Evaluation of Enhanced Syphilis Screening Among HIV-positive Men

• Sponsor: Unity Health Toronto (Other)
• Overall Status: Completed
• CT.gov ID: NCT02019043
• Collaborator: Canadian Institutes of Health Research (CIHR) (Other), University of Toronto (Other), Toronto General Hospital (Other), Ontario HIV Treatment Network (Other), The Ottawa Hospital (Other), Sunnybrook Health Sciences Centre (Other), Ontario Agency for Health Protection and Promotion (Other)
• Enrollment: 3,895
• Locations: 4
• Arms: 2
• Actual Duration (Months): 29.9
• Patients Per Site: 973.8
• Patients Per Site Per Month: 32.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Syphilis	Other: Syphilis testing with routine HIV bloodwork	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3895 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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.Note: Although the trial period and recruitment is complete, data entry is ongoing. Completion of data entry is anticipated for August 2018.
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Enhanced Syphilis Screening Among HIV-positive Men (ESSAHM): Evaluation of a Clinic-based Intervention
• Actual Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Jul 31, 2017
• Actual Study Completion Date: Jul 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Syphilis testing with routine HIV bloodwork The intervention condition will be implemented as standing orders for syphilis serology whenever patients undergo their standard battery of follow-up bloodwork, i.e., when there is an order for HIV viral load or CD4 cell count.	Other: Syphilis testing with routine HIV bloodwork; The intervention condition will be implemented as standing orders for syphilis serology whenever patients undergo their standard battery of follow-up bloodwork, i.e., when there is an order for HIV viral load or CD4 cell count. It is standard practice for HIV patients to undergo such tests every 3-6 months. We anticipate that the change in practice will be straightforward, involving minimal training of clinic staff. Team members who are physicians at these clinics will guide the specific approach that will be appropriate and sustainable for their setting. Options are quite simple. They include pre-printing a checkmark for 'syphilis serology' onto existing pre-printed requisitions for routine bloodwork; addition of the serology request form to the routine blood work package; or programming 'syphilis serology' into existing computerized routine order sets.
No Intervention: Current care practice The control condition will remain the current care practice, which is generally opportunistic screening or diagnostic testing for those presenting with signs/symptoms or who report sexual risk behaviour.

Outcome Measures

Primary Outcome Measures

1. Change in rate of detection of new, previously untreated syphilis cases [At 30 months]

   We will use a cluster-randomized controlled trial (CRCT) using a stepped wedge design that will gradually introduce the intervention across four clinics. Each clinic will be randomized to one of the four roll-out periods, and will have at minimum one 6-month control period and one 6-month intervention period. The main hypothesis to be tested is H0: θ=0 versus Ha: θ= θa where θ represents the increase in the case detection rate due to the intervention and θa represents a 75% increase over the baseline rate.

Secondary Outcome Measures

1. Change in screening coverage [At 30 months]

   Proportion tested for syphilis at least once per year

2. Change in screening frequency [At 30 months]

   Number of times tested for syphilis, per year.

Other Outcome Measures

1. Direct and indirect costing of each additional screen-detected syphilis diagnosis [Month 30]

   Costs will include inpatient services (initial screening and follow-up management costs), drug costs, syphilis test kits and technician time.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male HIV patients

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

Exclusion Criteria:

• Women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ottawa General Hospital	Ottawa	Ontario	Canada	K1H 8L6
2	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
3	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
4	Toronto General Hospital	Toronto	Ontario	Canada	M5G 2C4

Sponsors and Collaborators

• Unity Health Toronto
• Canadian Institutes of Health Research (CIHR)
• University of Toronto
• Toronto General Hospital
• Ontario HIV Treatment Network
• The Ottawa Hospital
• Sunnybrook Health Sciences Centre
• Ontario Agency for Health Protection and Promotion

Investigators

• Principal Investigator: Ann N Burchell, PhD, Unity Health Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Unity Health Toronto
• ClinicalTrials.gov Identifier: NCT02019043
• Other Study ID Numbers: MOP 130440
• First Posted: Dec 24, 2013
• Last Update Posted: Jul 26, 2018
• Last Verified: Jul 1, 2018

• Additional relevant MeSH terms: Syphilis

Study Results

No Results Posted as of Jul 26, 2018