Clinical trial NCT04656522: Comic Intervention for Sexual Violence Prevention and Post-rape Care
Official title: A Participatory Comic Intervention for Sexual Violence Prevention and Post-rape Care With Refugee Adolescents and Youth in a Humanitarian Setting in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knowledge, Attitudes, Practice
Post-exposure Prophylaxis
Keywords: Digital health intervention
Forcibly displaced youth
Uganda
Post-exposure prophylaxis
Bystander practices
Sexual Violence Stigma
Gender based violence
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm, pre-test/post-test trial design will be used to evaluate the effectiveness of a participatory comic intervention on changes in PEP knowledge and acceptability, sexual violence stigma, and bystander beahviour with displaced/refugee youth and health care providers in Bidi Bidi Refugee Settlement, Uganda.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in PEP Knowledge & Acceptability
timeFrame: Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)
measure: Changes in Bystander Practices
timeFrame: Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)
measure: Changes in Sexual Violence Stigma
timeFrame: Time 1 (0), Time 2 (5hours), Time 3 (4 weeks post-workshop)
Secondary outcomes:
measure: Changes in Gender Equitable Norms
timeFrame: Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)
measure: Changes in Depression
timeFrame: Time 1 (0-baseline), Time 3 (4 week follow-up)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Factor-Inwentash Faculty of Social Work, University of Toronto
state: Ontario
city: Arua
country: Uganda
facility: Uganda Refugee and Disaster Management Council
Study officials:
affiliation: University of Toronto, Canada
name: Carmen H Logie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Logie CH, Okumu M, Loutet M, Berry I, Lukone SO, Kisubi N, Mwima S, Kyambadde P. Mixed-methods findings from the Ngutulu Kagwero (agents of change) participatory comic pilot study on post-rape clinical care and sexual violence prevention with refugee youth in a humanitarian setting in Uganda. Glob Public Health. 2023 Jan;18(1):2092178. doi: 10.1080/17441692.2022.2092178. Epub 2022 Jun 30.