The Georgia Latino AIDS/HIV Diagnosis and Linkage in Youth (GLADLY) Project (GLADLY)
19 de enero de 2021 actualizado por: Andres Camacho-Gonzalez, Emory University
This study aims to understand the barriers to receiving HIV testing and retention of care for at risk and HIV positive young adults.
This study also seeks to determine the feasibility and acceptability of HIV testing in a non-clinical setting.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study aims to identify factors that can facilitate or impede the use of non-clinical HIV testing venues as well as identify potential testing sites and assess acceptability of an HIV prevention intervention.
In addition, the study will implement a pilot intervention to test the feasibility non-clinical HIV testing and follow up events for HIV positive youth.
Tipo de estudio
Intervencionista
Inscripción (Actual)
2
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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Georgia
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Atlanta, Georgia, Estados Unidos, 30303
- Grady Health System
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Atlanta, Georgia, Estados Unidos, 30308
- Ponce De Leon Center
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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 a 24 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Sexually active
- HIV positive or negative
- Latino youth ages 18-24 years
- Residents of the state of Georgia and can understand spoken and written English or Spanish.
Exclusion Criteria:
- Unmet inclusion criteria
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: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Focus Group
Participants will complete a questionnaire and will be involved in a group discussion regarding good sites within the community to perform HIV testing.
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Otro: Venue Testing Group- Negative Test
Participants will perform a rapid HIV test and will be asked to answer questions about their sexual life and living situation.
No followup is needed for a negative HIV test.
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A small survey will be conducted to identify risk factors and assess demographics.
Participants will receive psychological support and counseling on reducing risk behavior for one year.
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Otro: Venue Testing Group- Positive Test
Participants will perform a rapid HIV test and will be asked to answer questions about their sexual life and living situation.
Participants with a positive HIV test will receive care from a psychologist and case manager for one year.
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A small survey will be conducted to identify risk factors and assess demographics.
Participants with a positive HIV test will receive standard HIV care, support, and guidance from a psychologist and case manager including an assessment of basic needs (food, clothing, shelter), and counseling on risk taking behaviors for one year.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Days to Linkage to Care
Periodo de tiempo: Post Diagnosis (Up to 3 months)
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For participants who test positive, linkage to care is measured as the number of days to seek HIV treatment.
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Post Diagnosis (Up to 3 months)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of medical care visits
Periodo de tiempo: Post Diagnosis (Up to one year)
|
For participants who test positive, engagement to care is measured as the number of medical care visits in a six month period after diagnosis.
One HIV medical care visit every six months is considered engaged.
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Post Diagnosis (Up to one year)
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Change in CD4 count
Periodo de tiempo: Baseline (Post Diagnosis), One year assessment (Up to one year)
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A CD4 count is a lab test that measures the number of CD4 T lymphocytes (CD4 cells) in a blood sample.
A very low CD4 count (less than 200 cells/mm3) is a way to determine whether an HIV infection has progressed.
Change is measured as the difference in CD4 count from baseline to the end of the study period.
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Baseline (Post Diagnosis), One year assessment (Up to one year)
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Change in viral load
Periodo de tiempo: Baseline (Post Diagnosis), One year assessment (Up to one year)
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A viral load test is a lab test that measures the number of HIV virus particles in a milliliter of blood.
A high viral load indicates the presence of more HIV within the body.
Change is measured as the difference in viral load from baseline to the end of the study period.
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Baseline (Post Diagnosis), One year assessment (Up to one year)
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Rate of venue acceptance
Periodo de tiempo: One year assessment (Up to one year)
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The rate of venue acceptance is measured as the number of venues that allow rapid HIV testing over he number of venues approached.
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One year assessment (Up to one year)
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Rate of study subject acceptance
Periodo de tiempo: One year assessment (Up to one year)
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The rate of study subject acceptance is measured as the number of participants who agree to participate in rapid HIV testing over the number of people approached.
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One year assessment (Up to one year)
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Change in HIV stigma scale score
Periodo de tiempo: Baseline (Post Diagnosis), One year assessment (Up to one year)
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The HIV stigma scale is a ten question self report measure that assesses perceived feelings of being stigmatized.
Answers are reported on a scale from 0 (not at all) to 4 (extremely).
A higher score indicates feelings of greater stigmatization.
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Baseline (Post Diagnosis), One year assessment (Up to one year)
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Change in HIV-AIDS stress scale score
Periodo de tiempo: Baseline (Post Diagnosis), One year assessment (Up to one year)
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The HIV-AIDS stress scale is a self report measure that assesses perceived emotional stress related to HIV.
Answers are reported on a scale from 0 (not at all) to 4 (extremely).
A higher score indicates more emotional stress.
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Baseline (Post Diagnosis), One year assessment (Up to one year)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Andres Camacho-Gonzalez, Emory University
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 agosto de 2015
Finalización primaria (Actual)
1 de agosto de 2017
Finalización del estudio (Actual)
1 de agosto de 2017
Fechas de registro del estudio
Enviado por primera vez
24 de septiembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
25 de septiembre de 2015
Publicado por primera vez (Estimar)
29 de septiembre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de enero de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
19 de enero de 2021
Última verificación
1 de enero de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- IRB00080817
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. .