About this trial
This study aims to learn more about anal cancer risk in men who have sex with men (MSM) who are using Pre-Exposure Prophylaxis (PrEP) to prevent HIV. Specifically, we want to check how common High-Grade Squamous Intraepithelial Lesions (HSIL) are in this group, how well anal swabs can screen for these lesions, and how having HSIL affects their quality of life. We'll also test if DNA methylation testing can give us extra information about the lesions.
The main questions the study aims to answer are:
* How common are HSIL in MSM using PrEP? * How accurate are anal swabs for detecting HSIL in this group? * How does having HSIL affect the quality of life of MSM using PrEP? * Can DNA methylation testing help improve our understanding of HSIL in these individuals?
Participants will:
* Answer questions about their health and quality of life. * Have an anal smear collected for testing. * Undergo High-Resolution Anoscopy (HRA) to check for HSIL and get a biopsy if deemed necessary.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Anal smear
- Self-administered questionnaire
- EQ-5D-5L questionnaire
- High Resolution Anoscopy (HRA)
Treatment groups
Sponsors and collaborators
Universitair Ziekenhuis Brussel
Lead sponsor
A.M.L.
Collaborator