Clinical trial for HIV 1 Infection
Official title A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test
ClinicalTrials.gov ID: NCT07563309
What this study is testing
- What it's testing
- The study aims to check if the test gives accurate results and is easy for healthcare workers to use and read.
- Who it's for
- This study is looking for trained healthcare workers who perform tests in clinics or other care settings.
- What's involved
- Participants will use the test on blood samples and answer questionnaires about how easy it is to use and how they interpret the results.
- Time commitment
- The study involves completing specific test tasks and surveys, but the total duration is not specified.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join 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
- At risk for any one of the target diseases
You likely can't join 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 people 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...
See the full eligibility 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
- At risk for any one of the target diseases
- Having signs or symptoms indicative of the target diseases
- Routine testing
- Note: people 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
- 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 people 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Johannesburg, Gauteng, South Africa
- Durban, KwaZulu-Natal, South Africa
- Cape Town, Western Cape, South Africa
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Johannesburg, Gauteng, South Africa; Durban, KwaZulu-Natal, South Africa; Cape Town, Western Cape, South Africa. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.