Addressing Discrimination and Mistrust Among Black Men: Phase III

Boston Children's Hospital

Status: Completed

Conditions: HIV

Treatments: Behavioral: Cognitive Behavioral Therapy techniques

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02223130

R34MH096544-03 (U.S. NIH Grant/Contract)

IRB-P00002878

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

64 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Participants will attend the baseline, first follow-up, and final follow-up study visits, at which they take computer surveys. After their baseline interview and before their first follow-up interview, participants attend the Intervention Group, which consist of 9 weekly group sessions. Each of the weekly sessions is led by a mental health professional and a peer facilitator who uses Cognitive Behavioral Therapy techniques to work with participants in tracking their cognitions, emotions, and behaviors in response to stressful/discrimination experiences.

Treatment:

Behavioral: Cognitive Behavioral Therapy techniques

Waitlist Control

No Intervention group

Description:

Participants are not given the Intervention Group while they are enrolled in the study. Instead, they only attend the baseline, first follow-up, and final follow-up study visits, at which they take computer surveys. After they have completed the study, participants from the first two cohorts are offered the option of attending an intervention group that is identical in content to the intervention group being studied.The third cohort is offered the intervention group after they have completed the first follow-up but before they complete the final follow-up due to timing and budgetary restraints. No data is collected and no incentives are given during these intervention groups.