- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03073421
Positive Pregnancy Program (P3)
A Qualitative Evaluation of the "Positive Pregnancy Program", an Inter-professional Multidisciplinary Program for the Care of HIV-positive Pregnant Women
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The aim of the P3 program is to provide supportive and comprehensive care from a variety of perspectives, including medical, social, and psychological. The premises on which the program are built include: a commitment to the respect, confidentiality, dignity and medical care of clients; health promotion; normalizing the care of HIV-positive pregnant women; knowledge translation; and the intentions to build a model of care that is transferable to other clinicians and to other conditions.
During antenatal visits, pregnant women are seen by a multidisciplinary team of professionals including an Obstetrician, Midwife, Prenatal Nurse and Social Worker. Different rooms are used for routine antenatal care maneuvers and for consultation and counseling. The Midwife attends the births of the women in the program, and does home post partum care visits. Care is provided that is patient- and family-centered. Partners are invited to attend as many visits as the couple wishes. Because of this team approach, significantly more time is spent with each woman than would occur at a routine prenatal visit.
The patient population at the St. Michael's clinic is largely made up of immigrant women. Many of these women are refugees, and have fled conflict zones or wars to come to Canada. More than 50% have lived in Canada for less than five years. Many of these women are marginalized, and may not access care elsewhere. They have many issues beyond HIV, and some of the social determinants of health that we observe during their time in the program include issues surrounding housing, finance, immigration, legal issues, social support, co-morbid conditions and substance use.
Since the launch of the program, there has been a rapid increase in the number of women attending each year. The program has also attracted significant attention, both from within the medical and health care communities and beyond.
This study seeks to determine if women cared for in the Positive Pregnancy Program will have a high degree of satisfaction with this model of care.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- HIV positive pregnant women who took part in P3 program
Exclusion Criteria:
- HIV negative
- did not take part in P3 program
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: HIV positive pregnant women
HIV positive pregnant women who took part in the P3 program will take part in a 2-hour qualitative interview.
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This interview will be 2 hours in length and will be conducted with a Peer Research Assistant (PRA).
The PRAs will be women living with HIV.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Degree of satisfaction with P3 program during antenatal period
Periodo de tiempo: 36 weeks gestation
|
A qualitative 2 hour interview will be conducted with HIV positive pregnant women taking part in the P3 program.
The first interview will be timed to occur late in the third trimester, at approximately 36 weeks gestation.
This interview will allow an evaluation of women's experiences during antenatal care.
The second interview will occur in the post partum period, and will be timed to coincide with the post partum visit at six weeks after birth.
This interview will allow an evaluation of women's experiences in the hospital, during labour and delivery, and on the post partum floor.
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36 weeks gestation
|
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Post-partum degree of satisfaction with P3 program
Periodo de tiempo: 6 weeks post-partum
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The second interview will occur in the post partum period, and will be timed to coincide with the post partum visit at six weeks after birth.
This interview will allow an evaluation of women's experiences in the hospital, during labour and delivery, and on the post partum floor.
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6 weeks post-partum
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
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
- Seropositividad al VIH
Otros números de identificación del estudio
- 12-124
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA 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. .