Study on the Prevention of Recidivism and the Consequences of Sexual Violence Suffered by Female Asylum Seekers in France

NCT07477314 | Not Yet Recruiting

• 2 other identifiers: RCAPHM25_04262025-A02052-47
• Study Type: observational
• Target: 675
• Locations: 1 country
• Sites: 6

Brief Summary

Women seeking asylum (WSA) are overexposed to sexual violence (SV) in their countries of origin, along migration routes, and within host countries. This overexposure does not cease upon arrival in host countries; on the contrary, the first months following arrival are characterised by heightened vulnerability, with an increased incidence of sexual violence, particularly among women with a prior history of victimisation. Sexual violence has major consequences on physical health, mental health, quality of life, and healthcare utilisation, and generates substantial individual and societal costs. International organisations, including the United Nations High Commissioner for Refugees, have identified the prevention of sexual violence and the improvement of care for survivors as public health priorities. Previous work suggests that addressing sexual violence within primary care, when embedded in a comprehensive, culturally informed, and coordinated approach integrating medical, psychological, social, and medico-legal dimensions, may contribute to preventing the occurrence or recurrence of sexual violence in host countries. However, no comparative study has yet evaluated the effectiveness of such a coordinated model of care on the prevention of sexual violence among women seeking asylum, nor assessed its efficiency or transferability. The primary objective of this study is to evaluate the effectiveness of a coordinated, transcultural, multidisciplinary outpatient care model on the prevention of sexual violence occurring in host European countries among women seeking asylum.

Conditions

Sexual Violence; Refugee Health; Physical Health; Access to Recommended Healthcare; Mental Health; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Occurrence of sexual violence within 12 months after inclusion

  The primary outcome is the occurrence of sexual violence during the first 12 months following inclusion. Sexual violence is defined as the occurrence of at least one of the following events: rape, attempted rape, sexual assault, or sexual exhibition, as assessed through structured interviews administered at follow-up visits.

  12 months after inclusion

Secondary Outcomes (46)

• Occurrence of rape within 12 months after inclusion

  12 months after inclusion

• Occurrence of sexual violence between 12 and 18 months after inclusion

  12 to 18 months after inclusion

• Occurrence of rape between 12 and 18 months after inclusion

  12 to 18 months after inclusion

• Measurement and Assessment of somatic symptoms

  at Baseline

• Measurement and Assessment of somatic symptoms

  at 3 months

Study Arms (2)

Coordinated care model

The coordinated outpatient care model is initiated through early identification at reception platforms by a dedicated mobile team and delivered over 12 months. It is based on proactive detection of sexual violence and structured coordination of care aimed at addressing its consequences and preventing recurrence. Through this coordination, the model aims to improve early access to care, continuity of follow-up, patient engagement, and effective mobilisation of existing services, including primary care, mental health services, sexual and reproductive health services, social support, and legal assistance when required.

Other: care coordinator; Other: a trained health mediator; Other: Access to care in the usual care; Other: Coordination; Other: Detection of sexual violence; Other: Medical follow-up; Other: Training of professionals

Comparator - Usual care

Participants in the comparator group receive usual care as implemented locally, which may include access to emergency or institutional services, primary care, or specialised structures, but without systematic coordination or proactive outreach.

Other: Access to care in the Coordinated care model; Other: Coordination; Other: Detection of sexual violence; Other: Medical follow-up; Other: Training of professionals

Interventions

care coordinator OTHER

The care coordinator ensures organisation of the care pathway, liaison between professionals, and longitudinal follow-up in collaboration with a general practitioner.

Coordinated care model

a trained health mediator OTHER

The health mediator facilitates communication, supports participants in navigating healthcare and social systems, and helps reduce linguistic, cultural, and administrative barriers.

Coordinated care model

Access to care in the usual care OTHER

Depends on asylum seekers' individual initiatives

Coordinated care model

Access to care in the Coordinated care model OTHER

Systematically initiated from registration at the first reception centre (PADA)

Comparator - Usual care

Coordination OTHER

Fragmented, dependent on local structures

Comparator - Usual care

Detection of sexual violence OTHER

Based on victims' self-reporting

Comparator - Usual care

Medical follow-up OTHER

Irregular, often interrupted due to precarious living conditions

Comparator - Usual care

Training of professionals OTHER

Variable, not standardized

Comparator - Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female seeking asylum in France

You may qualify if:

• Woman seeking asylum in France
• Self-identified female gender.
• Age ≥ 18 years.
• Received study information and provided informed consent to participate

You may not qualify if:

• Re-examination of a previous asylum application.
• Major cognitive impairment (e.g. dementia or intellectual disability) preventing reliable collection of study outcomes.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (6)

Maison de Santé de Saint André

Bordeaux, France

Location

MSP soins premiers Villeurbanne Est

Lyon, France

Location

Maison de Santé PEYSSONEL

Marseille, France

Location

Maison de Santé Butte Sainte Anne

Nantes, France

Location

MSP Mathagon

Paris, France

Location

Maison de santé Bonnefoy Périole Roseraie

Toulouse, France

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Health Services Accessibility

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• François Crémieux

  AP-HM

  STUDY DIRECTOR

Central Study Contacts

Jeremy Khouani, MD

CONTACT

0033491435903; jeremy.KHOUANI@univ-amu.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: March 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

FR (6)