A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test (NCT07569913) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test
Australia500 participantsStarted 2026-09-01
Plain-language summary
To evaluate the clinical performance of each analyte (HIV, HBsAg, and Syphilis) on the TruPlex HIV/HepB/Syphilis Rapid Test (TruPlex Test) using capillary blood (fingerstick), EDTA whole blood, EDTA-plasma, and SST-serum samples collected by trained operators at point-of-care settings. Additionally, to evaluate the usability of the TruPlex test through: structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years of age or older
* Subject is able to provide and willing to sign and date the Informed Consent Form
* Subject is able to complete the required testing on the allocated testing day.
* Subject is able to speak/read/write English or a translator is available
* Subject is getting tested for HIV, and/or Syphilis, and/or Hepatitis B for one or more of the following reasons:
* At risk for any one of the target diseases
* Having signs or symptoms indicative of the target diseases
* Routine testing
* Note: Subjects who are pregnant and re-infected are eligible to participate
* Unknown HIV or known HIV positive status with less than 12 months of Anti-Retroviral Treatment (ART).
* Subject is willing to provide the fingerstick blood sample(s) and whole blood samples collected through venous blood draw (approximately 16 ml) required for the study.
* Subject willing to participate in the study site's standard of care counselling and testing program and receive the study site's standard of care test results
Exclusion Criteria:
* Subject has a bleeding disorder
* Subject is currently undergoing Syphilis treatment
* Subject has received any experimental HIV vaccine
* Subject received HBV vaccine within the last 7 days
* Known HIV positive subjects and currently on ART for 12 months or longer
* Any condition which, in the opinion of the Investigator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.