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"Participants in the proposed research will be those who registered in the mSTUDY, and the aim of this research is to determine the preliminary efficacy and acceptability of antibacterial mouthwash use for the prevention of pharyngeal gonorrhea in a cohort of high risk HIV-negative and HIV-positive MSM. " Among mSTUDY participants at a high risk of pharyngeal gonorrhea, the investigators recommend a double-blind, placebo-randomized crossover trial of daily antibacterial mouthwash use as compared to a placebo mouthwash. Participants will be randomly selected to either first be treated with a 12-week antibacterial mouthwash followed by 12-weeks of placebo mouthwash or start with 12-weeks of placebo mouthwash and crossover to 12-weeks of antibacterial mouthwash. The antibacterial mouthwash and placebo are commercially available products and are chosen based on research demonstrating inhibitory activity of the antibacterial mouthwash against N. gonorrhoeae. The randomization scheme will be linked to the study number and stored by study participants not involved in participant recruitment or data analysis; in order to guarantee that the placebo and active product have an identical appearance, the placebo and active product will be linked to the study number and location; the mouthwash will be in bottles. According to their randomized research group, participants will be given a 12-week supply of mouthwash and will be shown how to rinse and gargle with the mouthwash on a daily basis at the time of study enrollment. Participants will also be encouraged to answer questions regarding study mouthwash use, including the frequency and timing of mouthwash use and acceptability of mouthwash. ".
Source link: https://clinicaltrials.gov/ct2/show/NCT04966507
"Women who have had a urogenital chlamydia or gonorrhea infection at any time during the 16 weeks leading up to enrollment were enrolled in one or two risk factors, or be found to be positive for either infection at Screening Visit with one or more risk factors. ".
Source link: https://clinicaltrials.gov/ct2/show/NCT04553068
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