Anal cancer screening for men on PrEP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter study enrolls HIV-uninfected men who have sex with men aged 35 or older who have used PrEP for at least three months. Participants complete health and quality-of-life questionnaires, provide an anal smear, and undergo high-resolution anoscopy (HRA) with biopsy when indicated. Anal cytology results will be compared to HRA/biopsy findings to measure screening accuracy, and DNA methylation testing will be run on samples to explore molecular markers for HSIL. The study will estimate HSIL prevalence in this PrEP-using population and describe any associated quality-of-life impacts.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* HIV-uninfected MSM (men who have sex with men) aged 35 years or older.
* participants must have been using PrEP for at least 3 months.
* Dutch, English or French speaking and writing

Exclusion Criteria:

* Any intervention in the (peri-)anal region within the past 3 months
* Enema usage within 2 h before sampling
* Currently undergoing peri-anal topical HPV-treatment
* HRA in the last year (anal swab or HRA prior to the last year is no exclusion)

Where it's running

• CHU Saint-Pierre
  Brussels, Belgium Recruiting
• Cliniques universitaires Saint-Luc - UCLouvain
  Brussels, Belgium Recruiting
• UZ Brussel
  Brussels, Belgium Recruiting
• UZ Gent
  Ghent, Belgium Recruiting
• Jessaziekenhuis
  Hasselt, Belgium Recruiting
• CHU Charleroi - Chimay
  Lodelinsart, Belgium Recruiting

Study contacts

• Study coordinator: Magali Surmont
• Email: magali.surmont@uzbrussel.be
• Phone: 024776001

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.