The study involves a randomized placebo controlled trial that aims to assess if a mouthwash (Listerine cool mint, LCM) is able to reduce the cumulative incidence of gonorrhoea (Ng), chlamydia (Ct) and syphilis in men who have sex with men and receiving preexposure prophylaxis (PrEP) at the Institute of Tropical Medicine (ITM).
The study aims to assess if there is a difference in the incidence rate of gonorrhea, chlamydia and syphilis detected at any site whilst individuals are on daily and pre/post sex Listerine cool mint (LCM) vs. placebo mouthwash. The study has a double-blind, cross-over design, in which subjects will be screened at the ITM and, if eligible, will be enrolled and randomized to group 1 (LCM) or group 2 (placebo). After 3 months, a crossover will occur and subjects will switch to the other intervention. Each participant will therefore be enrolled for 6 months (2 x 3 months, no wash out period). Subjects will be recruited from the existing PrEP cohort at the Institute of Tropical Medicine Antwerp. A total of 320 subjects will be recruited (160 in each arm).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
343
Subjects will mouthwash daily with LCM and before/after sex
Subjects will mouthwash daily with placebo and before/after sex
Institute of Tropical Medicine
Antwerp, Belgium
Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period
The sum of new diagnoses of Gonnorhea (Ng), Chlamydia (Ct) and syphilis in a 3 month period on LCM/placebo. Each participant can only contribute one diagnosis of Ct and one diagnosis of Ng per visit - regardless of number of sites infected. Thus each participant can contribute up to 3 diagnoses (Ct/Ng/syphilis) at each visit. The diagnosis of Ng and Ct will be made via molecular testing and syphilis via Rapid Plasma Reagin test (RPR) and Treponema Pallidum Antibodies tests (TPA) according to currently used European case definitions.
Time frame: 3-month period following each intervention
Difference in Incidence Rate of Pharyngeal Ng Between Each Study Arm for Each Period
Incidence rate of new pharyngeal Ng cases in each allocation arm for each study period of 3 months.
Time frame: 3-month period following each intervention
Difference in Incidence Rate of Ct (Combined Pharyngeal, Urethral and Rectal) Between Each Study Arm for Each Period
Incidence rate of new Ct cases in each allocation arm (LCM and placebo) for each study period of 3 months.
Time frame: 3-month period following each intervention
Difference in Incidence Rate of Syphilis Between Periods on LCM vs. Placebo
Incidence rate of new syphilis cases in each allocation arm (LCM and placebo) for each study period of 3 months.
Time frame: 3-month period following each intervention
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex
Daily: Proportion of days in study used mouthwash at least daily Post sex: Proportion of casual sexual contacts in study when mouthwash used post sex. Pre sex: proportion of casual sexual contacts in study when mouthwash used pre sex
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Time frame: 6-month period
Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash
Incidence rate of Ng, Ct and syphilis between both groups (LCM and placebo) post controlling for adherence to mouthwash
Time frame: 3-month period following each intervention
Difference in Cumulative Numbers of Antibiotics Used Between Periods on LCM vs. Placebo
Cumulative number of antibiotics used between both groups (LCM and placebo) for each period
Time frame: 3-month period following each intervention