Human Papilloma VirusNCT06255938
Prevalence of HPV (Human Papilloma Virus) and HPV Vaccination Among Victims of Sexual Violence
An observational study of Human Papilloma Virus and Sexual Assault, run by Centre Hospitalier Universitaire Saint Pierre.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus, Sexual Assault, Sex Abuse
- What is being tested?
- smears
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Feb 2026
- 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 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women admitted for sexual assault to the SACC (Sexual Assault Care Center) of the CHU Saint-Pierre of Brussel
Who may be able to join
- 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)
Who cannot join
- tourist or other people who will not in belgium one year after their first test
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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).
- Conditions
- Human Papilloma Virus, Sexual Assault, Sex Abuse
- Being tested
- smears
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smearsDiagnostic test
PCR smears for HPV testing will be performed
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the prevalence of HPV infections in the population of women over 15 years victim of sexual assault
Measured: at the admission
Secondary outcomes (2)
To characterize HPV subtypes, according to the type of assault and infected sites
Measured: at the admission
To determine the prevalence of HPV and the clearance in HPV-vaccinated and unvaccinated patients
Measured: at the admission and one year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Charlotte Rousseau, Dr, Principal investigator, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255938
- Sponsor's protocol ID
- B0762023230706
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- 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 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of HPV and HPV Vaccination Among Victims of Sexual Violence
- ClinicalTrials.gov ID
- NCT06255938
- Acronym / sponsor ID
- B0762023230706
- Conditions
- Human Papilloma Virus, Sexual Assault, Sex Abuse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 13 Feb 2024 (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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women admitted for sexual assault to the SACC (Sexual Assault Care Center) of the CHU Saint-Pierre of Brussel
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- tourist or other people who will not in belgium one year after their first test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smearsPCR smears for HPV testing will be performed | Diagnostic test | – |
Primary outcome
to evaluate the prevalence of HPV infections in the population of women over 15 years victim of sexual assault
Time frame: at the admission
2 secondary outcomes
To characterize HPV subtypes, according to the type of assault and infected sites
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Human Papilloma Virus
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
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.
Charlotte Rousseau, Dr principal investigator
Centre Hospitalier Universitaire Saint Pierre
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papilloma Virus and Sexual Assault, run by Centre Hospitalier Universitaire Saint Pierre.
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 1 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 13 Feb 2024. 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 charlotte Rousseau, Dr (003225067075, charlotte.rousseau@stpierre-bru.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the prevalence of HPV infections in the population of women over 15 years victim of sexual assault (time frame: at the admission). 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 13 Feb 2024.