SyphilisSHIVERNCT05863117
Syphilis and HIV Point of Care Testing (POCT) in Saskatchewan
A study testing Reveal Rapid TP (from MedMira) in people with Syphilis and HIV Infections, run by Wellness Wheel Medical Clinic at 2 sites in Canada.
Trial summary
The goal of this clinical trial is to learn about Syphilis and HIV point of care testing among inner city, remote, rural and hard to reach populations in Saskatchewan. The main question[s] it aims to answer are: 1. To evaluate the field diagnostic test performance (e.g. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Syphilis, HIV Infections
- What is being tested?
- Reveal Rapid TP (from MedMira)
- How many people
- 1,650 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Feb 2023to Jul 2024
- 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
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1650 consecutive individuals
- > 16 years accessing STBBI testing at specific locations and able to provide informed consent. PLWH and persons who are syphilis positive may also eligible to participate.
Who cannot join
- ° Less than 16 years, unable to provide signed informed consent (e.g., intoxicated)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Queen City Wellness Pharmacy
Regina, Saskatchewan, S4P 0H7
Sara Kozusko, (306) 522-2266, skozusko@nbly.ca
- Recruiting
Wellness Wheel Medical Clinic
Regina, Saskatchewan, S4T0L6
Susanne Nicolay, RN, 1-306-520-2846, susanne.nicolay@wellnesswheelclinic.ca
Vicky Schultz, RN, 1-306-520-3889, viky.schultz@wellnesswheelclinic.ca
About this study
Official title: Syphilis and HIV Point of Care Testing (POCT) to Improve Access to Testing Among Inner City, Remote, Rural and Hard to Reach Populations in Saskatchewan
The goal of this clinical trial is to learn about Syphilis and HIV point of care testing among inner city, remote, rural and hard to reach populations in Saskatchewan. The main question[s] it aims to answer are:
- To evaluate the field diagnostic test performance (e.g. sensitivity, specificity, predictive values) of finger prick whole blood point of care testing (POCT) when compared to standard serum based testing for syphilis POCT, HIV POCT and dual syphilis and HIV POCT.
- To evaluate the clinical utility of POCT for the prompt management and public health follow up of syphilis and HIV cases as compared to usual testing, specifically:
- Time to diagnosis
- Time to treatment
- Number of contacts exposed to untreated infections
- For HIV diagnoses, time to connection to clinical provider for ongoing management of HIV
- To evaluate the acceptability and feasibility of POCT among different populations for syphilis and HIV among at risk and/or hard to reach populations, specifically:
- Health care provider experiences of feasibility and acceptability of the POCT used in this pilot
- Client acceptability and experiences with POCT in this pilot
- Client preferences for test offered (syphilis only, HIV only, or dual test of HIV and syphilis 4. To evaluate the acceptability and feasibility of syphilis alone, HIV alone or combined syphilis/HIV POCT among at-risk and/or hard to reach populations.
Participants will be assessed for risk factors that may increase risk of infectious disease such as substance use and sexual habits. They will then be offered a choice of 1 of 3 POCT(Syphilis alone, HIV alone or a dual HIV/Syphilis test). Serology will be obtained for sexually transmitted and blood born infections (STBBI's) and then the point of care test (POCT) will be completed. Following the testing the participant will complete a short survey on their experience.
- Conditions
- Syphilis, HIV Infections
- Being tested
- Reveal Rapid TP (from MedMira)
- Keywords
- point of care testing
- Medical subject headings
- Syphilis, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reveal Rapid TP (from MedMira)Diagnostic test
Also called INSTI HIV-1/2 HIV test, INSTI Multiplex HIV-1/2 Syphilis
Point of care tests for HIV and Syphilis
What is being measured
The primary outcome is the main question the study is designed to answer.
Syphilis-Comparison between point of care testing and serology testing for Syphilis and HIV
To evaluate the field diagnostic test performance of finger prick whole blood point of care testing (POCT) when compared to standard serum based testing for syphilis POCT.
Measured: 12-18 months
HIV- Comparison between point of care testing and serology testing for Syphilis and HIV
HIV- To evaluate the field diagnostic test performance of finger prick whole blood point of care testing (POCT) when compared to standard serum based testing for HIV POCT.
Measured: 12-18 months
Syphilis/HIV- Comparison between point of care testing and serology testing for Syphilis and HIV
Dual HIV/Syphilis-To evaluate the field diagnostic test performance of finger prick whole blood point of care testing (POCT) when compared to standard serum based testing for dual syphilis and HIV POCT.
Measured: 12-18 months
Secondary outcomes (8)
Time to diagnosis-Clinical utility of POCT for management and follow up of Syphilis and HIV
To evaluate the clinical utility of POCT for the prompt management and public health follow up of syphilis and HIV cases as compared to usual testing, specifically: Time to diagnosis
Measured: 12-18 months
Evaluate the acceptability and feasibility of POCT for syphilis and HIV
To evaluate the acceptability and feasibility by using a patient experience survey of POCT among different populations for syphilis and HIV among at risk and/or hard to reach populations, specifically: Health care provider experiences of feasibility and acceptability of the POCT used in this pilot b) Client acceptability and experiences with POCT in this pilot c) Client preferences for test offered (syphilis only, HIV only, or dual test of HIV and syphilis
Measured: 12-18 months
HIV-Comparison of acceptability and feasibility by using a patient experience survey of syphilis alone, HIV alone and dual HIV/Syphilis point of care testing among different populations.
To evaluate the acceptability and feasibility of HIV alone among at-risk and/or hard to reach populations
Measured: 12-18 months
Dual HIV/Syphilis-Comparison of acceptability and feasibility by using a patient experience survey of syphilis alone, HIV alone and dual HIV/Syphilis point of care testing among different populations.
To evaluate the acceptability and feasibility of combined syphilis/HIV POCT among at-risk and/or hard to reach populations
Measured: 12-18 months
Syphilis-Comparison of acceptability and feasibility by using a patient experience survey of syphilis alone, HIV alone and dual HIV/Syphilis point of care testing among different populations.
To evaluate the acceptability and feasibility of syphilis alone, among at-risk and/or hard to reach populations
Measured: 12-18 months
Time to treatment-Clinical utility of POCT for management and follow up of Syphilis and HIV
To evaluate the clinical utility of POCT for the prompt management and public health follow up of syphilis and HIV cases as compared to usual testing, specifically:Time to treatment
Measured: 12-18 months
Number of contacts-Clinical utility of POCT for management and follow up of Syphilis and HIV
To evaluate the clinical utility of POCT for the prompt management and public health follow up of syphilis and HIV cases as compared to usual testing, specifically: Number of contacts exposed to untreated infections
Measured: 12-18 months
Time to connection-Clinical utility of POCT for management and follow up of Syphilis and HIV
To evaluate the clinical utility of POCT for the prompt management and public health follow up of syphilis and HIV cases as compared to usual testing, specifically: For HIV diagnoses, time to connection to clinical provider for ongoing management of HIV.
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Feb 2023
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyphilisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wellness Wheel Medical Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- CIHR Canadian HIV Trials Network, University of Saskatchewan, Saskatchewan Health Authority - Regina Area
- Responsible party
- Sponsor
- Investigators
- Stuart Skinner, MD, Principal investigator, Saskatchewan Health Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863117
- Sponsor's protocol ID
- NFL-CBD-0
- Acronym
- SHIVER
- Status last verified
- May 2023
- First submitted
- 19 Apr 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Syphilis and HIV Point of Care Testing (POCT) to Improve Access to Testing Among Inner City, Remote, Rural and Hard to Reach Populations in Saskatchewan
- ClinicalTrials.gov ID
- NCT05863117
- Acronym / sponsor ID
- SHIVER / NFL-CBD-0
- Conditions
- Syphilis, HIV Infections
- Keywords
- point of care testing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,650 participants (estimated)
- Lead sponsor
- Wellness Wheel Medical ClinicUniversity, hospital or other
- Collaborators
- CIHR Canadian HIV Trials Network, University of Saskatchewan, Saskatchewan Health Authority - Regina Area
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 17 May 2023 (actual)
- 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.
The goal of this clinical trial is to learn about Syphilis and HIV point of care testing among inner city, remote, rural and hard to reach populations in Saskatchewan. The main question[s] it aims to answer are:
- To evaluate the field diagnostic test performance (e.g. sensitivity, specificity, predictive values) of finger prick whole blood point of care testing (POCT) when compared to standard serum based testing for syphilis POCT, HIV POCT and dual syphilis and HIV POCT.
- To evaluate the clinical utility of POCT for the prompt management and public health follow up of syphilis and HIV cases as compared to usual testing, specifically:
- Time to diagnosis
- Time to treatment
- Number of contacts exposed to untreated infections
- For HIV diagnoses, time to connection to clinical provider for ongoing management of HIV
- To evaluate the acceptability and feasibility of POCT among different populations for syphilis and HIV among at risk and/or hard to reach populations, specifically:
- Health care provider experiences of feasibility and acceptability of the POCT used in this pilot
- Client acceptability and experiences with POCT in this pilot
- Client preferences for test offered (syphilis only, HIV only, or dual test of HIV and syphilis 4. To evaluate the acceptability and feasibility of syphilis alone, HIV alone or combined syphilis/HIV POCT among at-risk and/or hard to reach populations.
Participants will be assessed for risk factors that may increase risk of infectious disease such as substance use and sexual habits. They will then be offered a choice of 1 of 3 POCT(Syphilis alone, HIV alone or a dual HIV/Syphilis test). Serology will be obtained for sexually transmitted and blood born infections (STBBI's) and then the point of care test (POCT) will be completed. Following the testing the participant will complete a short survey on their experience.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 1650 consecutive individuals
- > 16 years accessing STBBI testing at specific locations and able to provide informed consent. PLWH and persons who are syphilis positive may also eligible to participate.
Key exclusion criteria (1 listed)
- ° Less than 16 years, unable to provide signed informed consent (e.g., intoxicated)
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 |
|---|---|---|
| Reveal Rapid TP (from MedMira)Also: INSTI HIV-1/2 HIV test, INSTI Multiplex HIV-1/2 SyphilisPoint of care tests for HIV and Syphilis | Diagnostic test | – |
Primary outcome
Syphilis-Comparison between point of care testing and serology testing for Syphilis and HIV
Time frame: 12-18 months
To evaluate the field diagnostic test performance of finger prick whole blood point of care testing (POCT) when compared to standard serum based testing for syphilis POCT.
HIV- Comparison between point of care testing and serology testing for Syphilis and HIV
Time frame: 12-18 months
HIV- To evaluate the field diagnostic test performance of finger prick whole blood point of care testing (POCT) when compared to standard serum based testing for HIV POCT.
Syphilis/HIV- Comparison between point of care testing and serology testing for Syphilis and HIV
Time frame: 12-18 months
Dual HIV/Syphilis-To evaluate the field diagnostic test performance of finger prick whole blood point of care testing (POCT) when compared to standard serum based testing for dual syphilis and HIV POCT.
8 secondary outcomes
Time to diagnosis-Clinical utility of POCT for management and follow up of Syphilis and HIV
Time frame: 12-18 months
Evaluate the acceptability and feasibility of POCT for syphilis and HIV
Time frame: 12-18 months
HIV-Comparison of acceptability and feasibility by using a patient experience survey of syphilis alone, HIV alone and dual HIV/Syphilis point of care testing among different populations.
Time frame: 12-18 months
Dual HIV/Syphilis-Comparison of acceptability and feasibility by using a patient experience survey of syphilis alone, HIV alone and dual HIV/Syphilis point of care testing among different populations.
Time frame: 12-18 months
Syphilis-Comparison of acceptability and feasibility by using a patient experience survey of syphilis alone, HIV alone and dual HIV/Syphilis point of care testing among different populations.
Time frame: 12-18 months
Time to treatment-Clinical utility of POCT for management and follow up of Syphilis and HIV
Time frame: 12-18 months
Number of contacts-Clinical utility of POCT for management and follow up of Syphilis and HIV
Time frame: 12-18 months
Time to connection-Clinical utility of POCT for management and follow up of Syphilis and HIV
Time frame: 12-18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: No
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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.
Stuart Skinner, MD principal investigator
Saskatchewan Health Region
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reveal Rapid TP (from MedMira) in people with Syphilis and HIV Infections, run by Wellness Wheel Medical Clinic at 2 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: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikki Williamson, RN (1-306-526-7350, nikki.williamson@wellnesswheelclinic.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Syphilis-Comparison between point of care testing and serology testing for Syphilis and HIV (time frame: 12-18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2023.