임상 레이더 AI | ||
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임상시험 NCT07477314 (PREVISEDA)은(는) 성폭력, 난민 건강, 신체 건강, 정신 건강, 삶의 질, Access to Recommended Healthcare에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Study on the Prevention of Recidivism and the Consequences of Sexual Violence Suffered by Female Asylum Seekers in France (PREVISEDA) 675 국제 예방
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07477314 (PREVISEDA)은(는) 성폭력, 난민 건강, 신체 건강, 정신 건강, 삶의 질, Access to Recommended Healthcare에 대해 알아보는 관찰연구입니다. 현재 상태는 대상자모집전이며, 2026년 4월 1일부터 참여 신청이 가능합니다. 675명의 참여자를 모집할 예정입니다. Assistance Publique Hopitaux De Marseille이(가) 진행하는 이 연구는 2028년 9월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 19일에 갱신되었습니다.
간단한 개요
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 victimisati...더 보기
상세한 설명
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 coordin...
더 보기공식 제목
Study on the Prevention of Recidivism and the Consequences of Sexual Violence Suffered by Female Asylum Seekers in France
질환명
성폭력난민 건강신체 건강정신 건강삶의 질Access to Recommended Healthcare기타 연구 식별자
- PREVISEDA
- RCAPHM25_0426
- 2025-A02052-47 (기타 식별자) (AP-HM)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
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, patie...더 보기 | care coordinator 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 mediator 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 care Depends on asylum seekers' individual initiatives Coordination Provided by a coordinating care professionnal Detection of sexual violence Proactive approach with health mediation and training of healthcare professionals Medical follow-up Progressive integration into mainstream healthcare services 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. | Access to care in the Coordinated care model Systematically initiated from registration at the first reception centre (PADA) Coordination Fragmented, dependent on local structures Detection of sexual violence Based on victims' self-reporting Medical follow-up Irregular, often interrupted due to precarious living conditions Training of professionals Variable, not standardized |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 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 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 symptom of anxiety or depression. | 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. | 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 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 |
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 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
여성
- 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
- Re-examination of a previous asylum application.
- Major cognitive impairment (e.g. dementia or intellectual disability) preventing reliable collection of study outcomes.
Assistance Publique Hopitaux De Marseille연구 대표 연락처
연락처: Jeremy Khouani, MD, 0033491435903, [email protected]
6 1개국에 임상시험 장소
Maison de Santé de Saint André, Bordeaux, France
Racha ONAISI, MD, 연락처, 0033556390590, [email protected]
MSP soins premiers Villeurbanne Est, Lyon, France
Anne HERSART DE LA VILLEMARQUE, MD, 연락처, 0033674805165, [email protected]
Maison de Santé PEYSSONEL, Marseille, France
Jérémy Khouani, MD, 연락처, [email protected]
Maison de Santé Butte Sainte Anne, Nantes, France
Jean-Pascal FOURNIER, MD, 연락처, [email protected]
MSP Mathagon, Paris, France
Josselin LE BEL, MD, 연락처, 0033188402450, [email protected]
Maison de santé Bonnefoy Périole Roseraie, Toulouse, France
Lisa OUHANON, MD, 연락처, 0033661594978, [email protected]