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

Human Papilloma Virus Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04950101
• Other study ID #: HPV Study
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: March 31, 2025

Study information

• Verified date: June 2024
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 304
• Est. completion date: March 31, 2025
• Est. primary completion date: May 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Human Papilloma Virus
• Papilloma
• Papillomavirus Infections
• Virus Diseases

Intervention

Other:
• 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

Locations

Country	Name	City	State
Belgium	Universitair ziekenhuis Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	to determine the correlation between abnormal cytology and HPV infection in MSM using PrEP		2 year
Other	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
Primary	To determine the prevalence of anal high risk HPV infection in MSM using PrEP		2 year
Secondary	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
Secondary	To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV infected MSM		2 year
Secondary	to determine the prevalence of abnormal anal cytology in MSM using PrEP and in HIV infected MSM		2 year