This is a placebo-controlled, triple-blind randomized clinical trial (RCT) designed to evaluate the feasibility of conducting a larger multicentric RCT investigating the effect of a Carrageenan mouthwash on oral HPV infection. Eligible participants will complete a single in-person visit at baseline, filling out a questionnaire on their electronic device and giving an oral rinse sample for HPV testing. They will receive an adequate supply of mouthwash and instructions on its use. They will subsequently be followed up for up to six months. Every two weeks, participants will fill out a follow-up questionnaire on mouthwash use and sexual activities and self-collect oral rinse sample to be returned by mail.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
40
15 - 20 ml of mouthwash to be gargled vigorously for 30 to 60 seconds daily (morning and night) as an adjunct to regular toothbrushing, and before and/or immediately after sexual activities.
McGill University
Montreal, Quebec, Canada
RECRUITINGRecruitment rate
This will be measured by the total number of participants recruited into the study. The investigators intend to recruit 40 participants. Recruitment rate will be calculated as number of participants per month.
Time frame: 1 year
Drop-out rate
The proportion of individuals who enrolled into the study but left before the end of the study will be documented.
Time frame: 1 year
Adherence rate for mouthwash use
This will be calculated as the proportion of participants who completed the study and complied with the mouthwash use regimen.
Time frame: 6 months
Adherence rate for self-sampling
This will be calculated as the proportion of participants who completed the study and complied with the bi-weekly self-sampling procedure
Time frame: 6 month
Acceptability of study procedures as assessed by satisfaction on a Visual Analog Scale
Qualitative and quantitative assessment will be used to evaluate participants' experience with the RCT through the follow-up questionnaire and an exit question. Participants will be asked to rate their satisfaction with the study procedure on a scale of 1-10 (10 being the highest satisfaction level). This will focus on level of satisfaction of the participants with mouthwash use around sexual activities and the level of satisfaction of the participants with the biweekly self-sampling.
Time frame: 6 months
Mouthwash safety (Pain score) as assessed by the Visual Analog Scale
The mean pain score (for any pain ascribed to the mouthwash e.g., burning mouth, recurrent aphthous stomatitis e.t.c.) measured on the VAS (1-10; 10 being the worst pain) will be recorded.
Time frame: 6 months
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