NCT07477314

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 675 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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
OTHER	Training of professionals	Variable, not standardized
OTHER	Training of professionals	Specialized and systematic training on sexual violence

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-04-01
• Completion: 2028-09-01
• First posted: 2026-03-17
• Last updated: 2026-03-19

Locations

6 sites across 1 country: France