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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04078789
Recruitment Status : Not yet recruiting
First Posted : September 6, 2019
Last Update Posted : April 1, 2022
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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
Sexually Transmitted Diseases

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
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Study Type : Observational
Estimated 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)
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. post-exposure prophylaxis requirement and surveillance termination [ Time Frame: 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 [ Time Frame: at 1 year ]
    Description of victims consulting at the medico-legal unit.

  2. Follow-up in medico-legal unit [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Anyone declaring to be a victim of sexual assault and consulting in the medico-legal unit on judicial requisition (minors and adults).
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04078789


Contacts
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Contact: Céline Dufort, MD +33147107698 céline.durfort@aphp.fr
Contact: Dhiba Marigot-Outtandy, MD +33147107770 dhiba.marigot-outtandy@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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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
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04078789    
Other Study ID Numbers: APHP190619
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: April 1, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
sex offenses
sexually transmitted diseases
traumatic injury
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Communicable Diseases
Infections
Genital Diseases
 Urogenital Diseases
Disease Attributes
Pathologic Processes