Chlamydia, Gonorrhoea and Mycoplasma genitalium Infections and Infestations
Conditions
Interventions
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 sex
Sponsors
University Hospitals Sussex NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
16 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of attendees with non-gonococcal urethritis (NGU), proctitis, or reporting as sexual contacts of a sexually transmitted infection (STI) who receive empiric antibiotic treatment at the index visit measured using Review of routinely collected clinical records / electronic patient records to identify presenting diagnosis or indication (NGU, proctitis, or STI contact) and antibiotic prescribing at the index visit; comparison between standard care and use of the Roche cobas® Liat® CT/NG/MG assay at Index visit, during: Baseline phase (12-week standard care period); Intervention phase (12-week period following implementation of Roche cobas® Liat® CT/NG/MG assay)Intervention phase (12-week period following implementation of Roche cobas® Liat® CT/NG/MG assay)Intervention phase (12-week period following implementation of Roche cobas® Liat® CT/NG/MG assay) | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of clinic visits per attendee from index presentation to completion of management, and proportion of attendees achieving same-day clinical closure measured using review of routinely collected clinical records / electronic patient records to determine total number of attendances and whether clinical management was completed on the same day as the index visit at index visit until completion of management;Patient-reported experience and satisfaction with point-of-care testing measured using Study-specific structured patient questionnaire administered at the index visit assessing experience and satisfaction with point-of-care testing at Index visit (during the intervention phase);Patient flow and service efficiency, including length of stay, waiting times, clinic throughput, staff time, and operational costs measured using Analysis of routinely collected service data, including clinic operational records, time-stamped patient flow data, staffing logs, and cost data at during: Baseline phase (12-week standard care period); Intervention phase (12-week period following implementation of Roche cobas® Liat® CT/NG/MG assay) | — |
Countries
England, United Kingdom
Contacts
Public ContactNatalie St Clair-Sullivan
Outcome results
None listed