Prevalence of Anal High-risk Human Papilloma Virus Infection and Abnormal Anal Cytology in Men Who Have Sex With Men Using Pre Exposure Prophylaxis

December 11, 2025 updated by: Universitair Ziekenhuis Brussel
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

304

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • HIV uninfected MSM of 18 years or older using PrEP since at least 3 months
  • HIV-infected MSM of 18 years or older

Exclusion Criteria for MSM using PrEP:

  • 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

Exclusion Criteria for MSM infected with HPV:

  • none

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

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HAS-N
In this arm the patient without HIV using PrEP will be included
Other: anal sampling
anal sampling will be performed both in men without HIV and men having HIV in order to see if they have HPV or not
Active Comparator: HAS-P
In this arm the patient with HIV will be included
Other: anal sampling
anal sampling will be performed both in men without HIV and men having HIV in order to see if they have HPV or not

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the prevalence of anal high risk HPV infection in MSM using PrEP
Time Frame: 2 year
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
comparation will be done with partially using literature
2 year
To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV infected MSM
Time Frame: 2 year
2 year
to determine the prevalence of abnormal anal cytology in MSM using PrEP and in HIV infected MSM
Time Frame: 2 year
2 year

Other Outcome Measures

Outcome Measure
Time Frame
to determine the correlation between abnormal cytology and HPV infection in MSM using PrEP
Time Frame: 2 year
2 year
To determine possible correlations between the characteristics asked in the questionnaire and the prevalence of high risk HPV infection in both MSM using PrEP and MSM who have HIV
Time Frame: 2 year
2 year

Collaborators and Investigators

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

Sponsor

Universitair Ziekenhuis Brussel

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 (Actual)

October 20, 2020

Primary Completion (Actual)

May 4, 2023

Study Completion (Actual)

November 30, 2025

Study Registration Dates

First Submitted

April 16, 2021

First Submitted That Met QC Criteria

June 24, 2021

First Posted (Actual)

July 6, 2021

Study Record Updates

Last Update Posted (Estimated)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPV Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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