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Clinical Trials/NCT06296602
NCT06296602RecruitingNot Applicable

Screening Anal HPV Colonization in Men Sex Men Using Pre-exposure Prophylaxis for HIV

Centre Hospitalier Universitaire de Besancon2 sites in 1 country100 target enrollmentStarted: March 4, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
2
Primary Endpoint
typing HPV

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • History of HPV related cancer

Arms & Interventions

ANAPreP-HPV

Experimental

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.

Intervention: 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. (Other)

Outcomes

Primary Outcomes

typing HPV

Time Frame: day 1

typing HPV

prevalence HPV

Time Frame: day 1

prevalence HPV

Secondary Outcomes

  • High risk HPV risk factors(day 1)
  • Cytologist abnormalies(day 1)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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