCT03899220
NCT03899220
Completed
Not Applicable

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)

Massachusetts General Hospital1 site in 1 country50 target enrollmentApril 24, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance Use Disorders
Sponsor
Massachusetts General Hospital
Enrollment
50
Locations
1
Primary Endpoint
Feasibility of Intervention
Status
Completed
Last Updated
4 months ago

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.

Registry
clinicaltrials.gov
Start Date
April 24, 2019
End Date
December 1, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Abigail Batchelder, Ph.D., M.P.H.

Assistant Professor and Staff Psychologist

Massachusetts General Hospital

Eligibility Criteria

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

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)

Study Sites (1)

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