Skip to content

Prevalence of HPV (Human Papilloma Virus) and HPV Vaccination Among Victims of Sexual Violence

Prevalence of HPV and HPV Vaccination Among Victims of Sexual Violence

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06255938
Enrollment
200
Registered
2024-02-13
Start date
2024-02-29
Completion date
2026-02-28
Last updated
2024-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papilloma Virus, Sexual Assault, Sex Abuse

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

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).

Interventions

DIAGNOSTIC_TESTsmears

PCR smears for HPV testing will be performed

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Centre Hospitalier Universitaire Saint Pierre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
to evaluate the prevalence of HPV infections in the population of women over 15 years victim of sexual assaultat the admission

Secondary

MeasureTime frame
To characterize HPV subtypes, according to the type of assault and infected sitesat the admission
To determine the prevalence of HPV and the clearance in HPV-vaccinated and unvaccinated patientsat the admission and one year later

Contacts

Primary Contactcharlotte Rousseau, Dr
charlotte.rousseau@stpierre-bru.be003225067075

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026