Condition category
Infections and Infestations
Date applied
24/06/2010
Date assigned
24/06/2010
Last edited
13/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English 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.

Trial website

Contact information

Type

Scientific

Primary contact

Dr Janet Wilson

ORCID ID

Contact details

Department of Genito-Urinary Medicine
Sunnybank Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7293

Study information

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

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

'Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Infection; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/03/2009

Overall trial end date

31/01/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned sample size: 4000

Participant exclusion criteria

1. Women who are unwilling or unable to give verbal consent
2. Women who have taken antibiotics in the previous 28 days

Recruitment start date

01/03/2009

Recruitment end date

31/01/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Genito-Urinary Medicine
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Leeds Teaching Hospitals NHS Trust (UK)

Sponsor details

Research and Development Department
34 Hyde Terrace
Leeds
LS2 9LN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.leedsteachinghospitals.com/

Funders

Funder type

Industry

Funder name

Gen-Probe Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23236032
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24982265

Publication citations

  1. Results

    Schoeman SA, Stewart CM, Booth RA, Smith SD, Wilcox MH, Wilson JD, Assessment of best single sample for finding chlamydia in women with and without symptoms: a diagnostic test study., BMJ, 2012, 345, e8013.

  2. Results

    Morris GC, Stewart CM, Schoeman SA, Wilson JD, A cross-sectional study showing differences in the clinical diagnosis of pelvic inflammatory disease according to the experience of clinicians: implications for training and audit., Sex Transm Infect, 2014, 90, 6, 445-451, doi: 10.1136/sextrans-2014-051646.

Additional files

Editorial Notes