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临床试验/NCT06296602
NCT06296602招募中不适用

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

Centre Hospitalier Universitaire de Besancon2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
typing HPV

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • History of HPV related cancer

研究组 & 干预措施

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.

干预措施: 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)

结局指标

主要结局

typing HPV

时间窗: day 1

typing HPV

prevalence HPV

时间窗: day 1

prevalence HPV

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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