A Double-blind Single Center, Crossover, Randomized Controlled Trial of Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of Gonorrhea/Chlamydia/Syphilis in MSM Taking HIV Pre-exposure Prophylaxis (PrEP)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 343
- 试验地点
- 2
- 主要终点
- Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period
研究概览
简要总结
The study involves a randomized placebo controlled trial that aims to assess if a mouthwash (Listerine cool mint, LCM) is able to reduce the cumulative incidence of gonorrhoea (Ng), chlamydia (Ct) and syphilis in men who have sex with men and receiving preexposure prophylaxis (PrEP) at the Institute of Tropical Medicine (ITM).
详细描述
The study aims to assess if there is a difference in the incidence rate of gonorrhea, chlamydia and syphilis detected at any site whilst individuals are on daily and pre/post sex Listerine cool mint (LCM) vs. placebo mouthwash.
The study has a double-blind, cross-over design, in which subjects will be screened at the ITM and, if eligible, will be enrolled and randomized to group 1 (LCM) or group 2 (placebo). After 3 months, a crossover will occur and subjects will switch to the other intervention. Each participant will therefore be enrolled for 6 months (2 x 3 months, no wash out period).
Subjects will be recruited from the existing PrEP cohort at the Institute of Tropical Medicine Antwerp. A total of 320 subjects will be recruited (160 in each arm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged 18 or more
- •Enrolled in Belgian PrEP program at ITM
- •Has had sex with another man in the previous year
- •Has had a symptomatic or asymptomatic STI (Ct/Ng/syphilis) in the previous 2 years
- •Willing to be enrolled in the cohort for 6 months and attend 3 monthly follow up visits
- •Willing to comply with the mouthwash study schema and willing to ask their casual partners to mouthwash pre- and post-sex
- •Prepared to fill out the online diary once a week
- •Able and willing to provide written informed consent
排除标准
- •Currently using a mouthwash and unwilling to cease use of this mouthwash
- •Enrolment in another interventional trial
- •Tests HIV positive at screening
结局指标
主要结局
Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period
时间窗: 3-month period following each intervention
The sum of new diagnoses of Gonnorhea (Ng), Chlamydia (Ct) and syphilis in a 3 month period on LCM/placebo. Each participant can only contribute one diagnosis of Ct and one diagnosis of Ng per visit - regardless of number of sites infected. Thus each participant can contribute up to 3 diagnoses (Ct/Ng/syphilis) at each visit. The diagnosis of Ng and Ct will be made via molecular testing and syphilis via Rapid Plasma Reagin test (RPR) and Treponema Pallidum Antibodies tests (TPA) according to currently used European case definitions.
次要结局
- Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash(3-month period following each intervention)
- Difference in Incidence Rate of Pharyngeal Ng Between Each Study Arm for Each Period(3-month period following each intervention)
- Difference in Cumulative Numbers of Antibiotics Used Between Periods on LCM vs. Placebo(3-month period following each intervention)
- Difference in Incidence Rate of Ct (Combined Pharyngeal, Urethral and Rectal) Between Each Study Arm for Each Period(3-month period following each intervention)
- Difference in Incidence Rate of Syphilis Between Periods on LCM vs. Placebo(3-month period following each intervention)
- Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex(6-month period)