Human Papilloma Virus
Conditions
Keywords
Oral HPV infection, Mouthwash, Carrageenan
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.
Interventions
OTHERMouthwash 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.
Sponsors
McGill University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to oral HPV clearance | 6 months | Time to type-specific oral HPV clearance will be recorded for participants with positive type-specific oral HPV status at baseline |
| Time to oral HPV infection | 6 months | Time to type-specific oral HPV infection will be recorded for participants with negative type-specific oral HPV status at baseline |
Countries
Canada
Contacts
Primary ContactBelinda Nicolau, DDS, PhD
Outcome results
None listed