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

NCT ID: NCT04950101

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2025-11-30

Brief Summary

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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

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Conditions

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Human Papilloma Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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HAS-N

In this arm the patient without HIV using PrEP will be included

Group Type ACTIVE_COMPARATOR

anal sampling

Intervention Type OTHER

anal sampling will be performed both in men without HIV and men having HIV in order to see if they have HPV or not

HAS-P

In this arm the patient with HIV will be included

Group Type ACTIVE_COMPARATOR

anal sampling

Intervention Type OTHER

anal sampling will be performed both in men without HIV and men having HIV in order to see if they have HPV or not

Interventions

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anal sampling

anal sampling will be performed both in men without HIV and men having HIV in order to see if they have HPV or not

Intervention Type OTHER

Eligibility Criteria

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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

* 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


* none
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitair ziekenhuis Brussel

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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HPV Study

Identifier Type: -

Identifier Source: org_study_id