Addressing Discrimination and Mistrust Among Black Men: Phase III
26 de enero de 2016 actualizado por: Laura Bogart, Boston Children's Hospital
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
64
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Fenway Health
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Masculino
Descripción
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).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
|
Sin intervención: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Coping
Periodo de tiempo: 3 months post-baseline
|
Improved coping scores on Brief Cope, Emotional and Behavioral Coping, and Africultural Coping scales
|
3 months post-baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mistrust
Periodo de tiempo: 3 months post-baseline
|
Reduced mistrust scores on Medical Mistrust scale
|
3 months post-baseline
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Laura M Bogart, PhD, Boston Children's Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2014
Finalización primaria (Actual)
1 de octubre de 2015
Finalización del estudio (Actual)
1 de diciembre de 2015
Fechas de registro del estudio
Enviado por primera vez
12 de agosto de 2014
Primero enviado que cumplió con los criterios de control de calidad
20 de agosto de 2014
Publicado por primera vez (Estimar)
22 de agosto de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
28 de enero de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
26 de enero de 2016
Última verificación
1 de enero de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- IRB-P00002878
- R34MH096544-03 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .