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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

‘Test n Treat (TnT)’– Rapid testing and same-day, on-site treatment to reduce rates of chlamydia in sexually active further education college students: study protocol for a cluster randomised feasibility trial

Authors: Sarah Kerry-Barnard, Charlotte Fleming, Fiona Reid, Rachel Phillips, Vari M. Drennan, Elisabeth J. Adams, Wendy Majewska, Anjella Balendra, Emma Harding-Esch, Emma Cousins, S. Tariq Sadiq, Pippa Oakeshott

Published in: Trials | Issue 1/2018

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Abstract

Background

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.

Methods

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.

Discussion

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.
Appendix
Available only for authorised users
Literature
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Metadata
Title
‘Test n Treat (TnT)’– Rapid testing and same-day, on-site treatment to reduce rates of chlamydia in sexually active further education college students: study protocol for a cluster randomised feasibility trial
Authors
Sarah Kerry-Barnard
Charlotte Fleming
Fiona Reid
Rachel Phillips
Vari M. Drennan
Elisabeth J. Adams
Wendy Majewska
Anjella Balendra
Emma Harding-Esch
Emma Cousins
S. Tariq Sadiq
Pippa Oakeshott
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2674-8

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