Routinized Syphilis Screening Among Men Living With Human Immunodeficiency Virus: A Stepped Wedge Cluster Randomized Controlled Trial

Ann N Burchell^{1

2

3}, Darrell H S Tan^{2

4

5

6}, Ramandip Grewal², Paul A MacPherson^{7

8

9}, Sharon Walmsley^{4

10}, Anita Rachlis^{4

11}, Nisha Andany^{4

11}, Sharmistha Mishra^{2

4

12}, Sandra L Gardner^{13

14}, Janet Raboud^{5

14}, David Fisman¹⁴, Curtis Cooper^{8

15}, Kevin Gough^{4

6}, John Maxwell¹⁶, Sean B Rourke^{2

17}, Rodney Rousseau¹⁸, Tony Mazzulli^{19

20}, Irving E Salit¹⁰, Vanessa G Allen²⁰

Affiliations

¹ Department of Family and Community Medicine, St Michael's Hospital, Unity Health, Toronto, Toronto, Ontario, Canada.
² MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.
³ Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
⁴ Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
⁵ Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada.
⁶ Division of Infectious Diseases, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.
⁷ Division of Infectious Diseases, The Ottawa Hospital, Ottawa, Ontario, Canada.
⁸ Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, Ontario, Canada.
⁹ Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
¹⁰ Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.
¹¹ Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
¹² Institute of Medical Science and Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.
¹³ Baycrest, Toronto, Ontario, Canada.
¹⁴ Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
¹⁵ Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
¹⁶ ACT, Toronto, Ontario, Canada.
¹⁷ Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
¹⁸ Department of Immunology, University of Toronto, Toronto, Ontario, Canada.
¹⁹ Mount Sinai Hospital, Toronto, Ontario, Canada.
²⁰ Public Health Ontario Laboratories, Public Health Ontario, Toronto, Ontario, Canada.

PMID: 34175944
PMCID: PMC8906680
DOI: 10.1093/cid/ciab582

Randomized Controlled Trial

Routinized Syphilis Screening Among Men Living With Human Immunodeficiency Virus: A Stepped Wedge Cluster Randomized Controlled Trial

Ann N Burchell et al. Clin Infect Dis. 2022.

. 2022 Mar 9;74(5):846-853.

doi: 10.1093/cid/ciab582.

Authors

Affiliations

¹ Department of Family and Community Medicine, St Michael's Hospital, Unity Health, Toronto, Toronto, Ontario, Canada.
² MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.
³ Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
⁴ Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
⁵ Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada.
⁶ Division of Infectious Diseases, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.
⁷ Division of Infectious Diseases, The Ottawa Hospital, Ottawa, Ontario, Canada.
⁸ Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, Ontario, Canada.
⁹ Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
¹⁰ Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.
¹¹ Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
¹² Institute of Medical Science and Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.
¹³ Baycrest, Toronto, Ontario, Canada.
¹⁴ Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
¹⁵ Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
¹⁶ ACT, Toronto, Ontario, Canada.
¹⁷ Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
¹⁸ Department of Immunology, University of Toronto, Toronto, Ontario, Canada.
¹⁹ Mount Sinai Hospital, Toronto, Ontario, Canada.
²⁰ Public Health Ontario Laboratories, Public Health Ontario, Toronto, Ontario, Canada.

PMID: 34175944
PMCID: PMC8906680
DOI: 10.1093/cid/ciab582

Abstract

Background: We implemented an opt-out clinic-based intervention pairing syphilis tests with routine human immunodeficiency virus (HIV) viral load testing. The primary objective was to determine the degree to which this intervention increased the detection of early syphilis.

Methods: The Enhanced Syphilis Screening Among HIV-Positive Men (ESSAHM) Trial was a stepped wedge cluster-randomized controlled trial involving 4 urban HIV clinics in Ontario, Canada, from 2015 to 2017. The population was HIV-positive adult males. The intervention was standing orders for syphilis serological testing with viral loads, and control was usual practice. We obtained test results via linkage with the centralized provincial laboratory and defined cases using a standardized clinical worksheet and medical record review. We employed a generalized linear mixed model with a logit link to estimate odds ratios (ORs) and 95% confidence intervals (CIs) of the intervention.

Results: A total of 3895 men were followed over 7471 person-years. The mean number of syphilis tests increased from 0.53 to 2.02 tests per person per year. There were 217 new diagnoses of syphilis (control, 81; intervention, 136), for which 147 (68%) were cases of early syphilis (control, 61 [75%]; intervention, 86 [63%]). The annualized proportion with newly detected early syphilis increased from 0.009 to 0.032 with implementation of the intervention; the corresponding time-adjusted OR was 1.25 (95% CI, .71-2.20).

Conclusions: The implementation of standing orders for syphilis testing with HIV viral loads was feasible and increased testing, yet produced less-than-expected increases in case detection compared to past uncontrolled pre-post trials.

Clinical trials registration: NCT02019043.

Keywords: HIV; cluster-randomized controlled trial; intervention; men; outpatient clinics; screening; syphilis.

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Figures

**Figure 1.**
Study flowchart. Dates are shown as day/month/year. Abbreviation: HIV, human immunodeficiency virus.

See this image and copyright information in PMC

References

1. Patton ME, Su JR, Nelson R, Weinstock H. Primary and secondary syphilis—United States, 2005–2013. MMWR Morb Mortal Wkly Rep 2014; 63:402–6. - PMC - PubMed
1. Dougan S, Evans BG, Elford J. Sexually transmitted infections in Western Europe among HIV-positive men who have sex with men. Sex Transm Dis 2007; 34:783–90. - PubMed
1. Verma K. P3.086 Changing patterns of syphilis in Asia-Pacific. Sex Transm Infect 2013; 89:A174–A174.
1. Public Health Agency of Canada. Report on sexually transmitted infections in Canada: 2013–2014. Ottawa, ON: Centre for Communicable Diseases and Infection Control, Infectious Disease Prevention and Control Branch, 2017.
1. Abara WE, Hess KL, Neblett Fanfair R, Bernstein KT, Paz-Bailey G. Syphilis trends among men who have sex with men in the United States and Western Europe: a systematic review of trend studies published between 2004 and 2015. PLoS One 2016; 11:e0159309. - PMC - PubMed

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Routinized Syphilis Screening Among Men Living With Human Immunodeficiency Virus: A Stepped Wedge Cluster Randomized Controlled Trial

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Routinized Syphilis Screening Among Men Living With Human Immunodeficiency Virus: A Stepped Wedge Cluster Randomized Controlled Trial

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