NCT06296602

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 29, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

March 4, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2024

Completed
Last Updated

March 8, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

February 29, 2024

Last Update Submit

March 7, 2024

Conditions

Pre-Exposure Prophylaxis

Keywords

PreP

Outcome Measures

Primary Outcomes (2)

  • prevalence HPV

    prevalence HPV

    day 1

  • typing HPV

    typing HPV

    day 1

Secondary Outcomes (2)

  • High risk HPV risk factors

    day 1

  • Cytologist abnormalies

    day 1

Study Arms (1)

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.

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.

Interventions

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

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.

Also known as: A questionnaire will be completed by the doctor to record the data of interest
ANAPreP-HPV

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besançon

Besançon, 25000, France

RECRUITING

Central Study Contacts

Cedric LEBRETON, Dr

CONTACT

03 81 21 88 98c1lebreton@chu-besancon.fr

Ingrid TISSOT

CONTACT

03 81 21 84 27itissot@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 6, 2024

Study Start

March 4, 2024

Primary Completion

November 4, 2024

Study Completion

November 4, 2024

Last Updated

March 8, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)