AS UMJ/SMI RPC: Evaluation of the Care Path of Patients Who Have Been Sexually Assaulted

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04078789
Collaborator
(none)
250
27

Study Details

Study Description

Brief Summary

The main objective of this study is to describe the care pathway of patients presenting in the medico-judicial unit of the Raymond Poincaré Hospital in Garches, France, following a complaint for sexual assault and suggest ways to improvement of the care adapted to the characteristics of the participants.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    AS secondary objectives, the study aims to:
    • Analyze the population of victims of sexual assault seen in consultation at the medico-judicial unit of Raymond Poincaré Hospital.

    • Analyze the decision elements of the initiation of the post-exposure treatment and evaluate them against the recommendations.

    • Analyze the data collected on the patients and their follow-up in consultation of infectious disease of the hospital of Garches following a sexual assault.

    • Identify obstacles encountered by participants to follow the complete follow-up path.

    For this purpose the data collection will be done initially within the forensic unit of Raymond Poincaré Hospital. Then, in a second step, the patients requiring the setting up of a post-exposure treatment, are addressed in the service of infectious diseases. The compilations of the data necessary for the study will then be continued until 3 months after the sexual assault.

    For the collection of data, they will be based on the medical records of the victims.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of the Care Path of Patients Who Have Been Sexually Assaulted, at Raymond Poincaré Hospital (France)
    Anticipated Study Start Date :
    Jun 1, 2022
    Anticipated Primary Completion Date :
    Sep 1, 2024
    Anticipated Study Completion Date :
    Sep 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. post-exposure prophylaxis requirement and surveillance termination [at 1 year]

      Prevalence of a consultant victim at the medico-legal unit, requiring post-exposure prophylaxis and completing their post-sexual assault surveillance.

    Secondary Outcome Measures

    1. Consulting at the medico-legal unit [at 1 year]

      Description of victims consulting at the medico-legal unit.

    2. Follow-up in medico-legal unit [at 1 year]

      Follow-up of the start of the post-exposure prophylaxis: indication, difficulty of the prescription, respect of the recommendations.

    3. Follow-up in the infectious diseases department [at 1 year]

      Description of the patients followed in the department of acute medicine specializing in infectious diseases sent by the medico-legal unit following sexual assault: monitoring of sexually transmitted infections, aspects of psychological care, state of coverage vaccine, rate of completion, causes of cessation of the treatment, reasons for the failure of follow-up.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • People declared being victim of sexual assault;

    • Consult at medical-legal unit;

    • Judicial requirement.

    Exclusion Criteria:
    • Absence of judicial requirement.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Céline Dufort, MD, Unité médico-judiciaire (UMJ), Hôpital Raymond Poincaré, Garches, France
    • Study Director: Dhiba Marigot-Outtandy, MD, Médecine aiguë spécialisée, Hôpital Raymond Poincaré, Garches, France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT04078789
    Other Study ID Numbers:
    • APHP190619
    First Posted:
    Sep 6, 2019
    Last Update Posted:
    Apr 1, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 1, 2022