Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT06893159
Eligibility Criteria:
Test participants:
Inclusion Criteria:
1. Individuals \> 16 years old accessing STBBI testing at specific locations
2. Able to provide informed consent.
Due to the number of sites across SK, AB, and MB, the diversity of the sites and local teams and the incremental addition of sites as the project progresses, the total number of participants to be recruited over the duration of the study (3 years), will be 10,000 individuals and there will be no requirement on local sample size, for the participating sites. (Please refer to Risks and Benefits). A competitive recruitment process will be in place and monitored closely throughout the study.
Exclusion Criteria:
1. \< 16 years
2. Unable to provide signed informed consent (e.g., intoxicated)
Non-Healthcare Professional Operators For the purposes of this study, the untrained non-HCP operators are defined as the personnel, including community health navigators who in the opinion of the Principal Investigator are able to perform the study procedures outlined in this protocol and who are employed by the site. These operators will only be using the investigational device in this study - Multiplo® Complete Syphilis point-of-care test.
Inclusion criteria:
1. Individuals \> 18 years old
2. Are able to read/understand English or French
3. Are able to provide informed consent
4. Are paid employees of the study site(s)
5. Are able to perform the study procedures outlined in the protocol
Exclusion criteria:
1. Individuals \< 18 years old
2. Have used or watched someone use the Multiplo® Complete Syphilis Test prior to this study
3. Are regulated healthcare professionals including nurses, nurse practitioners, physicians, dentists, pharmacists, and laboratory technologists
Healthcare Professional Operators For the purposes of this study, the healthcare professionals are defined as the paid personnel who in the opinion of the Principal Investigator are able to perform the study procedures outlined in this protocol and who are employed by the site.
Inclusion criteria:
1. Regulated healthcare professional
2. Are able to read/understand English or French
3. Are able to provide informed consent
4. Are paid employees of the study site(s)
5. Are able to perform the study procedures outlined in the protocol
Exclusion criteria:
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT06893159
Study Brief:
Protocol Section:
NCT06893159