Evaluation of Enhanced Syphilis Screening Among HIV-positive Men Who Have Sex With Men

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2014 by Ontario HIV Treatment Network
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
University of Toronto
Public Health Ontario
Toronto General Hospital
St. Michael's Hospital, Toronto
The Ottawa Hospital
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Ann N. Burchell, Ontario HIV Treatment Network
ClinicalTrials.gov Identifier:
NCT02019043
First received: December 11, 2013
Last updated: October 17, 2014
Last verified: October 2014

December 11, 2013
October 17, 2014
December 2014
December 2016   (final data collection date for primary outcome measure)
Change in rate of detection of new, previously untreated syphilis cases [ Time Frame: At 30 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT02019043 on ClinicalTrials.gov Archive Site
  • Change in screening coverage [ Time Frame: At 30 months ] [ Designated as safety issue: No ]
    Proportion tested for syphilis at least once per year
  • Change in screening frequency [ Time Frame: At 30 months ] [ Designated as safety issue: No ]
    Number of times tested for syphilis, per year.
Same as current
Direct and indirect costing of each additional screen-detected syphilis diagnosis [ Time Frame: Month 30 ] [ Designated as safety issue: No ]
Costs will include inpatient services (initial screening and follow-up management costs), drug costs, syphilis test kits and technician time.
Same as current
 
Evaluation of Enhanced Syphilis Screening Among HIV-positive Men Who Have Sex With Men
Enhanced Syphilis Screening Among HIV-positive Men Who Have Sex With Men: 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 proportion of men who undergo syphilis testing at least annually (screening coverage); (2) shortens the interval between tests (screening frequency); (3) reaches men at highest risk; and, ultimately, (4) results in more detected cases of untreated, and especially infectious, syphilis and the incremental cost to the health-care system for each additional diagnosis. 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening
Syphilis
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.
  • 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.
    Intervention: Other: Syphilis testing with routine HIV bloodwork
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
3131
December 2016
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Women
Male
16 Years and older
No
Contact: Ann N Burchell, PhD 416-642-6486 ext 2210 aburchell@ohtn.on.ca
Canada
 
NCT02019043
MOP 130440
No
Ann N. Burchell, Ontario HIV Treatment Network
Ontario HIV Treatment Network
  • Canadian Institutes of Health Research (CIHR)
  • University of Toronto
  • Public Health Ontario
  • Toronto General Hospital
  • St. Michael's Hospital, Toronto
  • The Ottawa Hospital
  • Sunnybrook Health Sciences Centre
Principal Investigator: Ann N Burchell, PhD Ontario HIV Treatment Network
Ontario HIV Treatment Network
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP