Standardised protocol for a prospective international multicentre clinical-based evaluation of point-of-care tests for the screening of genital and extragenital chlamydial and gonococcal infections in men who have sex with men and for the screening of genital chlamydial, gonococcal and Trichomonas vaginalis infections in at risk women
Introduction In 2016, WHO estimated there were roughly 374 million new infections among adults of the following four curable sexually transmitted infections (STIs): chlamydia (caused by Chlamydia trachomatis (CT)), gonorrhoea (Neisseria gonorrhoeae (NG)), syphilis (Treponema pallidum) and trichomoni...
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| author | Carlos F Cáceres James Kiarie Rosanna W Peeling Magnus Unemo Karel Blondeel Igor Toskin Amina Hançali Silver Vargas Carlos Caceres Christian S Alvarez Ranmini Kularatne Ting-Ting Jiang Soe Soe Thwin Maddalena Cordioli Lorenzo Gios Massimo Mirandola Antonella Zorzi Christopher Barbara Valeska Padovese Hicham Oumzi Rosanna Peeling Ronald Ballard Elsy Camey Ron Ballard Christian S. Alvarez Elsy Camey de Astorga |
| author_facet | Carlos F Cáceres James Kiarie Rosanna W Peeling Magnus Unemo Karel Blondeel Igor Toskin Amina Hançali Silver Vargas Carlos Caceres Christian S Alvarez Ranmini Kularatne Ting-Ting Jiang Soe Soe Thwin Maddalena Cordioli Lorenzo Gios Massimo Mirandola Antonella Zorzi Christopher Barbara Valeska Padovese Hicham Oumzi Rosanna Peeling Ronald Ballard Elsy Camey Ron Ballard Christian S. Alvarez Elsy Camey de Astorga |
| collection | DOAJ |
| description | Introduction In 2016, WHO estimated there were roughly 374 million new infections among adults of the following four curable sexually transmitted infections (STIs): chlamydia (caused by Chlamydia trachomatis (CT)), gonorrhoea (Neisseria gonorrhoeae (NG)), syphilis (Treponema pallidum) and trichomoniasis (Trichomonas vaginalis (TV)). Accurate point-of-care tests (POCTs) for screening of genital and extragenital CT, NG and TV infections are of great value and have been developed during recent decade. Several tests are commercially available and have shown encouraging performance compared with ‘gold-standard’ reference tests in laboratory-based studies. However, there is limited data on their clinical performance, including at the POC. Key populations, such as men who have sex with men (MSM), are at higher risk of these STIs at genital and extragenital sites and these STIs are often asymptomatic, especially in extragenital sites and in women. We will conduct a clinical-based evaluation to assess the performance characteristics and acceptability to end-users of molecular-based diagnostic technology for POC/near patient use of the Xpert CT/NG (Cepheid, Sunnyvale, California, USA) test for screening of genital, anorectal and pharyngeal CT and NG infections in MSM and the Xpert CT/NG and Xpert TV (Cepheid, Sunnyvale, California, USA) for screening of genital CT, NG and TV among women at risk for these STIs compared with gold-standard reference nucleic acid amplification tests. This master protocol outlines the overall research approach that will be used in seven countries.Method and analyses Consecutive MSM and women at risk presenting at the clinical sites in high, and low- and middle-income countries will be enrolled. The POCTs to be evaluated are Xpert CT/NG and Xpert TV. All procedures will be carried out by trained healthcare staff and tests performed in strict accordance with the manufacturer’s instructions. The sensitivity, specificity, positive and negative predictive values for each POCT will be calculated. The study is ongoing with recruitment expected to be completed in all countries by mid-2022 to late-2022.Ethics and dissemination Prior to enrolment, this core protocol was independently peer-reviewed and approved by the research project review panel (RP2) of the WHO Department of Sexual and Reproductive Health and Research and by the WHO Ethics Review Committee (ERC). The core protocol has been slightly adapted accordingly to individual countries and adaptations approved by both RP2 and ERC, as well as all relevant institutional review boards at each participating site. Results will be disseminated through peer-reviewed journals and presented at relevant national/international conferences. |
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| institution | DOAJ |
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| language | English |
| publishDate | 2024-06-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-118a4df704ce4ac59aeb4c53232be9292025-08-20T02:40:52ZengBMJ Publishing GroupBMJ Open2044-60552024-06-0114610.1136/bmjopen-2023-073565Standardised protocol for a prospective international multicentre clinical-based evaluation of point-of-care tests for the screening of genital and extragenital chlamydial and gonococcal infections in men who have sex with men and for the screening of genital chlamydial, gonococcal and Trichomonas vaginalis infections in at risk women Carlos F Cáceres0James Kiarie1Rosanna W Peeling2Magnus Unemo3Karel Blondeel4Igor Toskin5Amina Hançali6Silver Vargas7Carlos CaceresChristian S Alvarez8Ranmini Kularatne9Ting-Ting Jiang10Soe Soe Thwin11Maddalena Cordioli12Lorenzo Gios13Massimo Mirandola14Antonella Zorzi15Christopher Barbara16Valeska Padovese17Hicham Oumzi18Rosanna PeelingRonald BallardElsy Camey19Ron Ballard20Christian S. AlvarezElsy Camey de Astorga10 Unit of Health, Sexuality and Human Development, Universidad Peruana Cayetano Heredia, Lima, PeruDepartment of Sexual and Reproductive Health and Research, including UNDP/ UNFPA/UNICEF/WHO/ World Bank Special programme of Research, Development and Research Training in Human Reproduction, World Health Organization, Geneva, Switzerland13 Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UKWorld Health Organization Collaborating Centre for Gonorrhoea and other Sexually Transmitted Infections, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden19 Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium18 Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland6 Ministry of Health, National Institute of Hygiene, Rabat, Morocco11 Laboratory of Sexual Health, Center for Interdisciplinary Research on Sexuality, AIDS and Society, Universidad Peruana Cayetano Heredia, Lima, Peru12 Sida y Sociedad ONG (SISO), Escuintla, Guatemala8 National Institute for Communicable Diseases, Johannesburg, South Africa9 Institute of Dermatology/Hospital for Skin Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, China20 Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland2 Infectious Division of Infectious Diseases, Department of Medicine, Verona University Hospital, Verona, Italy1 WHO Collaborating Centre for Sexual Health and Vulnerable Populations - Epidemiology Unit - Division of Infectious Diseases, Department of Medicine, Verona University Hospital, Verona, Italy1 WHO Collaborating Centre for Sexual Health and Vulnerable Populations - Epidemiology Unit - Division of Infectious Diseases, Department of Medicine, Verona University Hospital, Verona, Italy1 WHO Collaborating Centre for Sexual Health and Vulnerable Populations - Epidemiology Unit - Division of Infectious Diseases, Department of Medicine, Verona University Hospital, Verona, Italy4 Pathology Department, Mater Dei Hospital, Msida, Malta, Malta4 Genitourinary Department, Mater Dei Hospital, Msida, Malta7 National Institute of Hygiene, Ministry of Health, Rabat, Morocco12 Sida y Sociedad ONG (SISO), Escuintla, Guatemala17 Consultant to WHO Headquarters - Geneva, The Villages, Florida, USAIntroduction In 2016, WHO estimated there were roughly 374 million new infections among adults of the following four curable sexually transmitted infections (STIs): chlamydia (caused by Chlamydia trachomatis (CT)), gonorrhoea (Neisseria gonorrhoeae (NG)), syphilis (Treponema pallidum) and trichomoniasis (Trichomonas vaginalis (TV)). Accurate point-of-care tests (POCTs) for screening of genital and extragenital CT, NG and TV infections are of great value and have been developed during recent decade. Several tests are commercially available and have shown encouraging performance compared with ‘gold-standard’ reference tests in laboratory-based studies. However, there is limited data on their clinical performance, including at the POC. Key populations, such as men who have sex with men (MSM), are at higher risk of these STIs at genital and extragenital sites and these STIs are often asymptomatic, especially in extragenital sites and in women. We will conduct a clinical-based evaluation to assess the performance characteristics and acceptability to end-users of molecular-based diagnostic technology for POC/near patient use of the Xpert CT/NG (Cepheid, Sunnyvale, California, USA) test for screening of genital, anorectal and pharyngeal CT and NG infections in MSM and the Xpert CT/NG and Xpert TV (Cepheid, Sunnyvale, California, USA) for screening of genital CT, NG and TV among women at risk for these STIs compared with gold-standard reference nucleic acid amplification tests. This master protocol outlines the overall research approach that will be used in seven countries.Method and analyses Consecutive MSM and women at risk presenting at the clinical sites in high, and low- and middle-income countries will be enrolled. The POCTs to be evaluated are Xpert CT/NG and Xpert TV. All procedures will be carried out by trained healthcare staff and tests performed in strict accordance with the manufacturer’s instructions. The sensitivity, specificity, positive and negative predictive values for each POCT will be calculated. The study is ongoing with recruitment expected to be completed in all countries by mid-2022 to late-2022.Ethics and dissemination Prior to enrolment, this core protocol was independently peer-reviewed and approved by the research project review panel (RP2) of the WHO Department of Sexual and Reproductive Health and Research and by the WHO Ethics Review Committee (ERC). The core protocol has been slightly adapted accordingly to individual countries and adaptations approved by both RP2 and ERC, as well as all relevant institutional review boards at each participating site. Results will be disseminated through peer-reviewed journals and presented at relevant national/international conferences.https://bmjopen.bmj.com/content/14/6/e073565.full |
| spellingShingle | Carlos F Cáceres James Kiarie Rosanna W Peeling Magnus Unemo Karel Blondeel Igor Toskin Amina Hançali Silver Vargas Carlos Caceres Christian S Alvarez Ranmini Kularatne Ting-Ting Jiang Soe Soe Thwin Maddalena Cordioli Lorenzo Gios Massimo Mirandola Antonella Zorzi Christopher Barbara Valeska Padovese Hicham Oumzi Rosanna Peeling Ronald Ballard Elsy Camey Ron Ballard Christian S. Alvarez Elsy Camey de Astorga Standardised protocol for a prospective international multicentre clinical-based evaluation of point-of-care tests for the screening of genital and extragenital chlamydial and gonococcal infections in men who have sex with men and for the screening of genital chlamydial, gonococcal and Trichomonas vaginalis infections in at risk women BMJ Open |
| title | Standardised protocol for a prospective international multicentre clinical-based evaluation of point-of-care tests for the screening of genital and extragenital chlamydial and gonococcal infections in men who have sex with men and for the screening of genital chlamydial, gonococcal and Trichomonas vaginalis infections in at risk women |
| title_full | Standardised protocol for a prospective international multicentre clinical-based evaluation of point-of-care tests for the screening of genital and extragenital chlamydial and gonococcal infections in men who have sex with men and for the screening of genital chlamydial, gonococcal and Trichomonas vaginalis infections in at risk women |
| title_fullStr | Standardised protocol for a prospective international multicentre clinical-based evaluation of point-of-care tests for the screening of genital and extragenital chlamydial and gonococcal infections in men who have sex with men and for the screening of genital chlamydial, gonococcal and Trichomonas vaginalis infections in at risk women |
| title_full_unstemmed | Standardised protocol for a prospective international multicentre clinical-based evaluation of point-of-care tests for the screening of genital and extragenital chlamydial and gonococcal infections in men who have sex with men and for the screening of genital chlamydial, gonococcal and Trichomonas vaginalis infections in at risk women |
| title_short | Standardised protocol for a prospective international multicentre clinical-based evaluation of point-of-care tests for the screening of genital and extragenital chlamydial and gonococcal infections in men who have sex with men and for the screening of genital chlamydial, gonococcal and Trichomonas vaginalis infections in at risk women |
| title_sort | standardised protocol for a prospective international multicentre clinical based evaluation of point of care tests for the screening of genital and extragenital chlamydial and gonococcal infections in men who have sex with men and for the screening of genital chlamydial gonococcal and trichomonas vaginalis infections in at risk women |
| url | https://bmjopen.bmj.com/content/14/6/e073565.full |
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