NCT07563309 A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test
| NCT ID | NCT07563309 |
| Status | Recruiting |
| Phase | — |
| Sponsor | bioLytical Laboratories |
| Condition | HIV 1 Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-12-18 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2025-12-18 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07563309 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV 1 Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07563309 currently recruiting?
Yes, NCT07563309 is actively recruiting participants. Contact the research team at asubramanian@biolytical.com for enrollment information.
Where is the NCT07563309 trial being conducted?
This trial is being conducted at Johannesburg, South Africa, Durban, South Africa, Cape Town, South Africa.
Who is sponsoring the NCT07563309 clinical trial?
NCT07563309 is sponsored by bioLytical Laboratories. The trial plans to enroll 1,000 participants.
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