Clinical trial NCT02019043: Evaluation of Enhanced Syphilis Screening Among HIV-positive Men
Official title: Enhanced Syphilis Screening Among HIV-positive Men (ESSAHM): Evaluation of a Clinic-based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syphilis
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: University of Toronto
name: Toronto General Hospital
name: Ontario HIV Treatment Network
name: The Ottawa Hospital
name: Sunnybrook Health Sciences Centre
name: Ontario Agency for Health Protection and Promotion
First posted: 2013-12-24
Enrollment: 3895
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Note: Although the trial period and recruitment is complete, data entry is ongoing. Completion of data entry is anticipated for August 2018.
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male HIV patients
* Must be attending at least one of the four participating hospital-based HIV outpatient clinics

Exclusion Criteria:

* Women

Primary outcomes:
measure: Change in rate of detection of new, previously untreated syphilis cases
timeFrame: At 30 months
Secondary outcomes:
measure: Change in screening coverage
timeFrame: At 30 months
measure: Change in screening frequency
timeFrame: At 30 months
Other outcomes:
measure: Direct and indirect costing of each additional screen-detected syphilis diagnosis
timeFrame: Month 30
Locations:
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Ann N Burchell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: MacKinnon KR, Grewal R, Tan DH, Rousseau R, Maxwell J, Walmsley S, MacPherson PA, Rachlis A, Andany N, Mishra S, Allen VG, Burchell AN. Patient perspectives on the implementation of routinised syphilis screening with HIV viral load testing: Qualitative process evaluation of the Enhanced Syphilis Screening Among HIV-positive Men trial. BMC Health Serv Res. 2021 Jun 30;21(1):625. doi: 10.1186/s12913-021-06602-1.
citation: Burchell AN, Tan DHS, Grewal R, MacPherson PA, Walmsley S, Rachlis A, Andany N, Mishra S, Gardner SL, Raboud J, Fisman D, Cooper C, Gough K, Maxwell J, Rourke SB, Rousseau R, Mazzulli T, Salit IE, Allen VG. Routinized Syphilis Screening Among Men Living With Human Immunodeficiency Virus: A Stepped Wedge Cluster Randomized Controlled Trial. Clin Infect Dis. 2022 Mar 9;74(5):846-853. doi: 10.1093/cid/ciab582.
citation: Burchell AN, Allen VG, Grewal R, MacPherson PA, Rachlis A, Walmsley S, Mishra S, Gardner SL, Raboud J, Cooper C, Gough K, Rourke SB, Rousseau R, Salit I, Tan DH. Enhanced syphilis screening among HIV-positive men (ESSAHM): a study protocol for a clinic-randomized trial with stepped wedge design. Implement Sci. 2016 Jan 16;11:8. doi: 10.1186/s13012-016-0371-0.