Carrageenan for the Prevention of Oral HPV Infection

Not Applicable

Recruiting

• Conditions: Human Papilloma Virus
• Interventions: Other: Mouthwash gargling

• Registration Number: NCT05746988
• Lead Sponsor: McGill University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-28
• Study Start: 2023-05-26
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-19
• Last Update Posted: 2023-06-22
• Primary Completion: 2023-12
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Mouthwash	Mouthwash gargling	Mouthwash without Carrageenan but similar in colour, taste, and "mouthfeel" to the experimental mouthwash
Carrageenan-based Mouthwash	Mouthwash gargling	Mouthwash with Carrageenan as an active ingredient

Primary Outcome Measures

Name	Time	Method
Adherence rate for mouthwash use	6 months	This will be calculated as the proportion of participants who completed the study and complied with the mouthwash use regimen.
Recruitment rate	1 year	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.
Adherence rate for self-sampling	6 month	This will be calculated as the proportion of participants who completed the study and complied with the bi-weekly self-sampling procedure
Acceptability of study procedures as assessed by satisfaction on a Visual Analog Scale	6 months	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.
Drop-out rate	1 year	The proportion of individuals who enrolled into the study but left before the end of the study will be documented.

Secondary Outcome Measures

Name	Time	Method
Mouthwash safety (Pain score) as assessed by the Visual Analog Scale	6 months	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.

Trial Locations

Locations (1)

McGill University; 🇨🇦 Montreal, Quebec, Canada