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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04656522
Other study ID # gcc_bidibidi
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 30, 2020
Est. completion date April 30, 2021

Study information

Verified date December 2021
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
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.

Locations

Country Name City State
Canada Factor-Inwentash Faculty of Social Work, University of Toronto Toronto Ontario
Uganda Uganda Refugee and Disaster Management Council Arua

Sponsors (1)

Lead Sponsor Collaborator
University of Toronto

Countries where clinical trial is conducted

Canada,  Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in PEP Knowledge & Acceptability 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)
Primary Changes in Bystander Practices 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)
Primary Changes in Sexual Violence Stigma 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. Time 1 (0), Time 2 (5hours), Time 3 (4 weeks post-workshop)
Secondary Changes in Gender Equitable Norms 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. Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)
Secondary Changes in Depression 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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