Addressing Discrimination and Mistrust Among Black Men: Phase III
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boston Children's Hospital
- Enrollment
- 64
- Locations
- 2
- Primary Endpoint
- Coping
Study Overview
Brief Summary
The purpose of this research study is to test a group program aimed at improving the quality of life of HIV+ Black men who have sex with men. The group will address ways to cope with discrimination and will help men examine mistrust that they may have about healthcare, including doctors and other healthcare providers and HIV medications. The aim is to provide a supportive community for HIV+ Black men.
Detailed Description
The aim of the study is to examine whether the pilot intervention can reduce mistrust and improve coping responses to discrimination among HIV positive Black men who have sex with men (MSM). We will conduct a small randomized pilot trial to test the feasibility of evaluation methods. All participants will attend a baseline, a first follow-up visit, and a final follow-up visit (each 3 months apart) at which they will take computer assessments. Participants who are assigned to the intervention will attend 9 weekly intervention sessions after baseline and before the first follow-up. Using a wait-list control design, control group participants from the first two cohorts will be offered the intervention after they complete the final follow-up visit. Control group participants from the third cohort will be offered the intervention after they complete the first final-up visit and before they complete their final follow-up due to timing and budgetary restraints. We will hold three consecutive groups for our small randomized control trial. This means that we will be recruiting continuously; once we finish recruiting for the first group, we will start recruiting for the second group, and so on. Each group has about 12 or 13 intervention and 7-11 control participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years-old or older
- •Biologically male at birth
- •Currently self-identifies as male
- •Self-identifies as Black or African American (mixed-race individuals will be eligible if they primarily identify as Black or African American)
- •HIV-positive
- •Reported having sex with men in lifetime
- •Able and willing to provide informed consent
Exclusion Criteria
- •Does not meet all of the inclusion criteria (e.g., if they are unable to provide proof of their HIV-positive status)
- •Unable to provide informed consent
- •Reports or presents evidence of severe mental health problems that require immediate treatment (e.g., psychotic symptoms, active suicidality at time of enrollment) or diagnosed mental disorder that would limit the ability to participate (e.g., dementia)
- •Reports or presents evidence of cognitive impairments that limit the ability to comprehend the informed consent or to fully participate in the various parts of the study (assessments, intervention, homework).
Outcomes
Primary Outcomes
Coping
Time Frame: 3 months post-baseline
Improved coping scores on Brief Cope, Emotional and Behavioral Coping, and Africultural Coping scales
Secondary Outcomes
- Mistrust(3 months post-baseline)
Investigators
Laura Bogart
Associate Professor of Pediatrics, Harvard Medical School; Research Director, Division of General Pediatrics, Boston Children's Hospital
Boston Children's Hospital