Article Text
Abstract
Background Frequent syphilis screening allows for early detection and treatment and decreased transmission. We conducted a clinic-based intervention incorporating opt-out syphilis testing into routine HIV viral loads. The primary objective was to determine the degree to which the intervention increased the detection rate of early syphilis.
Methods The Enhanced Syphilis Screening in HIV-positive Men (ESSAHM) Trial was a stepped wedge cluster-randomized controlled trial in 4 urban HIV clinics in Ontario, Canada from 01/02/2015 to 31/07/2017 (ClinicalTrials.gov: NCT02019043). Population: adult males. Intervention (I): standing orders for syphilis serological testing with HIV viral loads. Control (C): maintenance of current, provider-initiated syphilis testing practice. Outcome: new diagnoses of early infectious syphilis. We obtained syphilis serologies via linkage with the centralized provincial laboratory and defined early syphilis cases using a standardized clinical worksheet and medical chart review. The trial was powered (≥80%) to detect a ≥75% increase in case detection rate, assuming 3 tests per patient per year. We employed a generalized linear mixed-effect model to estimate time- and age-adjusted rate ratios (aRR) comparing intervention to control periods.
Results 3,893 men were followed over 7,468 person-years (PY), and had a mean of 2 viral load tests per year. The mean number of syphilis tests per person per year increased from 0.65 in control to 1.44 in intervention periods. There were 217 new diagnoses of syphilis in total (C: 81; I: 136), for which 147 were cases of early syphilis (C:61; I:86). The detection rate increased from 1.51 per 100PY in control to 2.50 per 100PY in intervention periods, with a corresponding aRR = 1.28 (95%CI 0.73, 2.24; p = 0.40).
Conclusion The implementation of standing orders for syphilis serological testing with HIV viral loads resulted in a modest but statistically non-significant increase in detection of new cases of early infectious syphilis.
Disclosure No significant relationships.