Phillips Rachel, Oakeshott Pippa, Kerry-Barnard Sarah, Reid Fiona
School of Population Health & Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.
Population Health Research Institute St George's, University of London, London, UK.
Trials. 2018 Jun 5;19(1):312. doi: 10.1186/s13063-018-2675-7.
There are high rates of sexually transmitted infections (STIs) in ethnically diverse, sexually active students aged 16-24 years attending London further education (FE) colleges. However, uptake of chlamydia screening remains low. The TnT study aims to assess the feasibility of conducting a future trial in FE colleges to investigate if frequent, rapid, on-site testing and treatment (TnT) reduces chlamydia rates. This article presents the statistical analysis plan for the main study publication as approved and signed off by the Trial Management Group prior to the first data extraction for the final report.
METHODS/DESIGN: TnT is a cluster-randomised feasibility trial conducted over 7 months with parallel qualitative and economic assessments. Colleges will be randomly allocated into the intervention (TnT) or the control group (no TnT). Six FE colleges in London will be included. At each college for 2 days, 80 consecutive sexually active students aged 16-24 years (total 480 students across all six colleges) will be recruited from public areas and asked to provide baseline samples. One and 4 months after recruitment intervention colleges will be visited on two consecutive days by the TnT team where participating students will be texted and invited to come for same-day, on-site, rapid chlamydia testing and, if positive, treatment. Participants in the control colleges will receive 'thank you' texts 1 and 4 months after recruitment. Seven months after recruitment, participants from both groups will be invited to complete questionnaires and provide samples for TnT. All samples will be tested, and same-day treatment offered to participants with positive results. Key feasibility outcomes include: recruitment rates, testing and treatment uptake rates (at 1 and 4 months) and follow-up rates (at 7 months).
ISRCTN 58038795 . Registered on 31 August 2016.
在伦敦继续教育（FE）学院中，年龄在16至24岁、具有不同种族背景且有性行为的学生中，性传播感染（STIs）的发生率很高。然而，衣原体筛查的接受率仍然很低。TnT研究旨在评估未来在FE学院进行一项试验的可行性，以调查频繁、快速、现场检测和治疗（TnT）是否能降低衣原体感染率。本文介绍了主要研究出版物的统计分析计划，该计划在为最终报告进行首次数据提取之前已获试验管理组批准并签署。
方法/设计：TnT是一项为期7个月的整群随机可行性试验，同时进行平行的定性和经济评估。学院将被随机分配到干预组（TnT）或对照组（无TnT）。将纳入伦敦的六所FE学院。在每所学院的两天时间里，将从公共场所招募80名连续的年龄在16至24岁、有性行为的学生（六所学院共480名学生），并要求他们提供基线样本。在招募后的1个月和4个月，TnT团队将连续两天访问干预学院，向参与的学生发送短信并邀请他们前来进行当日现场快速衣原体检测，如果检测呈阳性则进行治疗。对照学院的参与者将在招募后的1个月和4个月收到“感谢”短信。在招募后的7个月，两组的参与者都将被邀请完成问卷并提供用于TnT的样本。所有样本都将进行检测，检测结果呈阳性的参与者将获得当日治疗。关键的可行性结果包括：招募率、检测和治疗接受率（在1个月和4个月时）以及随访率（在7个月时）。
ISRCTN 58038795。于2016年8月31日注册。
