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Trial Title:
Prevalence of HPV (Human Papilloma Virus) and HPV Vaccination Among Victims of Sexual Violence
NCT ID:
NCT06255938
Condition:
Human Papilloma Virus
Sexual Assault
Sex Abuse
Conditions: Official terms:
Papilloma
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
smears
Description:
PCR smears for HPV testing will be performed
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
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 5/02/2024 and 05/02/2024 for rape (vaginal and/or oral and/or 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 victim's 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).
Criteria for eligibility:
Study pop:
Women admitted for sexual assault to the SACC (Sexual Assault Care Center) of the CHU
Saint-Pierre of Brussel
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- women over 15 years admitted for rape speaking in french, dutch or english (and
therefore able to sign an inform consent in french, dutch or english)
Exclusion Criteria:
- tourist or other people who will not in belgium one year after their first test
Gender:
Female
Minimum age:
15 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
February 2024
Completion date:
February 2026
Lead sponsor:
Agency:
Centre Hospitalier Universitaire Saint Pierre
Agency class:
Other
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Centre Hospitalier Universitaire Saint Pierre
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06255938
