Syphilis Clinical Trial
Official title:
Enhanced Syphilis Screening Among HIV-positive Men (ESSAHM): Evaluation of a Clinic-based Intervention
This study aims to enhance syphilis testing among HIV-positive men who have sex with men (MSM), so that more men will undergo testing, they will test more often, and more cases will be treated early. The intervention will combine syphilis tests with the standard HIV blood tests that are routinely done every 3-6 months for persons in care at hospital-based HIV clinics in Toronto and Ottawa, Canada.
A clinic-based intervention to incorporate syphilis testing with routine HIV bloodwork among
HIV-positive men who have sex with men (MSM) attending 4 hospital-based HIV clinics in
Toronto and Ottawa will be conducted. The objectives are to determine to what degree the
intervention: (1) increases the detection rate of untreated syphilis; (2) increases the
proportion of men who undergo syphilis testing at least annually (increased screening
coverage); (3) reduces the interval between syphilis tests (increased screening frequency);
and (4) reaches men at highest risk according to sexual behaviours. The main hypotheses are
that the intervention will increase screening coverage to a minimum of 85% of men undergoing
syphilis testing annually, increase screening frequency to a median of 3 tests per person per
year, and increase the case detection rate by 75% or more.
The design of this study is a cluster-randomized controlled trial with stepped wedge design
that will gradually introduce the intervention across clinics. This pragmatic approach
incorporates a concurrent comparison group, allows for assessment of time trends, will be
well-powered, and will generate more generalizable results due to its inclusion of multiple
clinics. The intervention will be operationalized as standing orders for syphilis serology
when there is an order for HIV viral load and/or CD4 cell count. Data sources include (1)
syphilis tests submitted to the Public Health Ontario Laboratory; (2) a standardized clinical
worksheet and medical chart review to validate diagnoses for screen test positives; and (3)
data collected from a subset of patients via their participation in the ongoing Ontario HIV
Treatment Network (OHTN) Cohort Study. The latter follows adults in HIV care and collects
data using chart reviews and annual face-to-face interviews including measures of sexual
behaviour.
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