Carrageenan for the Prevention of Oral HPV Infection: a Feasibility, Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- McGill University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Adherence rate for mouthwash use
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Carrageenan-based Mouthwash
Mouthwash with Carrageenan as an active ingredient
Intervention: Mouthwash gargling (Other)
Placebo Mouthwash
Mouthwash without Carrageenan but similar in colour, taste, and "mouthfeel" to the experimental mouthwash
Intervention: Mouthwash gargling (Other)
Outcomes
Primary Outcomes
Adherence rate for mouthwash use
Time Frame: 6 months
This will be calculated as the proportion of participants who completed the study and complied with the mouthwash use regimen.
Adherence rate for self-sampling
Time Frame: 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
Time Frame: 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.
Recruitment rate
Time Frame: 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.
Drop-out rate
Time Frame: 1 year
The proportion of individuals who enrolled into the study but left before the end of the study will be documented.
Secondary Outcomes
- Mouthwash safety (Pain score) as assessed by the Visual Analog Scale(6 months)
Investigators
Dr. Belinda Nicolau
Professor
McGill University