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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Céline Dufort, MD; Phone Number: +33147107698; Email: céline.durfort@aphp.fr
• Study Contact Backup: Name: Dhiba Marigot-Outtandy, MD; Phone Number: +33147107770; Email: dhiba.marigot-outtandy@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 120 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

Inclusion Criteria:

• People declared being victim of sexual assault;
• Consult at medical-legal unit;
• Judicial requirement.

Exclusion Criteria:

- Absence of judicial requirement.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-exposure prophylaxis requirement and surveillance termination	Prevalence of a consultant victim at the medico-legal unit, requiring post-exposure prophylaxis and completing their post-sexual assault surveillance.	at 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consulting at the medico-legal unit	Description of victims consulting at the medico-legal unit.	at 1 year
Follow-up in medico-legal unit	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	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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: September 2, 2019
• First Submitted That Met QC Criteria: September 2, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: sex offenses; sexually transmitted diseases; traumatic injury
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: APHP190619

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No