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

Not Applicable

Active, not recruiting

• Conditions: Human Papilloma Virus
• Interventions: Other: anal sampling

• Registration Number: NCT04950101
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-20
• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-07-06
• Primary Completion: 2023-05-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 304

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HAS-N	anal sampling	In this arm the patient without HIV using PrEP will be included
HAS-P	anal sampling	In this arm the patient with HIV will be included

Primary Outcome Measures

Name	Time	Method
To determine the prevalence of anal high risk HPV infection in MSM using PrEP	2 year

Secondary Outcome Measures

Name	Time	Method
To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV uninfected MSM not using PrEP	2 year	comparation will be done with partially using literature
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

Trial Locations

Locations (1)

Universitair ziekenhuis Brussel; 🇧🇪 Brussels, Belgium