- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00130273
Managed Problem Solving to Increase Treatment Adherence in Individuals With HIV (MAPS)
Managed Problem Solving: An HIV Adherence Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
HAART is considered to be the most effective treatment for HIV. However, sustained and consistent adherence to HAART is necessary for long-term success. Issues such as memory problems, lack of social support, medication side effects, depression, and substance abuse can significantly reduce patient adherence to HAART. This study will evaluate the effectiveness of a managed problem solving strategy to increase HAART adherence in patients with HIV. Both treatment-naive and treatment-experienced participants will be recruited for this study.
The treatment part of this study will last 12 months. Participants will be randomly assigned to receive the managed problem solving intervention or standard of care for 12 months. Participants in the managed problem solving group will have 4 study visits and will receive 3 phone calls for the first 3 months of the study, and 1 phone call every month for the following 9 months. At each study visit, participants will identify barriers to adherence. During the phone calls, participants will be asked about any steps they have taken to improve their adherence. A medication event monitoring system (MEMS) will be used to assess participants' treatment adherence. MEMS uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings. Participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes. Blood collection at the beginning and end of the study will be used to measure viral load and CD4 count. Follow-up phone interviews will be conducted every year for 3 years after the end of treatment.
Study hypothesis: Managed problem solving will result in better adherence to highly active antiretroviral therapy (HAART) and better virologic control and immunological outcomes at the end of 1 year compared with a control group receiving standard or care.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania School of Medicine
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria for All Participants:
- HIV infected
- Infection likely to be susceptible to a specific treatment regimen
- Have access to a telephone
- Willing and able to comply with all study requirements
Exclusion Criteria for All Participants:
- Live in a care facility that provides medications on schedule
Inclusion Criteria for Treatment-Experienced Participants:
- Restarting HAART after a treatment interruption of at least 3 months OR after virologic failure with a viral load greater than 1,000 copies/ml
- On a treatment regimen for less than 2 weeks prior to study entry
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 1
Participants will receive managed problem solving for 12 months
|
Participants in the managed problem solving group will have four study visits and will receive three phone calls for the first 3 months of the study, and one phone call every month for the following 9 months.
At each study visit, participants will identify barriers to adherence.
During the phone calls, participants will be asked about any steps they have taken to improve their adherence.
A medication event monitoring system (MEMS) will be used to assess participants' treatment adherence.
MEMS uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings.
Participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes.
Blood collection at the beginning and end of the study will be used to measure viral load and CD4 count.
|
|
Comparador activo: 2
Participants will receive standard of care for 12 months
|
Participants will receive standard of care for 12 months.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Improved adherence
Periodo de tiempo: Measured at Year 4
|
Measured at Year 4
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Decrease in viral load
Periodo de tiempo: Measured at Year 4
|
Measured at Year 4
|
|
Increase in CD4 count
Periodo de tiempo: Measured at Year 4
|
Measured at Year 4
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Robert Gross, MD, MSCE, University of Pennsylvania
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Infecciones por VIH
Otros números de identificación del estudio
- R01MH067498 (Subvención/contrato del NIH de EE. UU.)
- DAHBR 9A-ASPG (National Institute of Mental Health (NIMH-DAHBR))
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. .