SYSTEMATIC: NAATS of pooled self-taken versus clinican-taken swabs - 1
Research type
Research Study
Full title
Swab-yourself trial with economic monitoring and testing for infections collectively (SYSTEMATIC): A study comparing clinician-taken versus self-taken rectal and pharyngeal samples, and separate versus pooled specimens, from each individual
IRAS ID
139124
Contact name
Janet D Wilson
Contact email
Sponsor organisation
Leeds teaching hospitals NHS Trust
Research summary
Routine screening for gonorrhoea and chlamydia involves urine samples in males and self-taken vulvo-vaginal 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 extra-genital 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 extra-genital swabs are not taken. Currently, routine community testing does not include extra-genital 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 extra-genital 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 self-taken samples. Recent studies suggest that self-taken swabs from the rectum and throat are acceptable to clients and may be as good as swabs taken by clinicians, but the cost-effectiveness of this approach has not been investigated.
Our aim is to establish whether in MSM and females self-taken samples that are pooled and processed by NAATs are as effective as the individual tests taken by clinicians.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
13/YH/0417
Date of REC Opinion
23 Dec 2013
REC opinion
Favourable Opinion