Evaluation of the Care Path of Patients Who Have Been Sexually Assaulted

Sexually Transmitted Diseases Clinical Trial

— AS UMJ/SMI RPC  

Official title:

Evaluation of the Care Path of Patients Who Have Been Sexually Assaulted, at Raymond Poincaré Hospital (France)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04078789
• Other study ID #: APHP190619
• Status: Not yet recruiting
• Start date: June 2022
• Est. completion date: September 2024

Study information

• Verified date: March 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Céline Dufort, MD
• Phone: +33147107698
• Email: céline.durfort[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Years

Eligibility

Inclusion Criteria:

• People declared being victim of sexual assault;

• Consult at medical-legal unit;

• Judicial requirement.

Exclusion Criteria:

• Absence of judicial requirement.

Related Conditions & MeSH terms

• Sexually Transmitted Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Consulting at the medico-legal unit	Description of victims consulting at the medico-legal unit.	at 1 year
Secondary	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
Secondary	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