- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02796586
Group Versus Individual Contraceptive Counseling for Resettled African Refugee Women
Salt Lake Refugee Women's Health Project-Group Versus Individual Contraceptive Counseling for Resettled African Refugee Women
Descripción general del estudio
Descripción detallada
Thousands of women refugees arrive in the United States each year, yet there is very little known about reproductive health and family planning needs of these women after resettlement.
This randomized controlled pilot study, in a population of resettled African refugee women, will evaluate differences between group and individual contraceptive counseling on the decision to use contraception, satisfaction with counseling method, and modern family planning knowledge.
Participants will arrive to clinic during an assigned "intervention day." An intake and exit survey will be performed before and after their counseling session. Demographics, attitudes towards contraception, and knowledge regarding contraceptive methods will be assessed via questionnaire. Participants will be randomized to either group or individual contraceptive counseling. After each session, participants will have the option to privately choose a reversible method of contraception free of charge.
Telephone survey follow-up with participants will occur every three months for one year. Follow-up surveys will include questions regarding method continuation, method satisfaction and and modern contraceptive knowledge.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Utah
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Salt Lake City, Utah, Estados Unidos, 84132
- University of Utah Hospital
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Resettled refugee
- Ability to speak and comprehend conversational Swahili, French or Lingala
- Interest in contraceptive counseling
- Willing to adhere to study protocols including randomization and follow-up
- Cellular phone access
Exclusion Criteria:
- Male
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Individual Contraceptive Counseling
Performed by a medical provider and planned to simulate a typical clinic visit addressing contraception.
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Participants will be randomly assigned to group versus individual contraceptive counseling
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Experimental: Group Contraceptive Counseling
Performed by a bicultural study staff member who speaks the primary languages of participants and had been formally trained in contraception counseling.
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Participants will be randomly assigned to group versus individual contraceptive counseling
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Knowledge Acquisition assessed via number of correct questions on modified FogZone questionnaire
Periodo de tiempo: Day of intervention (Study Day 1)
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Evaluate knowledge acquisition by comparing results on pre and post test of modern contraceptive knowledge.
Contraceptive knowledge will be assessed using a modified version of the FogZone questionnaire
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Day of intervention (Study Day 1)
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Contraceptive uptake
Periodo de tiempo: Day of intervention (Study day 1)
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Evaluate contraceptive uptake via query of method choice after counseling
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Day of intervention (Study day 1)
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Service Satisfaction via questionnaire
Periodo de tiempo: Day of intervention (Study day 1)
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Evaluate satisfaction with service and type of counseling received using questionnaire
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Day of intervention (Study day 1)
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Service satisfaction via Likert Scale
Periodo de tiempo: Day of intervention (Study day 1)
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Evaluate satisfaction with service and type of counseling received using questionnaire
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Day of intervention (Study day 1)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Method Continuation
Periodo de tiempo: 3, 6, 9 and 12 months post-intervention
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Evaluate method continuation via telephone survey
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3, 6, 9 and 12 months post-intervention
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Knowledge Retention assessed via modified FogZone questionnaire
Periodo de tiempo: 3, 6, 9 and 12 months post-intervention
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Evaluate knowledge retention by repeating knowledge questionnaire and comparing baseline and interval results.
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3, 6, 9 and 12 months post-intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Par Royer, MD MSCI, University of Utah
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
Palabras clave
Otros números de identificación del estudio
- 00080655
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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