About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Woman seeking asylum in France
Asylum application registered less than 3 months before inclusion.
Self-identified female gender.
Age ≥ 18 years.
Disqualifiers
Re-examination of a previous asylum application.
Major cognitive impairment (e.g. dementia or intellectual disability) preventing reliable collection of study outcomes.
Trial population
Female seeking asylum in France
Trial design
Cohort
Prospective
Treatments tested in this trial
care coordinator
Other interventionThe care coordinator ensures organisation of the care pathway, liaison between professionals, and longitudinal follow-up in collaboration with a general practitioner.
a trained health mediator
Other interventionThe health mediator facilitates communication, supports participants in navigating healthcare and social systems, and helps reduce linguistic, cultural, and administrative barriers.
Access to care in the usual care
Other interventionDepends on asylum seekers' individual initiatives
Access to care in the Coordinated care model
Other interventionSystematically initiated from registration at the first reception centre (PADA)
Coordination
Other interventionFragmented, dependent on local structures
Coordination
Other interventionProvided by a coordinating care professionnal
Detection of sexual violence
Other interventionBased on victims' self-reporting
Detection of sexual violence
Other interventionProactive approach with health mediation and training of healthcare professionals
Medical follow-up
Other interventionIrregular, often interrupted due to precarious living conditions
Medical follow-up
Other interventionProgressive integration into mainstream healthcare services
Training of professionals
Other interventionVariable, not standardized
Training of professionals
Other interventionSpecialized and systematic training on sexual violence
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Occurrence of rape within 12 months after inclusion
Occurrence of rape during the first 12 months following inclusion, assessed through structured interviews
Occurrence of sexual violence between 12 and 18 months after inclusion
Occurrence of sexual violence events (rape, attempted rape, sexual assault, or sexual exhibition) during the period between 12 and 18 months following inclusion.
Occurrence of rape between 12 and 18 months after inclusion
Occurrence of rape events reported between 12 and 18 months following inclusion.
Measurement and Assessment of somatic symptoms
Somatic health assessed using the Cumulative Illness Rating Scale (CIRS).This scale, consisting of 14 items each corresponding to an organ system. Score ranged from 0 to 4, with lower scores indicating better health.
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