2022-502224-49-00招募中4 期
Human papillomavirus vaccine effectiveness study among men who have sex with men
Geneeskundige En Gezondheidsdienst Amsterdam1 个研究点 分布在 1 个国家目标入组 730 人开始时间: 2023年1月27日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 730
- 试验地点
- 1
- 主要终点
- We will conduct an observational study and compare anal HPV-16/18 prevalence between vaccinated and unvaccinated MSM attending the sexual health center (SHC). We will primarily measure HPV-16 and HPV-18 DNA positivity.
研究概览
简要总结
To assess the direct effectiveness of vaccination with the bivalent HPV vaccine (Cervarix ®) against anal HPV-16/18 infections among men who have sex with men (MSM) aged 19-26 years who visit the Sexual Health Clinic (SHC) of Amsterdam.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •(Group 1, recruited at baseline) Being male and reporting sex with other men in preceding 6 months
- •(Group 2, recruited month 24) Being male and reporting sex with other men in the preceding 6 months
- •(Group 2, recruited month 24) Age 21-28 years
- •(Group 2, recruited month 24) Attending the Sexual Health Clinic in Amsterdam
- •(Group 2, recruited month 24) Accepting hypothetically prophylactic HPV vaccination
- •(Group 2, recruited month 24) Providing informed consent
- •(Group 1, recruited at baseline) Age 19-26 years
- •(Group 1, recruited at baseline) Attending the SHC in Amsterdam
- •(Group 1, recruited at baseline) Accepting prophylactic HPV vaccination
- •(Group 1, recruited at baseline) Planning to stay in or around Amsterdam over the next two years
- •(Group 1, recruited at baseline) Willing and able to return for 1 subsequent visit for vaccination
- •(Group 1, recruited at baseline) Willing and able to complete an online questionnaire at month 15
- •(Group 1, recruited at baseline) Willing and able to return for a month 24 final study visit
- •(Group 1, recruited at baseline) Providing informed consent
排除标准
- •(Group 1 & 2) Having been vaccinated with one or more doses of any of the HPV vaccines
- •(Group 1 & 2) Not able to read/understand Dutch or English
- •(Group 1 & 2) Previous enrolment in the study
- •(Group 1 & 2) History of anal cancer or anal intraepithelial neoplasia (AIN)
- •(Group 1 & 2) Unlikely to adhere to the study protocol
- •(Group 1 & 2) Allergy to one or more components of the vaccine
结局指标
主要结局
We will conduct an observational study and compare anal HPV-16/18 prevalence between vaccinated and unvaccinated MSM attending the sexual health center (SHC). We will primarily measure HPV-16 and HPV-18 DNA positivity.
We will conduct an observational study and compare anal HPV-16/18 prevalence between vaccinated and unvaccinated MSM attending the sexual health center (SHC). We will primarily measure HPV-16 and HPV-18 DNA positivity.
次要结局
- DNA HPV16/18 DNA positivity and HPV16/18 seropositivity
- HPV16/18 seropositivity 24 months post HPV vaccination
研究者
Prof. dr. M.F. Schim van der Loeff
Scientific
Geneeskundige En Gezondheidsdienst Amsterdam
研究点 (1)
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