Effect of screening for Neisseria gonorrhoeae and Chlamydia trachomatis on incidence of these infections in men who have sex with men and transgender women taking HIV pre-exposure prophylaxis (the Gonoscreen study): results from a randomised, multicentre, controlled trial.
Male; Humans; Female; Neisseria gonorrhoeae; Homosexuality, Male; Chlamydia trachomatis; Incidence; Pre-Exposure Prophylaxis/methods; HIV Infections/epidemiology; HIV Infections/prevention & control; HIV Infections/drug therapy; Gonorrhea/diagnosis; Gonorrhea/epidemiology; Gonorrhea/prevention & control; Transgender Persons; Sexual and Gender Minorities; Chlamydia Infections/diagnosis; Chlamydia Infections/epidemiology; Chlamydia Infections/prevention & control; Chlamydia Infections; Gonorrhea; HIV Infections; Pre-Exposure Prophylaxis; Epidemiology; Immunology; Infectious Diseases; Virology
Abstract :
[en] [en] BACKGROUND: Guidelines recommend screening for Neisseria gonorrhoeae and Chlamydia trachomatis at three anatomical sites (urethra, anus, and pharynx) every 3 months (3 × 3) in men who have sex with men (MSM) and transgender women taking HIV pre-exposure prophylaxis (PrEP). We present the first randomised controlled trial to compare the effect of screening versus non-screening for N gonorrhoeae and C trachomatis on the incidence of these infections in MSM and transgender women taking PrEP.
METHODS: A multicentre, randomised, controlled trial of 3 × 3 screening for N gonorrhoeae and C trachomatis versus non-screening was done among MSM and transgender women taking PrEP in five HIV reference centers in Belgium. Participants attended the PrEP clinics quarterly for 12 months. N gonorrhoeae and C trachomatis was tested at each visit in both arms, but results were not provided to the non-screening arm, if asymptomatic. The primary outcome was incidence rate of N gonorrhoeae and C trachomatis infections in each arm, assessed in the per-protocol population. Non-inferiority of the non-screening arm was proven if the upper limit of the 95% CI of the incidence rate ratio (IRR) was lower than 1·25. This trial is registered with ClinicalTrials.gov, NCT04269434, and is completed.
FINDINGS: Between Sept 21, 2020, and June 4, 2021, 506 participants were randomly assigned to the 3 × 3 screening arm and 508 to the non-screening arm. The overall incidence rate of N gonorrhoeae and C trachomatis was 0·155 cases per 100 person-days (95% CI 0·128-0·186) in the 3 × 3 screening arm and 0·205 (95% CI 0·171-0·246) in the non-screening arm. The incidence rate was significantly higher in the non-screening arm (IRR 1·318, 95% CI 1·068-1·627). Participants in the non-screening arm had a higher incidence of C trachomatis infections and symptomatic C trachomatis infections. There were no significant differences in N gonorrhoeae infections. Participants in the non-screening arm consumed significantly fewer antimicrobial drugs. No serious adverse events were reported.
INTERPRETATION: We failed to show that non-screening for N gonorrhoeae and C trachomatis is non-inferior to 3 × 3 screening in MSM and transgender women taking PrEP in Belgium. However, screening was associated with higher antibiotic consumption and had no effect on the incidence of N gonorrhoeae. Further research is needed to assess the benefits and harms of N gonorrhoeae and C trachomatis screening in this population.
FUNDING: Belgian Health Care Knowledge Centre.
Disciplines :
Microbiology
Author, co-author :
Vanbaelen, Thibaut; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium. Electronic address: tvanbaelen@itg.be
Tsoumanis, Achilleas; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium
Florence, Eric; ITM - Institute of Tropical Medicine > Department of Clinical Sciences
Van Dijck, Christophe; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium
Huis In 't Veld, Diana; Department of Infectious Diseases, Ghent University Hospital, Ghent, Belgium
Sauvage, Anne-Sophie ; Université de Liège - ULiège > Département des sciences cliniques > Immunopathologie - Maladies infectieuses et médecine interne générale
Herssens, Natacha; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium
De Baetselier, Irith; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium
Rotsaert, Anke; Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium
Verhoeven, Veronique; Department of Family Medicine and Population Health, University of Antwerp, Antwerp, Belgium
Henrard, Sophie ; Université de Liège - ULiège > Département des sciences sociales > Méthodologie quantitative ; Department of Infectious Diseases, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium
Van Herrewege, Yven; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium
Van den Bossche, Dorien; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium
Goffard, Jean-Christophe; Department of Infectious Diseases, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium
Padalko, Elizaveta; Department of Medical Microbiology, Ghent University Hospital, Ghent, Belgium
Reyniers, Thijs; Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium
Vuylsteke, Bea; Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium
Hayette, Marie-Pierre ; Université de Liège - ULiège > Département des sciences biomédicales et précliniques > Bactériologie, mycologie, parasitologie, virologie et microbiologie
Libois, Agnes; Department of Infectious Diseases, Saint Pierre University Hospital, Université Libre de Bruxelles, Brussels, Belgium
Kenyon, Chris; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium
Effect of screening for Neisseria gonorrhoeae and Chlamydia trachomatis on incidence of these infections in men who have sex with men and transgender women taking HIV pre-exposure prophylaxis (the Gonoscreen study): results from a randomised, multicentre, controlled trial.
The authors thank all study participants, caregivers and investigators involved in the study. This study was funded by the Belgian Healthcare Knowledge Center (KCE, INV 18\u20131133).
scite shows how a scientific paper has been cited by providing the context of the citation, a classification describing whether it supports, mentions, or contrasts the cited claim, and a label indicating in which section the citation was made.
Bibliography
Andermann, A, Blancquaert, I, Beauchamp, S, Déry, V, Revisiting Wilson and Jungner in the genomic age: a review of screening criteria over the past 40 years. Bull World Health Organ 86 (2008), 317–319.
Davidson, KW, Barry, MJ, Mangione, CM, et al. Screening for chlamydia and gonorrhea: US Preventive Services Task Force recommendation statement. JAMA 326 (2021), 949–956.
Hocking, JS, Temple-Smith, M, Guy, R, et al. Population effectiveness of opportunistic chlamydia testing in primary care in Australia: a cluster-randomised controlled trial. Lancet 392 (2018), 1413–1422.
van den Broek, IVF, van Bergen, JEAM, Brouwers, EEHG, et al. Effectiveness of yearly, register based screening for chlamydia in the Netherlands: controlled trial with randomised stepped wedge implementation. BMJ, 345, 2012, e4316.
Williams, E, Williamson, DA, Hocking, JS, Frequent screening for asymptomatic chlamydia and gonorrhoea infections in men who have sex with men: time to re-evaluate?. Lancet Infect Dis 23 (2023), e558–e566.
Marcus, U, Mirandola, M, Schink, SB, Gios, L, Schmidt, AJ, Changes in the prevalence of self-reported sexually transmitted bacterial infections from 2010 and 2017 in two large European samples of men having sex with men – is it time to re- evaluate STI-screening as a control strategy?. PLoS One 16 (2021), 1–24.
Vickers, DM, Osgood, ND, The arrested immunity hypothesis in an immunoepidemiological model of chlamydia transmission. Theor Popul Biol 93 (2014), 52–62.
Tang, EC, Vittinghoff, E, Philip, SS, et al. Quarterly screening optimizes detection of sexually transmitted infections when prescribing HIV preexposure prophylaxis. AIDS 34 (2020), 1181–1186.
Center for Disease Contol and Prevention. Preexposure prophylaxis for the prevention of HIV infection in the United States—2021 update. 2021, Center for Disease Control and Prevention, Atlanta, GA.
Kenyon, C, Baetselier, I, Wouters, K, Screening for STIs in PrEP cohorts results in high levels of antimicrobial consumption. Int J STD AIDS 31 (2020), 1215–1218.
Vanbaelen, T, Van Dijck, C, De Baetselier, I, et al. Screening for STIs is one of the main drivers of macrolide consumption in PrEP users. 2021, SAGE Publications, London.
Kenyon, C, Manoharan-Basil, SS, Van Dijck, C, Is there a resistance threshold for macrolide consumption? Positive evidence from an ecological analysis of resistance data from Streptococcus pneumoniae, Treponema pallidum, and Mycoplasma genitalium. Microb Drug Resist 27 (2021), 1079–1086.
Van Dijck, C, Laumen, J, Zlotorzynska, M, Manoharan-Basil, SS, Kenyon, C, Association between STI screening intensity in men who have sex with men and gonococcal susceptibility in 21 states in the USA: an ecological study. Sex Transm Infect 96 (2020), 537–540.
Lewis, DA, The role of core groups in the emergence and dissemination of antimicrobial-resistant N gonorrhoeae. Sex Transm Infect 89:suppl 4 (2013), iv47–iv51.
De Baetselier, I, Cuylaerts, V, Smet, H, et al. Neisseria gonorrhoeae antimicrobial resistance surveillance report of Belgium–2022. 2022, Institute of Tropical Medicine, Antwerp.
De Baetselier, I, Vuylsteke, B, Reyniers, T, et al. Worryingly high prevalence of resistance-associated mutations to macrolides and fluoroquinolones in Mycoplasma genitalium among men who have sex with men with recurrent sexually transmitted infections. Int J STD AIDS 33 (2022), 385–390.
Seppälä, H, Klaukka, T, Vuopio-Varkila, J, et al. The effect of changes in the consumption of macrolide antibiotics on erythromycin resistance in group A streptococci in Finland. Finnish Study Group for Antimicrobial Resistance. N Engl J Med 337 (1997), 441–446.
Jespers, V, Stordeur, S, Desomer, A, et al. Diagnosis and management of gonorrhoea and syphilis. 2019, Belgian Health Care Knowledge Centre, Brussels.
Barbee, LA, Khosropour, CM, Soge, OO, et al. The natural history of rectal gonococcal and chlamydial infections: the ExGen study. Clin Infect Dis 74 (2022), 1549–1556.
Chow, EPF, Camilleri, S, Ward, C, et al. Duration of gonorrhoea and chlamydia infection at the pharynx and rectum among men who have sex with men: a systematic review. Sex Health 13 (2016), 199–204.
Vuylsteke, B, Reyniers, T, De Baetselier, I, et al. Daily and event-driven pre-exposure prophylaxis for men who have sex with men in Belgium: results of a prospective cohort measuring adherence, sexual behaviour and STI incidence. J Int AIDS Soc, 22, 2019, e25407.
Kent, CK, Chaw, JK, Wong, W, et al. Prevalence of rectal, urethral, and pharyngeal chlamydia and gonorrhea detected in 2 clinical settings among men who have sex with men: San Francisco, California, 2003. Clin Infect Dis 41 (2005), 67–74.
Williamson, DA, Chow, EPF, Gorrie, CL, et al. Bridging of Neisseria gonorrhoeae lineages across sexual networks in the HIV pre-exposure prophylaxis era. Nat Commun 10 (2019), 1–10.
Duan, QI, Carmody, CI, Donovan, BI, et al. Modelling response strategies for controlling gonorrhoea outbreaks in men who have sex with men in Australia. PLoS Comput Biol, 14, 2021, 10009385.
Unemo, M, Ross, J, Serwin, AB, Gomberg, M, Cusini, M, Jensen, JS, European guideline for the diagnosis and treatment of gonorrhoea in adults. Int J STD AIDS 2020 (2020), 1–17.
Traeger, MW, Cornelisse, VJ, Asselin, J, et al. Association of HIV preexposure prophylaxis with incidence of sexually transmitted infections among individuals at high risk of HIV infection. JAMA 321 (2019), 1380–1390.
Kenyon, CR, Schwartz, IS, Effects of sexual network connectivity and antimicrobial drug use on antimicrobial resistance in Neisseria gonorrhoeae. Emerg Infect Dis 24 (2018), 1195–1203.
Brunham, RC, Rekart, ML, The arrested immunity hypothesis and the epidemiology of chlamydia control. Sex Transm Dis 35 (2008), 53–54.
Jenness, SM, Weiss, KM, Goodreau, SM, et al. Incidence of gonorrhea and chlamydia following human immunodeficiency virus preexposure prophylaxis among men who have sex with men: a modeling study. Clin Infect Dis 65 (2017), 712–718.
Tsoumanis, A, Hens, N, Kenyon, CR, Is screening for chlamydia and gonorrhea in men who have sex with men associated with reduction of the prevalence of these infections? A systematic review of observational studies. Sex Transm Dis 45 (2018), 615–622.
Reyniers, T, Rotsaert, A, Thunissen, E, et al. Reduced sexual contacts with non-steady partners and less PrEP use among MSM in Belgium during the first weeks of the COVID-19 lockdown: results of an online survey. Sex Transm Infect 97 (2021), 414–419.
Traeger, MW, Mayer, KH, Krakower, DS, Gitin, S, Jenness, SM, Marcus, JL, Potential impact of doxycycline post-exposure prophylaxis prescribing strategies on incidence of bacterial sexually transmitted infections. Clin Infect Dis, 2023 published online Sept 18. https://doi.org/10.1093/cid/ciad488.
Vanbaelen, T, Tsoumanis, A, Kenyon, C, Total antimicrobial consumption in doxyPEP cohorts depends on the intensity of screening for bacterial sexually transmitted infections. Clin Infect Dis, 2023 published online Sept 18. https://doi.org/10.1093/cid/ciad553.
This website uses cookies to improve user experience. Read more
Save & Close
Accept all
Decline all
Show detailsHide details
Cookie declaration
About cookies
Strictly necessary
Performance
Strictly necessary cookies allow core website functionality such as user login and account management. The website cannot be used properly without strictly necessary cookies.
This cookie is used by Cookie-Script.com service to remember visitor cookie consent preferences. It is necessary for Cookie-Script.com cookie banner to work properly.
Performance cookies are used to see how visitors use the website, eg. analytics cookies. Those cookies cannot be used to directly identify a certain visitor.
Used to store the attribution information, the referrer initially used to visit the website
Cookies are small text files that are placed on your computer by websites that you visit. Websites use cookies to help users navigate efficiently and perform certain functions. Cookies that are required for the website to operate properly are allowed to be set without your permission. All other cookies need to be approved before they can be set in the browser.
You can change your consent to cookie usage at any time on our Privacy Policy page.
