Enhanced Syphilis Screening among HIV-Positive Men (ESSAHM): A Study Protocol for a Clinic-Randomized Trial with Stepped Wedge Design

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/DESIGN:

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.

DISCUSSION:

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.

Below:  Stepped wedge design for the Enhanced Syphilis Screening among HIV-positive Men (ESSAHM) Trial

Full article at:   http://goo.gl/mcmgsa

By:  Burchell AN1,2,3, Allen VG4, Grewal R5, MacPherson PA6,7,8, Rachlis A9,10, Walmsley S11,12, Mishra S13,14, Gardner SL15,16, Raboud J17,18, Cooper C19,Gough K20,21, Rourke SB22,23,24, Rousseau R25,26, Salit I27,28, Tan DH29,30,31,32.

• 1Department of Family and Community Medicine, St. Michael's Hospital, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada. burchella@smh.ca.
• 2Centre for Research on Inner City Health, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada. burchella@smh.ca.
• 3Dalla Lana School of Public Health, University of Toronto, Toronto, Canada. burchella@smh.ca.
• 4Public Health Ontario Laboratories, Public Health Ontario, Toronto, Canada. vanessa.allen@oahpp.ca.
• 5Centre for Research on Inner City Health, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada. grewalra@smh.ca.
• 6Division of Infectious Diseases, The Ottawa Hospital, Ottawa, Canada. pmacpherson@ottawahospital.on.ca.
• 7Ottawa Hospital Research Institute, Ottawa, Canada. pmacpherson@ottawahospital.on.ca.
• 8Department of Medicine, University of Ottawa, Ottawa, Canada. pmacpherson@ottawahospital.on.ca.
• 9Sunnybrook Health Sciences Centre, Toronto, Canada. anita.rachlis@sunnybrook.ca.
• 10Department of Medicine, University of Toronto, Toronto, Canada. anita.rachlis@sunnybrook.ca.
• 11Department of Medicine, University of Toronto, Toronto, Canada. sharon.walmsley@uhn.ca.
• 12Toronto General Hospital, University Health Network, Toronto, Canada. sharon.walmsley@uhn.ca.
• 13Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada. sharmistha.mishra@utoronto.ca.
• 14Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Canada. sharmistha.mishra@utoronto.ca.
• 15Dalla Lana School of Public Health, University of Toronto, Toronto, Canada. sgardner@ohtn.on.ca.
• 16Ontario HIV Treatment Network, Toronto, Canada. sgardner@ohtn.on.ca.
• 17Dalla Lana School of Public Health, University of Toronto, Toronto, Canada. jraboud@uhnresearch.ca.
• 18Toronto General Research Institute, University Health Network, Toronto, Canada. jraboud@uhnresearch.ca.
• 19Ottawa Hospital Research Institute, Ottawa, Canada. ccooper@ottawahospital.on.ca.
• 20Department of Medicine, University of Toronto, Toronto, Canada. goughk@smh.ca.
• 21Division of Infectious Diseases, St. Michael's Hospital, Toronto, Canada. goughk@smh.ca.
• 22Centre for Research on Inner City Health, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada. sean.rourke@utoronto.ca.
• 23Ontario HIV Treatment Network, Toronto, Canada. sean.rourke@utoronto.ca.
• 24Department of Psychiatry, University of Toronto, Toronto, Canada. sean.rourke@utoronto.ca.
• 25Department of Immunology, University of Toronto, Toronto, Canada. r.rousseau@mail.utoronto.ca.
• 26Poz Prevention Working Group, Gay Men's Sexual Health Alliance, Toronto, Canada. r.rousseau@mail.utoronto.ca.
• 27Department of Medicine, University of Toronto, Toronto, Canada. irving.salit@uhn.on.ca.
• 28Toronto General Hospital, University Health Network, Toronto, Canada. irving.salit@uhn.on.ca.
• 29Centre for Research on Inner City Health, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada. darrell.tan@gmail.com.
• 30Department of Medicine, University of Toronto, Toronto, Canada. darrell.tan@gmail.com.
• 31Toronto General Research Institute, University Health Network, Toronto, Canada. darrell.tan@gmail.com.
• 32Division of Infectious Diseases, St. Michael's Hospital, Toronto, Canada. darrell.tan@gmail.com. 
• Implement Sci. 2016 Jan 16;11(1):8. doi: 10.1186/s13012-016-0371-0.

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