Abstract
BackgroundThere 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/designTnT 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 registrationISRCTN 58038795. Registered on 31 August 2016.
Highlights
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
It is estimated that 10–16% of women with untreated chlamydia will develop clinical pelvic inflammatory disease of whom 8% will have an ectopic pregnancy and 11% will suffer from tubal-factor infertility [6]
Introducing rapid, on-the-spot chlamydia tests and treatment into the community could make it easier for young people to get tested and treated faster before they can pass on their infection
Summary
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 [1,2,3,4], with around 8% testing positive for Chlamydia trachomatis. Barriers to reducing chlamydia rates include low uptake of testing by those most at risk [5, 7] (such as teenagers, people from ethnic minorities and people who are socioeconomically deprived), and long delays in receiving a positive diagnosis or attending for treatment [8, 9]. Introducing rapid, on-the-spot chlamydia tests and treatment into the community could make it easier for young people to get tested and treated faster before they can pass on their infection. It might prevent complications [10, 11]. There have been no UK trials of rapid sexually transmitted infection (STI) tests and same-day, on-site treatment in non-healthcare settings
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