Evaluation of Enhanced Syphilis Screening Among HIV-positive Men
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|ClinicalTrials.gov Identifier: NCT02019043|
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : July 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Syphilis||Other: Syphilis testing with routine HIV bloodwork||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3895 participants|
|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.|
|Masking:||None (Open Label)|
|Official Title:||Enhanced Syphilis Screening Among HIV-positive Men (ESSAHM): Evaluation of a Clinic-based Intervention|
|Actual Study Start Date :||February 1, 2015|
|Actual Primary Completion Date :||July 31, 2017|
|Actual Study Completion Date :||July 31, 2017|
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.
- Change in rate of detection of new, previously untreated syphilis cases [ Time Frame: 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.
- Change in screening coverage [ Time Frame: At 30 months ]Proportion tested for syphilis at least once per year
- Change in screening frequency [ Time Frame: At 30 months ]Number of times tested for syphilis, per year.
- Direct and indirect costing of each additional screen-detected syphilis diagnosis [ Time Frame: Month 30 ]Costs will include inpatient services (initial screening and follow-up management costs), drug costs, syphilis test kits and technician time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019043
|Ottawa General Hospital|
|Ottawa, Ontario, Canada, K1H 8L6|
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Ann N Burchell, PhD||St. Michael's Hospital, Toronto|