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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

Primary Purpose

Human Papilloma Virus

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
anal sampling
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Human Papilloma Virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Universitair ziekenhuis BrusselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HAS-N

HAS-P

Arm Description

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

In this arm the patient with HIV will be included

Outcomes

Primary Outcome Measures

To determine the prevalence of anal high risk HPV infection in MSM using PrEP

Secondary Outcome Measures

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
To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV infected MSM
to determine the prevalence of abnormal anal cytology in MSM using PrEP and in HIV infected MSM

Full Information

First Posted
April 16, 2021
Last Updated
August 3, 2022
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT04950101
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HAS-N
Arm Type
Active Comparator
Arm Description
In this arm the patient without HIV using PrEP will be included
Arm Title
HAS-P
Arm Type
Active Comparator
Arm Description
In this arm the patient with HIV will be included
Intervention Type
Other
Intervention Name(s)
anal sampling
Intervention Description
anal sampling will be performed both in men without HIV and men having HIV in order to see if they have HPV or not
Primary Outcome Measure Information:
Title
To determine the prevalence of anal high risk HPV infection in MSM using PrEP
Time Frame
2 year
Secondary Outcome Measure Information:
Title
To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV uninfected MSM not using PrEP
Description
comparation will be done with partially using literature
Time Frame
2 year
Title
To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV infected MSM
Time Frame
2 year
Title
to determine the prevalence of abnormal anal cytology in MSM using PrEP and in HIV infected MSM
Time Frame
2 year
Other Pre-specified Outcome Measures:
Title
to determine the correlation between abnormal cytology and HPV infection in MSM using PrEP
Time Frame
2 year
Title
To determine possible correlations between the characteristics asked in the questionnaire and the prevalence of high risk HPV infection in both MSM using PrEP and MSM who have HIV
Time Frame
2 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Allard
Phone
1923369
Email
sabine.allard@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Virgini Van Buggenhout
Phone
1925014
Email
virgini.vanbuggenhout@uzbrussel.be
Facility Information:
Facility Name
Universitair ziekenhuis Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Allard
Phone
1923369
Email
sabine.allard@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Virgini Van Buggenhout
Phone
1925014
Email
virgini.vanbuggenhout@uzbrussel.be

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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