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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Human Papilloma Virus

Intervention / Treatment
-----------------
* Other: anal sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HAS-N<br>In this arm the patient without HIV using PrEP will be included | Other: anal sampling<br>* anal sampling will be performed both in men without HIV and men having HIV in order to see if they have HPV or not<br>|
| Active Comparator: HAS-P<br>In this arm the patient with HIV will be included | Other: anal sampling<br>* anal sampling will be performed both in men without HIV and men having HIV in order to see if they have HPV or not<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the prevalence of anal high risk HPV infection in MSM using PrEP |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV uninfected MSM not using PrEP | comparation will be done with partially using literature | 2 year | 
| To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV infected MSM |  | 2 year | 
| to determine the prevalence of abnormal anal cytology in MSM using PrEP and in HIV infected MSM |  | 2 year |