TruPlex rapid test for HIV, Hepatitis B, and syphilis performance and usability
A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test by Trained Personnel at Near-Patient and Point-of-Care Settings
This project will test whether the TruPlex rapid test can accurately detect HIV, hepatitis B, and syphilis when used by trained healthcare workers on adults getting tested for these infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | bioLytical Laboratories Industry-sponsored |
| Locations | 3 sites (Johannesburg, Gauteng and 2 other locations) |
| Trial ID | NCT07563309 on ClinicalTrials.gov |
What this trial studies
The study will have trained on-site operators perform the TruPlex rapid test using capillary (fingerstick) blood, EDTA whole blood, EDTA plasma, and SST serum collected at point-of-care sites. Collected samples will also be sent to a central laboratory for confirmatory testing for HIV, syphilis, and HBsAg, with leftover samples stored for discrepancy testing or future research. Usability will be measured via structured questionnaires completed by trained operators, and contrived result interpretation will ask intended users to read predefined strong/weak positives, negatives, and invalids. The protocol uses at least two TruPlex lots and includes multiple clinical sites in South Africa to capture operator variability.
Who should consider this trial
Good fit: Adults (18+) getting tested for HIV, hepatitis B, or syphilis — including people at risk, those with symptoms, routine testers, pregnant people with reinfection, and people with unknown HIV status or <12 months of ART — are appropriate candidates.
Not a fit: People under 18, those unwilling or unable to provide blood or informed consent, and individuals on long-term ART or with conditions that interfere with rapid test accuracy may not receive direct benefit from participation.
Why it matters
Potential benefit: If successful, the TruPlex test could enable faster, on-site detection of HIV, hepatitis B, and syphilis to speed counseling and linkage to care.
How similar studies have performed: Rapid point-of-care tests for each infection have established performance individually, but combined multiplex rapid tests like TruPlex have been less extensively validated and need dedicated performance and usability data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 of study assessment, consent form and questionnaire etc. or bias the study outcome.
Where this trial is running
Johannesburg, Gauteng and 2 other locations
- Epicentre Health Research (Johannesburg) — Johannesburg, Gauteng, South Africa (Recruiting)
- Epicentre Health Research — Durban, KwaZulu-Natal, South Africa (Recruiting)
- Epicentre Health Research (Cape Town) — Cape Town, Western Cape, South Africa (Recruiting)
Study contacts
- Study coordinator: Ana Subramanian
- Email: asubramanian@biolytical.com
- Phone: 16042046784
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.