TruPlex rapid test for HIV, Hepatitis B, and syphilis performance and usability

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TruPlex HIV/HepB/Syphilis Rapid Test performance and usability in real-world settings

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• GS-0415 safety and PK in people with HIV on ART

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.