SyphilisNCT02019043
Evaluation of Enhanced Syphilis Screening Among HIV-positive Men
A study testing Syphilis testing with routine HIV bloodwork in people with Syphilis, run by Unity Health Toronto at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, men only
- Conditions the study is for
- Syphilis
- What is being tested?
- Syphilis testing with routine HIV bloodwork
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,895 participants
- Where
- 4 sitesCanada
- Study dates
- 1 Feb 2015to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male HIV patients
- Must be attending at least one of the four participating hospital-based HIV outpatient clinics
Who cannot join
- Women
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Ottawa General Hospital
Ottawa, Ontario, K1H 8L6
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
Official title: Enhanced Syphilis Screening Among HIV-positive Men (ESSAHM): 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.
Read the 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 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.
- Conditions
- Syphilis
- Being tested
- Syphilis testing with routine HIV bloodwork
- Medical subject headings
- Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syphilis testing with routine HIV bloodworkOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 30 months
Secondary outcomes (2)
Change in screening coverage
Proportion tested for syphilis at least once per year
Measured: At 30 months
Change in screening frequency
Number of times tested for syphilis, per year.
Measured: At 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study start1 Feb 2015
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SyphilisStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 3,895 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Toronto, Toronto General Hospital, Ontario HIV Treatment Network, The Ottawa Hospital, Sunnybrook Health Sciences Centre, Ontario Agency for Health Protection and Promotion
- Responsible party
- Sponsor
- Investigators
- Ann N Burchell, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019043
- Sponsor's protocol ID
- MOP 130440
- Status last verified
- Jul 2018
- First submitted
- 11 Dec 2013
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34193138Burchell 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.
PubMed 34175944Burchell 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.
PubMed 26772390
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Syphilis Screening Among HIV-positive Men (ESSAHM): Evaluation of a Clinic-based Intervention
- ClinicalTrials.gov ID
- NCT02019043
- Acronym / sponsor ID
- MOP 130440
- Conditions
- Syphilis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,895 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Toronto, Toronto General Hospital, Ontario HIV Treatment Network, The Ottawa Hospital, Sunnybrook Health Sciences Centre, Ontario Agency for Health Protection and Promotion
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Note: Although the trial period and recruitment is complete, data entry is ongoing. Completion of data entry is anticipated for August 2018.
| Arm | Type | Receives |
|---|---|---|
| Syphilis testing with routine HIV bloodwork | Experimental | Other: Syphilis testing with routine HIV bloodworkThe 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. |
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Male HIV patients
- Must be attending at least one of the four participating hospital-based HIV outpatient clinics
Key exclusion criteria (1 listed)
- Women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Syphilis testing with routine HIV bloodworkThe 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. | Other | Syphilis testing with routine HIV bloodwork |
Primary outcome
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.
2 secondary outcomes
Change in screening coverage
Time frame: At 30 months
Change in screening frequency
Time frame: At 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Derived from this study: PubMed 34193138MacKinnon 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.
- Derived from this study: PubMed 34175944Burchell 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.
- Derived from this study: PubMed 26772390Burchell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann N Burchell, PhD principal investigator
Unity Health Toronto
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Syphilis testing with routine HIV bloodwork in people with Syphilis, run by Unity Health Toronto at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rate of detection of new, previously untreated syphilis cases (time frame: At 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02019043, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.