Human Papilloma VirusNCT04950101
Prevalence of Anal High-risk Human Papilloma Virus Infection and Abnormal Anal Cytology in Men Who Have Sex With Men Using Pre Exposure Prophylaxis
A study testing anal sampling in people with Human Papilloma Virus, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The aim of the study is to determine the prevalence of anal high-risk HPV infection and abnormal cytology in HIV uninfected Men who have sex with men (MSM) using PrEP and HIV infected MSM followed-up at the S-kliniek or HRC of the UZ Brussel. 200 participants will be preferably included in the study. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus
- What is being tested?
- anal sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Oct 2020to 30 Nov 2025
- Phase
- Interventional
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV uninfected MSM of 18 years or older using PrEP since at least 3 months
- HIV-infected MSM of 18 years or older
Who cannot join
- Any intervention in the (peri-) anal region in the past 3 months
- enema within 24h before sampling
- receptive anal sex within 24h before sampling
- current/ongoing peri-anal topical HPV-treatment
- none
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to determine the prevalence of anal high-risk HPV infection and abnormal cytology in HIV uninfected Men who have sex with men (MSM) using PrEP and HIV infected MSM followed-up at the S-kliniek or HRC of the UZ Brussel. 200 participants will be preferably included in the study. The data will be collected using a self-administered questionnaire where socio-demographic characteristics, health-related issues and sexual behavior will be questioned. Also anal canal sampling will be performed for cytological analysis. For the HIV infected MSM, additional information will be extracted from the patient files: CD4+ T-cell count and nadir and duration of combination antiretroviral therapy.
- Conditions
- Human Papilloma Virus
- Being tested
- anal sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anal samplingOther
anal sampling will be performed both in men without HIV and men having HIV in order to see if they have HPV or not
| Study group | Role | What they receive |
|---|---|---|
| HAS-N | Active comparator | In this arm the patient without HIV using PrEP will be included Receives: Other: anal sampling |
| HAS-P | Active comparator | In this arm the patient with HIV will be included Receives: Other: anal sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the prevalence of anal high risk HPV infection in MSM using PrEP
Measured: 2 year
Secondary outcomes (3)
To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV uninfected MSM not using PrEP
comparation will be done with partially using literature
Measured: 2 year
To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV infected MSM
Measured: 2 year
to determine the prevalence of abnormal anal cytology in MSM using PrEP and in HIV infected MSM
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start20 Oct 2020
- Primary completion4 May 2023
- Study completion30 Nov 2025
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.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950101
- Sponsor's protocol ID
- HPV Study
- Status last verified
- Jun 2024
- First submitted
- 16 Apr 2021
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Anal High-risk Human Papilloma Virus Infection and Abnormal Anal Cytology in Men Who Have Sex With Men Using Pre Exposure Prophylaxis
- ClinicalTrials.gov ID
- NCT04950101
- Acronym / sponsor ID
- HPV Study
- Conditions
- Human Papilloma Virus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 6 Jul 2021 (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.
The aim of the study is to determine the prevalence of anal high-risk HPV infection and abnormal cytology in HIV uninfected Men who have sex with men (MSM) using PrEP and HIV infected MSM followed-up at the S-kliniek or HRC of the UZ Brussel. 200 participants will be preferably included in the study. The data will be collected using a self-administered questionnaire where socio-demographic characteristics, health-related issues and sexual behavior will be questioned. Also anal canal sampling will be performed for cytological analysis. For the HIV infected MSM, additional information will be extracted from the patient files: CD4+ T-cell count and nadir and duration of combination antiretroviral therapy.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAS-N | Active comparator | Other: anal samplingIn this arm the patient without HIV using PrEP will be included |
| HAS-P | Active comparator | Other: anal samplingIn this arm the patient with HIV will be included |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV uninfected MSM of 18 years or older using PrEP since at least 3 months
- HIV-infected MSM of 18 years or older
Key exclusion criteria (5 listed)
- Any intervention in the (peri-) anal region in the past 3 months
- enema within 24h before sampling
- receptive anal sex within 24h before sampling
- current/ongoing peri-anal topical HPV-treatment
- none
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 |
|---|---|---|
| anal samplinganal sampling will be performed both in men without HIV and men having HIV in order to see if they have HPV or not | Other | HAS-N, HAS-P |
Primary outcome
To determine the prevalence of anal high risk HPV infection in MSM using PrEP
Time frame: 2 year
3 secondary outcomes
To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV uninfected MSM not using PrEP
Time frame: 2 year
To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV infected MSM
Time frame: 2 year
to determine the prevalence of abnormal anal cytology in MSM using PrEP and in HIV infected MSM
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anal sampling in people with Human Papilloma Virus, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the prevalence of anal high risk HPV infection in MSM using PrEP (time frame: 2 year). 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 18 Dec 2025.