SYSTEMATIC: NAATS of Pooled Selftaken Versus Clinicantaken Swabs 1

Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371109
• Other study ID #: GU12/10329
• Status: Completed
• Start date: December 9, 2014
• Est. completion date: July 14, 2017

Study information

• Verified date: August 2019
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1786
• Est. completion date: July 14, 2017
• Est. primary completion date: September 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Infection

Intervention

Other:
• selftaken versus clinically taken swabs

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity and specificity of the self taken swabs analysed together as a pooled sample, compared with individually analysed (nonpooled) clinican taken samples.		The study duration