Study on the Prevention of Recidivism and the Consequences of Sexual Violence Suffered by Female Asylum Seekers in France
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: care coordinator, a trained health mediator, Access to care in the usual care, Access to care in the Coordinated care model.
- Who it may be relevant to
- Registry conditions: Sexual Violence, Refugee Health, Physical Health, Mental Health. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Study design This is a multicentre, comparative, prospective observational cohort study conducted across six French cities.
"Here-Elsewhere" design: Here centres - 12 months of coordinated care, followed by 6 months of follow-up under usual care.
Elsewhere centres - 18 months of usual care.
Before-after design within the "Elsewhere" group:
Before group - 18 months of usual care. After group - 12 months of coordinated care, followed by 6 months of follow-up under usual care.
The duration of participation for asylum-seeking women is 18 months, with a total study duration of 30 months.
The 6-month follow-up period after the 12 months of coordinated care is intended to evaluate participants' integration into the mainstream healthcare system after the coordinated care intervention ends. It also aims to assess the persistence of the intervention's effects over time, beyond its completion, which is a key element for decision-making and for informing public policy.
The addition of the before-after component allows centres initially serving as comparison settings to access the same care model, thereby facilitating participation and adherence to the study design. This approach also helps to reduce ethical tensions related to differential access to care models, to mitigate centre-level effects, and to improve the precision of effect estimates over time.
Population Participants are adult women (≥18 years) seeking asylum, identified within three months of their official registration in France, and recruited at mandatory reception platforms for asylum seekers. Eligibility is based on self-identified female gender, recent asylum application, and absence of major cognitive impairment limiting participation. Information is provided in an accessible and culturally adapted manner, with professional interpretation when required, and participation is based on non-opposition.
Follow-up and outcomes Participants are followed for 18 months, with assessments at inclusion and every three months. The primary outcome is the occurrence of sexual violence during the first 12 months following inclusion, defined as any reported incident of rape, attempted rape, sexual assault, or sexual exhibition.
Secondary outcomes include the occurrence of sexual violence and rape between 12 and 18 months, physical and mental health status, health-related quality of life, access to recommended healthcare, acceptability of the care model, fidelity of implementation, efficiency, and transposability. Quantitative data are complemented by qualitative analyses exploring participant and professional experiences, implementation barriers, and facilitators.
The follow-up period between 12 and 18 months, conducted after completion of the coordinated care phase, is intended to assess the persistence of effects after the end of active care coordination. This period allows evaluation of whether the model facilitates sustained integration into routine healthcare services and whether protective effects, particularly regarding exposure to sexual violence and related health outcomes, are maintained beyond the coordination phase.
Expected Outcomes and Impact Women seeking asylum constitute a population characterised by heightened vulnerability and a particularly high exposure to sexual violence throughout the migration trajectory. By evaluating a coordinated, transcultural model of care explicitly designed to account for this vulnerability within a preventive framework, this study aims to generate robust evidence on an approach that goes beyond isolated clinical or social interventions.
Identifying a coordinated care model capable of preventing sexual violence in host countries would support its extension across European settings and inform the development of harmonised, evidence-based public policies addressing violence prevention among asylum-seeking populations. Such generalisation could contribute to reducing sexual violence among a population already disproportionately affected and to improving equity in access to care.
More broadly, this project seeks to evaluate a model of vulnerability-informed care that could be adapted and transferred to other populations exposed to violence in different social and healthcare contexts. To date, no care-model evaluation studies have addressed the prevention of sexual violence in the general population. Demonstrating the effectiveness, feasibility, and efficiency of this coordinated model of care in a high-risk population may therefore have wider international implications, informing public health strategies, guiding policy-makers in the organisation of inclusive and preventive health systems, and contributing to the development of transferable frameworks that integrate vulnerability as a core determinant of care organisation within contemporary societies.
Interventions
- Other care coordinator
The care coordinator ensures organisation of the care pathway, liaison between professionals, and longitudinal follow-up in collaboration with a general practitioner. - Other a trained health mediator
The health mediator facilitates communication, supports participants in navigating healthcare and social systems, and helps reduce linguistic, cultural, and administrative barriers. - Other Access to care in the usual care
Depends on asylum seekers' individual initiatives - Other Access to care in the Coordinated care model
Systematically initiated from registration at the first reception centre (PADA) - Other Coordination
Fragmented, dependent on local structures - Other Coordination
Provided by a coordinating care professionnal - Other Detection of sexual violence
Based on victims' self-reporting - Other Detection of sexual violence
Proactive approach with health mediation and training of healthcare professionals - Other Medical follow-up
Irregular, often interrupted due to precarious living conditions - Other Medical follow-up
Progressive integration into mainstream healthcare services
Primary outcome measures
- Occurrence of sexual violence within 12 months after inclusion [Time frame: 12 months after inclusion]
Secondary outcome measures (12)
- Occurrence of rape within 12 months after inclusion [Time frame: 12 months after inclusion]
- Occurrence of sexual violence between 12 and 18 months after inclusion [Time frame: 12 to 18 months after inclusion]
- Occurrence of rape between 12 and 18 months after inclusion [Time frame: 12 to 18 months after inclusion]
- Measurement and Assessment of somatic symptoms [Time frame: at Baseline]
- Measurement and Assessment of somatic symptoms [Time frame: at 3 months]
- Measurement and Assessment of somatic symptoms [Time frame: at 6 months]
- Measurement and Assessment of somatic symptoms [Time frame: at 9 months]
- Measurement and Assessment of somatic symptoms [Time frame: at 12 months]
- Measurement and Assessment of somatic symptoms [Time frame: at 15 months]
- Measurement and Assessment of somatic symptoms [Time frame: at 18 months]
- Measurement and Assessment of anxiety and depression symptoms [Time frame: at Baseline]
- Measurement and Assessment of anxiety and depression symptoms [Time frame: at 3 months]
Eligibility criteria
Inclusion criteria
- Woman seeking asylum in France
- Asylum application registered less than 3 months before inclusion.
- Self-identified female gender.
- Age ≥ 18 years.
- Received study information and provided informed consent to participate
Exclusion criteria
- Re-examination of a previous asylum application.
- Major cognitive impairment (e.g. dementia or intellectual disability) preventing reliable collection of study outcomes.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 6 centers
- Maison de Santé de Saint André — Bordeaux
- MSP soins premiers Villeurbanne Est — Lyon
- Maison de Santé PEYSSONEL — Marseille
- Maison de Santé Butte Sainte Anne — Nantes
- MSP Mathagon — Paris
- Maison de santé Bonnefoy Périole Roseraie — Toulouse
Identifiers
NCT: NCT07477314 · RCAPHM25_0426 · 2025-A02052-47