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 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT06716450
Eligibility Criteria:
Inclusion Criteria:
* Are ≥18 years of age.
* Can speak/read/write English or French.
* Have presented for voluntary testing for HIV and/or syphilis infection in the clinic or community-based setting.
* Are willing to participate in the study site's standard of care HIV and syphilis counselling and testing program and receive the study site's standard of care test results.
* Are willing to be a participant in the study.
* Can provide informed consent i.e. understand and sign or instruct the Observer to sign the informed consent form.
* Can complete the required testing on the allocated testing day.
* Are willing to provide the necessary fingerstick and venipuncture blood for use in the study protocol testing methods.
* Are of unknown HIV and syphilis status (last HIV and syphilis negative test must be a minimum of 3 months prior).
Exclusion Criteria:
* Do not meet the inclusion criteria.
* Are known HIV and/or syphilis positive.
* Have ever tested positive for syphilis or HIV at any time.
* Have any experience in conducting rapid point-of-care tests on patients for HIV, syphilis or any other infectious disease.
* Are familiar with the Multiplo® TP/HIV Self-Test.
* Are investigator site employees or immediate family members of sponsor or investigator sites.
* Have participated in any prior, or concurrent trial of HIV and syphilis self-tests.
* Are a practicing medical healthcare professional (doctor, nurse or HIV counsellor that performs HIV testing with Rapid Tests).
* Any condition which, in the opinion of the Observer, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the assessment, consent form and questionnaire etc. or bias the outcome (e.g. being unable to see/read by forgetting to bring reading glasses, being intoxicated, acute sickness, visibly distressed).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06716450
Study Brief:
Protocol Section:
NCT06716450