- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04656522
Comic Intervention for Sexual Violence Prevention and Post-rape Care
23 december 2021 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
16 år och äldre (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in PEP Knowledge & Acceptability
Tidsram: 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)
|
|
Changes in Bystander Practices
Tidsram: 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.
|
Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)
|
|
Changes in Sexual Violence Stigma
Tidsram: 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.
|
Time 1 (0), Time 2 (5hours), Time 3 (4 weeks post-workshop)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in Gender Equitable Norms
Tidsram: Time 1 (0-baseline), Time 2 ( 6 hours follow-up), Time 3 (4 week follow-up)
|
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)
|
|
Changes in Depression
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Carmen H Logie, PhD, University of Toronto, Canada
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
30 november 2020
Primärt slutförande (Faktisk)
30 april 2021
Avslutad studie (Faktisk)
30 april 2021
Studieregistreringsdatum
Först inskickad
13 november 2020
Först inskickad som uppfyllde QC-kriterierna
30 november 2020
Första postat (Faktisk)
7 december 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 december 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 december 2021
Senast verifierad
1 december 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- gcc_bidibidi
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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