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Table 2 Summary of study time and collection of specimens and data

From: A multicentre double-blind randomised controlled trial evaluating the efficacy of daily use of antibacterial mouthwash against oropharyngeal gonorrhoea among men who have sex with men: the OMEGA (Oral Mouthwash use to Eradicate GonorrhoeA) study protocol

Week

0

3

6

9

12

Location

Clinic

Home

Clinic

Home

Clinic

A. Biospecimens

 Oropharyngeal swab on both tonsillar fossae for gonorrhoea tested by NAAT

  

 

 Oropharyngeal swab on posterior oropharynx for gonorrhoea tested by NAAT

  

 

 Oropharyngeal swab on both tonsillar fossae for gonorrhoea tested by culture

  

 

 Oropharyngeal swab on posterior oropharynx for gonorrhoea tested by culture

  

 

 Oropharyngeal swab on both tonsillar fossae for gonorrhoea and chlamydia tested by NAAT

    

 Oropharyngeal swab on posterior oropharynx for gonorrhoea and chlamydia tested by NAAT

    

 Saliva for gonorrhoea tested by NAAT

 

 First-void urine for gonorrhoea and chlamydia tested by NAAT

    

 Anorectal swab for gonorrhoea and chlamydia tested by NAAT

    

 Serology for HIV and syphilisa

    

B. Questionnaire data

 Demographic characteristics (e.g. age, country of birth, education level)

    

 History of mouthwash use (e.g. frequency, type of mouthwash)

    

 Sexual risk behaviours

 Antibiotic use

 Mouthwash adherence

 

 Adverse events

 

 Mouthwash acceptability/tolerability

    

  1. NAAT Nucleic acid amplification test
  2. aHIV-positive men will only be tested for syphilis but not HIV