Welcome
Support Centre
02 September 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Self-taken vaginal swabs and gonorrhoea detection
ISRCTN ISRCTN42867448
DOI 10.1186/ISRCTN42867448
ClinicalTrials.gov identifier
EudraCT number
Public title Self-taken vaginal swabs and gonorrhoea detection
Scientific title Comparison of self-taken vaginal swabs versus clinician taken urethral and endocervical swabs for the detection of gonorrhoea using the Gen-Probe Aptima Combo 2 assay
Acronym N/A
Serial number at source 7293
Study hypothesis This is a prospective cohort study to compare self-taken vaginal swabs for the detection of gonorrhoea using the Gen-Probe Aptima Combo 2 assay versus clinician taken urethral and endocervical swabs for the detection of gonorrhoea by standard culture. Furthermore, we will assess the cost effectiveness of the different methods of detecting gonorrhoea.
Lay summary Background and study aims
Chlamydia and gonorrhoea are common sexually transmitted infections (STIs) in the UK. Infected women often have no symptoms, but without treatment they can become infertile. Finding these unrecognised infections is therefore important. For gonorrhoea, the standard test is to attempt to grow the bacteria in a laboratory. An instrument called a speculum is gently inserted into the vagina to hold the walls of the vagina open so that the neck of the womb is visible. A small brush-like instrument will be used to take some cells from the neck of the womb. Special storage and transport are needed to ensure the samples arrive promptly and safely at the laboratory.
The nucleic acid amplification test (NAAT) method, currently used to detect chlamydia, is now able to detect gonorrhoea on the same sample. It is a test that can be done on non−invasive samples i.e. urine and self−taken vaginal swabs.
Women prefer these tests and special storage or transport arrangements are not needed. If the NAATs gonorrhoea test was as good as the current standard gonorrhea test, women with no symptoms could be tested for both chlamydia and gonorrhoea without needing to have an examination. We therefore plan to compare the NAATs gonorrhoea test with the standard gonorrhoea test. The NAATs test we plan to use is FDA cleared and CE Marked for use on all the swabs we plan to take.

Who can participate?
Women attending our clinic for STI tests.

What does the study involve?
We will invite women attending our clinic for STI tests to do a self−taken vaginal swab in addition to the standard tests we perform when we examine them. Performing a self−taken vaginal swab has no side effects and has previously been found to be easy and acceptable. We will then be able to evaluate the effectiveness of the self−taken vaginal swab for detecting gonorrhoea in comparison with the standard cultures.

What are the possible benefits and risks of participating?
The possible benefits are that you will be having an additional sample taken for gonorrhoea and chlamydia testing and it is known that the more samples that are performed, the better the detection rate of any infection that is present. There are no known risks of participating in the study.

Where is the study run from?
The study is taking place at the Centre for Sexual Health at the Leeds General Infirmary.

When is the study starting and how long is it expected to run for?
The study will be starting in early 2009 and is expected to run for up to one year.

Who is funding the study?
The extra swabs and tests will be funded by Gen−Probe, who are the manufacturers.

Who is the main contact?
The main contact for the study is Dr Janet Wilson at the Centre for Sexual Health at the Leeds General Infirmary.
Ethics approval Leeds (East) Research Ethics Committee approved on the 3rd February 2009 (ref: 09/H1306/4)
Study design Single centre randomised interventional screening trial
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: Infection; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology
Participants - inclusion criteria 1. Women aged 16 years and over
2. Presenting for a new or re-registration visit
3. Wish to be tested for both chlamydia and gonorrhoea
4. Give consent
Participants - exclusion criteria 1. Women who are unwilling or unable to give verbal consent
2. Women who have taken antibiotics in the previous 28 days
Anticipated start date 01/03/2009
Anticipated end date 31/01/2010
Status of trial Completed
Patient information material 'Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Planned sample size: 4000
Interventions A self taken vulvo-vaginal swab analysed for gonorrhoea by the Aptima Combo 2 assay, followed by clinician taken urethral and endocervical samples analysed for gonorrhoea by culture then an endocervical sample analysed for gonorrhoea by the Aptima Combo 2 assay. All positive Aptima Combo 2 assays for gonorrhoea will be confirmed using the Aptima GC assay.

The cost of each procedure will be assessed including the cost of the test and staff time.
Primary outcome measure(s) Sensitivity, specificity, positive and negative predictive values of the Gen-Probe Aptima Combo 2 assay for the detection of gonorrhoea using self-taken vaginal swabs compared with clinician taken urethral and endocervical swabs for the detection of gonorrhoea by standard culture.
Secondary outcome measure(s) Sensitivity, specificity, positive and negative predictive values of self-taken vaginal swabs compared with clinician taken endocervical swabs for the detection of gonorrhoea using the Gen-Probe Aptima Combo 2 assay.
Sources of funding Gen-Probe Inc. (USA)
Trial website
Publications 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23236032
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24982265
Contact name Dr  Janet  Wilson
  Address Department of Genito-Urinary Medicine
Sunnybank Wing
Leeds General Infirmary
  City/town Leeds
  Zip/Postcode LS1 3EX
  Country United Kingdom
Sponsor Leeds Teaching Hospitals NHS Trust (UK)
  Address Research and Development Department
34 Hyde Terrace
  City/town Leeds
  Zip/Postcode LS2 9LN
  Country United Kingdom
  Sponsor website: http://www.leedsteachinghospitals.com/
Date applied 24/06/2010
Last edited 13/08/2014
Date ISRCTN assigned 24/06/2010
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.