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

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 Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Mental Health; Sexual Violence; Physical Health; Refugee Health; Access to Recommended Healthcare
• Intervention / Treatment: Other: care coordinator; Other: a trained health mediator; Other: Access to care in the usual care; Other: Coordination; Other: Coordination; Other: Detection of sexual violence; Other: Detection of sexual violence; Other: Medical follow-up; Other: Medical follow-up; Other: Training of professionals; Other: Training of professionals; Other: Access to care in the Coordinated care model

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.

• Study Type: Observational
• Enrollment (Estimated): 675

Contacts and Locations

• Study Contact: Name: Jeremy Khouani, MD; Phone Number: 0033491435903; Email: jeremy.KHOUANI@univ-amu.fr

Study Locations

• France
  • Bordeaux, France
    • Maison de Santé de Saint André
    • Contact: Racha ONAISI, MD; Phone Number: 0033556390590; Email: racha.onaisi@u-bordeaux.fr
  • Lyon, France
    • MSP soins premiers Villeurbanne Est
    • Contact: Anne HERSART DE LA VILLEMARQUE, MD; Phone Number: 0033674805165; Email: anne.hersart-de-la-villemarque@univ-lyon1.fr
  • Marseille, France
    • Maison de Santé PEYSSONEL
    • Contact: Jérémy Khouani, MD; Email: jeremy.KHOUANI@univ-amu.fr
  • Nantes, France
    • Maison de Santé Butte Sainte Anne
    • Contact: Jean-Pascal FOURNIER, MD; Email: jean-pascal.fournier@univ-nantes.fr
  • Paris, France
    • MSP Mathagon
    • Contact: Josselin LE BEL, MD; Phone Number: 0033188402450; Email: josselin.lebel@medecin.mssante.fr
  • Toulouse, France
    • Maison de santé Bonnefoy Périole Roseraie
    • Contact: Lisa OUHANON, MD; Phone Number: 0033661594978; Email: lisa.ouanhnon@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Female seeking asylum in France

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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: 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
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: 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; Other: Access to care in the Coordinated care model; Systematically initiated from registration at the first reception centre (PADA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of rape within 12 months after inclusion	Occurrence of rape during the first 12 months following inclusion, assessed through structured interviews	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.	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.	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.	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.	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.	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.	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.	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.	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.	at 18 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 indicated lowers or none symptoms of anxiety or depression.	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 symptoms of anxiety or depression.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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	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	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	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	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	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	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	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.	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.	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.	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.	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	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)	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	From inclusion to 12 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.	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 indicating lowers or none symptom of anxiety or depression.	at 6 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.	at 12 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: François CREMIEUX, AP-HM

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being; Health Services Administration; Delivery of Health Care; Health Care Quality, Access, and Evaluation; Patient Care Management; Health Services Accessibility
• Other Study ID Numbers: RCAPHM25_0426; 2025-A02052-47 (Other Identifier: AP-HM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No