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.
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.
Study Type
OBSERVATIONAL
Enrollment
675
The care coordinator ensures organisation of the care pathway, liaison between professionals, and longitudinal follow-up in collaboration with a general practitioner.
The health mediator facilitates communication, supports participants in navigating healthcare and social systems, and helps reduce linguistic, cultural, and administrative barriers.
Depends on asylum seekers' individual initiatives
Systematically initiated from registration at the first reception centre (PADA)
Fragmented, dependent on local structures
Provided by a coordinating care professionnal
Based on victims' self-reporting
Proactive approach with health mediation and training of healthcare professionals
Irregular, often interrupted due to precarious living conditions
Progressive integration into mainstream healthcare services
Variable, not standardized
Specialized and systematic training on sexual violence
Maison de Santé de Saint André
Bordeaux, France
MSP soins premiers Villeurbanne Est
Lyon, France
Maison de Santé PEYSSONEL
Marseille, France
Maison de Santé Butte Sainte Anne
Nantes, France
MSP Mathagon
Paris, France
Maison de santé Bonnefoy Périole Roseraie
Toulouse, France
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.
Time frame: 12 months after inclusion
Occurrence of rape within 12 months after inclusion
Occurrence of rape during the first 12 months following inclusion, assessed through structured interviews
Time frame: 12 months after inclusion
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.
Time frame: 12 to 18 months after inclusion
Occurrence of rape between 12 and 18 months after inclusion
Occurrence of rape events reported between 12 and 18 months following inclusion.
Time frame: 12 to 18 months after 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.
Time frame: at Baseline
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.
Time frame: at 3 months
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.
Time frame: at 6 months
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.
Time frame: at 9 months
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.
Time frame: at 12 months
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.
Time frame: at 15 months
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 indicated better health.
Time frame: at 18 months
Measurement and Assessment of anxiety and depression symptoms
Mental health assessed using scales PHQ-4 for anxiety and depression. PHQ-4 scale consists of 4 items with score ranged from 0 to 12, with lower scores indicating no symptom of anxiety or depression.
Time frame: at Baseline
Measurement and Assessment of anxiety and depression symptoms
Mental health assessed using scales HSCL-25 for anxiety and depression. HSCL-25 scale consists of 25 items with score ranged from 1 to 4, with lower scores indicated lowers or none symptoms of anxiety or depression.
Time frame: at 3 months
Measurement and Assessment of anxiety and depression symptoms
Mental health assessed using scales HSCL-25 for anxiety and depression. HSCL-25 scale consists of 25 items with score ranged from 1 to 4, with lower scores indicating lowers or none symptom of anxiety or depression.
Time frame: at 6 months
Measurement and Assessment of anxiety and depression symptoms
Mental health assessed using scales HSCL-25 for anxiety and depression. HSCL-25 scale consists of 25 items with score ranged from 1 to 4, with lower scores indicating lowers or none symptoms of anxiety or depression.
Time frame: at 9 months
Measurement and Assessment of anxiety and depression symptoms
Mental health assessed using scales HSCL-25 for anxiety and depression. HSCL-25 scale consists of 25 items with score ranged from 1 to 4, with lower scores indicating lowers or none symptoms of anxiety or depression.
Time frame: at 12 months
Measurement and Assessment of anxiety and depression symptoms
Mental health assessed using scales HSCL-25 for anxiety and depression. HSCL-25 scale consists of 25 items with score ranged from 1 to 4, with lower scores indicating lowers or none symptoms of anxiety or depression.
Time frame: at 15 months
Measurement and Assessment of anxiety and depression symptoms
Mental health assessed using scales HSCL-25 for anxiety and depression. HSCL-25 scale consists of 25 items with score ranged from 1 to 4, with lower scores indicating lowers or none symptoms of anxiety or depression.
Time frame: at 18 months
Measurement and Assessment of post-traumatic symdrom
Mental health assessed using scale PC-PTSD-5 for post-traumatic symdrom. PC-PTSD-5 scale consits of 5 items with score ranged from 0 to 5, with lower scores indicating no symptoms.
Time frame: at Baseline
Measurement and Assessment of post-traumatic symdrom
Mental health assessed using scale PCL-5 for post-traumatic symdrom. PCL-5 scale consits of 20 items with score ranged from 0 to 80, with scores below 20 indicating no symptoms.
Time frame: at 3 months
Measurement and Assessment of post-traumatic symdrom
Mental health assessed using scale PCL-5 for post-traumatic symdrom. PCL-5 scale consits of 20 items with score ranged from 0 to 80, with scores below 20 indicating no symptoms.
Time frame: at 6 months
Measurement and Assessment of post-traumatic symdrom
Mental health assessed using scale PCL-5 for post-traumatic symdrom. PCL-5 scale consits of 20 items with score ranged from 0 to 80, with scores below 20 indicating no symptoms.
Time frame: at 9 months
Measurement and Assessment of post-traumatic symdrom
Mental health assessed using scale PCL-5 for post-traumatic symdrom. PCL-5 scale consits of 20 items with score ranged from 0 to 80, with scores below 20 indicating no symptoms.
Time frame: at 12 months
Measurement and Assessment of post-traumatic symdrom
Mental health assessed using scale PCL-5 for post-traumatic symdrom. PCL-5 scale consits of 20 items with score ranged from 0 to 80, with scores below 20 indicating no symptoms.
Time frame: at 15 months
Measurement and Assessment of post-traumatic symdrom
Mental health assessed using scale PCL-5 for post-traumatic symdrom. PCL-5 scale consits of 20 items with score ranged from 0 to 80, with scores below 20 indicating no symptoms.
Time frame: at 18 months
Measurement and assesmment of perceived health
the perceived health is assessed using the scale EQ-5D-5L. The scale consits in 5 items. Scores range from 0 and 1, with higher scores indicating better quality of life.
Time frame: at Baseline
Measurement and assesmment of perceived health
the perceived health is assessed using the scale EQ-5D-5L. The scale consits in 5 items. Scores range from 0 and 1, with higher scores indicating better quality of life.
Time frame: at 3 months
Measurement and assesmment of perceived health
the perceived health is assessed using the scale EQ-5D-5L. The scale consits in 5 items. Scores range from 0 and 1, with higher scores indicating better quality of life.
Time frame: at 6 months
Measurement and assesmment of perceived health
the perceived health is assessed using the scale EQ-5D-5L. The scale consits in 5 items. Scores range from 0 and 1, with higher scores indicating better quality of life.
Time frame: at 9 months
Measurement and assesmment of perceived health
the perceived health is assessed using the scale EQ-5D-5L. The scale consits in 5 items. Scores range from 0 and 1, with higher scores indicating better quality of life.
Time frame: at 12 months
Measurement and assesmment of perceived health
the perceived health is assessed using the scale EQ-5D-5L. The scale consits in 5 items. Scores range from 0 and 1, with higher scores indicating better quality of life.
Time frame: at 15 months
Measurement and assesmment of perceived health
the perceived health is assessed using the scale EQ-5D-5L. The scale consits in 5 items. Scores range from 0 and 1, with higher scores indicating better quality of life.
Time frame: at 18 months
Measurement and assesment of quality of life
Health-related quality of life is assessed using the Short form 12 Health Survey (SF-12). Two subscores: Physical component score (PCS) for physical health-related quality of life (HRQoL), mental component score (MCS) for mental HRQoL. Scores range from 0 to 100 with higher scores indicating better HRQoL
Time frame: at Baseline
Measurement and assesment of quality of life
Health-related quality of life is assessed using the Short form 12 Health Survey (SF-12). Two subscores: Physical component score (PCS) for physical health-related quality of life (HRQoL), mental component score (MCS) for mental HRQoL. Scores range from 0 to 100 with higher scores indicating better HRQoL
Time frame: at 3 months
Measurement and assesment of quality of life
Health-related quality of life is assessed using the Short form 12 Health Survey (SF-12). Two subscores: Physical component score (PCS) for physical health-related quality of life (HRQoL), mental component score (MCS) for mental HRQoL. Scores range from 0 to 100 with higher scores indicating better HRQoL
Time frame: at 6 months
Measurement and assesment of quality of life
Health-related quality of life is assessed using the Short form 12 Health Survey (SF-12). Two subscores: Physical component score (PCS) for physical health-related quality of life (HRQoL), mental component score (MCS) for mental HRQoL. Scores range from 0 to 100 with higher scores indicating better HRQoL
Time frame: at 9 months
Measurement and assesment of quality of life
Health-related quality of life is assessed using the Short form 12 Health Survey (SF-12). Two subscores: Physical component score (PCS) for physical health-related quality of life (HRQoL), mental component score (MCS) for mental HRQoL. Scores range from 0 to 100 with higher scores indicating better HRQoL
Time frame: at 12 months
Measurement and assesment of quality of life
Health-related quality of life is assessed using the Short form 12 Health Survey (SF-12). Two subscores: Physical component score (PCS) for physical health-related quality of life (HRQoL), mental component score (MCS) for mental HRQoL. Scores range from 0 to 100 with higher scores indicating better HRQoL
Time frame: at 15 months
Measurement and assesment of quality of life
Health-related quality of life is assessed using the Short form 12 Health Survey (SF-12). Two subscores: Physical component score (PCS) for physical health-related quality of life (HRQoL), mental component score (MCS) for mental HRQoL. Scores range from 0 to 100 with higher scores indicating better HRQoL
Time frame: at 18 months
Analysis of access to recommended healthcare
Access to recommended biological is measured by the number of participants completing recommended biological tests : Complete blood count, serum creatinine, AST, ALT, HIV serology, hepatitis B serology (HBs antigen, anti-HBs antibodies, anti-HBc antibodies), hepatitis C serology, syphilis testing, and first-void urine PCR for Chlamydia trachomatis and Neisseria gonorrhoeae.
Time frame: at 3 months
Analysis of access to recommended healthcare
Access to recommended biological is measured by the number of participants completing recommended biological tests : Complete blood count, serum creatinine, AST, ALT, HIV serology, hepatitis B serology (HBs antigen, anti-HBs antibodies, anti-HBc antibodies), hepatitis C serology, syphilis testing, and first-void urine PCR for Chlamydia trachomatis and Neisseria gonorrhoeae.
Time frame: at 12 months
Analysis of the acceptability of the coordinated care model
The acceptability is assessed using the Client Satisfaction Questionnaire (CSQ-8). The scale consits in 8 items. Scores range from 8 to 32, with higher scores indicating hight satisfaction.
Time frame: at 12 months
Analysis of the acceptability of the coordinated care model
Qualitative data will be collected through semi-structured, face-to-face interviews with participants using professional interpretation services when necessary. The interviews will cover the following themes: * Their lived experience of care since their inclusion in the study, explored through several dimensions (accessibility of care, relational aspects, medical aspects, satisfaction); * Their perceptions of the healthcare system and their behaviors within the care pathway; * The barriers and facilitators to engaging in the proposed pathway; * Their expectations regarding the proposed intervention The semi-structured interviews will be conducted by researchers specifically trained in qualitative research interviewing techniques.
Time frame: at 12 months
Analysis of the fidelity of the coordinated care model
Fidelity of implementation of the coordinated, multidisciplinary care model will be assessed based on the extent to which providers adhered to what was specified in the protocol in terms of content, frequency, duration, and coverage of the target population. The content refers to the activities and knowledge that the coordinated multidisciplinary care model is intended to deliver to its beneficiaries. Frequency and duration assess whether the components of the coordinated multidisciplinary care model were delivered as regularly and for as long as planned. Coverage will be evaluated by examining whether all participants assigned to the coordinated multidisciplinary outpatient care model actually received the intervention.
Time frame: at 12 months
Analysis of the transferability of the coordinated care model
Transferability of the coordinated care model is assessed through qualitative interviews with healthcare professionals
Time frame: at 12 months
Analysis of the transferability of the coordinated care model
Transferability of the coordinated care model is assessed through evaluation of integration of participants into routine care pathways (description of the healthcare and support services received by the participants)
Time frame: At 18 months
Evaluation of the Cost-effectiveness of the coordinated care model
Efficiency will be evaluated by comparing the costs associated with healthcare utilization at 12 months, as well as the costs of social and legal support and quality-of-life outcomes. In addition, an incremental cost-utility ratio will be calculated to compare the coordinated multidisciplinary outpatient care model with usual care over the 12-month follow-up period
Time frame: From inclusion to 12 months
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