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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04950101

Enrollment

304

Registered

2021-07-06

Start date

2020-10-20

Completion date

2025-11-30

Last updated

2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papilloma Virus

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.

Interventions

OTHERanal 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
To determine the prevalence of anal high risk HPV infection in MSM using PrEP	2 year

Secondary

Measure	Time frame	Description
To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV uninfected MSM not using PrEP	2 year	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	2 year	—
to determine the prevalence of abnormal anal cytology in MSM using PrEP and in HIV infected MSM	2 year	—

Other

Measure	Time frame
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026