Evaluation of the 'Colli-Pee', a first-void urine collection device for self-sampling at home for the detection of sexually transmitted infections, versus a routine clinic-based urine collection in a one-to-one comparison study design: efficacy and acceptability among MSM in Belgium

Irith De Baetselier, Hilde Smet, Said Abdellati, Bénédicte De Deken, Vicky Cuylaerts, Thijs Reyniers, Bea Vuylsteke, Tania Crucitti, Irith De Baetselier, Hilde Smet, Said Abdellati, Bénédicte De Deken, Vicky Cuylaerts, Thijs Reyniers, Bea Vuylsteke, Tania Crucitti

Abstract

Objectives: Pre-exposure prophylaxis (PrEP) users are screened bi-annual for sexually transmitted infections (STIs). A novel device, called the Colli-Pee, collects first-void urine in a standardised way and the collector tube can be easily delivered by regular post to a certified laboratory. The aim of the study was a one-to-one comparison between the STI test results obtained with the urine collected in the clinic, versus urine collected at home in a real-life setting by Men who have Sex with Men (MSM) in Belgium. The user-friendliness and acceptability of the Colli-Pee device by the users was also evaluated.

Design: A single-site nested substudy in a prospective PrEP demonstration project (Be-PrEP-ared) among MSM in Belgium.

Participants: A total of 473 home-based samples from 213 MSM were received with a mean age of 38.5 years.

Interventions: Participants were requested to collect a urine sample at home using the Colli-Pee device and to send it to the laboratory via regular mail.

Primary and secondary outcome measures: The presence of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma genitalium (MG) and Trichomonas vaginalis (TV) was determined using molecular amplification assays. Agreement between test results of samples collected at the clinic and collected at home were evaluated using Cohen's kappa statistic.

Results: TV was not detected. A very good to almost perfect agreement was found for CT, NG and MG of κ=0.75, 0.87 and 0.85, respectively. Using the Colli-Pee device only one low positive CT and two MG infections were missed, however, three additional CT, two NG and six MG infections were detected.

Conclusions: The Colli-Pee device is a feasible and convenient way to collect urine at home for STI testing. This may be particularly relevant for populations that need frequent STI testing, such as PrEP users and patients who prefer home-sampling.

Trial registration number: NCT02552914; Pre-results.

Keywords: MSM; chlamydia trachomatis; neisseria gonorrhoeae; pre-exposure prophylaxis; screening; urine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
The Colli-Pee device instructions for use.

References

    1. WHO. Global health sector strategy on sexually transmitted infections 2016-2021: World Heal Organ, 2016:63.
    1. Lanjouw E, Ouburg S, de Vries HJ, et al. . 2015 European guideline on the management of Chlamydia trachomatis infections. Int J STD AIDS 2016;27:333–48. 10.1177/0956462415618837
    1. Bignell C, Unemo M. 2012 European guideline on the diagnosis and treatment of gonorrhoea in adults. Int J STD AIDS 2013;24:85–92. 10.1177/0956462412472837
    1. Lunny C, Taylor D, Hoang L, et al. . Self-Collected versus clinician-collected sampling for chlamydia and gonorrhea screening: a systemic review and meta-analysis. PLoS One 2015;10:e0132776 10.1371/journal.pone.0132776
    1. McNicol J, Debattista J. Use of the uriswab collection device for testing of chlamydia trachomatis and neisseria gonorrhoeae: implications for a postal testing service. Int J STD AIDS 2013;24:477–80. 10.1177/0956462412472834
    1. Vorsters A, Van den Bergh J, Micalessi I, et al. . Optimization of HPV DNA detection in urine by improving collection, storage, and extraction. Eur J Clin Microbiol Infect Dis 2014;33:2005–14. 10.1007/s10096-014-2147-2
    1. Theodorescu D, Schiffer E, Bauer HW, et al. . Discovery and validation of urinary biomarkers for prostate cancer. Proteomics Clin Appl 2008;2:556–70. 10.1002/prca.200780082
    1. Wisniewski CA, White JA, Michel CE, et al. . Optimal method of collection of first-void urine for diagnosis of Chlamydia trachomatis infection in men. J Clin Microbiol 2008;46:1466–9. 10.1128/JCM.02241-07
    1. Johnson DJ, Calderaro AC, Roberts KA. Variation in nuclear DNA concentrations during urination. J Forensic Sci 2007;52:110–3. 10.1111/j.1556-4029.2006.00329.x
    1. Traeger MW, Schroeder SE, Wright EJ, et al. . Effects of pre-exposure prophylaxis for the prevention of human immunodeficiency virus infection on sexual risk behavior in men who have sex with men: a systematic review and meta-analysis. Clin Infect Dis 2018;67:676–86. 10.1093/cid/ciy182
    1. Kojima N, Davey DJ, Klausner JD. Pre-exposure prophylaxis for HIV infection and new sexually transmitted infections among men who have sex with men. AIDS 2016;30:2251–2. 10.1097/QAD.0000000000001185
    1. Salazar N. EACS HIV guidelines 8.1, 2016.
    1. World Heal Organ. WHO implementation tool for pre-exposure prophylaxis (PrEP) of HIV infection. Geneva: World Heal Organ, 2017.
    1. De Baetselier I, Reyniers T, Nöstlinger C, et al. . Pre-Exposure Prophylaxis (PrEP) as an additional tool for hiv prevention among men who have sex with men in Belgium: the Be-PrEP-ared study protocol. JMIR Res Protoc 2017;6:e11 10.2196/resprot.6767
    1. Chen CY, Chi KH, Alexander S, et al. . A real-time quadriplex PCR assay for the diagnosis of rectal lymphogranuloma venereum and non-lymphogranuloma venereum chlamydia trachomatis infections. Sex Transm Infect 2008;84:273–6. 10.1136/sti.2007.029058
    1. Hopkins MJ, Ashton LJ, Alloba F, et al. . Validation of a laboratory-developed real-time PCR protocol for detection of chlamydia trachomatis and neisseria gonorrhoeae in urine. Sex Transm Infect 2010;86:207–11. 10.1136/sti.2009.040634
    1. Müller EE, Venter JM, Magooa MP, et al. . Development of a rotor-gene real-time PCR assay for the detection and quantification of Mycoplasma genitalium. J Microbiol Methods 2012;88:311–5. 10.1016/j.mimet.2011.12.017
    1. Yuan CC, Miley W, Waters D. A quantification of human cells using an ERV-3 real time PCR assay. J Virol Methods 2001;91:109–17. 10.1016/S0166-0934(00)00244-5
    1. Reyniers T, Nöstlinger C, Laga M, et al. . Choosing between daily and event-driven pre-exposure prophylaxis: results of a Belgian PrEP demonstration project. J Acquir Immune Defic Syndr 2018;79:186-194 10.1097/QAI.0000000000001791
    1. Morré SA, van Valkengoed IG, de Jong A, et al. . Mailed, home-obtained urine specimens: a reliable screening approach for detecting asymptomatic Chlamydia trachomatis infections. J Clin Microbiol 1999;37:976–80.
    1. Fajardo-Bernal L, Aponte-Gonzalez J, Vigil P, et al. . Home-based versus clinic-based specimen collection in the management of Chlamydia trachomatis and Neisseria gonorrhoeae infections. Cochrane Database Syst Rev 2015:CD011317 10.1002/14651858.CD011317.pub2
    1. Toskin I, Blondeel K, Peeling RW, et al. . Advancing point of care diagnostics for the control and prevention of STIs: the way forward. Sex Transm Infect 2017;93:S81–8. 10.1136/sextrans-2016-053073
    1. De Baetselier I, Mwambarangwe L, Cuylaerts V, et al. . Evaluation of an enzymatic Chlamydia trachomatis point-of-care rapid assay in Rwanda: the BioChekSwab rapid test. Sex Transm Infect 2016;92:430–2. 10.1136/sextrans-2015-052202
    1. Peeling RW, Holmes KK, Mabey D, et al. . Rapid tests for sexually transmitted infections (STIs): the way forward. Sex Transm Infect 2006;82:v1–6. 10.1136/sti.2006.024265
    1. European Centre for Disease Prevention and Control. Novel approaches to testing for sexually transmitted infections, including HIV and hepatitis B and C in Europe. Stockholm: European Centre for Disease Prevention and Control, 2012.
    1. Wilson E, Free C, Morris TP, et al. . Internet-accessed sexually transmitted infection (e-STI) testing and results service: a randomised, single-blind, controlled trial. PLoS Med 2017;14:e1002479 10.1371/journal.pmed.1002479
    1. Platteau T, Fransen K, Apers L, et al. . Swab2know: an HIV-testing strategy using oral fluid samples and online communication of test results for men who have sex with men in Belgium. J Med Internet Res 2015;17:e213 10.2196/jmir.4384
    1. Mathew T, O’Mahony C, Mallinson H. Shortening the voiding interval for men having chlamydia nucleic acid amplification tests. Int J STD AIDS 2009;20:752–3. 10.1258/ijsa.2009.009225
    1. Barnard S, Free C, Bakolis I, et al. . Comparing the characteristics of users of an online service for STI self-sampling with clinic service users: a cross-sectional analysis. Sex Transm Infect 2018;94:377–83. 10.1136/sextrans-2017-053302
    1. Paudyal P, Llewellyn C, Lau J, et al. . Obtaining self-samples to diagnose curable sexually transmitted infections: a systematic review of patients' experiences. PLoS One 2015;10:e0124310 10.1371/journal.pone.0124310

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe