None listed
Conditions
Brief summary
Men who have sex with men tested positive for pharyngeal gonorrhoea at Melbourne Sexual Health Centre (MSHC) who volunteer will be randomised to rinse and gargle the study mouthwash every day within the next 12 weeks. The primary outcome is the proportion of MSM with diagnosed with pharyngeal gonorrhoea within 12 weeks.
Interventions
Men will receive four 500mL bottles of study mouthwash (Mouthwash A) in a plain, clean and opaque bottle labelled with participant’s study ID. Mouthwash A contains 0% alcohol and is available in the supermarkets or chemists. All participants will be asked to rinse and garage 20 mL of the given mouthwash for 60 seconds at least once every day during the 12-week study period but no more than 5 times per day as per the product recommendation.
Adherence will be monitored by the self-admitted questi
Men will receive four 500mL bottles of study mouthwash (Mouthwash A) in a plain, clean and opaque bottle labelled with participant’s study ID. Mouthwash A contains 0% alcohol and is available in the supermarkets or chemists. All participants will be asked to rinse and garage 20 mL of the given mouthwash for 60 seconds at least once every day during the 12-week study period but no more than 5 times per day as per the product recommendation. Adherence will be monitored by the self-admitted questionnaires and returning the mouthwash bottles at clinic visits week 6 and 12.
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Men who self-report having sex with another man and aged 16 years or above. 2. Men who fulfil one of the following criteria: (a) Aged 16-24 years old, tested positive or negative for pharyngeal gonorrhoea by nucleic acid amplification test (NAAT) detection or treated 30 days prior to the enrolment ; OR (b) Aged 25 years or above, tested positive for pharyngeal gonorrhoea by nucleic acid amplification test (NAAT) detection or treated 30 days prior to the enrolment. 3. Men who provide consent to contact their GP to clarify the use and name of antibiotics over the 12-week study period . 4. Men who have sufficient English language proficiency to understand the requirements of the study and complete the questionnaire. 5. Men who are willing and able to complete the study procedures. 6. Men who are able to provide written informed consent to the study.
Exclusion criteria
1. Men who will be away for more than 3 weeks within the next 12 weeks. 2. Men who report known contraindications to use mouthwash or food dye such as allergy. 3. Men who report use of long-term use of antibiotics for more than 4 weeks. 4. Men who use mouthwash regularly and are not willing to only use the study mouthwash within the next 12 weeks. 5. Transgender individuals. 6. Men who have previously enrolled in the OMEGA study. 7. Men who are not able to provide consent to contact their GP to clarify the use and name of antibiotics over the 12-week study period. 8. Men who have a member living in the household is on the OMEGA study.
Outcome results
None listed