Study on the Prevention of Recidivism and the Consequences of Sexual Violence Suffered by Female Asylum Seekers in France
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 675
- 试验地点
- 6
- 主要终点
- Occurrence of sexual violence within 12 months after inclusion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Re-examination of a previous asylum application.
- •Major cognitive impairment (e.g. dementia or intellectual disability) preventing reliable collection of study outcomes.
研究组 & 干预措施
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.
干预措施: care coordinator (Other)
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.
干预措施: a trained health mediator (Other)
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.
干预措施: Access to care in the usual care (Other)
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.
干预措施: Coordination (Other)
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.
干预措施: Detection of sexual violence (Other)
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.
干预措施: Medical follow-up (Other)
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.
干预措施: Training of professionals (Other)
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.
干预措施: Access to care in the Coordinated care model (Other)
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.
干预措施: Coordination (Other)
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.
干预措施: Detection of sexual violence (Other)
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.
干预措施: Medical follow-up (Other)
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.
干预措施: Training of professionals (Other)
结局指标
主要结局
Occurrence of sexual violence within 12 months after inclusion
时间窗: 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.
次要结局
- Occurrence of rape within 12 months after inclusion(12 months after inclusion)
- Occurrence of sexual violence between 12 and 18 months after inclusion(12 to 18 months after inclusion)
- Occurrence of rape between 12 and 18 months after inclusion(12 to 18 months after inclusion)
- Measurement and Assessment of somatic symptoms(at Baseline)
- Measurement and Assessment of somatic symptoms(at 3 months)
- Measurement and Assessment of somatic symptoms(at 6 months)
- Measurement and Assessment of somatic symptoms(at 9 months)
- Measurement and Assessment of somatic symptoms(at 12 months)
- Measurement and Assessment of somatic symptoms(at 15 months)
- Measurement and Assessment of somatic symptoms(at 18 months)
- Measurement and Assessment of anxiety and depression symptoms(at 3 months)
- Measurement and Assessment of anxiety and depression symptoms(at 9 months)
- Measurement and Assessment of anxiety and depression symptoms(at 12 months)
- Measurement and Assessment of anxiety and depression symptoms(at 15 months)
- Measurement and Assessment of anxiety and depression symptoms(at 18 months)
- Measurement and Assessment of post-traumatic symdrom(at Baseline)
- Measurement and Assessment of post-traumatic symdrom(at 3 months)
- Measurement and Assessment of post-traumatic symdrom(at 6 months)
- Measurement and Assessment of post-traumatic symdrom(at 9 months)
- Measurement and Assessment of post-traumatic symdrom(at 12 months)
- Measurement and Assessment of post-traumatic symdrom(at 15 months)
- Measurement and Assessment of post-traumatic symdrom(at 18 months)
- Measurement and assesmment of perceived health(at Baseline)
- Measurement and assesmment of perceived health(at 3 months)
- Measurement and assesmment of perceived health(at 6 months)
- Measurement and assesmment of perceived health(at 9 months)
- Measurement and assesmment of perceived health(at 12 months)
- Measurement and assesmment of perceived health(at 15 months)
- Measurement and assesmment of perceived health(at 18 months)
- Measurement and assesment of quality of life(at Baseline)
- Measurement and assesment of quality of life(at 3 months)
- Measurement and assesment of quality of life(at 6 months)
- Measurement and assesment of quality of life(at 9 months)
- Measurement and assesment of quality of life(at 12 months)
- Measurement and assesment of quality of life(at 15 months)
- Measurement and assesment of quality of life(at 18 months)
- Analysis of access to recommended healthcare(at 3 months)
- Analysis of access to recommended healthcare(at 12 months)
- Analysis of the acceptability of the coordinated care model(at 12 months)
- Analysis of the fidelity of the coordinated care model(at 12 months)
- Analysis of the transferability of the coordinated care model(at 12 months)
- Analysis of the transferability of the coordinated care model(At 18 months)
- Evaluation of the Cost-effectiveness of the coordinated care model(From inclusion to 12 months)
- Measurement and Assessment of anxiety and depression symptoms(at Baseline)
- Measurement and Assessment of anxiety and depression symptoms(at 6 months)