Carrageenan for the Prevention of Oral HPV Infection

Study Overview
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Brief Summary
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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.

Official Title
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Carrageenan for the Prevention of Oral HPV Infection: a Feasibility, Randomized Clinical Trial

Conditions
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Human Papilloma Virus

Intervention / Treatment
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* Other: Mouthwash gargling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 and 45 years old Sexually active and have had oral sex in the past month Will be residing in Montreal for the next six (6) months after study enrolment Exclusion Criteria: Previous vaccination against HPV Previous cancer of the mouth or throat

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carrageenan-based Mouthwash<br>Mouthwash with Carrageenan as an active ingredient | Other: Mouthwash gargling<br>* 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.<br>|
| Placebo Comparator: Placebo Mouthwash<br>Mouthwash without Carrageenan but similar in colour, taste, and mouthfeel to the experimental mouthwash | Other: Mouthwash gargling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment 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. | 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. | 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. | 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 | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral HPV infection, Mouthwash, Carrageenan