‘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

‘Test n Treat (TnT)’– Rapid testing and same-day, on-site treatment to reduce rates of... 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. (Continued on next page) * Correspondence: oakeshot@sgul.ac.uk Population Health Research Institute, St George’s, University of London, London SW17ORE, UK Full list of author information is available at the end of the article © 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. Kerry-Barnard et al. Trials (2018) 19:311 Page 2 of 8 (Continued from previous page) 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. Keywords: Rapid chlamydia tests, Screening, Young people, Further education colleges, Test and treat, Cluster randomised, Feasibility trial Background 1. To assess the feasibility of conducting a trial of TnT There are high rates of sexually transmitted infections in FE colleges, and obtain estimates of key values to (STIs) in ethnically diverse, sexually active students aged inform sample size estimates and timescales for a 16–24 years attending London further education (FE) col- definitive trial leges [1–4], with around 8% testing positive for Chlamydia 2. To explore the acceptability of TnT through a trachomatis. However, uptake of chlamydia screening re- qualitative evaluation mains low: below 30% annually in 16–24-year-olds in Eng- 3. To estimate the cost per person tested and treated land [4, 5]. Although chlamydia primarily affects young in TnT versus usual care people, the consequences of infection such as infertility, chronic pelvic pain or epididymitis can last a lifetime. It is Design estimated that 10–16% of women with untreated chlamydia Cluster randomised controlled feasibility trial over 7 will develop clinical pelvic inflammatory disease of whom months with parallel qualitative and economic assess- 8% will have an ectopic pregnancy and 11% will suffer from ments (Fig. 1 and Additional file 1: Standard Protocol tubal-factor infertility [6]. The cost of chlamydia to the Items: Recommendations for Interventional Trials NHS is estimated to be over £100 million each year. (SPIRIT) 2013 Checklist (Fig. 2)). The outcome is within Barriers to reducing chlamydia rates include low up- one academic year to optimise follow-up. take of testing by those most at risk [5, 7] (such as sexu- ally active teenagers, people from ethnic minorities and Setting people who are socioeconomically deprived), and long Six ethnically diverse FE colleges in London FE colleges delays in receiving a positive diagnosis or attending for take students from the age of 16 years and teach both treatment. Introducing rapid, on-the-spot chlamydia academic subjects and vocational courses such as tests and treatment into the community could make it plumbing and hairdressing. As previously [3] we will easier for young people to get tested and treated faster, first obtain agreement from staff and student bodies. and before they can pass on their infection. It might also prevent complications [8, 9]. These novel tests can have Participants 99% sensitivity and 99.4% specificity [10], and studies At each site during 2 days, 80 consecutive sexually active have demonstrated their feasibility in remote communi- students (total 480 students across all sites) aged 16– ties [11]. However, there have been no UK trials of rapid 24 years will be recruited. We previously found that STI tests and same-day, on-site treatment (Test and such students are a high-risk group: 43% report two or Treat (TnT)) in non-healthcare settings. more sexual partners in the past year, 34% smoke ciga- We will use a test that checks for gonorrhoea as well rettes, 50% are teenagers and 30% are from black ethnic as chlamydia as this would likely be included in a minority groups [3]. real-life roll out. However, as people diagnosed with gonorrhoea are best managed by a sexual health clinic they will not receive on-site treatment. Hence, TnT will Exclusion criteria be just for chlamydia. Students who have never had penetrative sexual inter- Our cluster randomised feasibility trial aims: course; students with severe learning disability. Kerry-Barnard et al. Trials (2018) 19:311 Page 3 of 8 Fig. 1 Shows the design of the Test n Treat (TnT) cluster randomised feasibility trial STUDY PERIOD Follow up Enrolment Allocation Post-allocation at 7 months TIMEPOINT** -t1 0 Month 1 TnT Month 4 TnT tx ENROLMENT: Eligibility screen Informed consent X Allocation INTERVENTIONS: [TnT test n treat @ 1 and 4 months] ASSESSMENTS: Provide genitourinary xx samples xX Questionnaire *Recommended content can be displayed using various schematic formats. See SPIRIT 2013 Explanation and Elaboration for examples from protocols. **List specific timepoints in this row. Fig. 2 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure showing the schedule of enrolment, interventions, and assessments for the Test n Treat (TnT) chlamydia screening feasibility trial Kerry-Barnard et al. Trials (2018) 19:311 Page 4 of 8 Recruitment and consent (September to October 2016) participants in intervention colleges will not be given Research assistants will approach students in common honoraria to attend for TnT after 1 and 4 months as this room areas [3, 12]. The students will be asked if they are would not happen were the intervention to be rolled out willing to help with research on sexual health. Students in future. aged 16–24 will be invited to come to the study table where recruiters will explain that as the study is about Data collection at baseline (September to October 2016) chlamydia and sexually transmitted infections, only stu- During recruitment, participants will be asked to dents who have had penetrative sexual intercourse complete a confidential baseline questionnaire using a should consider taking part. Those who are interested tablet computer. Questions will include date of birth, will be given a patient information sheet and consent self-assigned ethnicity, smoking, alcohol, age at sexual form to read and be encouraged to ask questions. debut, condom use, contraception, number of sexual The information sheet will explain that participants partners in the previous 12 months, when they last had will be asked to complete short confidential electronic sex with a new partner, recent STI testing and treatment, questionnaires on sexual health using a tablet computer, history of STI, and genitourinary symptoms in the past 6 and to provide samples on this day and again after months [3]. All participants will also be asked to provide 7 months (urine for males and self-taken vaginal swabs samples in the nearest toilet. for females). In half the colleges, students will also be asked to provide samples for rapid testing for chlamydia Randomisation and gonorrhoea after 1 and 4 months, and those found Randomisation will take place once recruitment is com- to be infected with chlamydia will be given same-day, pleted and baseline data collected for all colleges. on-site treatment. Some students may also be invited to Using a computer programme, colleges will be ran- take part in interviews [13]. domly allocated into the intervention (TnT) or the con- Research assistants will ensure that all participants under- trol (no TnT) by the trial statisticians RP and FR. The stand that samples provided at recruitment will not be randomisation will be constrained to ensure that three tested for 7 months and it is the student’s responsibility to colleges are allocated to each group. get tested separately [3] (e.g. at a sexual health clinic or at a general practice) if they are allocated to the control group Intervention TnT colleges – rapid chlamydia/gonorrhoea or if they want to be tested for other STIs such as HIV. testing and same-day chlamydia treatment (1 and 4 These stored baseline samples are for three reasons: months after recruitment) In November 2016, 1 month after recruitment, each 1. To emulate the processes of a future definitive trial intervention campus will be visited on two consecutive 2. To ensure that all participants know how simple it days by the TnT team. These will be the same days of is to provide samples for testing the week as at recruitment to optimise student attend- 3. To measure baseline chlamydia prevalence at each ance. The 80 participating students in each campus will site in order to refine the intra-class correlation be texted and invited to come for on-site rapid chla- coefficient (ICC) for sample size calculations mydia/gonorrhoea testing and same-day treatment for chlamydia. As at recruitment they will be invited to Students who agree to take part will be asked to sign a complete a questionnaire and provide a sample, but this consent form and to provide full contact details includ- time the sample will be tested immediately on site using ing mobile number and email for follow-up and text re- the Cepheid GeneXpert system which takes 90 min. Par- minders [3]. They will be asked for consent to obtain ticipants will be given a card containing information their NHS numbers and to allow the researchers to ac- about the local GUM/sexual health clinic, a link to the cess their GP, hospital, and genitourinary medicine Brook sexual health website: https://www.brook.org.uk, (GUM) clinic records [14]. and TnT study contact details. Negative results will be texted. Participants with posi- Honoraria for participants tive results will be telephoned by the nurse health ad- Honoraria will be provided both to facilitate recruitment viser and invited to see her in the college nurse’s room [15, 16] and to encourage participants to return repeat for confidential same-day treatment if positive for chla- samples at the end of the trial. (We have ethical approval mydia, partner notification, advice, and follow-up. In- for honoraria and have shown them to be very effective fected students will be asked to bring any sexual [16]). Participants will be given £5 when they return partners who attend the college so they can also be completed sample packs at recruitment, and £10 at the tested and treated. (In a survey in 2014, 9% of 103 stu- final 7-month follow-up. Participants in the qualitative dents said they had a sexual partner at the same FE col- interviews will be given £10 for their time. However, lege.) Students who are positive for gonorrhoea will be Kerry-Barnard et al. Trials (2018) 19:311 Page 5 of 8 asked to attend St George’s NHS Trust GUM clinic for treatment group. By the time of the first TnT interven- further testing and review by a clinician. tion 1 month after baseline, participants and research as- All participants in the three intervention colleges will sistants will no longer be blinded. be invited to provide repeat samples for on-site TnT 4 months after recruitment (i.e. the next term January– Qualitative evaluation exploring the acceptability of TnT February 2017). A research assistant will conduct semi-structured inter- views [13] with a purposive sample of male and female Control ‘usual care’ colleges (1 and 4 months after college staff and students to investigate views on the ac- recruitment) ceptability of TnT including barriers and facilitators to Participants from the three control colleges will not get uptake and possible harms. TnT but will receive texts 1 and 4 months after recruit- ment thanking them for being in the study. 1. College staff (n = 12) Data collection at 7-month follow-up (April–May 2017) We will interview teaching and student welfare staff All participants will be asked to provide samples for and explore opinions of the acceptability of the interven- TnT and to complete questionnaires at college at 7 tion, barriers, facilitators, harms, and challenges to months. Follow-up questionnaires will include additional reaching certain subgroups such as male teenagers from questions about STI testing and treatment, oral sex, vac- ethnic minorities. We will also explore views on the trial cination against human papillomavirus (HPV), and use methodology and suggested improvements. of healthcare services for sexual health since recruitment date, including attendances at general practice, sexual 2. Students (n = 30) health or hospital clinics, hospital admissions, and drug treatment [3, 17]. These interviews will explore opinions on acceptabil- When we invite them to the outcome assessment we will ity, barriers, and facilitators to uptake of TnT, and views send participants a link to an additional consent form and of potential harms of on-site rapid tests and treatment. information sheet explaining that we will be asking them to We will also seek views as to the trial methodology and provide optional mouthwash samples (for future testing for suggested improvements. HPV and chlamydia/gonorrhoea) as well as genitourinary Interviews will focus on three distinct groups: samples. We will also put this information on the study 1. Students who declined to participate in the trial webpage. For those who attend we will provide paper cop- (n = 10) who agree to be interviewed to explore ies of the additional consent form and information sheet factors influencing their decision and answer any questions. We will explain that providing 2. Participants (n = 10) in intervention sites who used the mouthwash sample is optional and for research pur- TnT poses only and, that as chlamydia/gonorrhoea and HPV 3. Participants (n = 10) in intervention sites who were tests are not validated on these samples, we will not feed- recruited but did not use TnT back results. Those who agree will be asked to sign the add- Interviews will be digitally recorded with permission, itional consent form. transcribed and thematically analysed. Testing at 7 months is required in the proposed full trial in order to calculate the main outcome (prevalence of chla- Health economic analysis mydia), and is included here to test the feasibility of collect- We will estimate the cost per person screened and ing these data. It will also help inform estimates of effect treated of implementing TnT in FE colleges compared size for sample size calculations. Treatment of those diag- with usual care (no TnT), and the incremental cost per nosed with infection at 7 months will also be offered. This chlamydia infection averted. Costs will be classified as is not part of the assessed intervention, but is offered to en- solely research; capital set-up costs; or on-going running hance testing uptake at this time, and participation in gen- costs. We will also assess the feasibility of obtaining eral among the control group. In addition, at the end of the questionnaire data on healthcare use during the study study stored baseline samples will be tested using standard period. Based on what participants report in their tests, and students with positive results will be contacted by 7-month questionnaires about healthcare setting the health adviser [3]. attended for chlamydia-related problems, we will explore the feasibility of estimating the health resources used in Masking both arms of the study using published tariff costs for Recruitment of colleges and participants will be con- GUM, hospital inpatient and outpatient visits, and GP 3,19 ducted prior to group allocation . Therefore, the base- attendance [17]. We will explore the marginal costs of line data collection from students will be blind to offering TnT at 1 and 4 months compared to no test. Kerry-Barnard et al. Trials (2018) 19:311 Page 6 of 8 Results will inform the cost of implementing TnT in a from another six colleges will improve the precision of definitive trial. this ICC, reducing the width of the confidence interval by around 20%. Main outcomes Assuming 70% followed up at 7 months (with £10 honoraria), final estimates of chlamydia prevalence 1. Key values to inform feasibility, sample size, and would be based on 168 students in each of the interven- timescales of a full trial of TnT in FE colleges: tion and control groups. The study is not powered to (a) Recruitment rates: find a statistically significant difference, but this may Recruitment rate: colleges and students provide useful information on possible effect size to in- Time taken to recruit 80 participants at each form future sample size calculations. site Age, gender, and ethnicity of students Statistical analysis recruited versus not recruited [16] Summary of baseline data and flow of patients (b) Testing and treatment uptake rates A Consolidated Standards of Reporting Trials (CONSORT) (1 and 4 months after recruitment): flow diagram will be produced to show the number of stu- Testing and treatment uptake rates, in dents recruited, the numbers attending at 7-month final intervention sites only follow-up, and for those not attending the reasons (where Time from provision of sample to treatment available) for non-attendance including lost-to-follow-up of chlamydia positives and withdrawal. Baseline descriptions of students recruited (c) Follow-up rates (at 7 months): to the study will be presented by treatment arm: including Percentage providing samples at all sites means and standard deviation or numbers and proportions Percentage completing final questionnaires as appropriate. This will be repeated to compare the base- (including data on healthcare usage) line characteristics of those in the intervention arm return- (d) Prevalence of chlamydia in participants at each ing for TnT at 1 and 4 months compared to those who did site at baseline and at 7 months. Chlamydia not return. Where available reasons for non-attendance at prevalence at baseline will enable us to refine the 1- and 4-month visits will be summarised. Summary the ICC, and prevalence at 7 months to refine characteristics of participants at the FE colleges will also be the estimated effect size, both required for summarised by treatment arm. No statistical significance sample size calculations for the substantive trial testing will be performed. 2. A perspective on the acceptability of TnT in FE colleges, emerging from qualitative interviews with Main outcomes analysis purposively sampled students and college staff Recruitment rates (colleges and students) will be calcu- 3. Health economic analysis (as described above) lated as proportions with corresponding 95% CIs. This will include the proportion of colleges participating in Estimate of the cost per person screened/treated in the study of the total number of colleges asked to par- TnT versus usual care. ticipate, and, where available, the proportion of students who were eligible of the total number of students who Sample size and statistical analysis were assessed for eligibility. The proportion of students Assuming a 30% recruitment rate [12], 1600 students tested, who obtain a positive test result and receive treat- will be approached to recruit 480 overall (80 per site ment, will be calculated at 1 and 4 months for the inter- across six sites, three intervention, and three control). vention group and at 7 months for both the intervention Estimates of testing uptake at 1 and 4 months (interven- and the control groups, and corresponding 95% CIs will tion sites only) will be based on 240 students, and at be presented. 7 months will be based on 480 students (all sites). The time taken to recruit students will be summarised Teare et al. [18] recommend that 60 to 100 subjects is by means and standard deviations or medians and sufficient to estimate an event rate with acceptable pre- inter-quartile ranges as appropriate, for each site and cision in a feasibility study. Prevalence of chlamydia at overall. At intervention colleges we will summarise the baseline will be estimated separately for each of the six time from providing a sample to treatment for students sites (80 students per site), and these prevalences will be with a positive chlamydia test at 1 and 4 months with used to inform the intraclass correlation coefficient means and standard deviations or medians and (ICC), required for the sample size calculation for the inter-quartile ranges as appropriate. All confidence inter- main study. From our previous research involving 11 vals will be two-sided and will be at the 95% level. A de- colleges [3], the ICC was estimated to be 0.005 (95% tailed statistical analysis plan has been developed and confidence interval (CI) − 0.013 to 0.026). Adding data approved by the Trial Steering Committee [19]. Kerry-Barnard et al. Trials (2018) 19:311 Page 7 of 8 Discussion Author details Population Health Research Institute, St George’s, University of London, To our knowledge this will be the first UK cluster rando- London SW17ORE, UK. Department of Primary Care and Public Health mised study exploring the feasibility of rapid chlamydia Sciences, King’s College London, 4th Floor, Addison House, Guy’s Campus, tests and same-day, on-site treatment in the community. If London SE1 1UL, UK. Centre for Health and Social Care Research, Kingston University and St George’s University of London, London SW17ORE, UK. the findings lead to a main trial which shows that TnT is Aquarius Population Health Limited, 58a Highgate High Street, London N6 acceptable, cost-effective and reduces chlamydia rates, 5 5HX, UK. WEM Consultancy Ltd., 96 Tantallon Road, London SW12 8DH, UK. implementing TnT in the community might improve the Infection and Immunity, St George’s, University of London, London SW17ORE, UK. sexual health of many hard-to-reach young people. Received: 26 April 2017 Accepted: 4 May 2018 Trial status We are recruiting participants. References Additional file 1. Oakeshott P, Aghaizu A, Reid F, Howell-Jones R, Hay PE, Sadiq ST, et al. Frequency and risk factors for prevalent, incident, and persistent genital carcinogenic human papillomavirus infection in sexually active women: Additional file 1: Standard Protocol Items: Recommendations for community based cohort study. BMJ. 2012;344:e4168. Interventional Trials (SPIRIT) 2013 Checklist: recommended items to 2. Oakeshott P, Aghaizu A, Hay P, Reid F, Kerry S, Atherton H, et al. Is address in a clinical trial protocol and related documents. (DOC 121 kb) Mycoplasma genitaliium in women the ‘new chlamydia’? Community-based prospective cohort study. Clin Infect Dis. 2010;51:1160–6. Abbreviations 3. Oakeshott P, Kerry S, Aghaizu A, Atherton H, Hay S, Taylor-Robinson D, et al. FE colleges: Further education colleges; GUM: Genitourinary medicine; Randomised controlled trial of screening for Chlamydia trachomatis to HPV: Human papillomavirus; ICC: Intraclass correlation coefficient; prevent pelvic inflammatory disease: the POPI (prevention of pelvic STI: Sexually transmitted infection; TnT: Test n Treat infection) trial. Br Med J. 2010;340:1642. 4. Aghaizu A, Reid F, Kerry S, Hay PE, Mallinson H, Jensen JS, et al. Frequency and risk factors for incident and redetected Chlamydia trachomatis infection Acknowledgements in sexually active, young, multi-ethnic women: a community based cohort We thank Georgie Timson and Alice Bonnissent of Cepheid International for study. Sex Transm Infect. 2014;90:524–8. providing the rapid chlamydia/gonorrhoea tests. 5. National Chlamydia Coalition. Getting more young women screened for chlamydia: findings from qualitative research, vol. 3; 2011. p. 1–17. Funding 6. Public Health England. Opportunistic chlamydia screening of young adults This independent research is funded by the NIHR under its Research for in England. London: Public Health England; 2014. Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-1014- 7. van den Broek IV, van Bergen JE, Brouwers EE, Fennema JS, Gotz HM, 35007). The views expressed are those of the authors and not necessarily Hoebe CJ, et al. Effectiveness of yearly, register based screening for those of the NHS, the NIHR or the Department of Health. The funding body chlamydia in the Netherlands: controlled trial with randomised stepped will have no role in the design of the study, the collection, analysis or inter- wedge implementation. BMJ. 2012;345:e4316. pretation of the data, or the write-up of the manuscript. 8. Adams EJ, Ehrlich A, Turner KM, Shah K, Macleod J, Goldenberg S, et al. The BMA Foundation for Medical Research TP Gunton award and the Mapping patient pathways and estimating resource use for point of Wellcome Trust Institution Strategic Support Fund grant number 204809/Z/ care versus standard testing and treatment of chlamydia and 16/Z will fund the HPV and chlamydia/gonorrhoea tests in oropharyngeal gonorrhoea in genitourinary medicine clinics in the UK. BMJ Open. samples. 2014;4(7):e005322. 9. Turner KM, Round J, Horner P, Macleod J, Goldenberg S, Deol A, et al. An Availability of data and materials early evaluation of clinical and economic costs and benefits of Data and materials may be obtained from SKB. implementing point of care NAAT tests for Chlamydia trachomatis and Neisseria gonorrhoea in genitourinary medicine clinics in England. Sex Authors’ contributions Transm Infect. 2014;90(2):104–11. PO, FR, STS, VMD, EA, and SKB designed the study and obtained the funding. 10. Gaydos CA, Van Der Pol B, Jett-Goheen M, Barnes M, Quinn N, Clark C, et al. FR and RP designed the statistical analysis plan and will analyse the data Performance of the Cepheid CT/NG Xpert Rapid PCR Test for detection of with trial manager SKB. SKB and CF wrote the first draft of the study protocol Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol. 2013; to which all authors (FR, RP, VMD, EJA, WM, AB, EHE, EC, STS) then 51(6):1666–72. contributed. All authors read and approved the final manuscript. 11. Guy RJ, Natoli L, Ward J, Causer L, Hengel B, Whiley D, et al. A randomised trial of point-of-care tests for chlamydia and gonorrhoea infections in Ethics approval and consent to participate remote Aboriginal communities: Test, Treat ANd GO- the ‘TTANGO’ trial The study was approved by Bromley REC reference 15/LO/1929. All protocol. BMC Infect Dis. 2013;13:485. participants will provide informed written consent. 12. Oakeshott P, Kerry S, Atherton H, Aghaizu A, Hay S, Taylor-Robinson D, et al. Community-based trial of screening for Chlamydia trachomatis to prevent Competing interests pelvic inflammatory disease: the POPI (Prevention Of Pelvic Infection) trial. Pippa Oakeshott is a member of the NIHR South London Collaboration for Trials. 2008;9:73. Leadership in Applied Health Research and Care. PO, STS, EHE, and EC are 13. Normansell R, Drennan V, Oakeshott P. Exploring female FE college members of the esti2 consortium funded under the UKCRC Translational students’ attitudes to regular sexually transmitted infection screening: a Infection Research Initiative supported by the Medical Research Council qualitative study. Health Expect. 2016;19:322–30. PMC5055273 (Grant Number G0901608) with contributions from the Biotechnology and 14. Ellis J, Green R, Kerry SR, Jesuratnam G, Rajamanoharan A, Patel R, et al. Biological Sciences Research Council, the National Institute for Health Acceptability of providing self-taken vaginal samples and allowing access to Research. NHS numbers and medical records: feasibility study in young female genitourinary medicine clinic attenders. Sex Transm Infect. 2012;88(4):300. Publisher’sNote 15. Hocking JS, Vodstrcil L, Huston WM, Timms P, Chen M, Worthington K, et al. Springer Nature remains neutral with regard to jurisdictional claims in A cohort study of Chlamydia trachomatis treatment failure in women: a published maps and institutional affiliations. study protocol. BMC Infect Dis. 2013;13(1):379. Kerry-Barnard et al. Trials (2018) 19:311 Page 8 of 8 16. Hunjan T, Kerry SR, Hay P, Planche T, Sadiq ST, Oakeshott P. Chlamydia testing: where are we now? Recruiting high risk women to a pilot STI screening trial. Sex Trans Infect. 2013;89:556. 17. AghaizuA,Adams EJ, TurnerK, Kerry S, HayP,Simms I, et al.What is the cost of pelvic inflammatory disease and how much could be prevented by screening for chlamydia trachomatis? Cost analysis of the Prevention of Pelvic Infection (POPI) trial. Sex Transm Infect. 2011;87(4):312–7. 18. Teare MD, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014;15:264. 19. Phillips R, Reid F. Test n Treat statistical analysis plan. "Test n Treat": a cluster randomised feasibility trial of frequent rapid testing and same day on-site treatment to reduce rates of chlamydia in further education college students. Trials. [in press] 2018. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Trials Springer Journals

‘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

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Medicine & Public Health; Medicine/Public Health, general; Biomedicine, general; Statistics for Life Sciences, Medicine, Health Sciences
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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. (Continued on next page) * Correspondence: oakeshot@sgul.ac.uk Population Health Research Institute, St George’s, University of London, London SW17ORE, UK Full list of author information is available at the end of the article © 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. Kerry-Barnard et al. Trials (2018) 19:311 Page 2 of 8 (Continued from previous page) 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. Keywords: Rapid chlamydia tests, Screening, Young people, Further education colleges, Test and treat, Cluster randomised, Feasibility trial Background 1. To assess the feasibility of conducting a trial of TnT There are high rates of sexually transmitted infections in FE colleges, and obtain estimates of key values to (STIs) in ethnically diverse, sexually active students aged inform sample size estimates and timescales for a 16–24 years attending London further education (FE) col- definitive trial leges [1–4], with around 8% testing positive for Chlamydia 2. To explore the acceptability of TnT through a trachomatis. However, uptake of chlamydia screening re- qualitative evaluation mains low: below 30% annually in 16–24-year-olds in Eng- 3. To estimate the cost per person tested and treated land [4, 5]. Although chlamydia primarily affects young in TnT versus usual care people, the consequences of infection such as infertility, chronic pelvic pain or epididymitis can last a lifetime. It is Design estimated that 10–16% of women with untreated chlamydia Cluster randomised controlled feasibility trial over 7 will develop clinical pelvic inflammatory disease of whom months with parallel qualitative and economic assess- 8% will have an ectopic pregnancy and 11% will suffer from ments (Fig. 1 and Additional file 1: Standard Protocol tubal-factor infertility [6]. The cost of chlamydia to the Items: Recommendations for Interventional Trials NHS is estimated to be over £100 million each year. (SPIRIT) 2013 Checklist (Fig. 2)). The outcome is within Barriers to reducing chlamydia rates include low up- one academic year to optimise follow-up. take of testing by those most at risk [5, 7] (such as sexu- ally active teenagers, people from ethnic minorities and Setting people who are socioeconomically deprived), and long Six ethnically diverse FE colleges in London FE colleges delays in receiving a positive diagnosis or attending for take students from the age of 16 years and teach both treatment. Introducing rapid, on-the-spot chlamydia academic subjects and vocational courses such as tests and treatment into the community could make it plumbing and hairdressing. As previously [3] we will easier for young people to get tested and treated faster, first obtain agreement from staff and student bodies. and before they can pass on their infection. It might also prevent complications [8, 9]. These novel tests can have Participants 99% sensitivity and 99.4% specificity [10], and studies At each site during 2 days, 80 consecutive sexually active have demonstrated their feasibility in remote communi- students (total 480 students across all sites) aged 16– ties [11]. However, there have been no UK trials of rapid 24 years will be recruited. We previously found that STI tests and same-day, on-site treatment (Test and such students are a high-risk group: 43% report two or Treat (TnT)) in non-healthcare settings. more sexual partners in the past year, 34% smoke ciga- We will use a test that checks for gonorrhoea as well rettes, 50% are teenagers and 30% are from black ethnic as chlamydia as this would likely be included in a minority groups [3]. real-life roll out. However, as people diagnosed with gonorrhoea are best managed by a sexual health clinic they will not receive on-site treatment. Hence, TnT will Exclusion criteria be just for chlamydia. Students who have never had penetrative sexual inter- Our cluster randomised feasibility trial aims: course; students with severe learning disability. Kerry-Barnard et al. Trials (2018) 19:311 Page 3 of 8 Fig. 1 Shows the design of the Test n Treat (TnT) cluster randomised feasibility trial STUDY PERIOD Follow up Enrolment Allocation Post-allocation at 7 months TIMEPOINT** -t1 0 Month 1 TnT Month 4 TnT tx ENROLMENT: Eligibility screen Informed consent X Allocation INTERVENTIONS: [TnT test n treat @ 1 and 4 months] ASSESSMENTS: Provide genitourinary xx samples xX Questionnaire *Recommended content can be displayed using various schematic formats. See SPIRIT 2013 Explanation and Elaboration for examples from protocols. **List specific timepoints in this row. Fig. 2 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure showing the schedule of enrolment, interventions, and assessments for the Test n Treat (TnT) chlamydia screening feasibility trial Kerry-Barnard et al. Trials (2018) 19:311 Page 4 of 8 Recruitment and consent (September to October 2016) participants in intervention colleges will not be given Research assistants will approach students in common honoraria to attend for TnT after 1 and 4 months as this room areas [3, 12]. The students will be asked if they are would not happen were the intervention to be rolled out willing to help with research on sexual health. Students in future. aged 16–24 will be invited to come to the study table where recruiters will explain that as the study is about Data collection at baseline (September to October 2016) chlamydia and sexually transmitted infections, only stu- During recruitment, participants will be asked to dents who have had penetrative sexual intercourse complete a confidential baseline questionnaire using a should consider taking part. Those who are interested tablet computer. Questions will include date of birth, will be given a patient information sheet and consent self-assigned ethnicity, smoking, alcohol, age at sexual form to read and be encouraged to ask questions. debut, condom use, contraception, number of sexual The information sheet will explain that participants partners in the previous 12 months, when they last had will be asked to complete short confidential electronic sex with a new partner, recent STI testing and treatment, questionnaires on sexual health using a tablet computer, history of STI, and genitourinary symptoms in the past 6 and to provide samples on this day and again after months [3]. All participants will also be asked to provide 7 months (urine for males and self-taken vaginal swabs samples in the nearest toilet. for females). In half the colleges, students will also be asked to provide samples for rapid testing for chlamydia Randomisation and gonorrhoea after 1 and 4 months, and those found Randomisation will take place once recruitment is com- to be infected with chlamydia will be given same-day, pleted and baseline data collected for all colleges. on-site treatment. Some students may also be invited to Using a computer programme, colleges will be ran- take part in interviews [13]. domly allocated into the intervention (TnT) or the con- Research assistants will ensure that all participants under- trol (no TnT) by the trial statisticians RP and FR. The stand that samples provided at recruitment will not be randomisation will be constrained to ensure that three tested for 7 months and it is the student’s responsibility to colleges are allocated to each group. get tested separately [3] (e.g. at a sexual health clinic or at a general practice) if they are allocated to the control group Intervention TnT colleges – rapid chlamydia/gonorrhoea or if they want to be tested for other STIs such as HIV. testing and same-day chlamydia treatment (1 and 4 These stored baseline samples are for three reasons: months after recruitment) In November 2016, 1 month after recruitment, each 1. To emulate the processes of a future definitive trial intervention campus will be visited on two consecutive 2. To ensure that all participants know how simple it days by the TnT team. These will be the same days of is to provide samples for testing the week as at recruitment to optimise student attend- 3. To measure baseline chlamydia prevalence at each ance. The 80 participating students in each campus will site in order to refine the intra-class correlation be texted and invited to come for on-site rapid chla- coefficient (ICC) for sample size calculations mydia/gonorrhoea testing and same-day treatment for chlamydia. As at recruitment they will be invited to Students who agree to take part will be asked to sign a complete a questionnaire and provide a sample, but this consent form and to provide full contact details includ- time the sample will be tested immediately on site using ing mobile number and email for follow-up and text re- the Cepheid GeneXpert system which takes 90 min. Par- minders [3]. They will be asked for consent to obtain ticipants will be given a card containing information their NHS numbers and to allow the researchers to ac- about the local GUM/sexual health clinic, a link to the cess their GP, hospital, and genitourinary medicine Brook sexual health website: https://www.brook.org.uk, (GUM) clinic records [14]. and TnT study contact details. Negative results will be texted. Participants with posi- Honoraria for participants tive results will be telephoned by the nurse health ad- Honoraria will be provided both to facilitate recruitment viser and invited to see her in the college nurse’s room [15, 16] and to encourage participants to return repeat for confidential same-day treatment if positive for chla- samples at the end of the trial. (We have ethical approval mydia, partner notification, advice, and follow-up. In- for honoraria and have shown them to be very effective fected students will be asked to bring any sexual [16]). Participants will be given £5 when they return partners who attend the college so they can also be completed sample packs at recruitment, and £10 at the tested and treated. (In a survey in 2014, 9% of 103 stu- final 7-month follow-up. Participants in the qualitative dents said they had a sexual partner at the same FE col- interviews will be given £10 for their time. However, lege.) Students who are positive for gonorrhoea will be Kerry-Barnard et al. Trials (2018) 19:311 Page 5 of 8 asked to attend St George’s NHS Trust GUM clinic for treatment group. By the time of the first TnT interven- further testing and review by a clinician. tion 1 month after baseline, participants and research as- All participants in the three intervention colleges will sistants will no longer be blinded. be invited to provide repeat samples for on-site TnT 4 months after recruitment (i.e. the next term January– Qualitative evaluation exploring the acceptability of TnT February 2017). A research assistant will conduct semi-structured inter- views [13] with a purposive sample of male and female Control ‘usual care’ colleges (1 and 4 months after college staff and students to investigate views on the ac- recruitment) ceptability of TnT including barriers and facilitators to Participants from the three control colleges will not get uptake and possible harms. TnT but will receive texts 1 and 4 months after recruit- ment thanking them for being in the study. 1. College staff (n = 12) Data collection at 7-month follow-up (April–May 2017) We will interview teaching and student welfare staff All participants will be asked to provide samples for and explore opinions of the acceptability of the interven- TnT and to complete questionnaires at college at 7 tion, barriers, facilitators, harms, and challenges to months. Follow-up questionnaires will include additional reaching certain subgroups such as male teenagers from questions about STI testing and treatment, oral sex, vac- ethnic minorities. We will also explore views on the trial cination against human papillomavirus (HPV), and use methodology and suggested improvements. of healthcare services for sexual health since recruitment date, including attendances at general practice, sexual 2. Students (n = 30) health or hospital clinics, hospital admissions, and drug treatment [3, 17]. These interviews will explore opinions on acceptabil- When we invite them to the outcome assessment we will ity, barriers, and facilitators to uptake of TnT, and views send participants a link to an additional consent form and of potential harms of on-site rapid tests and treatment. information sheet explaining that we will be asking them to We will also seek views as to the trial methodology and provide optional mouthwash samples (for future testing for suggested improvements. HPV and chlamydia/gonorrhoea) as well as genitourinary Interviews will focus on three distinct groups: samples. We will also put this information on the study 1. Students who declined to participate in the trial webpage. For those who attend we will provide paper cop- (n = 10) who agree to be interviewed to explore ies of the additional consent form and information sheet factors influencing their decision and answer any questions. We will explain that providing 2. Participants (n = 10) in intervention sites who used the mouthwash sample is optional and for research pur- TnT poses only and, that as chlamydia/gonorrhoea and HPV 3. Participants (n = 10) in intervention sites who were tests are not validated on these samples, we will not feed- recruited but did not use TnT back results. Those who agree will be asked to sign the add- Interviews will be digitally recorded with permission, itional consent form. transcribed and thematically analysed. Testing at 7 months is required in the proposed full trial in order to calculate the main outcome (prevalence of chla- Health economic analysis mydia), and is included here to test the feasibility of collect- We will estimate the cost per person screened and ing these data. It will also help inform estimates of effect treated of implementing TnT in FE colleges compared size for sample size calculations. Treatment of those diag- with usual care (no TnT), and the incremental cost per nosed with infection at 7 months will also be offered. This chlamydia infection averted. Costs will be classified as is not part of the assessed intervention, but is offered to en- solely research; capital set-up costs; or on-going running hance testing uptake at this time, and participation in gen- costs. We will also assess the feasibility of obtaining eral among the control group. In addition, at the end of the questionnaire data on healthcare use during the study study stored baseline samples will be tested using standard period. Based on what participants report in their tests, and students with positive results will be contacted by 7-month questionnaires about healthcare setting the health adviser [3]. attended for chlamydia-related problems, we will explore the feasibility of estimating the health resources used in Masking both arms of the study using published tariff costs for Recruitment of colleges and participants will be con- GUM, hospital inpatient and outpatient visits, and GP 3,19 ducted prior to group allocation . Therefore, the base- attendance [17]. We will explore the marginal costs of line data collection from students will be blind to offering TnT at 1 and 4 months compared to no test. Kerry-Barnard et al. Trials (2018) 19:311 Page 6 of 8 Results will inform the cost of implementing TnT in a from another six colleges will improve the precision of definitive trial. this ICC, reducing the width of the confidence interval by around 20%. Main outcomes Assuming 70% followed up at 7 months (with £10 honoraria), final estimates of chlamydia prevalence 1. Key values to inform feasibility, sample size, and would be based on 168 students in each of the interven- timescales of a full trial of TnT in FE colleges: tion and control groups. The study is not powered to (a) Recruitment rates: find a statistically significant difference, but this may Recruitment rate: colleges and students provide useful information on possible effect size to in- Time taken to recruit 80 participants at each form future sample size calculations. site Age, gender, and ethnicity of students Statistical analysis recruited versus not recruited [16] Summary of baseline data and flow of patients (b) Testing and treatment uptake rates A Consolidated Standards of Reporting Trials (CONSORT) (1 and 4 months after recruitment): flow diagram will be produced to show the number of stu- Testing and treatment uptake rates, in dents recruited, the numbers attending at 7-month final intervention sites only follow-up, and for those not attending the reasons (where Time from provision of sample to treatment available) for non-attendance including lost-to-follow-up of chlamydia positives and withdrawal. Baseline descriptions of students recruited (c) Follow-up rates (at 7 months): to the study will be presented by treatment arm: including Percentage providing samples at all sites means and standard deviation or numbers and proportions Percentage completing final questionnaires as appropriate. This will be repeated to compare the base- (including data on healthcare usage) line characteristics of those in the intervention arm return- (d) Prevalence of chlamydia in participants at each ing for TnT at 1 and 4 months compared to those who did site at baseline and at 7 months. Chlamydia not return. Where available reasons for non-attendance at prevalence at baseline will enable us to refine the 1- and 4-month visits will be summarised. Summary the ICC, and prevalence at 7 months to refine characteristics of participants at the FE colleges will also be the estimated effect size, both required for summarised by treatment arm. No statistical significance sample size calculations for the substantive trial testing will be performed. 2. A perspective on the acceptability of TnT in FE colleges, emerging from qualitative interviews with Main outcomes analysis purposively sampled students and college staff Recruitment rates (colleges and students) will be calcu- 3. Health economic analysis (as described above) lated as proportions with corresponding 95% CIs. This will include the proportion of colleges participating in Estimate of the cost per person screened/treated in the study of the total number of colleges asked to par- TnT versus usual care. ticipate, and, where available, the proportion of students who were eligible of the total number of students who Sample size and statistical analysis were assessed for eligibility. The proportion of students Assuming a 30% recruitment rate [12], 1600 students tested, who obtain a positive test result and receive treat- will be approached to recruit 480 overall (80 per site ment, will be calculated at 1 and 4 months for the inter- across six sites, three intervention, and three control). vention group and at 7 months for both the intervention Estimates of testing uptake at 1 and 4 months (interven- and the control groups, and corresponding 95% CIs will tion sites only) will be based on 240 students, and at be presented. 7 months will be based on 480 students (all sites). The time taken to recruit students will be summarised Teare et al. [18] recommend that 60 to 100 subjects is by means and standard deviations or medians and sufficient to estimate an event rate with acceptable pre- inter-quartile ranges as appropriate, for each site and cision in a feasibility study. Prevalence of chlamydia at overall. At intervention colleges we will summarise the baseline will be estimated separately for each of the six time from providing a sample to treatment for students sites (80 students per site), and these prevalences will be with a positive chlamydia test at 1 and 4 months with used to inform the intraclass correlation coefficient means and standard deviations or medians and (ICC), required for the sample size calculation for the inter-quartile ranges as appropriate. All confidence inter- main study. From our previous research involving 11 vals will be two-sided and will be at the 95% level. A de- colleges [3], the ICC was estimated to be 0.005 (95% tailed statistical analysis plan has been developed and confidence interval (CI) − 0.013 to 0.026). Adding data approved by the Trial Steering Committee [19]. Kerry-Barnard et al. Trials (2018) 19:311 Page 7 of 8 Discussion Author details Population Health Research Institute, St George’s, University of London, To our knowledge this will be the first UK cluster rando- London SW17ORE, UK. Department of Primary Care and Public Health mised study exploring the feasibility of rapid chlamydia Sciences, King’s College London, 4th Floor, Addison House, Guy’s Campus, tests and same-day, on-site treatment in the community. If London SE1 1UL, UK. Centre for Health and Social Care Research, Kingston University and St George’s University of London, London SW17ORE, UK. the findings lead to a main trial which shows that TnT is Aquarius Population Health Limited, 58a Highgate High Street, London N6 acceptable, cost-effective and reduces chlamydia rates, 5 5HX, UK. WEM Consultancy Ltd., 96 Tantallon Road, London SW12 8DH, UK. implementing TnT in the community might improve the Infection and Immunity, St George’s, University of London, London SW17ORE, UK. sexual health of many hard-to-reach young people. Received: 26 April 2017 Accepted: 4 May 2018 Trial status We are recruiting participants. References Additional file 1. Oakeshott P, Aghaizu A, Reid F, Howell-Jones R, Hay PE, Sadiq ST, et al. Frequency and risk factors for prevalent, incident, and persistent genital carcinogenic human papillomavirus infection in sexually active women: Additional file 1: Standard Protocol Items: Recommendations for community based cohort study. BMJ. 2012;344:e4168. Interventional Trials (SPIRIT) 2013 Checklist: recommended items to 2. Oakeshott P, Aghaizu A, Hay P, Reid F, Kerry S, Atherton H, et al. Is address in a clinical trial protocol and related documents. (DOC 121 kb) Mycoplasma genitaliium in women the ‘new chlamydia’? Community-based prospective cohort study. Clin Infect Dis. 2010;51:1160–6. Abbreviations 3. Oakeshott P, Kerry S, Aghaizu A, Atherton H, Hay S, Taylor-Robinson D, et al. FE colleges: Further education colleges; GUM: Genitourinary medicine; Randomised controlled trial of screening for Chlamydia trachomatis to HPV: Human papillomavirus; ICC: Intraclass correlation coefficient; prevent pelvic inflammatory disease: the POPI (prevention of pelvic STI: Sexually transmitted infection; TnT: Test n Treat infection) trial. Br Med J. 2010;340:1642. 4. Aghaizu A, Reid F, Kerry S, Hay PE, Mallinson H, Jensen JS, et al. Frequency and risk factors for incident and redetected Chlamydia trachomatis infection Acknowledgements in sexually active, young, multi-ethnic women: a community based cohort We thank Georgie Timson and Alice Bonnissent of Cepheid International for study. Sex Transm Infect. 2014;90:524–8. providing the rapid chlamydia/gonorrhoea tests. 5. National Chlamydia Coalition. Getting more young women screened for chlamydia: findings from qualitative research, vol. 3; 2011. p. 1–17. Funding 6. Public Health England. Opportunistic chlamydia screening of young adults This independent research is funded by the NIHR under its Research for in England. London: Public Health England; 2014. Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-1014- 7. van den Broek IV, van Bergen JE, Brouwers EE, Fennema JS, Gotz HM, 35007). The views expressed are those of the authors and not necessarily Hoebe CJ, et al. Effectiveness of yearly, register based screening for those of the NHS, the NIHR or the Department of Health. The funding body chlamydia in the Netherlands: controlled trial with randomised stepped will have no role in the design of the study, the collection, analysis or inter- wedge implementation. BMJ. 2012;345:e4316. pretation of the data, or the write-up of the manuscript. 8. Adams EJ, Ehrlich A, Turner KM, Shah K, Macleod J, Goldenberg S, et al. The BMA Foundation for Medical Research TP Gunton award and the Mapping patient pathways and estimating resource use for point of Wellcome Trust Institution Strategic Support Fund grant number 204809/Z/ care versus standard testing and treatment of chlamydia and 16/Z will fund the HPV and chlamydia/gonorrhoea tests in oropharyngeal gonorrhoea in genitourinary medicine clinics in the UK. BMJ Open. samples. 2014;4(7):e005322. 9. Turner KM, Round J, Horner P, Macleod J, Goldenberg S, Deol A, et al. An Availability of data and materials early evaluation of clinical and economic costs and benefits of Data and materials may be obtained from SKB. implementing point of care NAAT tests for Chlamydia trachomatis and Neisseria gonorrhoea in genitourinary medicine clinics in England. Sex Authors’ contributions Transm Infect. 2014;90(2):104–11. PO, FR, STS, VMD, EA, and SKB designed the study and obtained the funding. 10. Gaydos CA, Van Der Pol B, Jett-Goheen M, Barnes M, Quinn N, Clark C, et al. FR and RP designed the statistical analysis plan and will analyse the data Performance of the Cepheid CT/NG Xpert Rapid PCR Test for detection of with trial manager SKB. SKB and CF wrote the first draft of the study protocol Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol. 2013; to which all authors (FR, RP, VMD, EJA, WM, AB, EHE, EC, STS) then 51(6):1666–72. contributed. All authors read and approved the final manuscript. 11. Guy RJ, Natoli L, Ward J, Causer L, Hengel B, Whiley D, et al. A randomised trial of point-of-care tests for chlamydia and gonorrhoea infections in Ethics approval and consent to participate remote Aboriginal communities: Test, Treat ANd GO- the ‘TTANGO’ trial The study was approved by Bromley REC reference 15/LO/1929. All protocol. BMC Infect Dis. 2013;13:485. participants will provide informed written consent. 12. Oakeshott P, Kerry S, Atherton H, Aghaizu A, Hay S, Taylor-Robinson D, et al. Community-based trial of screening for Chlamydia trachomatis to prevent Competing interests pelvic inflammatory disease: the POPI (Prevention Of Pelvic Infection) trial. Pippa Oakeshott is a member of the NIHR South London Collaboration for Trials. 2008;9:73. Leadership in Applied Health Research and Care. PO, STS, EHE, and EC are 13. Normansell R, Drennan V, Oakeshott P. Exploring female FE college members of the esti2 consortium funded under the UKCRC Translational students’ attitudes to regular sexually transmitted infection screening: a Infection Research Initiative supported by the Medical Research Council qualitative study. Health Expect. 2016;19:322–30. PMC5055273 (Grant Number G0901608) with contributions from the Biotechnology and 14. Ellis J, Green R, Kerry SR, Jesuratnam G, Rajamanoharan A, Patel R, et al. Biological Sciences Research Council, the National Institute for Health Acceptability of providing self-taken vaginal samples and allowing access to Research. NHS numbers and medical records: feasibility study in young female genitourinary medicine clinic attenders. Sex Transm Infect. 2012;88(4):300. Publisher’sNote 15. Hocking JS, Vodstrcil L, Huston WM, Timms P, Chen M, Worthington K, et al. Springer Nature remains neutral with regard to jurisdictional claims in A cohort study of Chlamydia trachomatis treatment failure in women: a published maps and institutional affiliations. study protocol. BMC Infect Dis. 2013;13(1):379. Kerry-Barnard et al. Trials (2018) 19:311 Page 8 of 8 16. Hunjan T, Kerry SR, Hay P, Planche T, Sadiq ST, Oakeshott P. Chlamydia testing: where are we now? Recruiting high risk women to a pilot STI screening trial. Sex Trans Infect. 2013;89:556. 17. AghaizuA,Adams EJ, TurnerK, Kerry S, HayP,Simms I, et al.What is the cost of pelvic inflammatory disease and how much could be prevented by screening for chlamydia trachomatis? Cost analysis of the Prevention of Pelvic Infection (POPI) trial. Sex Transm Infect. 2011;87(4):312–7. 18. Teare MD, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014;15:264. 19. Phillips R, Reid F. Test n Treat statistical analysis plan. "Test n Treat": a cluster randomised feasibility trial of frequent rapid testing and same day on-site treatment to reduce rates of chlamydia in further education college students. Trials. [in press] 2018.

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TrialsSpringer Journals

Published: Jun 5, 2018

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