Addressing Discrimination and Mistrust Among Black Men: Phase III

HIV Clinical Trial

Official title:

Addressing Discrimination and Mistrust Among Black Men: Phase III

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223130
• Other study ID #: IRB-P00002878
• Secondary ID: R34MH096544-03
• Status: Completed
• Phase: N/A
• First received: August 12, 2014
• Last updated: January 26, 2016
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Cognitive 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.

Locations

Country	Name	City	State
United States	Fenway Health	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Boston	Fenway Community Health, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coping	Improved coping scores on Brief Cope, Emotional and Behavioral Coping, and Africultural Coping scales	3 months post-baseline	No
Secondary	Mistrust	Reduced mistrust scores on Medical Mistrust scale	3 months post-baseline	No