NCT04656522

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

5 months

First QC Date

November 13, 2020

Last Update Submit

December 23, 2021

Conditions

Keywords

Digital health interventionForcibly displaced youthUgandaPost-exposure prophylaxisBystander practicesSexual Violence StigmaGender based violence

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (2)

  • Changes in Gender Equitable Norms

    Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)

  • Changes in Depression

    Time 1 (0-baseline), Time 3 (4 week follow-up)

Study Arms (1)

Participatory Comic Intervention

EXPERIMENTAL

This is a pre-test/post-test trial, therefore all participants will participate in the participatory comic intervention.

Behavioral: Participatory Comic Intervention

Interventions

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.

Participatory Comic Intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Resides in Bidi Bidi Refugee Settlement Zone 3
  • Identify as a refugee/displaced person
  • Aged 16-24 years
  • Speak English, Bari or Arabic

You may not qualify if:

  • 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
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Factor-Inwentash Faculty of Social Work, University of Toronto

Toronto, Ontario, M5S1V4, Canada

Location

Uganda Refugee and Disaster Management Council

Arua, Uganda

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Behavior

Study Officials

  • Carmen H Logie, PhD

    University of Toronto, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 13, 2020

First Posted

December 7, 2020

Study Start

November 30, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

December 28, 2021

Record last verified: 2021-12

Locations