- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01280136
Web-Based Middle School HIV Prevention Curricula: Aspiring for Reach and Impact
12 de junio de 2014 actualizado por: Melissa Peskin, The University of Texas Health Science Center, Houston
The purpose of this study is to evaluate the effectiveness of a web-based HIV, sexually transmitted infection (STI), and pregnancy prevention curriculum as a stand alone intervention for 8th grade students in a large urban school district.
This web-based curriculum will be adapted from the computer-based component of an existing successful prevention program, It's Your Game…Keep it Real, (IYG) but will be enhanced to include critical elements from the IYG classroom component.
The primary hypothesis to be tested is: (1) students who receive the web-based curriculum will delay sexual activity relative to those who receive standard care.
The major dependent variable is the proportion of students initiating sexual activity (vaginal, oral, or anal sex).
Secondary hypotheses will examine the effect of the web-based curriculum on specific types of sex (e.g., vaginal, oral, anal) and psychosocial variables such as students' intentions, knowledge, self-efficacy, attitudes, and perceived norms related to sexual risk-taking behavior.
Secondary hypotheses will also examine the effect of the intervention on the proportion of students who are sexually active, number of times students engage in unprotected sexual intercourse, and students' number of sexual partners.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The purpose of this study is to evaluate the effectiveness of a web-based HIV, sexually transmitted infection (STI), and pregnancy prevention curriculum as a stand alone intervention for 8th grade students in a large urban school district.
Twenty middle schools were invited to participate in the study.
From those schools, we randomized 10 to the intervention group and 10 to the comparison condition, and will then recruit a cohort of 2,000 8th grade students into the study.
Parental permission and youth assent will be required prior to participation.
Students will be asked to complete a baseline and 12-month follow-up survey.
The web-based curriculum will be adapted from the computer-based component of an existing successful prevention program, It's Your Game…Keep it Real, (IYG) but will be enhanced to include critical elements from the IYG classroom component.
The web-based intervention will consist of 13 lessons and will tailor information to the individual's gender and to his/her intentions or behaviors related to sexual risk-taking.
The program will address peer norms, attitudes, self-efficacy, refusal skills, and communication skills related to healthy relationships, dating, and sexual risk-taking behavior.
The primary hypothesis to be tested is: (1) students who receive the web-based curriculum will delay sexual activity relative to those who receive standard care.
The major dependent variable is the proportion of students initiating sexual activity (vaginal, oral, or anal sex).
Secondary hypotheses will examine the effect of the web-based curriculum on specific types of sex (e.g., vaginal, oral, anal) and psychosocial variables such as students' intentions, knowledge, self-efficacy, attitudes, and perceived norms related to sexual risk-taking behavior.
Secondary hypotheses will also examine the effect of the intervention on the proportion of students who are sexually active, number of times students engage in unprotected sexual intercourse, and students' number of sexual partners.
Tipo de estudio
Intervencionista
Inscripción (Actual)
1700
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
-
-
Texas
-
Houston, Texas, Estados Unidos, 77030
- University of Texas Houston School of Public Health
-
-
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
12 años a 16 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 8th graders attending regular classes in large urban school district in Southeast Texas
Exclusion Criteria:
- No students will be excluded based on race/ethnicity, age, or gender
- Students will be informed that the surveys and intervention will only be available in English and will be asked to consider their comfort level with participating in the study.
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: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: It's Your Game Tech
An interactive web-based HIV, sexually transmitted infection (STI), and pregnancy prevention program for 8th grade students.
This web-based intervention will be adapted from the computer-based component of an existing successful prevention program, It's Your Game…Keep it Real, (IYG) as well as include critical elements from the IYG classroom component.
The web-based intervention will consist of 13 lessons and will tailor information to the individual's gender and to his/her intentions or behaviors related to sexual risk-taking.
The program will address peer norms, attitudes, self-efficacy, refusal skills, and communication skills related to healthy relationships, dating, and sexual risk-taking behavior.
|
An interactive web-based intervention for 8th grade students.
This web-based intervention will be adapted from the computer-based component of an existing successful prevention program, It's Your Game…Keep it Real, (IYG) as well as include critical elements from the IYG classroom component.
The web-based intervention will consist of 13 lessons and will tailor information to the individual's gender and to his/her intentions or behaviors related to sexual risk-taking.
The program will address peer norms, attitudes, self-efficacy, refusal skills, and communication skills related to healthy relationships, dating, and sexual risk-taking behavior.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
sexual initiation
Periodo de tiempo: baseline prior to intervention
|
baseline prior to intervention
|
|
sexual initiation
Periodo de tiempo: 12 month follow-up
|
12 month follow-up
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
sexual activity in past 3 months
Periodo de tiempo: baseline prior to intervention
|
baseline prior to intervention
|
|
unprotected sexual intercourse
Periodo de tiempo: baseline prior to intervention
|
baseline prior to intervention
|
|
number of sexual partners
Periodo de tiempo: baseline prior to intervention
|
baseline prior to intervention
|
|
sexual activity in past 3 months
Periodo de tiempo: 12 month follow-up
|
12 month follow-up
|
|
unprotected sexual intercourse
Periodo de tiempo: 12 month follow-up
|
12 month follow-up
|
|
number of sexual partners
Periodo de tiempo: 12 month follow-up
|
12 month follow-up
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
Investigadores
- Investigador principal: Melissa Peskin, PhD, University of Texas Houston School of Public Health
- Investigador principal: Ross Shegog, PhD, University of Texas Houston School of Public Health
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 diciembre de 2009
Finalización primaria (Actual)
1 de junio de 2013
Finalización del estudio (Actual)
1 de junio de 2013
Fechas de registro del estudio
Enviado por primera vez
14 de enero de 2011
Primero enviado que cumplió con los criterios de control de calidad
18 de enero de 2011
Publicado por primera vez (Estimar)
20 de enero de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
13 de junio de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
12 de junio de 2014
Última verificación
1 de junio de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01MH085594 (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. .