Knowledge, Attitudes, PracticeNCT04656522
Comic Intervention for Sexual Violence Prevention and Post-rape Care
A study testing Participatory Comic Intervention in people with Knowledge, Attitudes, Practice and Post-exposure Prophylaxis, run by University of Toronto at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knowledge, Attitudes, Practice, Post-exposure Prophylaxis
- What is being tested?
- Participatory Comic Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Nov 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Resides in Bidi Bidi Refugee Settlement Zone 3
- Identify as a refugee/displaced person
- Aged 16-24 years
- 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
Who cannot join
- 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
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Canada1 site
Factor-Inwentash Faculty of Social Work, University of Toronto
Toronto, Ontario, M5S1V4
About this study
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
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.
Read the 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.
- Being tested
- Participatory Comic Intervention
- Keywords
- Digital health intervention, Forcibly displaced youth, Uganda, Post-exposure prophylaxis, Bystander practices, Sexual Violence Stigma, Gender based violence
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participatory Comic InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Participatory Comic Intervention | Experimental | This is a pre-test/post-test trial, therefore all participants will participate in the participatory comic intervention. Receives: Behavioral: Participatory Comic Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Time 1 (0), Time 2 (5hours), Time 3 (4 weeks post-workshop)
Secondary outcomes (2)
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.
Measured: Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)
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.
Measured: Time 1 (0-baseline), Time 3 (4 week follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start30 Nov 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmen Logie, MSW, PhD, University of Toronto
- Investigators
- Carmen H Logie, PhD, Principal investigator, University of Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656522
- Sponsor's protocol ID
- gcc_bidibidi
- Status last verified
- Dec 2021
- First submitted
- 13 Nov 2020
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35770702
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04656522
- Acronym / sponsor ID
- gcc_bidibidi
- Keywords
- Digital health intervention, Forcibly displaced youth, Uganda, Post-exposure prophylaxis, Bystander practices, Sexual Violence Stigma, Gender based violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participatory Comic Intervention | Experimental | Behavioral: Participatory Comic InterventionThis is a pre-test/post-test trial, therefore all participants will participate in the participatory comic intervention. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Resides in Bidi Bidi Refugee Settlement Zone 3
- Identify as a refugee/displaced person
- Aged 16-24 years
- Speak English, Bari or Arabic
- Provides healthcare services in Bidi Bidi Refugee Settlement and/or Yumbe, Uganda
Key exclusion criteria (7 listed)
- 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
- Does not provide healthcare services in Bidi Bidi Refugee Settlement and/or Yumbe, Uganda
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participatory Comic InterventionThis 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. | Behavioural | Participatory Comic Intervention |
Primary outcome
Changes in PEP Knowledge & Acceptability
Time frame: 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.
Changes in Bystander Practices
Time frame: Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)
Bystander practices assessed through the Bystander Decision Balance Scale and Slaby Bystander Efficacy Scale (Range 16-64). Higher scores indicate increased bystander practices.
Changes in Sexual Violence Stigma
Time frame: 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.
2 secondary outcomes
Changes in Gender Equitable Norms
Time frame: Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)
Changes in Depression
Time frame: Time 1 (0-baseline), Time 3 (4 week follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Derived from this study: PubMed 35770702Logie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen H Logie, PhD principal investigator
University of Toronto, Canada
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participatory Comic Intervention in people with Knowledge, Attitudes, Practice and Post-exposure Prophylaxis, run by University of Toronto at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in PEP Knowledge & Acceptability (time frame: Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04656522, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021; AzTrials last refreshed its copy on 30 Oct 2026.