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.
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
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)
Single group
Anal smear
Diagnostic testThe intervention in this study involves the anal smear collection using the FLOQSwab® (COPAN, pouch type 502CS01). The swab is inserted 3-5 cm into the anal canal, reaching the transitional zone, the pressed against the canal wall and withdrawn in a spiral motion over approximately 20 seconds. After collection, the swab is immediately placed into a ThinPrep vial containing 20 ml of PreservCyt® and rinsed vigorously. The procedure is performed by a physician or trained study team member and is designed to be quick, minimally invasive, and comfortable for participants. The FLOQSwab®'s patient-friendly design reduces irritation and false-positive results in comparison to earlier methods. Samples collected in the ThinPrep PreservCyt® solution should be stored at room temperature and transferred to AML within a maximum of six weeks
Self-administered questionnaire
BehavioralIt includes questions related to: Socio-demographic characteristics Health-related issues Past HPV vaccination (indication? age at vaccination?) History of condylomata and/or other STIs Drug use, tobacco use, alcohol use Anal symptoms: discomfort, itch, pain, nodules, blood loss/discharge, constipation Sexual behavior Insertive/receptive intercourse, chemsex, number of sex partners (stable, occasional, anonymous), condom use.
EQ-5D-5L questionnaire
BehavioralThis questionnaire will be used after a negative HRA or during the communication of the results (per telephone) and during the treatment if indicated. This questionnaire assesses the impact of health conditions and treatments on person's quality of life. We will use an adapted version of the EQ-5D-5L. This modified version includes additional questions tailored to assess specific domains highlighted in the A-HRSI. The additional items cover: * Physical Symptoms: Question on anal symptoms such as pain, discharge, and burning sensations. * Impact on Physical Functioning: Question on how these symptoms affect daily activities, including work, sitting, and social interactions. * Impact on Psychological Functioning: Question on psychological and sexual well-being, including enjoyment and desire for sex, as well as challenges with intimacy.
High Resolution Anoscopy (HRA)
Diagnostic testHRA will be conducted using advanced tools, such as the Zeiss Extaro at UZ Brussel. HRA will be conducted at participating centers with expertise in the technique, including UZ Brussel, UZ Gent, UZ Leuven, UZ Antwerpen, CHU St Pierre, AZ Sint-Jan Brugge, and Citadelle Liège. However, all biopsy specimens will be sent to AML Lab for analysis and stored in the biobank (BB190002). In certain centers, HRA is performed using high-resolution scopes.
Prevalence of anal high-risk HPV infection in MSM-PrEP in Belgium
The primary endpoint aims to determine the prevalence of HR HPV in MSM-PrEP in Belgium.
Prevalence of abnormal anal cytology in MSM using PrEP in Belgium
The secondary endpoint aims to determine the prevalence of abnormal anal cytology in MSM using PrEP in Belgium
Prevalence of abnormal histology, i.e. LSIL and HSIL in MSM using PrEP in Belgium
The third endpoint aims to determine the prevalence of abnormal anal histology in MSM using PrEP in Belgium
Methylation on cytology (screening) samples and histology (HRA) samples
The fourth endpoint aims to investigate methylation profiles according to the cytological or histo-logical results
Accuracy of anal HPV genotyping, anal cytology and methylation, together or as separate tests in the prediction of hHSIL
The fifth endpoint aims to determinate the specificity and sensitivity of anal HPV genotyping, anal cytology and methylation, together and as separate tests, used as screening tests for hHSIL.
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Universitair Ziekenhuis Brussel
Lead sponsor
A.M.L.
Collaborator
