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

Study acronym: PREVISEDA
StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. Notable Recruitment opened Show 4 more changesShow less
    • Start date changed from estimate of Apr 2026 to Apr 29, 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 39 of 46 entries
    • Site details revised at 6 of 6 sites
  2. Minor Secondary endpoints: details revised at 3 of 46 entriesv2
  3. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07477314
Lead Sponsor Assistance Publique Hopitaux De Marseille
Conditions
(from sponsor)
Sexual Violence, Refugee Health, Physical Health, Mental Health, Quality of Life, Access to Recommended Healthcare
Related terms Psychological Well-Being
Enrollment 675 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov