Division of Cancer Epidemiology, McGill University, Montreal, Canada.
Division of Cancer Epidemiology, McGill University, Montreal, Canada; Department of Pharmacoepidemiology, Merck Research Laboratories, West Point, PA, USA.
Contemp Clin Trials. 2021 Nov;110:106560. doi: 10.1016/j.cct.2021.106560. Epub 2021 Sep 4.
Human papillomavirus (HPV) infection, a common sexually transmitted infection, is causally associated with cervical cancer. Vaccination against HPV provides protection; however, HPV vaccines are exclusively prophylactic. Carrageenan, an extract from red algae, demonstrated potent anti-HPV activity in in vitro and animal studies. We describe the protocol for the Carrageenan-gel Against Transmission of Cervical Human papillomavirus (CATCH) study, an ongoing randomized controlled trial among sexually active young females, aimed at evaluating the efficacy of a carrageenan-based gel in reducing type-specific incidence (i.e. new detections of HPV) and prevalence (i.e. absence of a previously detected HPV) of genital HPV infections as well as participant adherence to the intervention. The CATCH study is a phase IIB double-blind randomized placebo-controlled trial. Eligible women 18 years and older are randomized 1:1 to the carrageenan-containing gel or placebo gel arm. For the first month, participants use the study gel intra-vaginally every other day, and over the 12-month study period, prior to and after each act of vaginal intercourse. At each study visit (months 0, 0.5, 1, 3, 6, 9, 12), participants provide a self-collected vaginal sample and record information on sexual activities, adherence, and adverse events using a computerized questionnaire. The primary outcomes are incident and prevalent type-specific cervicovaginal HPV infection. The primary analyses are based on intention-to-treat whereas per-protocol analyses are conducted based on measures of adherence. Trial registration: ISRCTN96104919.
人乳头瘤病毒（HPV）感染是一种常见的性传播感染，与宫颈癌有因果关系。HPV 疫苗接种提供了保护；然而，HPV 疫苗是专门预防性的。角叉菜胶是从红藻中提取的，在体外和动物研究中显示出很强的抗 HPV 活性。我们描述了正在进行的针对性活跃年轻女性的 Carrageenan-gel Against Transmission of Cervical Human papillomavirus（CATCH）研究的方案，旨在评估角叉菜胶凝胶在降低特定类型 HPV 感染（即 HPV 的新检测）和流行率（即先前检测到的 HPV 缺失）以及参与者对干预措施的依从性方面的疗效。CATCH 研究是一项 IIB 期双盲随机安慰剂对照试验。符合条件的 18 岁及以上女性按 1:1 随机分配到含角叉菜胶凝胶或安慰剂凝胶组。在第一个月，参与者每隔一天使用研究凝胶阴道内给药，在 12 个月的研究期间，在每次阴道性交前后使用。在每次研究访视（第 0、0.5、1、3、6、9、12 个月）时，参与者提供自我采集的阴道样本，并使用计算机化问卷记录性行为、依从性和不良事件的信息。主要结局是新发和现患的特定型别宫颈阴道 HPV 感染。主要分析基于意向治疗，而基于依从性措施的方案分析。试验注册：ISRCTN96104919。
