Objectives: To compare self-taken penile meatal swabs versus first-catch urine samples for the detection of chlamydia, gonorrhoea and Mycoplasma genitalium from the penile urethra using nucleic acid amplification tests. To assess the acceptability of self-taken penile meatal swabs compared with first-catch urine samples. To assess the prevalence of Mycoplasma genitalium in those with urethritis. To assess the prevalence of Mycoplasma genitalium antimicrobial resistance. To evaluate the utility of using Mycoplasma genitalium resistance-guided therapy. To compare the cost of using self-taken penile meatal swabs versus FCU samples for the correct detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium. Methods: Men and transwomen presenting for a sexual health screen will perform a self-taken penile meatal swab followed by a first-catch urine (FCU) sample. Both will be analysed using the Aptima Combo 2 test (Hologic, San Diego, California \[CA\], USA) for chlamydia and gonorrhoea. In those with urethritis they will also be analysed using Aptima MGen test for Mycoplasma genitalium. Details of demographics, past history, sexual history, clinical symptoms and signs will be collected. The acceptability of each sample will be assessed using a patient questionnaire. The samples of those infected with Mycoplasma genitalium will be tested for Mycoplasma genitalium macrolide and fluoroquinolone resistance mutations by in-house polymerase chain reaction (PCR) using Sanger sequencing to characterise mutants in the 23s gene for macrolide resistance and DNA gyrase subunit A (gyrA) and DNA topoisomerase IV subunit C (parC) genes for fluoroquinolone resistance. The result of this will be used to guide the therapy prescribed to treat the infection. Primary outcome: Sensitivity, specificity, positive and negative predictive values of self-taken penile meatal swabs compared with FCU samples for the detection of chlamydia, gonorrhoea and Mycoplasma genitalium in the penile urethra. Secondary outcomes: Acceptability of self-taken penile meatal swabs compared with FCU samples for the detection of chlamydia, gonorrhoea and Mycoplasma genitalium. Prevalence of Mycoplasma genitalium in those with urethritis. Prevalence of Mycoplasma genitalium antimicrobial resistance. Utility of using Mycoplasma genitalium resistance-guided therapy. Cost of using self-taken penile meatal swabs versus FCU samples for the correct detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium.
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Sensitivities, specificities, positive and negative predictive values
Timeframe: At time of enrollment