- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04078789
Evaluation of the Care Path of Patients Who Have Been Sexually Assaulted (AS UMJ/SMI RPC)
Evaluation of the Care Path of Patients Who Have Been Sexually Assaulted, at Raymond Poincaré Hospital (France)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Céline Dufort, MD
- Telefonnummer: +33147107698
- E-mail: céline.durfort@aphp.fr
Undersøgelse Kontakt Backup
- Navn: Dhiba Marigot-Outtandy, MD
- Telefonnummer: +33147107770
- E-mail: dhiba.marigot-outtandy@aphp.fr
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- People declared being victim of sexual assault;
- Consult at medical-legal unit;
- Judicial requirement.
Exclusion Criteria:
- Absence of judicial requirement.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
post-exposure prophylaxis requirement and surveillance termination
Tidsramme: at 1 year
|
Prevalence of a consultant victim at the medico-legal unit, requiring post-exposure prophylaxis and completing their post-sexual assault surveillance.
|
at 1 year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Consulting at the medico-legal unit
Tidsramme: at 1 year
|
Description of victims consulting at the medico-legal unit.
|
at 1 year
|
|
Follow-up in medico-legal unit
Tidsramme: at 1 year
|
Follow-up of the start of the post-exposure prophylaxis: indication, difficulty of the prescription, respect of the recommendations.
|
at 1 year
|
|
Follow-up in the infectious diseases department
Tidsramme: 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.
|
at 1 year
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Céline Dufort, MD, Unité médico-judiciaire (UMJ), Hôpital Raymond Poincaré, Garches, France
- Studieleder: Dhiba Marigot-Outtandy, MD, Médecine aiguë spécialisée, Hôpital Raymond Poincaré, Garches, France
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- APHP190619
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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