- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05007431
Violence Sexual Incidence During the First Year of Residence on Asylum Seekers (INCIDAVI)
Violence Sexual Incidence During the First Year of Residence in the French Territory on Asylum Seekers in Marseille and Nice
Asylum seekers women are particularly exposed to sexual violence. One in seven women in France and one in three in the world say they have been a victim of sexual violence at least once in her life.
The main objective of this study is to measure the incidence of sexual violence suffered by women in asylum proceedings during their first year of stay on French territory, in Marseille and Nice.
Study Overview
Detailed Description
Introduction: One in seven women in France and one in three in the world say they have been a victim of sexual violence at least once in his life. They are exacerbated in vulnerable populations, marginalized, in post-conflict situations or population displacement.
Therefore asylum seekers women are particularly exposed to sexual violence. This is why OFPRA and the Ministry of Solidarity and Health have protected these women with regard to sexual violence, one of the priority issues for public health. Yet, the investigators do not know the proportion of women seeking asylum who have suffered violence on French soil. In addition, the investigators did not find an international study of the incidence of violence sexual abuse suffered in the host country by women seeking asylum. Objective: Determine the incidence of sexual violence that occurred in the year following the arrival on French soil of adult women in the asylum process in Marseille and Nice.
Methodology: Multicentric longitudinal observational study (Marseille and Nice) based on a historical cohort of sexual violence among women in the application process asylum. 1,800 adult women seeking asylum were registered in 2019 in Marseille and Nice. The number of subjects required is 450 women (1: 4 sample of the target population).
Data collection will be carried out by hetero-questionnaire carried out in the presence of the questioned.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Marseille, France
- AP-HM
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Nice, France
- Chu de Nice
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age> 18 years old
- Major arrival (> 18 years old) on French territory
- In the asylum application procedure with the GUDA in Marseille or Nice
- Having a decline of residence on French soil of twelve months over the last 2 years.
- No objection to participating in the study
Exclusion Criteria:
- Existence of cognitive disorders (dementia, mental retardation) limiting the collection of criteria for judgment
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Women asylum seekers
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Data collection will be carried out by hetero-questionnaire carried out in the presence of the questioned.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Questionnaires on sexual violence suffered v1.1
Time Frame: 6 months
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The incidence of any of the following four events: rape or attempted rape or sexual assault or sexual exhibition that occurred on French soil during the first year of residence in France with women in the asylum procedure in France, defined by at least one positive response on the questionnaire.
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6 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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