An interventional study of Reveal Rapid TP (from MedMira) in Syphilis and HIV Infections, sponsored by Wellness Wheel Medical Clinic. Recruiting at 2 sites in Canada. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by Wellness Wheel Medical Clinic · Not applicable, Interventional, and Screening
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 clinical utility of POCT for the prompt management and public health follow up of syphilis and HIV cases as compared to usual testing, specifically:
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:
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.
126 studies on the registry are indexed under Syphilis; 34 are open to participants now.
This study's planned enrollment of 1,650 is above the median of 354 across 85 interventional studies indexed under Syphilis.
Browse Syphilis studies →This is the only study on the registry with Wellness Wheel Medical Clinic as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
° Less than 16 years, unable to provide signed (e.g., intoxicated)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Point of care tests for HIV and Syphilis
Also known as: INSTI HIV-1/2 HIV test, INSTI Multiplex HIV-1/2 Syphilis
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.
Time frame: 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.
Time frame: 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.
Time frame: 12-18 months
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
Time frame: 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
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.
To evaluate the acceptability and feasibility of HIV alone among at-risk and/or hard to reach 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.
To evaluate the acceptability and feasibility of combined syphilis/HIV POCT among at-risk and/or hard to reach 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.
To evaluate the acceptability and feasibility of syphilis alone, among at-risk and/or hard to reach populations
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 12-18 months
Plan to share: No
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