A Trial to Compare Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men (MSM) Taking HIV Pre-Exposure Prophylaxis (PrEP)
NCT ID: NCT03881007
Last Updated: 2021-05-07
Study Results
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View full resultsBasic Information
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TERMINATED
NA
343 participants
INTERVENTIONAL
2019-04-03
2020-06-15
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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LCM, then placebo
Mouthwash with LCM for 3 months followed by mouthwash with placebo for 3 months.
Mouthwash with LCM
Subjects will mouthwash daily with LCM and before/after sex
Mouthwash with placebo
Subjects will mouthwash daily with placebo and before/after sex
Placebo, then LCM
Mouthwash with placebo for 3 months followed by mouthwash with LCM for 3 months
Mouthwash with LCM
Subjects will mouthwash daily with LCM and before/after sex
Mouthwash with placebo
Subjects will mouthwash daily with placebo and before/after sex
Interventions
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Mouthwash with LCM
Subjects will mouthwash daily with LCM and before/after sex
Mouthwash with placebo
Subjects will mouthwash daily with placebo and before/after sex
Eligibility Criteria
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Inclusion Criteria
* Enrolled in Belgian PrEP program at ITM
* Has had sex with another man in the previous year
* Has had a symptomatic or asymptomatic STI (Ct/Ng/syphilis) in the previous 2 years
* Willing to be enrolled in the cohort for 6 months and attend 3 monthly follow up visits
* Willing to comply with the mouthwash study schema and willing to ask their casual partners to mouthwash pre- and post-sex
* Prepared to fill out the online diary once a week
* Able and willing to provide written informed consent
Exclusion Criteria
* Enrolment in another interventional trial
* Tests HIV positive at screening
18 Years
MALE
Yes
Sponsors
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Institute of Tropical Medicine, Belgium
OTHER
Responsible Party
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Principal Investigators
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Chris Kenyon, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Tropical Medicine Antwerp
Locations
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Institute of Tropical Medicine
Antwerp, , Belgium
Countries
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References
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Akomoneh EA, Laumen JGE, Abdellati S, Van Dijck C, Vanbaelen T, Britto XB, Manoharan-Basil SS, Kenyon C. The Discovery of Oropharyngeal Microbiota with Inhibitory Activity against Pathogenic Neisseria gonorrhoeae and Neisseria meningitidis: An In Vitro Study of Clinical Isolates. Microorganisms. 2022 Dec 16;10(12):2497. doi: 10.3390/microorganisms10122497.
Van Dijck C, Tsoumanis A, Rotsaert A, Vuylsteke B, Van den Bossche D, Paeleman E, De Baetselier I, Brosius I, Laumen J, Buyze J, Wouters K, Lynen L, Van Esbroeck M, Herssens N, Abdellati S, Declercq S, Reyniers T, Van Herrewege Y, Florence E, Kenyon C. Antibacterial mouthwash to prevent sexually transmitted infections in men who have sex with men taking HIV pre-exposure prophylaxis (PReGo): a randomised, placebo-controlled, crossover trial. Lancet Infect Dis. 2021 May;21(5):657-667. doi: 10.1016/S1473-3099(20)30778-7. Epub 2021 Mar 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ITM201801
Identifier Type: -
Identifier Source: org_study_id
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