Screening Anal HPV Colonization in Men Sex Men Using Pre-exposure Prophylaxis for HIV (ANAPreP'HPV)

Not Applicable

Recruiting

• Conditions: Pre-Exposure Prophylaxis
• Interventions: Other: A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.

• Registration Number: NCT06296602
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

This is an interventional study investigating HPV carriage and liquid-based cytology at anal level. It will be offered to all patients undergoing PreP consultations at Besançon University Hospital. The anal swab will be taken by the doctor using a cyto-brush during the consultation.

Detailed Description

The duration of participation in the study is 3 months for the submission of the results of the samples. A medical proctology consultation may also be offered, depending on the results of the screening.

This will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.

A questionnaire will be completed by the doctor to record the data of interest. From additional data already entered in the e-NADIS software will be included for study.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-29
• Study First Submitted QC: 2024-02-29
• Study Start: 2024-03-04
• Study First Posted: 2024-03-06
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-08
• Primary Completion: 2024-11-04
• Study Completion: 2024-11-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

Men sex Men Using Pre-exposure Prophylaxis for HIV Follow up au CHU de Besançon.

Exclusion Criteria

• Women
• No MSM
• Under 18
• History of HPV related cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ANAPreP-HPV	A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.	A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections. A questionnaire will be completed by the doctor to record the data of interest.

Primary Outcome Measures

Name	Time	Method
typing HPV	day 1	typing HPV
prevalence HPV	day 1	prevalence HPV

Secondary Outcome Measures

Name	Time	Method
High risk HPV risk factors	day 1	High risk HPV risk factors
Cytologist abnormalies	day 1	Cytologist abnormalies

Trial Locations

Locations (1)

CHU Besançon; 🇫🇷 Besancon, France