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) (PReGo)

Institute of Tropical Medicine, Belgium

Status: Terminated

Conditions: Sexually Transmitted Diseases

Treatments: Other: Mouthwash with placebo; Other: Mouthwash with LCM

Study type: Interventional

Funder types: Other

Identifiers

NCT03881007

ITM201801

Details and patient eligibility

About

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).

Full 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).

Enrollment: 343 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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343 participants in 2 patient groups

LCM, then placebo

Experimental group

Description:

Mouthwash with LCM for 3 months followed by mouthwash with placebo for 3 months.

Treatment:

Other: Mouthwash with LCM

Other: Mouthwash with placebo

Placebo, then LCM

Experimental group

Description:

Mouthwash with placebo for 3 months followed by mouthwash with LCM for 3 months

Treatment:

Other: Mouthwash with LCM

Other: Mouthwash with placebo