Training Community Members to Deliver HIV Prevention Programs to Urban Youth
7 de marzo de 2012 actualizado por: Icahn School of Medicine at Mount Sinai
Community Partnerships to Prevent Urban Youth Health Risks (CHAMPions)
This study will examine methods for involving local community members in programs to teach urban youth about how to prevent transmission of HIV.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
HIV is a sexually transmitted virus that damages or destroys a body's immune system. When the infection progresses to its later stages, AIDS can develop. Several programs have been developed for educating adolescents about how to prevent HIV transmission. Preventing infection is particularly important because there is not yet a way to cure HIV. This study will examine the processes needed to train community members to deliver HIV prevention programs to urban youth.
This study has three steps. In Step 1, an existing group of urban community members who have already delivered the Be Proud! Be Responsible! HIV prevention program will be invited to serve as mentors for new HIV educators in the community. Participants in this step will complete self-administered assessments of their willingness to collaborate with university-based researchers, their confidence in skills necessary for collaborative projects, and any foreseeable obstacles to participation. The goal of this step is to examine the response over time to ongoing HIV leadership.
In Step 2, parents from the targeted community will be recruited and trained in HIV prevention programs. They will be randomly assigned to one of three programs: Becoming a Responsible Teen, Be Proud! Be Responsible!, and Reducing the Risk. All three of these programs involve group meetings with adolescents to discuss puberty, sexuality, communication, self-esteem, HIV/AIDS, and setting and achieving goals and dreams. Participants in this phase will undergo the same assessments as those in Step 1.
In Step 3, the parents trained in Step 2 will be randomly assigned to a middle school or high school where they will deliver the program in which they were trained. Randomly selected adolescent participants from these schools will be assigned to whichever program is being offered at their school. All three prevention programs will include four to six sessions over 4 to 6 weeks. Adolescent participants will be required to complete interviews and questionnaires when they enter the study, after 3 months, and after 15 months. These interviews and questionnaires will measure HIV/AIDS knowledge, self-esteem, intention to protect health, and engagement in risk-taking behaviors. Parent participants in Step 3 will repeat the assessments from Steps 1 and 2 before and after delivering their prevention curriculums.
Tipo de estudio
Intervencionista
Inscripción (Actual)
901
Fase
- Fase 3
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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New York
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New York, New York, Estados Unidos, 10029
- Mount Sinai School of Medicine
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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
12 años a 60 años (Niño, Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria
- Adult community HIV educators who are parents of a middle or high school aged child
- Adult participants must be between 25 and 60 years of age
- Youth participants must be between 12 and 15 years of age
- Residents of target communities in Bronx, NY
Exclusion Criteria:
- Parent or guardian is excluded if youth participant cannot provide informed consent because of mental health or substance abuse diagnosis
- Significant cognitive impairment that might interfere with understanding of program content or informed consent process
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: BART
Participants will complete the Becoming a Responsible Teen (BART) program.
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This program consists of highly structured modules administered using intervention manuals in community-based settings.
Each intervention session involves group discussion, videos, games, presentations, demonstrations, role plays, and practice.
Youth learn problem solving, decision-making, communication, condom negotiation and use skills, and behavioral self-management.
Youth also meet with HIV infected peers to promote risk recognition and improve their perception of vulnerability.
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Experimental: Reducing the Risk
Participants will complete the Reducing the Risk program.
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This program consists of instruction on developing social skills to reduce sexual risk-taking behavior and role plays to practice and model skills.
Additional activities-such as teaching decision making and assertive communication skills, offering encouragement to obtain relevant health information from stores and clinics, and asking parents about their views on abstinence and birth control-support the premise that students should avoid unprotected intercourse, either by remaining abstinent or using contraceptives.
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Comparador activo: Be Proud Be Responsible
Participants will complete the Be Proud!
Be Responsible!
program.
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This intervention consists of highly structured modules that involve group discussions, videos, games, brainstorming, experiential exercises, and skill building activities.
The program encourages participants to be proud of themselves and their community, to behave responsibly for themselves and their community, and to consider their goals for the future and how risk behaviors may interfere with the attainment of their goals.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Youth sexual risk behaviors
Periodo de tiempo: Measured at baseline
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Measured at baseline, after 3 to 4 months, and after 15 months
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Measured at baseline
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Youth sexual risk behaviors
Periodo de tiempo: Measured after 3 to 4 months
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Measured at baseline, after 3 to 4 months, and after 15 months
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Measured after 3 to 4 months
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Youth sexual risk behaviors
Periodo de tiempo: Measured after 15 months
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Measured at baseline, after 3 to 4 months, and after 15 months
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Measured after 15 months
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HIV educators' intentions to collaborate
Periodo de tiempo: Measured at baseline
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Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
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Measured at baseline
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HIV educators' intentions to collaborate
Periodo de tiempo: Measured at post-intervention
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Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
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Measured at post-intervention
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HIV educators' intentions to collaborate
Periodo de tiempo: Measured at 3-month follow-up
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Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
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Measured at 3-month follow-up
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HIV educators' intentions to collaborate
Periodo de tiempo: Measured at 15-month follow-up
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Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
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Measured at 15-month follow-up
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Collaboration by HIV educators
Periodo de tiempo: Measured at baseline
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Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
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Measured at baseline
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Collaboration by HIV educators
Periodo de tiempo: Measured at post-intervention
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Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
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Measured at post-intervention
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Collaboration by HIV educators
Periodo de tiempo: Measured at 3-month follow-up
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Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
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Measured at 3-month follow-up
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Collaboration by HIV educators
Periodo de tiempo: Measured at 15-month follow-up
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Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
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Measured at 15-month follow-up
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Youth sexual behavior
Periodo de tiempo: Measured at baseline
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Measured at baseline, after 3 to 4 months, and after 15 months
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Measured at baseline
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Youth sexual behavior
Periodo de tiempo: Measured after 3 to 4 months
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Measured at baseline, after 3 to 4 months, and after 15 months
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Measured after 3 to 4 months
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Youth sexual behavior
Periodo de tiempo: Measured after 15 months
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Measured at baseline, after 3 to 4 months, and after 15 months
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Measured after 15 months
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Youth negotiation of sexual risk situations
Periodo de tiempo: Measured at baseline
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Measured at baseline, after 3 to 4 months, and after 15 months
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Measured at baseline
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Youth negotiation of sexual risk situations
Periodo de tiempo: Measured after 3 to 4 months
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Measured at baseline, after 3 to 4 months, and after 15 months
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Measured after 3 to 4 months
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Youth negotiation of sexual risk situations
Periodo de tiempo: Measured after 15 months
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Measured at baseline, after 3 to 4 months, and after 15 months
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Measured after 15 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Leadership skills of HIV educators
Periodo de tiempo: Measured at baseline
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Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
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Measured at baseline
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Leadership skills of HIV educators
Periodo de tiempo: Measured at post-intervention
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Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
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Measured at post-intervention
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Leadership skills of HIV educators
Periodo de tiempo: Measured at 3-month follow-up
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Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
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Measured at 3-month follow-up
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Leadership skills of HIV educators
Periodo de tiempo: Measured at 15-month follow-up
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Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
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Measured at 15-month follow-up
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HIV/AIDS knowledge and attitudes of educators and youth
Periodo de tiempo: Measured at baseline
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Measured at baseline, after 3 to 4 months, and after 15 months
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Measured at baseline
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HIV/AIDS knowledge and attitudes of educators and youth
Periodo de tiempo: Measured after 3 to 4 months
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Measured at baseline, after 3 to 4 months, and after 15 months
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Measured after 3 to 4 months
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HIV/AIDS knowledge and attitudes of educators and youth
Periodo de tiempo: Measured after 15 months
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Measured at baseline, after 3 to 4 months, and after 15 months
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Measured after 15 months
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Self-esteem and self-efficacy of HIV educators
Periodo de tiempo: Measured at baseline
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Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
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Measured at baseline
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Self-esteem and self-efficacy of HIV educators
Periodo de tiempo: Measured at post-intervention
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Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
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Measured at post-intervention
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Self-esteem and self-efficacy of HIV educators
Periodo de tiempo: Measured at 3-month follow-up
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Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
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Measured at 3-month follow-up
|
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Self-esteem and self-efficacy of HIV educators
Periodo de tiempo: Measured at 15-month follow-up
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Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
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Measured at 15-month follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mary M. McKay, PhD, Icahn School of Medicine at Mount Sinai
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 marzo de 2009
Finalización primaria (Actual)
1 de marzo de 2012
Finalización del estudio (Actual)
1 de marzo de 2012
Fechas de registro del estudio
Enviado por primera vez
6 de marzo de 2009
Primero enviado que cumplió con los criterios de control de calidad
6 de marzo de 2009
Publicado por primera vez (Estimar)
10 de marzo de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
8 de marzo de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
7 de marzo de 2012
Última verificación
1 de marzo de 2012
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
- GCO 03-0888
- DAHBR 9A-ASPA (National Institute of Mental Health)
- R01MH069934 (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. .