The PhD will mainly be based on research concerning gonorrhea resistance, its molecular and epidemiological features and ways to reduce its incidence and prevalence. A randomized controlled trial is set up to prevent new gonorrhea infection in men who have sex with men. The rationale is that the prevalence of antimicrobial resistant gonorrhea is higher among men who have sex with men. This is believed to be due to an interaction between a high incidence of infection, subsequent frequent antimicrobial treatment and a dense sexual network (the pharmacoecological theory). The main study is a double-blind, single-center, randomized controlled clinical trial with a cross-over design which compares an antimicrobial versus a placebo mouthwash. The population of interest is men who have sex with men who consult at ITM outpatient clinic for HIV-pre-exposure prophylaxis. Three hundred twenty participants will be recruited for a duration of 6 months each. After 3 months, each of them will cross over to the other arm: those who initially used the antimicrobial mouthwash will then receive the placebo mouthwash and vice versa. The primary outcome of interest is the incidence of sexually transmitted diseases (mainly gonorrhea). Also, information concerning adherence and sexual risk behavior will be collected at each encounter (every 3 months). Further, pharyngeal and anorectal samples will be collected for microbiome and resistome analysis at each of the study visits. These will be analyzed at the University of Antwerp. We will evaluate whether recent use of the mouthwashes and/or antimicrobials has an influence on these outcomes. Also, a qualitative substudy will focus on aspects like the participant’s experiences and the acceptability of the mouthwash as a preventive strategy. This part will be performed in collaboration with a social scientist.
|Effective start/end date||3/07/19 → …|
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