- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04656522
Comic Intervention for Sexual Violence Prevention and Post-rape Care
23 de diciembre de 2021 actualizado por: Carmen Logie, MSW, PhD, University of Toronto
A Participatory Comic Intervention for Sexual Violence Prevention and Post-rape Care With Refugee Adolescents and Youth in a Humanitarian Setting in Uganda
In humanitarian settings, sexual and gender-based violence disproportionately impacts women and children.
However, there continues to be a lack of evidence regarding both sexual violence prevention and post-rape care interventions in low- and middle-income humanitarian contexts, with even less evidence supporting adolescents and youth in these settings.
Participatory comics offer a youth-friendly, low-cost, scalable approach for preventing sexual violence and training clinicians in post-rape care in humanitarian settings.
This study aims to develop, implement, and evaluate the effectiveness of a comic intervention on preventing sexual violence and improving post-rape care with youth aged 16-24 and health care providers in the Bidi Bidi refugee settlement.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
Uganda is Sub-Saharan Africa's largest refugee host community; with over 250,000 residents, Bidi Bidi is the largest refugee settlement in Uganda and the second largest globally.
In humanitarian settings, sexual and gender-based violence disproportionately impacts women and children.
However, there continues to be a lack of evidence regarding both sexual violence prevention and post-rape care interventions in low- and middle-income humanitarian contexts, with even less evidence supporting adolescents and youth in these settings.
Stigma directed toward adolescent sexual practices and engagement in sexual and reproductive health services, such as contraception, HIV testing, and post-exposure prophylaxis (PEP), is also associated with social isolation, violence and mental health challenges.
Participatory comics offer a youth-friendly, low-cost, scalable approach for preventing sexual violence and training clinicians in post-rape care in humanitarian settings.
This study aims to develop, implement, and evaluate the effectiveness of a comic intervention on preventing sexual violence and improving post-rape care with youth aged 16-24 and health care providers in the Bidi Bidi refugee settlement.
Participating youth and health care providers will take part in 4-hour peer-facilitated workshops exploring topics of social, sexual, and psychological needs and pro-social interventions (youth) and post-rape care responses and attending to the needs of youth refugees who have experienced sexual violence (health care providers) using comics developed with qualitative data collected from an earlier study phase.
Using a pre-test/post-test design, this study will assess changes in participants' PEP knowledge and acceptance, bystander behaviour, and sexual violence stigma.
Tipo de estudio
Intervencionista
Inscripción (Actual)
100
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.
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
16 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria (Youth):
- Resides in Bidi Bidi Refugee Settlement Zone 3
- Identify as a refugee/displaced person
- Aged 16-24 years
- Speak English, Bari or Arabic
Exclusion Criteria (Youth):
- Does not reside in Bidi Bidi Refugee Settlement Zone 3
- Does not identify as a refugee/displaced person
- Is less than age 16 years or older than age 24 years
- Does not speak English, Bari or Arabic
Inclusion Criteria (Healthcare Provider):
- Provides healthcare services in Bidi Bidi Refugee Settlement and/or Yumbe, Uganda
- Aged greater than or equal to 18 years
- Speak English, Bari or Arabic
Exclusion Criteria (Healthcare Provider):
- Does not provide healthcare services in Bidi Bidi Refugee Settlement and/or Yumbe, Uganda
- Less than age 18 years
- Does not speak English, Bari or Arabic
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Participatory Comic Intervention
This is a pre-test/post-test trial, therefore all participants will participate in the participatory comic intervention.
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This participatory comic intervention promotes sexual violence prevention and post-rape care with refugee youth and health care providers.
In 4-hour workshops, a customized comic book featuring eight sexual violence scenarios will be distributed.
Each 1-page scenario speaks to a unique theme of sexual violence experiences among youth or post-rape care preferences.
During the workshop participants will explore social, sexual, and psychological needs of youth in Bidi Bidi and practice ways of developing and maintaining healthy relationships (youth) as well as discuss post-rape care responses that attend to the needs and priorities of young refugees in Bidi Bidi who have experienced sexual violence (health care providers).
Each workshop will include 20 participants and will be facilitated by trained staff from Real Medicine, Uganda.
Further, each workshop will have at least 2 facilitators who are trained in the bystander model.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in PEP Knowledge & Acceptability
Periodo de tiempo: Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)
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PEP knowledge and acceptability assessed through testing participants on their knowledge of correct PEP use and asked to report on their acceptance towards PEP use and adherence.
Scores are binary yes/no.
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Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)
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Changes in Bystander Practices
Periodo de tiempo: Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)
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Bystander practices assessed through the Bystander Decision Balance Scale and Slaby Bystander Efficacy Scale (Range 16-64).
Higher scores indicate increased bystander practices.
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Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)
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Changes in Sexual Violence Stigma
Periodo de tiempo: Time 1 (0), Time 2 (5hours), Time 3 (4 weeks post-workshop)
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Attitudes and beliefs towards sexual violence will be assessed using the Sexual Violence Stigma scale (Range 17-68).
Higher score indicates poorer attitudes and beliefs, and thus greater stigma, towards sexual violence and sexual violence survivors.
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Time 1 (0), Time 2 (5hours), Time 3 (4 weeks post-workshop)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in Gender Equitable Norms
Periodo de tiempo: Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)
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Gender Equitable Norms will be assessed using the physical violence subscale (Range 6-18) of the gender equitable men (GEM) scale to measure attitudes towards gender equitable norms considering the prevailing norms in the community concerning physical violence.
A higher score indicates positive attitudes towards gender equitable norms.
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Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)
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Changes in Depression
Periodo de tiempo: Time 1 (0-baseline), Time 3 (4 week follow-up)
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Depression outcomes will be assessed using the Patient Health Questionnaire 2-item (PHQ-2) (Range 0-6).
Scores of 3 or above signal major depressive disorder.
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Time 1 (0-baseline), Time 3 (4 week follow-up)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Carmen H Logie, PhD, University of Toronto, Canada
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 (Actual)
30 de noviembre de 2020
Finalización primaria (Actual)
30 de abril de 2021
Finalización del estudio (Actual)
30 de abril de 2021
Fechas de registro del estudio
Enviado por primera vez
13 de noviembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
30 de noviembre de 2020
Publicado por primera vez (Actual)
7 de diciembre de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de diciembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
23 de diciembre de 2021
Última verificación
1 de diciembre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- gcc_bidibidi
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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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