Clinical trial NCT02223130: Addressing Discrimination and Mistrust Among Black Men: Phase III
Official title: Addressing Discrimination and Mistrust Among Black Men: Phase III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Discrimination
Coping
Medical Mistrust
HIV Outcomes
Cognitive Behavioral Therapy
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Fenway Community Health
name: National Institute of Mental Health (NIMH)
First posted: 2014-08-22
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Coping
timeFrame: 3 months post-baseline
Secondary outcomes:
measure: Mistrust
timeFrame: 3 months post-baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Fenway Health
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Laura M Bogart, PhD
role: PRINCIPAL_INVESTIGATOR
References: