A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test

Recruiting now · Not applicable

Conditions studied: HIV 1 Infection, HIV 2 Infection, Syphilis Infection, Hepatitis B Infection

In brief

The objectives of this study are as follows: To evaluate the clinical performance of the TruPlex test using capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care settings To evaluate the usability of the TruPlex test through: Structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings. To assess user interpretation accuracy through a contrived result interpretation questionnaire, where intended users evaluate a set of pre-defined test results (e.g., strong/weak positives, negatives, invalids). To monitor test system reliability, including invalid rates.

Key facts

Study ID

NCT07563309

Run by

bioLytical Laboratories

People needed

1000

Starts

2025-12-18

Expected to finish

2027-01-01

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 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

You may not qualify if…

• 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 of study assessment, consent form and questionnaire etc. or bias the study outcome.

Where it is running

• Epicentre Health Research (Johannesburg) — Johannesburg, Gauteng, South Africa (enrolling)
• Epicentre Health Research — Durban, KwaZulu-Natal, South Africa (enrolling)
• Epicentre Health Research (Cape Town) — Cape Town, Western Cape, South Africa (enrolling)

Full record on ClinicalTrials.gov

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