Using rapid testing in sexual health clinics to support targeted antibiotic treatment
| ISRCTN | ISRCTN37359112 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37359112 |
| Integrated Research Application System (IRAS) | 368875 |
| Central Portfolio Management System (CPMS) | 74211 |
| Sponsor | University Hospitals Sussex NHS Foundation Trust |
| Funder | Roche Diagnostics |
- Submission date
- 02/06/2026
- Registration date
- 03/06/2026
- Last edited
- 03/07/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Sexually transmitted infections such as chlamydia, gonorrhoea and Mycoplasma genitalium are common and increasing in the UK. Many people with these infections do not have symptoms, but untreated infections can lead to serious health problems. Current testing usually involves sending samples to a laboratory, meaning results can take several days. Because of this delay, people are often given antibiotics before their results are known. This can lead to unnecessary antibiotic use and may contribute to antibiotic resistance.
This study aims to evaluate whether a rapid test that provides results during the same clinic visit can help healthcare staff give more targeted antibiotic treatment. The study will also assess whether the test improves patient experience and reduces the number of clinic visits needed.
Who can participate?
Adults aged 16 years and over attending the Morley Street Sexual Health Clinic in Brighton may be able to take part if they:
Have symptoms that may be caused by chlamydia, gonorrhoea or Mycoplasma genitalium, or
Have had sexual contact with someone diagnosed with one of these infections
Participants must be willing to provide a urine sample or vaginal swab and take part in the consent process.
What does the study involve?
The study has three phases. First, researchers will review routine clinic data collected before the rapid test is introduced. Second, clinic staff will be trained to use the rapid test and new clinic pathways will be developed. Third, the rapid test will be introduced into routine care at the clinic.
Participants in the intervention phase will attend the clinic as normal. They will receive information about the study and be asked to give written consent. A urine sample or vaginal swab will be collected as part of routine sexually transmitted infection testing. Samples will also be tested on-site using the rapid test, which provides results in around 20 minutes.
Participants may be asked to complete a short questionnaire about their experience of the rapid test. Healthcare staff using the test will also complete questionnaires about how the test works in routine clinic care.
What are the possible benefits and risks of participating?
Participants may benefit from receiving test results during the same clinic visit, which could allow faster and more targeted treatment. The study may also help improve future sexual health services and reduce unnecessary antibiotic use.
The risks are low. Sample collection may cause mild discomfort. As with any diagnostic test, there is a small possibility of incorrect or delayed results. However, all routine laboratory testing will still be carried out to confirm results, and any unexpected findings will be managed according to standard clinic procedures.
Where is the study run from?
The study is being run at the Morley Street Walk-In Sexual Health Clinic in Brighton, United Kingdom.
When is the study starting and how long is it expected to run for?
The study is expected to start in May 2026 and finish in June 2027.
Who is funding the study?
The study is funded by Roche Diagnostics.
Who is the main contact?
Professor Jaime Vera
Brighton and Sussex Medical School
Email: J.Vera@bsms.ac.uk
Contact information
Principal investigator
BSMS Teaching Building, University of Sussex, Falmer
Brighton
BN1 9PX
United Kingdom
 ORCID ID |
0000-0002-1165-0573 |
|---|---|
| Phone | +44 1273523087 |
| J.vera@bsms.ac.uk |
Scientific
Royal Sussex County Hospital, Eastern Road
Brighton
BN2 5BE
United Kingdom
| ORCID ID |
0000-0002-8957-8233 |
|---|---|
| Phone | +44 7977129105 |
| suneeta.soni@nhs.net |
Public
BSMS Teaching Building, University of Sussex
Brighton
BN1 9PX
United Kingdom
| Phone | +44 1273523087 |
|---|---|
| N.StClair-Sullivan2@bsms.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Non-randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Historical |
| Assignment | Single |
| Purpose | Diagnostic, Health services research, Treatment |
| Scientific title | The clinical utility of the Roche Cobas Liat point of care test to inform targeted antibiotic use for chlamydia, gonorrhoea and mycoplasma genitalium in sexual health services |
| Study objectives | Primary objective: To evaluate whether use of the Roche cobas® Liat® CT/NG/MG assay reduces antibiotic use among attendees presenting to the sexual health clinics with symptoms consistent with non-gonococcal urethritis (NGU) or proctitis, or as a sexual contact of an STI Secondary objectives: 1. To determine whether use of the assay reduces the number of clinic visits required per attendee 2. To assess patient experience and satisfaction with point-of-care testing 3. To evaluate the impact of different clinical pathways incorporating the assay on patient flow and service efficiency |
| Ethics approval(s) |
Approved 19/06/2026, East Midlands - Leicester South Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, United Kingdom; +44 2071048093; leicestersouth.rec@hra.nhs.uk), ref: 26/EM/0113 |
| Health condition(s) or problem(s) studied | Chlamydia, Gonorrhoea and Mycoplasma genitalium |
| Intervention | Intervention: introducing the Roche cobas Liat CT/NG/MG point-of-care assay into routine workflows at a sexual health clinic. The Roche cobas Liat CT/NG/MG assay will be implemented in a walk in sexual health clinic (Morley Street). Data collection will continue prospectively, using the same outcomes as in baseline for before–after comparison. Participants will also be asked to complete a brief questionnaire to explore patient experience and acceptability of receiving same visit CT/NG results. Healthcare professionals involved in using the Roche cobas Liat CT/NG/MG assay in clinic will also be asked to complete a brief questionnaire to explore acceptability, usability, and workflow impact of the cobas Liat device and the new pathway. The questionnaires used will be the PSDT-Q and CSDT-Q which are both validated for measuring satisfaction with a diagnostic test among patients and clinicians. Patient questionnaires will be available in English, Spanish, Portuguese, French, Arabic, and Mandarin, reflecting the most commonly spoken languages among attendees at the clinic. |
| Intervention type | Drug/Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Roche cobas® /MGLiat® CT/NG point-of-care test |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/06/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 242 |
| Key inclusion criteria | 1. Capable of giving informed consent 2. Aged 16 years or older 3. Reported sexual activity within the past six months 4. Presenting either: 4.1. Symptomatic with suspected genital CT, NG or MG infection 4.2. Asymptomatic and presenting as a sexual contact of a CT- or NG- or MG-positive index case, with last sexual contact occurring more than 2 weeks prior 5. Able and willing to provide an appropriate specimen: 5.1. 25–50 mL first-catch urine sample 5.2. Clinician- or self-collected vaginal swab |
| Key exclusion criteria | 1. Symptomatic with suspected rectal CT, NG or MG infection 2. Previous participation in this study 3. Current or recent antimicrobial therapy (antibiotic use within 14 days prior to clinic visit) 4. Urination within the 1 hour prior to specimen collection |
| Date of first enrolment | 01/09/2026 |
| Date of final enrolment | 30/11/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Brighton
BN2 9RE
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
03/07/2026: CPMS number added.
23/06/2026: The ethics approval was added.
03/06/2026: Trial's existence confirmed by University Hospitals Sussex NHS Foundation Trust.
