title: Design of the FemCure study: prospective multicentre study on the transmission of genital and extra-genital Chlamydia trachomatis infections in women receiving routine care.
abstract: BACKGROUND
  In women, anorectal infections with Chlamydia trachomatis (CT) are about as common as genital CT, yet the anorectal site remains largely untested in routine care. Anorectal CT frequently co-occurs with genital CT and may thus often be treated co-incidentally. Nevertheless, post-treatment detection of CT at both anatomic sites has been demonstrated. It is unknown whether anorectal CT may play a role in post-treatment transmission. This study, called FemCure, in women who receive routine treatment (either azithromycin or doxycycline) aims to understand the post-treatment transmission of anorectal CT infections, i.e., from their male sexual partner(s) and from and to the genital region of the same woman. The secondary objective is to evaluate other reasons for CT detection by nucleic acid amplification techniques (NAAT) such as treatment failure, in order to inform guidelines to optimize CT control.
  
  
  METHODS
  A multicentre prospective cohort study (FemCure) is set up in which genital and/or anorectal CT positive women (n = 400) will be recruited at three large Dutch STI clinics located in South Limburg, Amsterdam and Rotterdam. The women self-collect anorectal and vaginal swabs before treatment, and at the end of weeks 1, 2, 4, 6, 8, 10, and 12. Samples are tested for presence of CT-DNA (by NAAT), load (by quantitative polymerase chain reaction -PCR), viability (by culture and viability PCR) and CT type (by multilocus sequence typing). Sexual exposure is assessed by online self-administered questionnaires and by testing samples for Y chromosomal DNA. Using logistic regression models, the impact of two key factors (i.e., sexual exposure and alternate anatomic site of infection) on detection of anorectal and genital CT will be assessed.
  
  
  CONCLUSIONS
  The FemCure study will provide insight in the role of anorectal chlamydia infection in maintaining the CT burden in the context of treatment, and it will provide practical recommendations to reduce avoidable transmission. Implications will improve care strategies that take account of anorectal CT.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02694497 .
authors: Department of Sexual Health, Infectious Diseases and Environmental Health, South Limburg Public Health Service (GGD South Limburg), Geleen, The Netherlands. nicole.dukers@ggdzl.nl.|Department of Medical Microbiology, School of Public Health and Primary Care (CAPHRI), Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands. nicole.dukers@ggdzl.nl.
authors: Nicole H T M
authors: NH
authors: Dukers-Muijrers
authors: Department of Medical Microbiology, School of Public Health and Primary Care (CAPHRI), Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands.
authors: Petra F G
authors: PF
authors: Wolffs
authors: Department of Sexual Health, Infectious Diseases and Environmental Health, South Limburg Public Health Service (GGD South Limburg), Geleen, The Netherlands.|Department of Medical Microbiology, School of Public Health and Primary Care (CAPHRI), Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands.
authors: Lisanne
authors: L
authors: Eppings
authors: Department Infectious Disease Control, Municipal Public Health Service Rotterdam-Rijnmond (GGD Rotterdam), Rotterdam, The Netherlands.|National Institute of Public Health and the Environment (RIVM), Epidemiology and Surveillance Unit, Centre for Infectious Disease Control, Bilthoven, The Netherlands.|Department of Public Health, Erasmus MC-University Medical Center Rotterdam, Rotterdam, The Netherlands.
authors: Hannelore M
authors: HM
authors: Götz
authors: Public Health Laboratory, Public Health Service of Amsterdam (GGD Amsterdam), Amsterdam, The Netherlands.
authors: Sylvia M
authors: SM
authors: Bruisten
authors: Department of Infectious Diseases, Public Health Service of Amsterdam (GGD Amsterdam), Amsterdam, The Netherlands.|Center for Infection and Immunity Amsterdam (CINIMA), Academic Medical Center (AMC), Amsterdam, The Netherlands.
authors: Maarten F
authors: MF
authors: Schim van der Loeff
authors: Department of Medical Microbiology, School of Public Health and Primary Care (CAPHRI), Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands.
authors: Kevin
authors: K
authors: Janssen
authors: Department of Medical Microbiology, School of Public Health and Primary Care (CAPHRI), Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands.
authors: Mayk
authors: M
authors: Lucchesi
authors: STI Outpatient Clinic, Public Health Service of Amsterdam (GGD Amsterdam), Amsterdam, The Netherlands.
authors: Titia
authors: T
authors: Heijman
authors: National Institute of Public Health and the Environment (RIVM), Epidemiology and Surveillance Unit, Centre for Infectious Disease Control, Bilthoven, The Netherlands.
authors: Birgit H
authors: BH
authors: van Benthem
authors: National Institute of Public Health and the Environment (RIVM), Epidemiology and Surveillance Unit, Centre for Infectious Disease Control, Bilthoven, The Netherlands.|Department of General Practice, Academic Medical Centre, Amsterdam, The Netherlands.|STI AIDS Netherlands (SOA AIDS Nederland), Amsterdam, The Netherlands.
authors: Jan E
authors: JE
authors: van Bergen
authors: Institute for Public Health Genomics (IPHG), Department of Genetics and Cell Biology, Research School GROW (School for Oncology and Developmental Biology), Faculty of Health, Medicine and Life Sciences, University of Maastricht, Maastricht, The Netherlands.|Department of Medical Microbiology and Infection Control, Laboratory of Immunogenetics, VU University Medical Center, Amsterdam, The Netherlands.
authors: Servaas A
authors: SA
authors: Morre
authors: DNalysis Maastricht, Maastricht, The Netherlands.
authors: Jos
authors: J
authors: Herbergs
authors: Department of Work and Social Psychology, Maastricht University, Maastricht, The Netherlands.
authors: Gerjo
authors: G
authors: Kok
authors: Department of Sexual Health, Infectious Diseases and Environmental Health, South Limburg Public Health Service (GGD South Limburg), Geleen, The Netherlands.
authors: Mieke
authors: M
authors: Steenbakkers
authors: STI Outpatient Clinic, Public Health Service of Amsterdam (GGD Amsterdam), Amsterdam, The Netherlands.
authors: Arjan A
authors: AA
authors: Hogewoning
authors: Department of Infectious Diseases, Public Health Service of Amsterdam (GGD Amsterdam), Amsterdam, The Netherlands.|Center for Infection and Immunity Amsterdam (CINIMA), Academic Medical Center (AMC), Amsterdam, The Netherlands.|STI Outpatient Clinic, Public Health Service of Amsterdam (GGD Amsterdam), Amsterdam, The Netherlands.|Department of Dermatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors: Henry J
authors: HJ
authors: de Vries
authors: Department of Sexual Health, Infectious Diseases and Environmental Health, South Limburg Public Health Service (GGD South Limburg), Geleen, The Netherlands.|Department of Medical Microbiology, School of Public Health and Primary Care (CAPHRI), Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands.
authors: Christian J P A
authors: CJ
authors: Hoebe
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D017963:Azithromycin / Q000627:therapeutic use; D002690:Chlamydia Infections / Q000175:diagnosis / Q000188:drug therapy / Q000635:transmission*; D002692:Chlamydia trachomatis / Q000235:genetics; D015331:Cohort Studies; D004269:DNA, Bacterial / Q000032:analysis; D004318:Doxycycline / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D009426:Netherlands; D021141:Nucleic Acid Amplification Techniques; D016133:Polymerase Chain Reaction; D011446:Prospective Studies; D012002:Rectal Diseases; D012725:Sexual Behavior; D012747:Sexual Partners; D014627:Vaginitis; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D004269:DNA, Bacterial; D017963:Azithromycin; D004318:Doxycycline
keywords: Anorectal; Chlamydia trachomatis; Genital; Heterosexual; Transmission