- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01087164
Brief Interventions to Increase HPV Vaccine Acceptance in School-based Health Centers
Brief Interventions to Increase HPV Vaccine Acceptance in School-based Health Centers in Adolescents
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The proposed study will employ a randomized, full factorial experimental design to examine the effects of brief message interventions on parents' acceptance of the first dose of HPV vaccine for their adolescents aged 11-14 years, as well as follow through with subsequent doses. Specifically, the study will employ a 2 x 2 experimental design, in which participants will be assigned randomly to one of two different message sidedness conditions (1 sided vs. 2 sided) and two social compliance conditions (high compliance request [HCR] vs. noHCR). The interventions will be administered by a bilingual research assistant who will read, verbatim, scripts provided to them. Computer assisted telephone interview (CATI) will be used to gather demographic and background information as well as parental health beliefs regarding preexisting worries about HPV vaccine leading to safety concerns (moderator variable) prior to administration of the interventions. After the interventions, additional health beliefs will be assessed (mediators).
- A greater proportion of girls as compared to boys will receive a first dose of vaccine.
- Among both girls and boys who receive a first dose of Gardasil™, no differences in completion rates will be detected.
- The social compliance intervention to be more effective with parents of girls as compared to parents of boys. This prediction of a differential effect is based on the fact that cervical cancer will be seen as a more serious and less stigmatizing condition than genital warts.
In summary, the implementation of this protocol will allow us to systematically examine the use of two different interventions on parents of both boys and girls. Thus, parents (n=800) of 11-14 year old girls and boys will be randomized to the two sets of interventions, resulting in a 2 X 2 design: message sidedness (1-sided; 2-sided) and HCR (yes; no).
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Texas
-
Galveston, Texas, Estados Unidos, 77550
- Teen Health Centers
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- The parents of adolescent males and females (aged 11-14 years) who have provided written consent for their adolescent to receive health care services through the Teen Health Center, Inc, a nonprofit organization that works in collaboration with the Department of Pediatrics at the University of Texas Medical Branch, Galveston, Texas and whose adolescents have not received their first dose of HPV vaccine, will be eligible to participate.
Exclusion Criteria:
- Having received one or more doses of the HPV vaccine Gardasil
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Compliance
Parents will be randomized to receive high or no compliance condition where those in the experimental group will be asked about whether or not they will protect their daughter from cervical cancer or for males, their son from genital warts.
|
Parent will either receive a high or no compliance condition where each is asked to endorse the importance of prevention cervical cancer or genital warts depending on their teen's gender.
|
Experimental: Message sidedness
Parents will be given either a one-sided verbal message or a two-sided verbal message about the HPV vaccine.
|
Parent will receive either a one-sided or two-sided message about the HPV vaccine
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Gardasil immunization
Periodo de tiempo: One year
|
Parent signs vaccine information sheet and returns to school-based health center.
Adolescent is vaccinated with first dose of Gardasil by licensed health care professional.
|
One year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Completion of three dose series of Gardasil
Periodo de tiempo: Three years
|
We will identify all enrolled parents to determine whether their adolescent received all three required Gardasil immunization across a three year period.
|
Three years
|
Message type
Periodo de tiempo: Two years
|
Determine whether the type of message delivered to parent, i.e., one-sided or two-sided, increases the number of first dose immunizations.
|
Two years
|
Gender
Periodo de tiempo: One year
|
Determine if there are gender differences between male and female children relative to first dose administration
|
One year
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Vaughn I Rickert, PsyD, Indiana University School of Medicine
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
- 0911-50
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. .