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Completed

NCT Number: NCT02223130

Addressing Discrimination and Mistrust Among Black Men: Phase III

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fenway Health

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Coping

    Time frame: 3 months post-baseline

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

Secondary outcomes

  1. Mistrust

    Time frame: 3 months post-baseline

    Reduced mistrust scores on Medical Mistrust scale

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Fenway Community Health
  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 22, 2014
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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