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临床试验/NCT04269434
NCT04269434已完成不适用

Does Screening for Gonorrhea and Chlamydia Affect the Incidence of These Infections in Men Who Have Sex With Men Taking HIV Pre Exposure Prophylaxis (PrEP): a Randomized, Multicentre Controlled Trial

Institute of Tropical Medicine, Belgium8 个研究点 分布在 1 个国家目标入组 1,014 人开始时间: 2020年9月21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
1,014
试验地点
8
主要终点
Incidence Rate of Ng Plus Ct Detected at Any Site Whilst Individuals Are Screened vs. Not Screened

研究概览

简要总结

A Multicentre, controlled, randomized trial of 3 site (urethra, pharynx and rectum) sampling performed every 3 months (3x3) for Neisseria gonorrhoea (Ng)/Chlamydia trachomatis (Ct) screening (comparator) vs. no screening (intervention).

详细描述

This study is a multicentre, controlled, randomized trial of 3x3 Ng/Ct screening (comparator) vs. no screening (intervention). It will be performed in the PrEP cohorts situated at the Institute of Tropical Medicine (ITM), Hôpital Saint-Pierre (HSP), Liège University Hospital (CHU), University Hospital of Gent (UZG) and Erasmus Hospital (EH). All men in follow up at these five centres who report having had sex with another man in the previous year and are enrolled for PrEP follow up will be eligible to participate in the study. After signing informed consent participants will be randomized via a computer-generated schema to either 3x3 screening or no Ng/Ct screening. In both arms, participants will be followed up in an identical fashion including 3x3 screening. The only difference between the arms will be that in the screening arm, Ng/Ct results will be sent by the STI Laboratory to the study physicians and these participants will be treated and partner contact tracing will be done. The Sexually Transmitted Infection (STI) Laboratory will only process the samples/report the results from the non-screening arm at the end of the study. In both arms, all individuals with symptoms compatible with Ng or Ct will be tested and treated for these infections according to current best practice guidelines. At the end of the 12-month study period, participants whose most recent tests were positive for Ng or Ct will receive treatment for these.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

盲法说明

The study statistician will be blinded until the statistical analysis plan (SAP) is approved

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

  • Able and willing to provide informed consent
  • Men (born as males) and transwomen aged 18 or more
  • Has had sex** with another man in the last 12 months
  • Enrolled in Belgian PrEP program at ITM/HSP/EH/CHU/UZG with approval for TDF/FTC (Tenofovir disoproxil fumarate/Emtricitabine) reimbursement from a Belgian Medical Aid
  • Willing to comply with the study procedures and to attend the clinic for the 3-monthly visits

排除标准

  • Enrolment in another interventional trial
  • Tests HIV-positive at screening
  • Symptoms of proctitis or urethritis

结局指标

主要结局

Incidence Rate of Ng Plus Ct Detected at Any Site Whilst Individuals Are Screened vs. Not Screened

时间窗: 12 months

number of diagnoses of Ng plus Ct in 12 months in screening/non-screening arms divided by number of scheduled study visits with available results for the diagnosis of Ng/Ct. The denominator does not include unscheduled visits.

次要结局

  • Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline)(12 months)
  • Incidence Rate of Symptomatic Ng Plus Ct(12 months)
  • Incidence Rate of Syphilis(12 months)

研究者

发起方
Institute of Tropical Medicine, Belgium
申办方类型
Other
责任方
Sponsor

研究点 (8)

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