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

February 12, 2024 updated by: Centre Hospitalier Universitaire Saint Pierre

Prevalence of HPV and HPV Vaccination Among Victims of Sexual Violence

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women admitted for sexual assault to the SACC (Sexual Assault Care Center) of the CHU Saint-Pierre of Brussel

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to evaluate the prevalence of HPV infections in the population of women over 15 years victim of sexual assault
Time Frame: at the admission
at the admission

Secondary Outcome Measures

Outcome Measure
Time Frame
To characterize HPV subtypes, according to the type of assault and infected sites
Time Frame: at the admission
at the admission
To determine the prevalence of HPV and the clearance in HPV-vaccinated and unvaccinated patients
Time Frame: at the admission and one year later
at the admission and one year later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Charlotte Rousseau, Dr, Centre Hospitalier Universitaire Saint Pierre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Estimated)

February 13, 2024

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B0762023230706

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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