Syphilis Clinical Trial
Official title:
Enhanced Syphilis Screening Among HIV-positive Men (ESSAHM): Evaluation of a Clinic-based Intervention
Verified date | July 2018 |
Source | St. Michael's Hospital, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3895 |
Est. completion date | July 31, 2017 |
Est. primary completion date | July 31, 2017 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - Male HIV patients - Must be attending at least one of the four participating hospital-based HIV outpatient clinics Exclusion Criteria: - Women |
Country | Name | City | State |
---|---|---|---|
Canada | Ottawa General Hospital | Ottawa | Ontario |
Canada | St. Michael's Hospital | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | Toronto General Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Michael's Hospital, Toronto | Canadian Institutes of Health Research (CIHR), Ontario HIV Treatment Network, Public Health Ontario, Sunnybrook Health Sciences Centre, The Ottawa Hospital, Toronto General Hospital, University of Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Direct and indirect costing of each additional screen-detected syphilis diagnosis | Costs will include inpatient services (initial screening and follow-up management costs), drug costs, syphilis test kits and technician time. | Month 30 | |
Primary | Change in rate of detection of new, previously untreated syphilis cases | 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: ?=0 versus Ha: ?= ?a where ? represents the increase in the case detection rate due to the intervention and ?a represents a 75% increase over the baseline rate. | At 30 months | |
Secondary | Change in screening coverage | Proportion tested for syphilis at least once per year | At 30 months | |
Secondary | Change in screening frequency | Number of times tested for syphilis, per year. | At 30 months |
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