InfectionNCT02371109
SYSTEMATIC: NAATS of Pooled Selftaken Versus Clinicantaken Swabs 1
An observational study of Infection, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Infection
- What is being tested?
- selftaken versus clinically taken swabs
- How many people
- 1,786 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Dec 2014to 14 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population is all patients who attend the Leeds Centre for Sexual Health for an appointment where diagnostic tests for gonorrhoea and chlamydia. All will be given the opportunity to take part in the research project.
Who may be able to join
- Attending the Leeds Centre for Sexual Health for an appointment where diagnostic tests for gonorrhoea and chlamydia will be taken Aged 16 or over
Who cannot join
- Attending the Leeds Centre for Sexual Health for an appointment where diagnostic tests for gonorrhoea and chlamydia will be taken Aged 16 or over
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS9 7TF
About this study
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.
- Conditions
- Infection
- Being tested
- selftaken versus clinically taken swabs
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selftaken versus clinically taken swabsOther
| Study group | Role | What they receive |
|---|---|---|
| selftaken vs clinical taken swabs | Not described Receives: Other: selftaken versus clinically taken swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of the self taken swabs analysed together as a pooled sample, compared with individually analysed (nonpooled) clinican taken samples.
Measured: The study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study start9 Dec 2014
- Primary completion19 Sep 2016
- Study completion14 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,786 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371109
- Sponsor's protocol ID
- GU12/10329
- Status last verified
- Aug 2019
- First submitted
- 26 Jan 2015
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Wilson JD, Wallace HE, Loftus-Keeling M, Ward H, Davies B, Vargas-Palacios A, Hulme C, Wilcox MH. Swab-Yourself Trial With Economic Monitoring and Testing for Infections Collectively (SYSTEMATIC): Part 2. A Diagnostic Accuracy and Cost-effectiveness Study Comparing Rectal, Pharyngeal, and Urogenital Samples Analyzed Individually, Versus as a Pooled Specimen, for the Diagnosis of Gonorrhea and Chlamydia. Clin Infect Dis. 2021 Nov 2;73(9):e3183-e3193. doi: 10.1093/cid/ciaa1546.
PubMed 33044490Wilson JD, Wallace HE, Loftus-Keeling M, Ward H, Davies B, Vargas-Palacios A, Hulme C, Wilcox MH. Swab-yourself Trial With Economic Monitoring and Testing for Infections Collectively (SYSTEMATIC): Part 1. A Diagnostic Accuracy and Cost-effectiveness Study Comparing Clinician-taken vs Self-taken Rectal and Pharyngeal Samples for the Diagnosis of Gonorrhea and Chlamydia. Clin Infect Dis. 2021 Nov 2;73(9):e3172-e3180. doi: 10.1093/cid/ciaa1266.
PubMed 32877521
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SYSTEMATIC: NAATS of Pooled Selftaken Versus Clinicantaken Swabs 1
- ClinicalTrials.gov ID
- NCT02371109
- Acronym / sponsor ID
- GU12/10329
- Conditions
- Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,786 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 9 Dec 2014 (actual)
- Primary completion
- 19 Sep 2016 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| selftaken vs clinical taken swabs | – | Other: selftaken versus clinically taken swabs |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is all patients who attend the Leeds Centre for Sexual Health for an appointment where diagnostic tests for gonorrhoea and chlamydia. All will be given the opportunity to take part in the research project.
Key inclusion criteria (1 listed)
- Attending the Leeds Centre for Sexual Health for an appointment where diagnostic tests for gonorrhoea and chlamydia will be taken Aged 16 or over
Key exclusion criteria (1 listed)
- Attending the Leeds Centre for Sexual Health for an appointment where diagnostic tests for gonorrhoea and chlamydia will be taken Aged 16 or over
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selftaken versus clinically taken swabs | Other | selftaken vs clinical taken swabs |
Primary outcome
The sensitivity and specificity of the self taken swabs analysed together as a pooled sample, compared with individually analysed (nonpooled) clinican taken samples.
Time frame: The study duration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Derived from this study: PubMed 33044490Wilson JD, Wallace HE, Loftus-Keeling M, Ward H, Davies B, Vargas-Palacios A, Hulme C, Wilcox MH. Swab-Yourself Trial With Economic Monitoring and Testing for Infections Collectively (SYSTEMATIC): Part 2. A Diagnostic Accuracy and Cost-effectiveness Study Comparing Rectal, Pharyngeal, and Urogenital Samples Analyzed Individually, Versus as a Pooled Specimen, for the Diagnosis of Gonorrhea and Chlamydia. Clin Infect Dis. 2021 Nov 2;73(9):e3183-e3193. doi: 10.1093/cid/ciaa1546.
- Derived from this study: PubMed 32877521Wilson JD, Wallace HE, Loftus-Keeling M, Ward H, Davies B, Vargas-Palacios A, Hulme C, Wilcox MH. Swab-yourself Trial With Economic Monitoring and Testing for Infections Collectively (SYSTEMATIC): Part 1. A Diagnostic Accuracy and Cost-effectiveness Study Comparing Clinician-taken vs Self-taken Rectal and Pharyngeal Samples for the Diagnosis of Gonorrhea and Chlamydia. Clin Infect Dis. 2021 Nov 2;73(9):e3172-e3180. doi: 10.1093/cid/ciaa1266.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of the self taken swabs analysed together as a pooled sample, compared with individually analysed (nonpooled) clinican taken samples. (time frame: The study duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02371109, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.