Sexually Transmitted DiseasesAS UMJ/SMI RPCNCT04078789
Evaluation of the Care Path of Patients Who Have Been Sexually Assaulted
An observational study of Sexually Transmitted Diseases, run by Assistance Publique - Hôpitaux de Paris.
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. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Sexually Transmitted Diseases
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Anyone declaring to be a victim of sexual assault and consulting in the medico-legal unit on judicial requisition (minors and adults).
Who may be able to join
- People declared being victim of sexual assault;
- Consult at medical-legal unit;
- Judicial requirement.
Who cannot join
- Absence of judicial requirement.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sexually Transmitted Diseases
- Keywords
- sex offenses, sexually transmitted diseases, traumatic injury
- Medical subject headings
- Sexually Transmitted Diseases, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 1 year
Secondary outcomes (3)
Consulting at the medico-legal unit
Description of victims consulting at the medico-legal unit.
Measured: 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.
Measured: 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.
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study startJun 2022 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline Dufort, MD, Principal investigator, Unité médico-judiciaire (UMJ), Hôpital Raymond Poincaré, Garches, FranceDhiba Marigot-Outtandy, MD, Study director, Médecine aiguë spécialisée, Hôpital Raymond Poincaré, Garches, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078789
- Sponsor's protocol ID
- APHP190619
- Acronym
- AS UMJ/SMI RPC
- Status last verified
- Mar 2022
- First submitted
- 2 Sep 2019
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Care Path of Patients Who Have Been Sexually Assaulted, at Raymond Poincaré Hospital (France)
- ClinicalTrials.gov ID
- NCT04078789
- Acronym / sponsor ID
- AS UMJ/SMI RPC / APHP190619
- Conditions
- Sexually Transmitted Diseases
- Keywords
- sex offenses, sexually transmitted diseases, traumatic injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Anyone declaring to be a victim of sexual assault and consulting in the medico-legal unit on judicial requisition (minors and adults).
Key inclusion criteria (3 listed)
- People declared being victim of sexual assault;
- Consult at medical-legal unit;
- Judicial requirement.
Key exclusion criteria (1 listed)
- Absence of judicial requirement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Consulting at the medico-legal unit
Time frame: at 1 year
Follow-up in medico-legal unit
Time frame: at 1 year
Follow-up in the infectious diseases department
Time frame: at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline Dufort, MD principal investigator
Unité médico-judiciaire (UMJ), Hôpital Raymond Poincaré, Garches, France
Dhiba Marigot-Outtandy, MD study director
Médecine aiguë spécialisée, Hôpital Raymond Poincaré, Garches, France
Questions about this trial
What is this clinical trial studying?
An observational study of Sexually Transmitted Diseases, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Céline Dufort, MD (+33147107698, céline.durfort@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-exposure prophylaxis requirement and surveillance termination (time frame: at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.