Kerry-Barnard, Sarah; Fleming, Charlotte; Reid, Fiona; Phillips, Rachel; Drennan, Vari M; Adams, Elisabeth J; Majewska, Wendy; Balendra, Anjella; Harding-Esch, Emma; Cousins, Emma; +2 more... Tariq Sadiq, S; Oakeshott, Pippa; (2018) '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. Trials, 19 (1). 311-. ISSN 1745-6215 DOI: https://doi.org/10.1186/s13063-018-2674-8
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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.
Item Type | Article |
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Keywords | Cluster randomised, Feasibility trial, Further education colleges, Rapid chlamydia tests, Screening, Test and treat, Young people |
Faculty and Department | Faculty of Infectious and Tropical Diseases > Dept of Clinical Research |
PubMed ID | 29871673 |
ISI | 434290800002 |
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