Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06255938
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-02-01
Brief Title:
Prevalence of HPV Human Papilloma Virus and HPV Vaccination Among Victims of Sexual Violence
Sponsor:
Centre Hospitalier Universitaire Saint Pierre
Organization:
Centre Hospitalier Universitaire Saint Pierre
Study Overview
Official Title:
Prevalence of HPV and HPV Vaccination Among Victims of Sexual Violence
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
By a prospective single center cohort study in the Sexual Assault Care Center SACC of the CHU Centre Hospitalier universitaire Saint Pierre in Brussels we would like to
to evaluate the prevalence of HPV infections in the population of women over 15 years old admitted for rape
to determine the prevalence of HPV and the clearance in HPV-vaccinated and unvaccinated patients
to evaluate the prevalence of HPV infections in the population of women over 15 years old admitted for rape
to determine the prevalence of HPV and the clearance in HPV-vaccinated and unvaccinated patients
Detailed Description:
The investigators will conduct a prospective single center cohort study in the SACC of the CHU Saint Pierre in Brussels
Population
the investigators will include all women over 15 years admitted to the SACC of Brussels between 5022024 and 05022024 for rape vaginal andor oral andor anal penetration after signing the consent
PCR polymerase chain reaction smears for HPV testing will be performed after obtaining consent from the victims These smears will be performed at the oral vaginal and anal site The smears will be taken either by the patient or by the legal nurse according to the victims wishes Ideally 3 smears should be taken oral vaginal and anal
It will be carried out at the same time as all other sexual transmitted deseases tests and should therefore not be perceived as more invasive or time-consuming
These smears will be performed two times at the first visit of the patients to the SACC and after 12 at 18 months
Appointment reminders will be sent by phone contact
The test used is a swab analyzed by PCR via the AML laboratory They confirmed that this is the most sensitive method for detecting HPV in vaginal and anal areas and probably also in oral areas
The HPVs obtained via PCR are 16 18 45 33 58 31 52 35 59 39 51 56 68 67 53 66 6 and 11 Results will therefore be classified as low-risk high-risk or HPV-negative
Patients will be notified if a high-risk HPV test is detected and treatment will be offered depending on the type of follow-up required according to the international recommendations
Outcomes
Define high-risk HPV carriage in the SACC population
Define the proportion of SACC patients vaccinated for HPV
Secondary objectives
To characterize HPV subtypes according to the type of assault and infected sites vaginal-cervical anal oral
To determine the prevalence of HPV and the clearance in HPV-vaccinated and unvaccinated patients itself assessed by the presence of one type of HPV in the first smear and its absence in the followed smears
Population
the investigators will include all women over 15 years admitted to the SACC of Brussels between 5022024 and 05022024 for rape vaginal andor oral andor anal penetration after signing the consent
PCR polymerase chain reaction smears for HPV testing will be performed after obtaining consent from the victims These smears will be performed at the oral vaginal and anal site The smears will be taken either by the patient or by the legal nurse according to the victims wishes Ideally 3 smears should be taken oral vaginal and anal
It will be carried out at the same time as all other sexual transmitted deseases tests and should therefore not be perceived as more invasive or time-consuming
These smears will be performed two times at the first visit of the patients to the SACC and after 12 at 18 months
Appointment reminders will be sent by phone contact
The test used is a swab analyzed by PCR via the AML laboratory They confirmed that this is the most sensitive method for detecting HPV in vaginal and anal areas and probably also in oral areas
The HPVs obtained via PCR are 16 18 45 33 58 31 52 35 59 39 51 56 68 67 53 66 6 and 11 Results will therefore be classified as low-risk high-risk or HPV-negative
Patients will be notified if a high-risk HPV test is detected and treatment will be offered depending on the type of follow-up required according to the international recommendations
Outcomes
Define high-risk HPV carriage in the SACC population
Define the proportion of SACC patients vaccinated for HPV
Secondary objectives
To characterize HPV subtypes according to the type of assault and infected sites vaginal-cervical anal oral
To determine the prevalence of HPV and the clearance in HPV-vaccinated and unvaccinated patients itself assessed by the presence of one type of HPV in the first smear and its absence in the followed smears
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None