Prevalence of Anal High-risk Human Papilloma Virus Infection and Abnormal Anal Cytology in Men Who Have Sex With Men Using Pre Exposure Prophylaxis
1 other identifier
interventional
304
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 20, 2020
CompletedFirst Submitted
Initial submission to the registry
April 16, 2021
CompletedFirst Posted
Study publicly available on registry
July 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2025
CompletedDecember 18, 2025
June 1, 2024
2.5 years
April 16, 2021
December 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the prevalence of anal high risk HPV infection in MSM using PrEP
2 year
Secondary Outcomes (3)
To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV uninfected MSM not using PrEP
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
Other Outcomes (2)
to determine the correlation between abnormal cytology and HPV infection in MSM using PrEP
2 year
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
2 year
Study Arms (2)
HAS-N
ACTIVE COMPARATORIn this arm the patient without HIV using PrEP will be included
HAS-P
ACTIVE COMPARATORIn this arm the patient with HIV will be included
Interventions
anal sampling will be performed both in men without HIV and men having HIV in order to see if they have HPV or not
Eligibility Criteria
You may qualify if:
- HIV uninfected MSM of 18 years or older using PrEP since at least 3 months
- HIV-infected MSM of 18 years or older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitair ziekenhuis Brussel
Brussels, 1090, Belgium
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2021
First Posted
July 6, 2021
Study Start
October 20, 2020
Primary Completion
May 4, 2023
Study Completion
November 30, 2025
Last Updated
December 18, 2025
Record last verified: 2024-06