HIVNCT02223130
Addressing Discrimination and Mistrust Among Black Men: Phase III
A study testing Cognitive Behavioral Therapy techniques in people with HIV, run by Boston Children's Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV
- What is being tested?
- Cognitive Behavioral Therapy techniques
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- HIV
- Being tested
- Cognitive Behavioral Therapy techniques
- Keywords
- HIV, Discrimination, Coping, Medical Mistrust, HIV Outcomes, Cognitive Behavioral Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy techniquesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coping
Improved coping scores on Brief Cope, Emotional and Behavioral Coping, and Africultural Coping scales
Measured: 3 months post-baseline
Secondary outcomes (1)
Mistrust
Reduced mistrust scores on Medical Mistrust scale
Measured: 3 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fenway Community Health, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Laura Bogart, Boston Children's Hospital
- Investigators
- Laura M Bogart, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223130
- Sponsor's protocol ID
- IRB-P00002878
- Other IDs
- R34MH096544-03
- Status last verified
- Jan 2016
- First submitted
- 12 Aug 2014
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Discrimination and Mistrust Among Black Men: Phase III
- ClinicalTrials.gov ID
- NCT02223130
- Acronym / sponsor ID
- IRB-P00002878
- Conditions
- HIV
- Keywords
- HIV, Discrimination, Coping, Medical Mistrust, HIV Outcomes, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Fenway Community Health, National Institute of Mental Health (NIMH)
- Study start
- Jul 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Cognitive Behavioral Therapy techniquesParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy techniquesParticipants 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. | Behavioural | Intervention Group |
Primary outcome
Coping
Time frame: 3 months post-baseline
Improved coping scores on Brief Cope, Emotional and Behavioral Coping, and Africultural Coping scales
1 secondary outcome
Mistrust
Time frame: 3 months post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura M Bogart, PhD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy techniques in people with HIV, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coping (time frame: 3 months post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.