Carrageenan for the Prevention of Oral HPV Infection: a Feasibility, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Adherence rate for mouthwash use
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Previous vaccination against HPV
- •Previous cancer of the mouth or throat
结局指标
主要结局
Adherence rate for mouthwash use
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 1 year
The proportion of individuals who enrolled into the study but left before the end of the study will be documented.
次要结局
- Mouthwash safety (Pain score) as assessed by the Visual Analog Scale(6 months)
研究者
Dr. Belinda Nicolau
Professor
McGill University