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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