Prevalence of Anal High-risk Human Papilloma Virus Infection and Abnormal Anal Cytology in Men Who Have Sex With Men Using Pre Exposure Prophylaxis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Human Papilloma Virus
- Sponsor
- Universitair Ziekenhuis Brussel
- Enrollment
- 304
- Locations
- 1
- Primary Endpoint
- To determine the prevalence of anal high risk HPV infection in MSM using PrEP
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
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:
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
To determine the prevalence of anal high risk HPV infection in MSM using PrEP
Time Frame: 2 year
Secondary Outcomes
- 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)