Carrageenan for the Prevention of Oral HPV Infection

Human Papilloma Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05746988
• Other study ID #: A03-M01-22A
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2023
• Est. completion date: March 2024

Study information

• Verified date: June 2023
• Source: McGill University
• Contact: Belinda Nicolau, DDS, PhD
• Phone: 1-514-398-7203
• Email: belinda.nicolau[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Human Papilloma Virus
• Infections
• Papilloma
• Papillomavirus Infections

Intervention

Other:
• Mouthwash gargling
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.

Locations

Country	Name	City	State
Canada	McGill University	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to oral HPV infection	Time to type-specific oral HPV infection will be recorded for participants with negative type-specific oral HPV status at baseline	6 months
Other	Time to oral HPV clearance	Time to type-specific oral HPV clearance will be recorded for participants with positive type-specific oral HPV status at baseline	6 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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