- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01142882
Comparative Effectiveness of Web-based Versus Traditional Adolescent HIV Prevention
Comparative Effectiveness of Web-based vs. Traditional Adolescent HIV Prevention
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This trial will examine the comparative effectiveness and cost-effectiveness of a web-based HIV, hepatitis and STI prevention intervention when offered to youth in outpatient, community-based substance abuse treatment as directly compared to a traditional HIV (and infectious disease) prevention intervention. We will assess the comparative effectiveness and cost-effectiveness of these interventions by primarily examining changes from pre- to post-intervention in accurate HIV/disease prevention knowledge, intentions to engage in safer sex and HIV risk behavior. Additionally, we will examine the extent to which the interventions impact relevant skills acquisition (e.g., communication skills, negotiation skills and condom use skills), attitudes toward safer sex and self-reported substance use, as well as the acceptability of each intervention. We also plan to evaluate youth at both 1 and 3 month post-intervention to examine the durability of effects (including any differential durability of effects across intervention conditions). The web-delivered prevention intervention to be evaluated in this study has the potential to allow for a complex intervention to be delivered at a low cost, without increasing demands on staff time or training needs, and may thereby expand the reach of evidence-based prevention for youth in substance-abuse treatment.
This study will be conducted at three collaborating, community-based adolescent substance abuse treatment programs all of which are housed within the Daytop Village network of services and are located in New York City: (1) Daytop Village's Brooklyn Outreach Center; (2) Daytop Village's Bronx Outreach Center; and (3) Daytop Village's Queens Outreach Center. We expect to recruit approximately one third of the total number of participants from each site.
A total of up to 160 (no fewer than 120) adolescent participants will be enrolled in this study. Participants will be randomly assigned to one of the two study conditions in an intent-to-treat design (n=60-80 per group): (1) computer-delivered intervention or (2) traditional (person-delivered intervention). Participants in the traditional prevention intervention condition will complete two sessions (of approx. one hour in duration) across the course of a week, conducted by a trained HIV (and infectious disease) prevention educator; these sessions will typically be conducted in small groups of 2-4 participants but may be offered individually. Participants in the computer-delivered intervention condition will complete an interactive, web-based HIV, hepatitis and STI prevention program instead of the traditional, person-delivered prevention intervention. Youth will be asked to complete a customized plan of approximately 2-4 hours in length using the web-based tool; participants will complete two 60-minute sessions per week until they complete their customized plan. Participants will access this intervention using dedicated computer stations set up at their substance abuse treatment program.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Honoria M. Guarino, Ph.D.
- Número de teléfono: 212-845-4540
- Correo electrónico: guarino@ndri.org
Ubicaciones de estudio
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-
New York
-
Bronx, New York, Estados Unidos, 10461
- Reclutamiento
- Daytop Village, Bronx Outreach Center
-
Contacto:
- Cassandra Melnikow, MA
- Número de teléfono: 2112 718-518-9007
- Correo electrónico: melnikow@ndri.org
-
Brooklyn, New York, Estados Unidos, 11217
- Reclutamiento
- Daytop Village, Brooklyn Outreach Center
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Contacto:
- Elaine Dillingham, B.A.
- Número de teléfono: 2811 718-625-1388
- Correo electrónico: dillingham@ndri.org
-
Jamaica, New York, Estados Unidos, 11435
- Reclutamiento
- Daytop Village, Queens Outreach Center
-
Contacto:
- Cassandra Melnikow, M.A.
- Número de teléfono: 2252 718-523-4242
- Correo electrónico: melnikow@ndri.org
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Enrolled in collaborating adolescent substance abuse treatment program (i.e., Daytop's Brooklyn Outreach Center, Bronx Outreach Center or Queens Outreach Center)
- 12-18 years of age
- Within first 30 days of substance abuse treatment (current treatment episode)
- Not yet received formal HIV prevention intervention during current treatment episode
Exclusion Criteria:
- Plans to move out of the area within the next 5 months
- Insufficient ability to understand and provide informed consent/assent to participate
- Insufficient ability to use English to participate in the consent process, the interventions and/or assessments
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Traditional Prevention
educator-delivered, small-group HIV & disease prevention education
|
Participants in the traditional prevention intervention condition will complete two sessions (of approx.
one hour in duration) across the course of a week, conducted by a trained HIV (and infectious disease) prevention educator; these sessions will typically be conducted in small groups of 2-4 participants but may be offered individually.
|
Experimental: Web-based Prevention
self-directed, interactive & customized web-based HIV & disease prevention education
|
Participants in the web-based intervention condition will complete an interactive, web-based HIV, hepatitis and STI prevention program.
Youth will be asked to complete a customized plan of approximately 2-4 hours in length using the web-based tool; participants will complete two 60-minute sessions per week until they complete their customized plan.
Participants can choose to access this intervention using dedicated computer stations set up at their substance abuse treatment setting or can complete these sessions at their own home via the web.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
HIV/disease prevention knowledge
Periodo de tiempo: 3 months
|
3 months
|
|
behavioral intentions
Periodo de tiempo: 3 months
|
intentions to engage in safer sex
|
3 months
|
HIV risk behavior
Periodo de tiempo: 3 months
|
sexual risk behavior
|
3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
skills acquisition
Periodo de tiempo: 3 months
|
communication skills; negotiaion skills & condom use skills
|
3 months
|
self-reported substance use
Periodo de tiempo: 3 months
|
as measured via Timeline Follow-back
|
3 months
|
intervention acceptability
Periodo de tiempo: post-intervention
|
post-intervention
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lisa A. Marsch, Ph.D., National Development and Research Institutes, Inc.
- Director de estudio: Honoria M. Guarino, Ph.D., National Development and Research Institutes, Inc.
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Otros números de identificación del estudio
- HIVPrev613
- 1RC1DA028415 (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. .
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