Evaluation of Enhanced Syphilis Screening Among HIV-positive Men

NCT02019043 | Completed

• 1 other identifier: MOP 130440
• Study Type: interventional
• Target: 3,895
• Locations: 1 country
• Sites: 4

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.

Conditions

Syphilis

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  At 30 months

Secondary Outcomes (2)

• Change in screening coverage

  At 30 months

• Change in screening frequency

  At 30 months

Other Outcomes (1)

• Direct and indirect costing of each additional screen-detected syphilis diagnosis

  Month 30

Study Arms (2)

Syphilis testing with routine HIV bloodwork

EXPERIMENTAL

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

Current care practice

NO INTERVENTION

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.

Interventions

Syphilis testing with routine HIV bloodwork OTHER

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.

Syphilis testing with routine HIV bloodwork

Eligibility Criteria

• Age: 16 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Women

Sponsors & Collaborators

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

Study Sites (4)

Ottawa General Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (3)

• MacKinnon KR, Grewal R, Tan DH, Rousseau R, Maxwell J, Walmsley S, MacPherson PA, Rachlis A, Andany N, Mishra S, Allen VG, Burchell AN. Patient perspectives on the implementation of routinised syphilis screening with HIV viral load testing: Qualitative process evaluation of the Enhanced Syphilis Screening Among HIV-positive Men trial. BMC Health Serv Res. 2021 Jun 30;21(1):625. doi: 10.1186/s12913-021-06602-1.

  PMID: 34193138 DERIVED

• Burchell AN, Tan DHS, Grewal R, MacPherson PA, Walmsley S, Rachlis A, Andany N, Mishra S, Gardner SL, Raboud J, Fisman D, Cooper C, Gough K, Maxwell J, Rourke SB, Rousseau R, Mazzulli T, Salit IE, Allen VG. Routinized Syphilis Screening Among Men Living With Human Immunodeficiency Virus: A Stepped Wedge Cluster Randomized Controlled Trial. Clin Infect Dis. 2022 Mar 9;74(5):846-853. doi: 10.1093/cid/ciab582.

  PMID: 34175944 DERIVED

• Burchell AN, Allen VG, Grewal R, MacPherson PA, Rachlis A, Walmsley S, Mishra S, Gardner SL, Raboud J, Cooper C, Gough K, Rourke SB, Rousseau R, Salit I, Tan DH. Enhanced syphilis screening among HIV-positive men (ESSAHM): a study protocol for a clinic-randomized trial with stepped wedge design. Implement Sci. 2016 Jan 16;11:8. doi: 10.1186/s13012-016-0371-0.

  PMID: 26772390 DERIVED

MeSH Terms

Conditions

Syphilis

Interventions

Syphilis Serodiagnosis

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Serologic Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Ann N Burchell, PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Note: Although the trial period and recruitment is complete, data entry is ongoing. Completion of data entry is anticipated for August 2018.

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 24, 2013
• Study Start: February 1, 2015
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

CA (4)