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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
  Purpose

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 Intervention
Syphilis
Other: Syphilis testing with routine HIV bloodwork

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Enhanced Syphilis Screening Among HIV-positive Men Who Have Sex With Men: Evaluation of a Clinic-based Intervention

Resource links provided by NLM:


Further study details as provided by Ontario HIV Treatment Network:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 3131
Study Start Date: December 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019043

Contacts
Contact: Ann N Burchell, PhD 416-642-6486 ext 2210 aburchell@ohtn.on.ca

Locations
Canada, Ontario
Ottawa General Hospital Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Paul A MacPherson, MD       pmacpherson@ottawahospital.on.ca   
Principal Investigator: Paul A Macpherson, MD         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Kevin Gough, MD       goughk@smh.ca   
Principal Investigator: Kevin Gough, MD         
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Anita Rachlis, MD       anita.rachlis@sunnybrook.ca   
Principal Investigator: Anita Rachlis, MD         
Toronto General Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Sharon L Walmsley, MD       sharon.walmsley@uhn.ca   
Principal Investigator: Sharon L Walmsley, MD         
Sponsors and Collaborators
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
Investigators
Principal Investigator: Ann N Burchell, PhD Ontario HIV Treatment Network
  More Information

No publications provided

Responsible Party: Ann N. Burchell, Scientist and Director, OHTN Cohort Study, Ontario HIV Treatment Network
ClinicalTrials.gov Identifier: NCT02019043     History of Changes
Other Study ID Numbers: MOP 130440
Study First Received: December 11, 2013
Last Updated: October 17, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
HIV Seropositivity
Syphilis
Bacterial Infections
Genital Diseases, Female
Genital Diseases, Male
Gram-Negative Bacterial Infections
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Infection
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases, Viral
Spirochaetales Infections
Treponemal Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014