Prevalence of Anal High-risk Human Papilloma Virus Infection and Abnormal Anal Cytology in Men Who Have Sex With Men Using Pre Exposure Prophylaxis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- To determine the prevalence of anal high risk HPV infection in MSM using PrEP
研究概览
简要总结
The aim of the study is to determine the prevalence of anal high-risk HPV infection and abnormal cytology in HIV uninfected Men who have sex with men (MSM) using PrEP and HIV infected MSM followed-up at the S-kliniek or HRC of the UZ Brussel. 200 participants will be preferably included in the study. The data will be collected using a self-administered questionnaire where socio-demographic characteristics, health-related issues and sexual behavior will be questioned. Also anal canal sampling will be performed for cytological analysis. For the HIV infected MSM, additional information will be extracted from the patient files: CD4+ T-cell count and nadir and duration of combination antiretroviral therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 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
- 是
入选标准
- •HIV uninfected MSM of 18 years or older using PrEP since at least 3 months
- •HIV-infected MSM of 18 years or older
排除标准
- •for MSM using PrEP:
- •Any intervention in the (peri-) anal region in the past 3 months
- •enema within 24h before sampling
- •receptive anal sex within 24h before sampling
- •current/ongoing peri-anal topical HPV-treatment
- •Exclusion Criteria for MSM infected with HPV:
研究组 & 干预措施
HAS-N
In this arm the patient without HIV using PrEP will be included
干预措施: anal sampling (Other)
HAS-P
In this arm the patient with HIV will be included
干预措施: anal sampling (Other)
结局指标
主要结局
To determine the prevalence of anal high risk HPV infection in MSM using PrEP
时间窗: 2 year
次要结局
- To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV uninfected MSM not using PrEP(2 year)
- To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV infected MSM(2 year)
- to determine the prevalence of abnormal anal cytology in MSM using PrEP and in HIV infected MSM(2 year)