HIV 1 InfectionNCT07563309
A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test
A study testing TruPlex HIV/HepB/Syphilis Rapid Test in people with HIV 1 Infection and HIV 2 Infection, run by bioLytical Laboratories at 3 sites in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV 1 Infection, HIV 2 Infection, Syphilis Infection
- What is being tested?
- TruPlex HIV/HepB/Syphilis Rapid Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 3 sitesSouth Africa
- Study dates
- 18 Dec 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa3 sites, 3 recruiting
- Recruiting
Epicentre Health Research (Cape Town)
Cape Town, Western Cape, 7925
Cherie Cawoood, +27 21 201 1658, cheriec@epicentre.org.za
- Recruiting
Epicentre Health Research
Durban, KwaZulu-Natal, 3650
Cherie Cawood, +27 31 880 2150, cheriec@epicentre.org.za
- Recruiting
Epicentre Health Research (Johannesburg)
Johannesburg, Gauteng, 2193
Cherie Cawood, cheriec@epicentre.org.za
About this study
Official title: 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
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.
Read the detailed description
The study is designed to evaluate TruPlex Test when used by trained users.
Non-invasive samples (fingerstick, EDTA whole blood, EDTA-plasma, and SST-serum) will be collected and tested on TruPlex tests by on-site trained operators. Capillary (fingerstick) whole blood and EDTA whole blood samples will be collected by healthcare professionals. The collected capillary and EDTA whole blood samples will be tested on the TruPlex tests. Subsequently, the EDTA whole blood and SST whole blood samples will be further processed to obtain EDTA plasma and SST serum, respectively, for testing on the TruPlex. Blood samples will be collected and sent to the central laboratory for confirmatory testing (HIV, Syphilis and HBsAg) using approved on-the-market assays. Any remaining samples will be stored for further discrepancy testing or future research use.
A minimum of two TruPlex Test lots will be used for the study.
The following studies will also be performed:
Usability evaluation to assess user experience and success in label comprehension of the TruPlex test via a questionnaire.
Contrived result interpretation with a minimum of 15 intended users across a minimum of 3 clinical sites. Participants will be trained healthcare professionals that are paid employees of the study sites. Participants will have prior experience using rapid tests. Participants will evaluate a set of contrived tests to determine and document if intended users can successfully interpret various TruPlex Test results that include - strong positive, weak positive, negative, and a range of invalid results.
- Being tested
- TruPlex HIV/HepB/Syphilis Rapid Test
- Keywords
- TruPlex HIV/HepB/Syphilis Rapid Test
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruPlex HIV/HepB/Syphilis Rapid TestDevice
A rapid in vitro diagnostic device designed to determine HIV, Syphilis and Hep B infection status
| Study group | Role | What they receive |
|---|---|---|
| TruPlex HIV/HepB/Syphilis Rapid Test Performance | Experimental | Capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care settings will be tested on the TruPlex HIV/HepB/Syphilis Rapid Test. Receives: Device: TruPlex HIV/HepB/Syphilis Rapid Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Evaluation
The diagnostic sensitivity and specificity between TruPlex Test and approved confirmatory assays for HIV, Syphilis and Hep B infection status will be determined. Performance evaluation will be conducted for all sites combined.
Test invalid rate will be tabulated and reported.
Measured: 6 months
Secondary outcomes (2)
Usability Evaluation
Usability will be determined via a questionnaire completed by trained personnel who used the device during testing. The usability questionnaire will use a scale of one (1) to 5 (1 - very difficult/very unlikely to 5 - very easy/very likely), with a rating of 3 being satisfactory.
Measured: 6 months
Contrived result interpretation evaluation
Trained operators will evaluate a panel of contrived (mock) TruPlexdevices. These devices are designed to represent a comprehensive range of test outcomes, including strong positives, weak positives, negatives and invalid results. Operators will interpret the results of the mock devices and record their interpretations which will be compared to the correct interpretation of the device.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start18 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV 1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- bioLytical Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Epicentre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563309
- Sponsor's protocol ID
- CLS-021A
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07563309
- Acronym / sponsor ID
- CLS-021A
- Keywords
- TruPlex HIV/HepB/Syphilis Rapid Test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- bioLytical LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Epicentre
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is designed to evaluate TruPlex Test when used by trained users.
Non-invasive samples (fingerstick, EDTA whole blood, EDTA-plasma, and SST-serum) will be collected and tested on TruPlex tests by on-site trained operators. Capillary (fingerstick) whole blood and EDTA whole blood samples will be collected by healthcare professionals. The collected capillary and EDTA whole blood samples will be tested on the TruPlex tests. Subsequently, the EDTA whole blood and SST whole blood samples will be further processed to obtain EDTA plasma and SST serum, respectively, for testing on the TruPlex. Blood samples will be collected and sent to the central laboratory for confirmatory testing (HIV, Syphilis and HBsAg) using approved on-the-market assays. Any remaining samples will be stored for further discrepancy testing or future research use.
A minimum of two TruPlex Test lots will be used for the study.
The following studies will also be performed:
Usability evaluation to assess user experience and success in label comprehension of the TruPlex test via a questionnaire.
Contrived result interpretation with a minimum of 15 intended users across a minimum of 3 clinical sites. Participants will be trained healthcare professionals that are paid employees of the study sites. Participants will have prior experience using rapid tests. Participants will evaluate a set of contrived tests to determine and document if intended users can successfully interpret various TruPlex Test results that include - strong positive, weak positive, negative, and a range of invalid results.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TruPlex HIV/HepB/Syphilis Rapid Test Performance | Experimental | Device: TruPlex HIV/HepB/Syphilis Rapid TestCapillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care settings will be tested on the TruPlex HIV/HepB/Syphilis Rapid Test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TruPlex HIV/HepB/Syphilis Rapid TestA rapid in vitro diagnostic device designed to determine HIV, Syphilis and Hep B infection status | Device | TruPlex HIV/HepB/Syphilis Rapid Test Performance |
Primary outcome
Performance Evaluation
Time frame: 6 months
The diagnostic sensitivity and specificity between TruPlex Test and approved confirmatory assays for HIV, Syphilis and Hep B infection status will be determined. Performance evaluation will be conducted for all sites combined. Test invalid rate will be tabulated and reported.
2 secondary outcomes
Usability Evaluation
Time frame: 6 months
Contrived result interpretation evaluation
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TruPlex HIV/HepB/Syphilis Rapid Test in people with HIV 1 Infection and HIV 2 Infection, run by bioLytical Laboratories at 3 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Subramanian (16042046784, asubramanian@biolytical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Evaluation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.