NCT05007431

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 6, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2022

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

July 29, 2021

Last Update Submit

June 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Women asylum seekers

Other: Questionnaires

Interventions

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

Women asylum seekers

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women asylum seekers victims of sexual violence

You may qualify if:

  • 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

You may not qualify if:

  • \- Existence of cognitive disorders (dementia, mental retardation) limiting the collection of criteria for judgment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AP-HM

Marseille, France

Location

Chu de Nice

Nice, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 16, 2021

Study Start

October 6, 2021

Primary Completion

April 6, 2022

Study Completion

April 6, 2022

Last Updated

June 8, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations