Addressing Discrimination and Mistrust Among Black Men: Phase III

NCT02223130 | Completed

• 2 other identifiers: IRB-P00002878R34MH096544-03
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; Discrimination; Coping; Medical Mistrust; HIV Outcomes; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• Coping

  Improved coping scores on Brief Cope, Emotional and Behavioral Coping, and Africultural Coping scales

  3 months post-baseline

Secondary Outcomes (1)

• Mistrust

  3 months post-baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Therapy techniques

Waitlist Control

NO INTERVENTION

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.

Interventions

Cognitive Behavioral Therapy techniques BEHAVIORAL

Participants attend 9 weekly group sessions. Each of the weekly sessions is led by a mental health professional and a peer facilitator who use Cognitive Behavioral Therapy techniques to work with participants in tracking their cognitions, emotions and behaviors in response to stressful/discrimination experiences.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Fenway Community Health: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Fenway Health

Boston, Massachusetts, 02215, United States

Location

Study Officials

• Laura M Bogart, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics, Harvard Medical School; Research Director, Division of General Pediatrics, Boston Children's Hospital

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 22, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

US (1)