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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05007431
Other study ID # 2021-05
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 6, 2021
Est. completion date April 6, 2022

Study information

Verified date June 2023
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 360
Est. completion date April 6, 2022
Est. primary completion date April 6, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaires
Data collection will be carried out by hetero-questionnaire carried out in the presence of the questioned.

Locations

Country Name City State
France AP-HM Marseille
France Chu de Nice Nice

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Questionnaires on sexual violence suffered v1.1 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. 6 months
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