- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01887210
A Pilot Gaming Adherence Program for Youth Living With HIV
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Despite need for consistent adherence to medical care, youth living with HIV (YLWH) have suboptimal rates of retention in care and adherence to antiretroviral medication (ARV) treatment. There are few adherence studies with YLWH and the results are mixed, so there is a great need for the development of novel interventions. Results of adult HIV adherence studies indicate that participants are interested in using technology-based methods and are most receptive toward interventions that couple technological devices with motivational components. Pill taking monitoring devices have been found to be a sensitive measure of adherence to ARV medications, but do not lead to sustained improvements in adherence or intrinsic motivation when used alone. Building on this knowledge, this study will examine a multi-level technology that integrates a medication monitoring device WITH an interactive smartphone based app/game that is attractive and engaging to YLWH. This multi-level approach will integrate theory driven content with novel, but intuitive, technology to improve HIV treatment adherence.
In this study, data on opening of the pill bottle will be transferred wirelessly from the bottle cap and a text on adherence sent to the phone. This developmental project will adapt and refine a smartphone app/game to include content consistent with the Information-Motivation-Behavioral Skills (IMB) Model. Creation and adaptation will occur from in-depth interviews with YLWH on ART (n=25) and an open trial of the Intervention (n=20). While gaming, participants will experience absorbing action-oriented adventures that increase information about their health (e.g. knowledge about HIV treatment), improve motivation (e.g. action-figures experience health benefits of adherence), and build skills (e.g. utilize clinicians as partners). A small randomized controlled pilot study (24 weeks) among 60 YLWH will examine the preliminary efficacy of the IMB Gaming Adherence Intervention (integration of the smart cap with the IMB informed app/game) compared to a comparison group who receive the smart cap and smartphone but no IMB game, on adherence and biological measures.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Rhode Island Hospital
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- English speaking
- in medical care for HIV and receiving antiretroviral treatment
- aware of their HIV status as per clinician and clinical record
- able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment
- detectable viral load
Exclusion Criteria:
- none
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: IMB Gaming Adherence Intervention
Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
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Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
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Comparador activo: Enhanced treatment as usual
Smart pill bottle cap and mobile phone but no game
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Smart pill bottle cap and mobile phone but no game
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Log10 HIV-1 Viral Load
Periodo de tiempo: 24 weeks
|
Log viral load at end of study for participants with available viral load data (Log10 copies/ml)
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24 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Electronically Measured Past 7-day Adherence
Periodo de tiempo: 24 weeks
|
Past 7 day medication adherence as measured by electronic medication monitoring device.
|
24 weeks
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Number of Kept Medical Appointments
Periodo de tiempo: 24 weeks
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Number of kept medical appointments since baseline.
|
24 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Information-Motivation-Behavioral Skills (IMB) Antiretroviral Therapy (ART) Behavioral Skills Scale
Periodo de tiempo: 24 weeks
|
Behavioral Skills subscale from the Information-Motivation-Behavioral Skills (IMB) scale.
This subscale measures self-efficacy for adherence to medical care related to antiretroviral medication and treatment.
Five items were summed to get a total Behavioral Skills subscale score.
Scores range from 5-25 where higher scores indicate greater self-efficacy for adherence to medical care related to ART medication and treatment.
|
24 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Larry K Brown, MD, Rhode Island Hospital
- Director de estudio: Laura Whiteley, MD, Rhode Island Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- R01HD074846-01 (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. .