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OpenTrials
Completed

NCT Number: NCT04950101

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

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.

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Key information

Conditions

Human Papilloma Virus

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Universitair ziekenhuis Brussel

Brussels, 1090, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anal sampling

Other

anal sampling will be performed both in men without HIV and men having HIV in order to see if they have HPV or not

Primary outcomes

  1. To determine the prevalence of anal high risk HPV infection in MSM using PrEP

    Time frame: 2 year

Secondary outcomes

  1. 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. To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV infected MSM

    Time frame: 2 year

  3. to determine the prevalence of abnormal anal cytology in MSM using PrEP and in HIV infected MSM

    Time frame: 2 year

Other outcomes

  1. to determine the correlation between abnormal cytology and HPV infection in MSM using PrEP

    Time frame: 2 year

  2. 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

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
Jul 6, 2021
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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