Screening for Anal Cancer in Men Who Have Sex With Men Using Pre-Exposure Prophylaxis (NCT07029152) | Clinical Trial Compass
RecruitingNot Applicable
Screening for Anal Cancer in Men Who Have Sex With Men Using Pre-Exposure Prophylaxis
Belgium296 participantsStarted 2025-09-23
Plain-language summary
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.
Who can participate
Age range
35 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of anal high-risk HPV infection in MSM-PrEP in Belgium
Timeframe: From screening to study completion for the patient (on average 8 months).