NCT04078789

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
2.7 years until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

2.3 years

First QC Date

September 2, 2019

Last Update Submit

March 21, 2022

Conditions

Sexually Transmitted Diseases

Keywords

sex offensessexually transmitted diseasestraumatic injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Consulting at the medico-legal unit

    at 1 year

  • Follow-up in medico-legal unit

    at 1 year

  • Follow-up in the infectious diseases department

    at 1 year

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • \- Absence of judicial requirement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sexually Transmitted DiseasesWounds and Injuries

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Céline Dufort, MD

    Unité médico-judiciaire (UMJ), Hôpital Raymond Poincaré, Garches, France

    PRINCIPAL INVESTIGATOR

  • Dhiba Marigot-Outtandy, MD

    Médecine aiguë spécialisée, Hôpital Raymond Poincaré, Garches, France

    STUDY DIRECTOR

Central Study Contacts

Céline Dufort, MD

CONTACT

+33147107698céline.durfort@aphp.fr

Dhiba Marigot-Outtandy, MD

CONTACT

+33147107770dhiba.marigot-outtandy@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2019

First Posted

September 6, 2019

Study Start

June 1, 2022

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

April 1, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share