Meatal Swab Yourself With Testing for Infections Collectively (MYSTIC)

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this study is 1. to improve the accuracy of chlamydia multi-site testing in men who have sex with men (MSM) and trans-women, whilst saving diagnostic costs, by comparing two new pooling methods with the 3-samples tested separately 2. to assess the diagnostic accuracy of pooled specimens for lymphogranuloma venereum detection (LGV) - a type of chlamydia infection Chlamydia and gonorrhoea testing for MSM and trans-women usually involves 3 samples from the throat, bum and wee-pipe. The tests can be combined into a single sample pot (pooled sample) which reduces costs, but in a previous study this reduced the accuracy for finding chlamydia. The main question for this study is: Can the accuracy of chlamydia testing in a pooled sample be improved by reducing the amount of urine added to minimise dilution, or by using a meatal sample instead of a urine sample? Participants will be asked to complete two sets of their own throat and bum samples, and then combine these into two pooled samples with 1)a meatal swab and 2)a smaller amount of first catch urine. The order of these samples will be randomised. These samples will be compared against separate samples taken at the same visit, to see how accurate the pooled samples are at diagnosing chlamydia and gonorrhoea with the different sampling techniques.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: t
View:

• 18 years and over. Willing to perform self-taken swabs in addition to any clinician required swabs. Able to provide informed consent

Locations
Other Locations
United Kingdom
Leeds Teaching Hospitals NHS Trust
RECRUITING
Leeds
Contact Information
Primary
Janet Wilson, MB ChB
janet-d.wilson@nhs.net
00 44 113 3920323
Backup
Harriet Wallace, MB ChB
harriet.wallace@nhs.net
00 44 113 3920323
Time Frame
Start Date: 2023-07-18
Estimated Completion Date: 2024-08-30
Participants
Target number of participants: 1250
Treatments
Other: All participants
All participants will receive:~1. Clinician or self-taken, pharyngeal and rectal swabs with FCU analysed individually~2. Self-taken pharyngeal, meatal, and rectal swabs analysed as a pooled specimen~3. Self-taken pharyngeal and rectal swabs with 1.5ml FCU analysed as a pooled specimen The FCU will be done after any meatal swabs. Patients will be instructed to only pass the first 5ml into the tube, and the tube will be pre-marked with a black line. Full pictoral instructions and verbal support will be given to enable them to complete the pooling process of the swabs and urine.
Sponsors
Leads: The Leeds Teaching Hospitals NHS Trust

This content was sourced from clinicaltrials.gov