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)

Sexually Transmitted Diseases Clinical Trial

— PReGo  

Official title:

A Double-blind Single Center, Crossover, Randomized Controlled Trial of Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of Gonorrhea/Chlamydia/Syphilis in MSM Taking HIV Pre-exposure Prophylaxis (PrEP)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03881007
• Other study ID #: ITM201801
• Status: Terminated
• Phase: N/A
• Start date: April 3, 2019
• Est. completion date: June 15, 2020

Study information

• Verified date: April 2021
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 343
• Est. completion date: June 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men aged 18 or more
• 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:

• Currently using a mouthwash and unwilling to cease use of this mouthwash
• Enrolment in another interventional trial
• Tests HIV positive at screening

Related Conditions & MeSH terms

• Sexually Transmitted Diseases

Intervention

Other:
• 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

Locations

Country	Name	City	State
Belgium	Institute of Tropical Medicine	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3-month period following each intervention
Secondary	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.	3-month period following each intervention
Secondary	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.	3-month period following each intervention
Secondary	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.	3-month period following each intervention
Secondary	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	6-month period
Secondary	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	3-month period following each intervention
Secondary	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	3-month period following each intervention