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

NCT ID: NCT06296602

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-04

Study Completion Date

2024-11-04

Brief Summary

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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

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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.

Conditions

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Pre-Exposure Prophylaxis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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 questionnaire will be completed by the doctor to record the data of interest.

Group Type 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.

Intervention Type 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. A questionnaire will be completed by the doctor to record the data of interest.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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A questionnaire will be completed by the doctor to record the data of interest

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Besançon

Besançon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cedric LEBRETON, Dr

Role: CONTACT

03 81 21 88 98 ext. +33

Ingrid TISSOT

Role: CONTACT

03 81 21 84 27 ext. +33

Facility Contacts

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Cédric LEBRETON, Dr

Role: primary

Other Identifiers

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2023/777

Identifier Type: -

Identifier Source: org_study_id

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