Kerry-Barnard Sarah, Fleming Charlotte, Reid Fiona, Phillips Rachel, Drennan Vari M, Adams Elisabeth J, Majewska Wendy, Balendra Anjella, Harding-Esch Emma, Cousins Emma, Tariq Sadiq S, Oakeshott Pippa
Population Health Research Institute, St George's, University of London, London, SW17ORE, UK.
Department of Primary Care and Public Health Sciences, King's College London, 4th Floor, Addison House, Guy's Campus, London, SE1 1UL, UK.
Trials. 2018 Jun 5;19(1):311. doi: 10.1186/s13063-018-2674-8.
Sexually active young people attending London further education (FE) colleges have high rates of chlamydia, but screening rates are low. We will conduct a cluster randomised feasibility trial of frequent, rapid, on-site chlamydia testing and same-day treatment (Test and Treat (TnT)) in six FE colleges (with parallel qualitative and economic assessments) to assess the feasibility of conducting a future trial to investigate if TnT reduces chlamydia rates.
We will recruit 80 sexually active students aged 16-24 years from public areas at each of six colleges. All participants (total n = 480) will be asked to provide samples (urine for males, self-taken vaginal swabs for females) and complete questionnaires on sexual lifestyle and healthcare use at baseline and after 7 months. Participants will be informed that baseline samples will not be tested for 7 months and be advised to get screened separately. Colleges will be randomly allocated to the intervention (TnT) or the control group (no TnT). One and 4 months after recruitment, participants at each intervention college (n = 3) will be texted and invited for on-site chlamydia tests using the 90-min Cepheid GeneXpert system. Students with positive results will be asked to see a visiting nurse health adviser for same-day treatment and partner notification, (backed by genitourinary medicine follow-up). Participants in control colleges (n = 3) 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 students with positive results. Acceptability of TnT will be assessed by qualitative interviews of purposively sampled students (n = 30) and college staff (n = 12). We will collect data on costs of TnT and usual healthcare.
Findings will provide key values to inform feasibility, sample size and timescales of a future definitive trial of TnT in FE colleges, including: Recruitment rates TnT uptake rates Follow-up rates Prevalence of chlamydia in participants at baseline and 7 months Acceptability of TnT to students and college staff Estimate of the cost per person screened/treated in TnT versus usual care TRIAL REGISTRATION: International Standard Randomised Controlled Trials Registry, ID: ISRCTN58038795 , Registered on 31 August 2016.
在伦敦继续教育学院就读的性活跃年轻人衣原体感染率很高，但筛查率很低。我们将在六所继续教育学院开展一项整群随机可行性试验，进行频繁、快速的现场衣原体检测和当天治疗（检测与治疗（TnT））（同时进行平行的定性和经济评估），以评估开展未来试验调查TnT是否能降低衣原体感染率的可行性。
我们将从六所学院的公共区域招募80名年龄在16 - 24岁的性活跃学生。所有参与者（共480人）将被要求提供样本（男性为尿液，女性为自行采集的阴道拭子），并在基线期和7个月后完成关于性生活方式和医疗保健使用情况的问卷调查。参与者将被告知基线样本在7个月内不会进行检测，并被建议另行筛查。学院将被随机分配到干预组（TnT）或对照组（无TnT）。招募后1个月和4个月，每个干预学院（共3所）的参与者将收到短信邀请，使用90分钟的赛沛GeneXpert系统进行现场衣原体检测。检测结果呈阳性的学生将被要求去见来访的护士健康顾问，以便当天接受治疗和通知其性伴侣（由泌尿生殖医学后续跟进）。对照学院（共3所）的参与者在招募后1个月和4个月将收到“感谢”短信。招募后7个月，两组的参与者都将被邀请完成问卷调查并提供样本进行TnT检测。所有样本都将进行检测，检测结果呈阳性的学生将在当天接受治疗。将通过对有目的抽样的学生（30人）和学院工作人员（12人）进行定性访谈来评估TnT的可接受性。我们将收集TnT和常规医疗保健的成本数据。
研究结果将提供关键数据，为未来在继续教育学院进行的TnT确定性试验的可行性、样本量和时间尺度提供参考，包括：招募率、TnT接受率、随访率、基线期和7个月时参与者的衣原体感染率、学生和学院工作人员对TnT的可接受性、TnT与常规护理相比每人筛查/治疗成本的估计。试验注册：国际标准随机对照试验注册库，ID：ISRCTN58038795，于2016年8月31日注册。
