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临床试验/NCT02371109
NCT02371109已完成不适用

SYSTEMATIC: NAATS of Pooled Selftaken Versus Clinicantaken Swabs 1

The Leeds Teaching Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 1,786 人开始时间: 2014年12月9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
1,786
试验地点
1
主要终点
The sensitivity and specificity of the self taken swabs analysed together as a pooled sample, compared with individually analysed (nonpooled) clinican taken samples.

研究概览

简要总结

Routine screening for gonorrhoea and chlamydia involves urine samples in males and selftaken vulvovaginal swabs (VVSs) in females. As well as infecting the urethra (pee tube) and cervix (neck of womb), gonorrhoea and chlamydia may also infect the rectum (bottom) and throat (both called extragenital sites), often with no symptoms. In some people infection will be found at more than one site, but in others it will only be in one, and if all anatomical sites are not tested some infections will be missed. In certain women one third of infections may be missed, in men who have sex with men (MSM) up to 90% may be missed, if extragenital swabs are not taken. Currently, routine community testing does not include extragenital sites. Until recently these samples could not easily be taken outside clinical settings (hospitals, clinics or surgeries), but new DNA tests for gonorrhoea, called NAATs, now make this possible.

However, they are expensive, and taking samples from extragenital sites would treble the costs. We propose that swabs from the three sites per person are pooled and analysed together rather than tested separately. This method would identify whether the person had the infection but not the anatomical site; this would not alter the management of the individual. Swabs from the rectum and throat have historically been taken by clinicians (doctors or nurses). The main attraction of community screening is that it is client led using selftaken samples. Recent studies suggest that selftaken swabs from the rectum and throat are acceptable to clients and may be as good as swabs taken by clinicians, but the costeffectiveness of this approach has not been investigated. Our aim is to establish whether in MSM and females selftaken samples that are pooled and processed by NAATs are as effective as the individual tests taken by clinicians.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Attending the Leeds Centre for Sexual Health for an appointment where diagnostic tests for gonorrhoea and chlamydia will be taken Aged 16 or over

排除标准

  • Attending the Leeds Centre for Sexual Health for an appointment where diagnostic tests for gonorrhoea and chlamydia will be taken Aged 16 or over

结局指标

主要结局

The sensitivity and specificity of the self taken swabs analysed together as a pooled sample, compared with individually analysed (nonpooled) clinican taken samples.

时间窗: The study duration

次要结局

未报告次要终点

研究者

发起方
The Leeds Teaching Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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