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临床试验/NCT03000933
NCT03000933已完成不适用

Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men Following Introduction of Universal Male HPV Vaccination Program in Australia

The Alfred1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Prevalence of quadrivalent vaccine HPV types

研究概览

简要总结

Australia was one of the countries to implement a universal school-based male vaccination program - in 2013. This research project will examine the prevalence of HPV among young men who have sex with men (MSM) who have been offered school-based HPV vaccination.

详细描述

HYPER-2, will be a cross-section study, using the same recruitment and testing strategies used in HYPER 1, which determined the prevalence of anal, genital and oral HPV among men who have sex with men aged 16-20 years. Given the differing age groups that will have been offered vaccination over the 2 study period, men aged 16-19 will be recruited in the first year (2017) and men aged 16-20 will be recruited in the second year (2018) to ensure that the participants included in the HYPER-2 study would have been eligible for the free male HPV vaccine in Australia. A total of 200 men will be recruited over a 2-year period, and HPV vaccination status for each participant will be verified against the National HPV Vaccination Program Register.

This 2-year cross-sectional study will recruit men who report sex with men aged from 16 to 20 years.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
16 Years 至 20 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • Men aged 16 to 20 (Must be aged 16-19 years from 1 January 2017 to 31 December 2017, and aged 16-20 years from 1 January 2018 to 31 December 2018)
  • Report any previous type of sexual contact (including but not restricted to oral or anal sex) with at least one other man ever
  • Able to complete all study requirements including questionnaire in English and completion of 2 visits
  • Residing in Australia since 2013 (This is to ensure that males included in the study were present in Australia at the time HPV vaccination was offered)

排除标准

  • Transgender male

结局指标

主要结局

Prevalence of quadrivalent vaccine HPV types

时间窗: Baseline

The primary outcome of interest will be the prevalence of quadrivalent vaccine types (6, 11, 16 and 18) among 16-20 year old MSM and comparison of these with non-quadrivalent vaccine HPV types which would be expected to remain high unless there is significant cross protection. Oral, penile, and anal HPV prevalence will be calculated.

次要结局

  • Persistent HPV infection(Day 7)

研究者

发起方
The Alfred
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Chow

Senior Research Fellow

The Alfred

研究点 (1)

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