MYSTIC
Research type
Research Study
Full title
Meatal swab yourself with testing for infections collectively (MYSTIC)
IRAS ID
326642
Contact name
Janet Wilson
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Testing for chlamydia and gonorrhoea in men who have sex with men (MSM) and trans women is recommended every three months for those taking HIV Pre-Exposure Prophylaxis (PrEP). Testing requires throat and bottom samples, and samples from the urethra (wee-pipe), usually a urine sample. However, many sexual health services struggle to afford the costs of these 3-samples, four-times per year, which may restrict numbers given PrEP.
Our previous research has shown that the 3-samples (throat, bottom, urine) can be combined into one pooled specimen to accurately find gonorrhoea and reduce laboratory costs. However, the chlamydia results of pooled samples were not as good, finding only 92 out of 100 infections compared with 99 out of 100 with 3 separate samples.
This study aims to improve the accuracy of chlamydia results by comparing two new pooling methods with the 3-samples tested separately.
MSM, and trans women, aged 18 years or over, attending our clinics for chlamydia and gonorrhoea testing will be invited to take part in the study. The pooling methods will be: 1) pooling with a smaller amount of urine to reduce the dilution of the other samples; and 2) pooling with a swab sample from the outside of the tip of the penis (meatal swab) instead of urine. Meatal swabs are taken by the person themselves. The swab does not go inside the penis so is easy to do and not painful. Studies suggest meatal swabs may be better at finding chlamydia than urine samples.
To ensure an accurate comparison, the order of taking the two pooling method samples, and the 3-samples tested separately, will be randomised.
We will recruit 1250 participants. This is a large enough number to show if either of the pooling methods can detect more chlamydia than 92 out of 100 infections.REC name
North West - Preston Research Ethics Committee
REC reference
23/NW/0194
Date of REC Opinion
14 Jul 2023
REC opinion
Further Information Favourable Opinion