Sexual ViolencePREVISEDANCT07477314
Study on the Prevention of Recidivism and the Consequences of Sexual Violence Suffered by Female Asylum Seekers in France
An observational study of Sexual Violence and Refugee Health, run by Assistance Publique Hopitaux De Marseille at 6 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sexual Violence, Refugee Health, Physical Health
- What is being tested?
- care coordinator, a trained health mediator and Access to care in the Coordinated care model
- How many people
- 675 participants
- Where
- 6 sitesFrance
- Study dates
- 29 Apr 2026to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female seeking asylum in France
Who may be able to join
- 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
Who cannot join
- Re-examination of a previous asylum application.
- Major cognitive impairment (e.g. dementia or intellectual disability) preventing reliable collection of study outcomes.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Maison de Santé de Saint André
Bordeaux
Racha ONAISI, MD, 0033556390590, racha.onaisi@u-bordeaux.fr
- Not yet recruiting
MSP soins premiers Villeurbanne Est
Lyon
Anne HERSART DE LA VILLEMARQUE, MD, 0033674805165, anne.hersart-de-la-villemarque@univ-lyon1.fr
- Recruiting
Maison de Santé PEYSSONEL
Marseille
Jérémy Khouani, MD, jeremy.KHOUANI@univ-amu.fr
- Recruiting
Maison de Santé Butte Sainte Anne
Nantes
Jean-Pascal FOURNIER, MD, jean-pascal.fournier@univ-nantes.fr
- Not yet recruiting
MSP Mathagon
Paris
Josselin LE BEL, MD, 0033188402450, josselin.lebel@medecin.mssante.fr
- Recruiting
Maison de santé Bonnefoy Périole Roseraie
Toulouse
Lisa OUHANON, MD, 0033661594978, lisa.ouanhnon@gmail.com
About this study
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.
Read more
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.
Read the 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
- Being tested
- care coordinator, a trained health mediator, Access to care in the usual care, Access to care in the Coordinated care model, Coordination
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care coordinatorOther
The care coordinator ensures organisation of the care pathway, liaison between professionals, and longitudinal follow-up in collaboration with a general practitioner.
a trained health mediatorOther
The 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 careOther
Depends on asylum seekers' individual initiatives
Access to care in the Coordinated care modelOther
Systematically initiated from registration at the first reception centre (PADA)
CoordinationOther
Fragmented, dependent on local structures
CoordinationOther
Provided by a coordinating care professionnal
Detection of sexual violenceOther
Based on victims' self-reporting
Detection of sexual violenceOther
Proactive approach with health mediation and training of healthcare professionals
Medical follow-upOther
Irregular, often interrupted due to precarious living conditions
Medical follow-upOther
Progressive integration into mainstream healthcare services
Training of professionalsOther
Variable, not standardized
Training of professionalsOther
Specialized and systematic training on sexual violence
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: care coordinator; Other: a trained health mediator; Other: Access to care in the usual care; Other: Coordination; Other: Detection of sexual violence; Other: Medical follow-up; Other: Training of professionals | |
| 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. Receives: Other: Access to care in the Coordinated care model; Other: Coordination; Other: Detection of sexual violence; Other: Medical follow-up; Other: Training of professionals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after inclusion
Secondary outcomes (46)
Occurrence of rape within 12 months after inclusion
Occurrence of rape during the first 12 months following inclusion, assessed through structured interviews
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: From inclusion to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start29 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual ViolenceStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 675 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Crémieux, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477314
- Sponsor's protocol ID
- RCAPHM25_0426
- Other IDs
- 2025-A02052-47
- Acronym
- PREVISEDA
- Status last verified
- Oct 2026
- First submitted
- 16 Feb 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Prevention of Recidivism and the Consequences of Sexual Violence Suffered by Female Asylum Seekers in France
- ClinicalTrials.gov ID
- NCT07477314
- Acronym / sponsor ID
- PREVISEDA / RCAPHM25_0426
- Conditions
- Sexual Violence, Refugee Health, Physical Health, Mental Health, Quality of Life, Access to Recommended Healthcare
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 675 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coordinated care model | – | Other: care coordinator, Other: a trained health mediator, Other: Access to care in the usual care, Other: Coordination, Other: Detection of sexual violence, Other: Medical follow-up, Other: Training of professionalsThe 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. |
| Comparator - Usual care | – | Other: Access to care in the Coordinated care model, Other: Coordination, Other: Detection of sexual violence, Other: Medical follow-up, Other: Training of professionalsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female seeking asylum in France
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Re-examination of a previous asylum application.
- Major cognitive impairment (e.g. dementia or intellectual disability) preventing reliable collection of study outcomes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| care coordinatorThe care coordinator ensures organisation of the care pathway, liaison between professionals, and longitudinal follow-up in collaboration with a general practitioner. | Other | Coordinated care model |
| a trained health mediatorThe health mediator facilitates communication, supports participants in navigating healthcare and social systems, and helps reduce linguistic, cultural, and administrative barriers. | Other | Coordinated care model |
| Access to care in the usual careDepends on asylum seekers' individual initiatives | Other | Coordinated care model |
| Access to care in the Coordinated care modelSystematically initiated from registration at the first reception centre (PADA) | Other | Comparator - Usual care |
| CoordinationFragmented, dependent on local structures | Other | Comparator - Usual care |
| CoordinationProvided by a coordinating care professionnal | Other | Coordinated care model |
| Detection of sexual violenceBased on victims' self-reporting | Other | Comparator - Usual care |
| Detection of sexual violenceProactive approach with health mediation and training of healthcare professionals | Other | Coordinated care model |
| Medical follow-upIrregular, often interrupted due to precarious living conditions | Other | Comparator - Usual care |
| Medical follow-upProgressive integration into mainstream healthcare services | Other | Coordinated care model |
| Training of professionalsVariable, not standardized | Other | Comparator - Usual care |
| Training of professionalsSpecialized and systematic training on sexual violence | Other | Coordinated care model |
Primary outcome
Occurrence of sexual violence within 12 months after inclusion
Time frame: 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.
46 secondary outcomes
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
Measurement and Assessment of anxiety and depression symptoms
Time frame: at 6 months
Measurement and Assessment of anxiety and depression symptoms
Time frame: at 9 months
Measurement and Assessment of anxiety and depression symptoms
Time frame: at 12 months
Measurement and Assessment of anxiety and depression symptoms
Time frame: at 15 months
Measurement and Assessment of anxiety and depression symptoms
Time frame: at 18 months
Measurement and Assessment of post-traumatic symdrom
Time frame: at Baseline
Measurement and Assessment of post-traumatic symdrom
Time frame: at 3 months
Measurement and Assessment of post-traumatic symdrom
Time frame: at 6 months
Measurement and Assessment of post-traumatic symdrom
Time frame: at 9 months
Measurement and Assessment of post-traumatic symdrom
Time frame: at 12 months
Measurement and Assessment of post-traumatic symdrom
Time frame: at 15 months
Measurement and Assessment of post-traumatic symdrom
Time frame: at 18 months
Measurement and assesmment of perceived health
Time frame: at Baseline
Measurement and assesmment of perceived health
Time frame: at 3 months
Measurement and assesmment of perceived health
Time frame: at 6 months
Measurement and assesmment of perceived health
Time frame: at 9 months
Measurement and assesmment of perceived health
Time frame: at 12 months
Measurement and assesmment of perceived health
Time frame: at 15 months
Measurement and assesmment of perceived health
Time frame: at 18 months
Measurement and assesment of quality of life
Time frame: at Baseline
Measurement and assesment of quality of life
Time frame: at 3 months
Measurement and assesment of quality of life
Time frame: at 6 months
Measurement and assesment of quality of life
Time frame: at 9 months
Measurement and assesment of quality of life
Time frame: at 12 months
Measurement and assesment of quality of life
Time frame: at 15 months
Measurement and assesment of quality of life
Time frame: at 18 months
Analysis of access to recommended healthcare
Time frame: at 3 months
Analysis of access to recommended healthcare
Time frame: at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François Crémieux study director
AP-HM
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Violence and Refugee Health, run by Assistance Publique Hopitaux De Marseille at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeremy Khouani, MD (0033491435903, jeremy.KHOUANI@univ-amu.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of sexual violence within 12 months after inclusion (time frame: 12 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.