title: Enhanced syphilis screening among HIV-positive men (ESSAHM): a study protocol for a clinic-randomized trial with stepped wedge design.
abstract: BACKGROUND
  The current syphilis epidemic among urban men who have sex with men (MSM) has serious implications for those co-infected with human immunodeficiency virus (HIV). Routine and frequent syphilis screening has the potential to ensure early detection and treatment, minimize disease burden, and help control the ongoing spread of syphilis and HIV. We aim to enhance syphilis screening among HIV-positive men by conducting a clinic-based intervention that incorporates opt-out syphilis testing into routine HIV laboratory evaluation for this population. Trial objectives are to determine the degree to which the intervention (1) increases the detection rate of untreated syphilis, (2) increases screening coverage, (3) increases screening frequency, and (4) reaches men at highest risk according to sexual behaviors.
  
  
  METHODS
  The trial is a pragmatic, stepped wedge cluster-randomized controlled trial that introduces the intervention stepwise across four urban HIV clinics in Ontario, Canada. The intervention includes standing orders for syphilis serological testing whenever a male in HIV care undergoes HIV viral load testing, which typically occurs every 3-6 months. The control condition is the maintenance of current, provider-initiated syphilis testing practice. Approximately 3100 HIV-positive men will be followed over 30 months. Test results will be obtained from the centralized provincial laboratory in Ontario and will be supplemented by a standardized clinical worksheet and medical chart review at the clinics. Detailed clinical, psychosocial, and behavioral data is available for a subset of men receiving HIV care who are also participants of the province-wide Ontario HIV Treatment Network Cohort Study. Process evaluation plans include audit and feedback of compliance of the participating centers to identify potential barriers to the introduction of this type of practice into routine care. Health economic components include evaluation of the impact and cost-effectiveness of the intervention.
  
  
  CONCLUSIONS
  This trial will be the first of its kind in Canada and will provide evidence regarding the feasibility, clinical effectiveness, and cost-effectiveness of a clinic-based intervention to improve syphilis screening among HIV-positive men. Involvement of knowledge users in all stages of trial design, conduct, and analysis will facilitate scale-up should the intervention be effective.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02019043.
authors.affiliation: Department of Family and Community Medicine, St. Michael's Hospital, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada. burchella@smh.ca.|Centre for Research on Inner City Health, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada. burchella@smh.ca.|Dalla Lana School of Public Health, University of Toronto, Toronto, Canada. burchella@smh.ca.
authors.forename: Ann N
authors.initials: AN
authors.lastname: Burchell
authors.affiliation: Public Health Ontario Laboratories, Public Health Ontario, Toronto, Canada. vanessa.allen@oahpp.ca.
authors.forename: Vanessa G
authors.initials: VG
authors.lastname: Allen
authors.affiliation: Centre for Research on Inner City Health, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada. grewalra@smh.ca.
authors.forename: Ramandip
authors.initials: R
authors.lastname: Grewal
authors.affiliation: Division of Infectious Diseases, The Ottawa Hospital, Ottawa, Canada. pmacpherson@ottawahospital.on.ca.|Ottawa Hospital Research Institute, Ottawa, Canada. pmacpherson@ottawahospital.on.ca.|Department of Medicine, University of Ottawa, Ottawa, Canada. pmacpherson@ottawahospital.on.ca.
authors.forename: Paul A
authors.initials: PA
authors.lastname: MacPherson
authors.affiliation: Sunnybrook Health Sciences Centre, Toronto, Canada. anita.rachlis@sunnybrook.ca.|Department of Medicine, University of Toronto, Toronto, Canada. anita.rachlis@sunnybrook.ca.
authors.forename: Anita
authors.initials: A
authors.lastname: Rachlis
authors.affiliation: Department of Medicine, University of Toronto, Toronto, Canada. sharon.walmsley@uhn.ca.|Toronto General Hospital, University Health Network, Toronto, Canada. sharon.walmsley@uhn.ca.
authors.forename: Sharon
authors.initials: S
authors.lastname: Walmsley
authors.affiliation: Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada. sharmistha.mishra@utoronto.ca.|Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Canada. sharmistha.mishra@utoronto.ca.
authors.forename: Sharmistha
authors.initials: S
authors.lastname: Mishra
authors.affiliation: Dalla Lana School of Public Health, University of Toronto, Toronto, Canada. sgardner@ohtn.on.ca.|Ontario HIV Treatment Network, Toronto, Canada. sgardner@ohtn.on.ca.
authors.forename: Sandra L
authors.initials: SL
authors.lastname: Gardner
authors.affiliation: Dalla Lana School of Public Health, University of Toronto, Toronto, Canada. jraboud@uhnresearch.ca.|Toronto General Research Institute, University Health Network, Toronto, Canada. jraboud@uhnresearch.ca.
authors.forename: Janet
authors.initials: J
authors.lastname: Raboud
authors.affiliation: Ottawa Hospital Research Institute, Ottawa, Canada. ccooper@ottawahospital.on.ca.
authors.forename: Curtis
authors.initials: C
authors.lastname: Cooper
authors.affiliation: Department of Medicine, University of Toronto, Toronto, Canada. goughk@smh.ca.|Division of Infectious Diseases, St. Michael's Hospital, Toronto, Canada. goughk@smh.ca.
authors.forename: Kevin
authors.initials: K
authors.lastname: Gough
authors.affiliation: Centre for Research on Inner City Health, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada. sean.rourke@utoronto.ca.|Ontario HIV Treatment Network, Toronto, Canada. sean.rourke@utoronto.ca.|Department of Psychiatry, University of Toronto, Toronto, Canada. sean.rourke@utoronto.ca.
authors.forename: Sean B
authors.initials: SB
authors.lastname: Rourke
authors.affiliation: Department of Immunology, University of Toronto, Toronto, Canada. r.rousseau@mail.utoronto.ca.|Poz Prevention Working Group, Gay Men's Sexual Health Alliance, Toronto, Canada. r.rousseau@mail.utoronto.ca.
authors.forename: Rodney
authors.initials: R
authors.lastname: Rousseau
authors.affiliation: Department of Medicine, University of Toronto, Toronto, Canada. irving.salit@uhn.on.ca.|Toronto General Hospital, University Health Network, Toronto, Canada. irving.salit@uhn.on.ca.
authors.forename: Irving
authors.initials: I
authors.lastname: Salit
authors.affiliation: Centre for Research on Inner City Health, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada. darrell.tan@gmail.com.|Department of Medicine, University of Toronto, Toronto, Canada. darrell.tan@gmail.com.|Toronto General Research Institute, University Health Network, Toronto, Canada. darrell.tan@gmail.com.|Division of Infectious Diseases, St. Michael's Hospital, Toronto, Canada. darrell.tan@gmail.com.
authors.forename: Darrell H S
authors.initials: DH
authors.lastname: Tan
mesh_terms: D000293:Adolescent; D000328:Adult; D015331:Cohort Studies; D060085:Coinfection; D042241:Early Diagnosis; D015658:HIV Infections / Q000150:complications*; D018451:Homosexuality, Male / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000458:organization & administration*; D008875:Middle Aged; D009864:Ontario / Q000453:epidemiology; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D013587:Syphilis / Q000175:diagnosis* / Q000453:epidemiology / Q000517:prevention & control*; D014505:Urban Population / Q000706:statistics & numerical data; D055815:Young Adult