Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students
23 de junio de 2014 actualizado por: Susan Tortolero, The University of Texas Health Science Center, Houston
HIV Prevention Programs for Middle School Students
This study will develop and evaluate a school-based HIV, STD, and pregnancy prevention program for 7th and 8th grade middle school students.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
The purpose of this study is to develop and evaluate a school-based HIV, STD, and pregnancy prevention program for 7th and 8th grade middle school students using a randomized-controlled intervention trial. The intervention program consists of a classroom-based curriculum and an interactive CD-ROM. Ten middle schools were recruited to participate in this intervention trial. Five middle schools were randomized to the intervention group; and five middle schools were randomized to the control group. The study is also developing a model for obtaining community support for the development of HIV, STD and pregnancy prevention programs for middle school youth.
The primary hypothesis to be tested is: Students attending middle schools who receive a multi-component HIV, STD, pregnancy prevention intervention will postpone sexual activity or reduce levels of current sexual activity relative to those in the comparison condition. The major dependent variables are proportion of students that are sexually active, and the proportion initiating sexual intercourse. Intentions to engage in sexual activity, number of times of unprotected sexual intercourse, and number of sexual partners will also be examined. Secondary hypotheses will examine the effect of the multi-component HIV, STD, and pregnancy prevention intervention on the student's knowledge, self-efficacy, attitudes, perceived norms, barriers, and communication with parents.
The specific aims of this project are to:
- Develop a model for obtaining community-based support for HIV, STD, and pregnancy prevention interventions for middle school students.
- Adapt a tested, school-based, HIV, STD, and pregnancy prevention curriculum for middle school students using qualitative data from the target population, parents, and community representatives.
- Develop an interactive CD-ROM-based tailored HIV, STD and pregnancy prevention intervention to provide individualized learning opportunities for middle school students.
- Evaluate the effect of the multi-component intervention (classroom curriculum and CD-ROM intervention) on sexual behavior outcomes (proportion of students who initiate sexual intercourse, proportion of currently sexually active students having unprotected sexual intercourse, number of sexual partners, and intentions to have sexual intercourse) among middle school students.
- Evaluate the effect of the multi-component intervention on student impact variables such as knowledge, self-efficacy, attitudes, barriers, and perceived norms related to sexual risk-taking behavior and academic achievement among middle school students.
- Disseminate findings to the scientific community, school districts, and community agencies.
Tipo de estudio
Intervencionista
Inscripción (Actual)
3007
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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Texas
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Houston, Texas, Estados Unidos, 77030
- University of Texas Houston Health Science Center - School of Public Health
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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
11 años a 16 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 7th Grade
- Attend one of the ten recruited schools
Exclusion Criteria:
- Non-English speaking
- Physical disability that prevents student from completing intervention and survey
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention Group
HIV, STD, and pregnancy prevention curriculum
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This HIV, STD, and pregnancy intervention program entitled, "It's Your Game...Keep it Real", consists of 12 lessons delivered in Grades 7 and 8.
In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers.
A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits.
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Experimental: Control Group
Standard sexual education curriculum
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Control curriculum consists of standard sexual education.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Initiation of Sexual Intercourse
Periodo de tiempo: Measured throughout the study, and at 2006/2007 school year
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The effect of the intervention on delayed sexual initiation at the 9th-grade follow-up for those students who reported no lifetime sexual activity at baseline was assessed as the primary outcome.
The primary hypothesis tested was that the intervention would decrease the number of adolescents who initiated sexual activity by the ninth grade relative to those in the comparison schools.
Sexual activity was defined as participation in vaginal, oral, or anal sex.
Sexual activity questions were defined in advance and were worded in a gender-neutral manner to illicit responses for same and opposite-sex partners.
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Measured throughout the study, and at 2006/2007 school year
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Knowledge
Periodo de tiempo: Measured throughout the study
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Measured throughout the study
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Self-efficacy
Periodo de tiempo: Measured throughout the study
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Measured throughout the study
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Attitudes
Periodo de tiempo: Measured throughout the study
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Measured throughout the study
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Perceived Norms
Periodo de tiempo: Measured throughout the study
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Measured throughout the study
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Barriers
Periodo de tiempo: Measured throughout the study
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Measured throughout the study
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Communication With Parents
Periodo de tiempo: Measured throughout the study
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Measured throughout the study
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Proportion of Students That Are Sexually Active
Periodo de tiempo: Measured over a period of 30 days
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Measured over a period of 30 days
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
Investigadores
- Investigador principal: Susan R. Tortolero, PhD, University of Texas Houston Health Science Center - School of Public Health
- Investigador principal: Christine M. Markham, PhD, University of Texas Houston Health Science Center - School of Public Health
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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 septiembre de 2002
Finalización primaria (Actual)
1 de marzo de 2007
Finalización del estudio (Actual)
1 de julio de 2008
Fechas de registro del estudio
Enviado por primera vez
8 de septiembre de 2005
Primero enviado que cumplió con los criterios de control de calidad
8 de septiembre de 2005
Publicado por primera vez (Estimar)
12 de septiembre de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
8 de julio de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
23 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
- R01MH066640 (Subvención/contrato del NIH de EE. UU.)
- R01MH066640-01 (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. .
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