- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04656522
Comic Intervention for Sexual Violence Prevention and Post-rape Care
23 décembre 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
100
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
16 ans et plus (Enfant, Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Participatory Comic Intervention
This is a pre-test/post-test trial, therefore all participants will participate in the participatory comic intervention.
|
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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in PEP Knowledge & Acceptability
Délai: Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)
|
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.
|
Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)
|
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Changes in Bystander Practices
Délai: 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.
|
Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)
|
|
Changes in Sexual Violence Stigma
Délai: Time 1 (0), Time 2 (5hours), Time 3 (4 weeks post-workshop)
|
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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in Gender Equitable Norms
Délai: 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
Délai: Time 1 (0-baseline), Time 3 (4 week follow-up)
|
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.
|
Time 1 (0-baseline), Time 3 (4 week follow-up)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Carmen H Logie, PhD, University of Toronto, Canada
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
30 novembre 2020
Achèvement primaire (Réel)
30 avril 2021
Achèvement de l'étude (Réel)
30 avril 2021
Dates d'inscription aux études
Première soumission
13 novembre 2020
Première soumission répondant aux critères de contrôle qualité
30 novembre 2020
Première publication (Réel)
7 décembre 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 décembre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 décembre 2021
Dernière vérification
1 décembre 2021
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- gcc_bidibidi
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .