Asymptomatic Sexually Transmitted Infections (STI) : Comparison of Two Screening Strategies Routine Screening Versus Screening as Reported by the Risks Taken by the Patient, in a Cohort of HIV Outpatients Men Who Have Sex With Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 495
- 试验地点
- 34
- 主要终点
- Sexually Transmitted Infections risk score in men HIV positive
研究概览
简要总结
Comparison of two screening strategies of asymptomatic sexually transmitted infections : routine screening versus screening as reported by the risks taken by the patient, in a cohort of HIV outpatients men who have sex with men. The aim of this study will be create and validate a simple tool for clinicians. A digital tool will be developed will allowed empowerment of HIV-positive men who have sex with men.
详细描述
Main objectives are :
create and validate a risk score for STIs (DRIVER score) in a population of HIV-positive men who have sex with men (MSM).
determine the prevalence of asymptomatic STIs in a population of HIV-positive MSM
Secondary objectives are :
compare 2 screening strategies regarding STIs in HIV-positive MSM (systematic screening vs screening according to self-declared risk factors) conduct a cost-efficiency analysis of both strategies evaluate patients' knowledge of STIs develop a DRIVER digital tool that will be made available to patients on websites, mobile apps...
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •HIV positive outpatients
- •Men who have sex with men
- •Speaking, literate french
- •Having a french health insurance or an equivalent
- •Asymptomatic for a STI the appointment day
排除标准
- •Men who never had sex with men
- •Protected adults (adults under guardianship)
- •Have a STI symptom ( anal discharge, urethritis, proctitis, chancre, rush)
结局指标
主要结局
Sexually Transmitted Infections risk score in men HIV positive
时间窗: 6 months
Construction of a STI risk score
次要结局
- prevalence of asymptomatic STIs in a population of HIV-positive MSM(6 months)
- cost-efficacy of a targeted screening versus universal screening(12 months)
- patients' knowledge of STIs evaluated by a Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ)(3 months)