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‘Test n Treat (TnT)’: a cluster-randomised feasibility trial of frequent, rapid-testing and same-day, on-site treatment to reduce rates of chlamydia in high-risk further education college students: statistical analysis plan

Phillips, R; Oakeshott, P; Kerry-Barnard, S; Reid, F (2018) ‘Test n Treat (TnT)’: a cluster-randomised feasibility trial of frequent, rapid-testing and same-day, on-site treatment to reduce rates of chlamydia in high-risk further education college students: statistical analysis plan. Trials, 19. p. 312. ISSN 1745-6215 https://doi.org/10.1186/s13063-018-2675-7
SGUL Authors: Oakeshott, Philippa Kerry-Barnard, Sarah Ruth

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Abstract

Background 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). Trial registration ISRCTN 58038795. Registered on 31 August 2016.

Item Type: Article
Additional Information: © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Keywords: General & Internal Medicine, 1102 Cardiovascular Medicine And Haematology, 1103 Clinical Sciences
SGUL Research Institute / Research Centre: Academic Structure > Population Health Research Institute (INPH)
Journal or Publication Title: Trials
ISSN: 1745-6215
Dates:
DateEvent
5 June 2018Published
4 May 2018Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
PB-PG-1014-35007National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
URI: https://openaccess.sgul.ac.uk/id/eprint/109865
Publisher's version: https://doi.org/10.1186/s13063-018-2675-7

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