CClinicalTrials.gg
CompletedNCT02223130Updated Jan 28, 2016

Addressing Discrimination and Mistrust Among Black Men: Phase III

An interventional study of Cognitive Behavioral Therapy techniques in HIV, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-28.

Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV

Keywords

  • HIV
  • Discrimination
  • Coping
  • Medical Mistrust
  • HIV Outcomes
  • Cognitive Behavioral Therapy
03

In context

Lead sponsor

Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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).
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Intervention Group

    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

  • No intervention
    Waitlist Control

    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

  • BehavioralCognitive Behavioral Therapy techniques

    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.

06

What researchers measure

Primary outcomes

  1. Coping

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

    Time frame: 3 months post-baseline

Secondary outcomes

  1. Mistrust

    Reduced mistrust scores on Medical Mistrust scale

    Time frame: 3 months post-baseline

07

Study locations

1 site
  • Fenway Health
    Boston, Massachusetts 02215, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02223130
Lead sponsor
Boston Children's Hospital
Collaborators
Fenway Community Health, National Institute of Mental Health (NIMH)
Responsible party
Laura Bogart (Associate Professor of Pediatrics, Harvard Medical School; Research Director, Division of General Pediatrics, Boston Children's Hospital, Boston Children's Hospital) — Principal investigator
First posted
Aug 22, 2014
Start date
Jul 2014
Primary completion
Oct 2015
Completion
Dec 2015
Last update
Jan 28, 2016

Study contacts

Laura M Bogart, PhD
principal investigator · Boston Children's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion