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

Universitair Ziekenhuis Brussel

Status: Completed

Conditions: Human Papilloma Virus

Treatments: Other: anal sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT04950101

HPV Study

Details and patient eligibility

About

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.

Enrollment: 304 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

304 participants in 2 patient groups

HAS-N

Active Comparator group

Description:

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

Treatment:

Other: anal sampling

HAS-P

Active Comparator group

Description:

In this arm the patient with HIV will be included

Treatment:

Other: anal sampling