Point-of-Care Tests for HIV Diagnosis

(EHPOC Trial)

No longer recruiting at 2 trial locations

Overseen By Matthew Hamill, MBChB, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Under 18, Unwilling, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of existing and new rapid HIV tests compared to standard methods. The goal is to deliver faster results, enabling quicker treatment initiation and reducing virus transmission. Participants will receive either a combination of new rapid tests, such as the Cepheid GeneXpert HIV-1 Qual POC HIV VL test, the DPP HIV-Syphilis test system, and the OraQuick Rapid HIV-1 Antibody Test, or the standard tests. This trial suits individuals living with or at high risk for HIV, including those who use injection drugs or have sexually transmitted infections. As an unphased trial, it offers a unique opportunity to advance rapid HIV testing, potentially benefiting many in the future.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these point-of-care tests are safe for HIV diagnosis?

In a previous study, the Cepheid GeneXpert HIV-1 Qual POC HIV VL test performed very well, with a sensitivity of 93.3%, correctly identifying most people with the virus. The World Health Organization recognizes this test for its quality and safety, reassuring those considering the trial.

The FDA has approved the DPP HIV-Syphilis test system, which detects antibodies for both HIV and syphilis in blood samples. Its FDA approval ensures it meets high standards for safety and effectiveness.

The OraQuick test, also FDA approved, quickly detects HIV antibodies, rapidly indicating exposure to the virus. This test is easy to use and has been proven safe for users.

These tests have been widely used and are considered safe. They do not involve medication, so there is little to no risk of side effects, making them well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Point-of-Care (POC) HIV Viral Load (VL) test because it offers rapid, on-the-spot results, unlike traditional lab-based testing that can take days to weeks. This quick turnaround is especially beneficial in resource-limited settings where timely results can significantly impact patient care and treatment decisions. Additionally, the POC HIV VL test combines testing for both HIV and syphilis, streamlining the diagnostic process and enhancing efficiency for healthcare providers and patients alike. By reducing the delay in receiving critical health information, this method holds promise for improving overall treatment outcomes and management of HIV.

What evidence suggests that these point-of-care tests are effective for HIV diagnosis?

This trial will compare different point-of-care tests for HIV diagnosis. Research has shown that the Cepheid GeneXpert HIV-1 Qual POC HIV VL test, used in the POC HIV VL Testing arm, is highly effective. It correctly identifies 97.9% of existing HIV infections and has a 99.80% accuracy rate in ruling out those without the infection. It also detects 90% of early infections and 98.5% of later acute infections, making it a reliable choice for quick HIV diagnosis. Participants in this arm will also receive the DPP HIV-Syphilis test, a rapid test that accurately detects antibodies for both HIV and syphilis, offering a convenient two-in-one solution. OraQuick, another rapid test included in the POC HIV VL Testing arm, has a 93% accuracy in identifying those with HIV and a 99% accuracy in identifying those without it. Together, these tests provide quick and accurate results, helping patients receive timely treatment and reducing the risk of spreading the virus. ^{1 2 4 6 7}

Who Is on the Research Team?

Matthew Hamill, MBChB, Ph.D

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are living with or at high risk for HIV, including MSM/transgender individuals, those using injection drugs, have known STIs or are being screened for them. Participants must be willing to share lab results, undergo blood and oral fluid tests, complete a questionnaire, attend follow-up visits, and allow their samples to be sent to the CDC.

Inclusion Criteria

Willing to have laboratory results shared with the clinician(s) associated with their care

I am willing to fill out a questionnaire.

You have a higher risk of getting HIV because of your sexual health history or use of injection drugs.

Exclusion Criteria

The study team may exclude you for other reasons they consider important.

I am under 18 years old.

I am not willing to follow the study's required procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care tests plus the HIV POC VL test or routine standard of care HIV testing

12 weeks

Multiple visits as needed for testing and linkage to care

Follow-up

Participants are monitored for linkage to PrEP or ART and changes in risk behavior

12 weeks

Follow-up visits to assess linkage and behavioral changes

What Are the Treatments Tested in This Trial?

Interventions

• Cepheid GeneXpert HIV-1 Qual POC HIV VL test
• DPP HIV-Syphilis test system
• OraQuick

Trial Overview The study is testing rapid point-of-care (POC) technologies like Cepheid GeneXpert HIV-1 Qual POC HIV VL test and others against standard lab procedures. It aims to see if these can speed up diagnosis of HIV/Syphilis and improve linking patients quickly to treatments or prevention services during one clinic visit.

How Is the Trial Designed?

Group I: POC HIV VL Testing Experimental Treatment 3 Interventions

Participants will receive the standard of care tests (DPP HIV-Syphilis Test System, OraQuick) plus the HIV POC VL test.

Group II: SOC HIV Testing Active Control 2 Interventions

Participants will receive routine standard of care HIV testing.

Cepheid GeneXpert HIV-1 Qual POC HIV VL test is already approved in United States, European Union for the following indications:

Approved in United States as Cepheid GeneXpert HIV-1 Qual for:

• HIV-1 viral load testing
• Early infant diagnosis of HIV

Approved in European Union as Cepheid GeneXpert HIV-1 Qual for:

• HIV-1 viral load testing
• Early infant diagnosis of HIV

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Roche Molecular Systems, Inc

Industry Sponsor

Trials

5

Recruited

9,600+

Cepheid

Industry Sponsor

Trials

24

Recruited

10,500+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Published Research Related to This Trial

In a study involving 287 individuals at high risk for HIV, 233 false-negative results were found using the OraQuick Advance Rapid HIV Test, indicating that the test can frequently miss infections, especially in certain conditions.

Factors contributing to these false negatives included the clinical site, test operator, preexposure prophylaxis use, low plasma viral load, and the expiration of the test kit, suggesting that negative results should be confirmed with blood tests in longitudinal studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of False-Negative Human Immunodeficiency Virus Rapid Tests Performed on Oral Fluid in 3 International Clinical Research Studies. Curlin, ME., Gvetadze, R., Leelawiwat, W., et al.[2022]

In a study of 3212 pregnant women, the Chembio DPP HIV-syphilis Assay showed high sensitivity (90.6%) and specificity (97.2%) for HIV, and moderate sensitivity (68.6%) with high specificity (98.5%) for syphilis, while the SD Bioline test had similar results for HIV (89.4% sensitivity, 96.3% specificity) and lower sensitivity for syphilis (66.2%).

Both rapid diagnostic tests were found to be highly acceptable and feasible for use in antenatal clinics, indicating their potential for effective implementation in real-world settings to improve maternal health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Field performance evaluation of dual rapid HIV and syphilis tests in three antenatal care clinics in Zambia. Kasaro, MP., Bosomprah, S., Taylor, MM., et al.[2022]

The BioPlex 2200 Syphilis IgG test demonstrated significantly higher specificity (89.7%) compared to the Architect Syphilis TP test (78.4%), while both tests showed 100% sensitivity, making BioPlex a more reliable option for diagnosing syphilis.

The BioPlex 2200 Syphilis IgM test showed a specificity of 94.9% and a sensitivity of 84.8%, indicating it could effectively complement IgG testing in identifying active syphilis infections, especially in high-volume laboratories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the BioPlex 2200 syphilis system as a first-line method of reverse-sequence screening for syphilis diagnosis. Marangoni, A., Nardini, P., Foschi, C., et al.[2021]

The OraQuick ADVANCE Rapid HIV-1/2 antibody test has been FDA approved for its high sensitivity and specificity, making it a reliable tool for diagnosing HIV using oral fluid, whole blood, or plasma.

This rapid test enhances access to voluntary counseling and testing, and supports the expansion of antiretroviral therapy, particularly in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OraQuick ADVANCE Rapid HIV-1/2 antibody test. Reynolds, SJ., Muwonga, J.[2019]

The Reveal Rapid TP Antibody test demonstrated a high sensitivity of 95.0% and a specificity of 83.3% for detecting infectious syphilis, while the DPP Syphilis Screen and Confirm test showed a sensitivity of 87.5% and a high specificity of 98.3%.

Both tests were particularly effective at detecting active syphilis in samples with higher VDRL titres (greater than 1:4), but their sensitivity decreased for samples with lower titres, indicating a need for further evaluation in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory evaluation of two point-of-care test kits for the identification of infectious syphilis. Tsang, RS., Shuel, M., Hayden, K., et al.[2022]

The smartphone-based electronic reader demonstrated high sensitivity (94.1% to 97.0%) and perfect specificity (100%) for detecting HIV antibodies in 201 serum samples, indicating its effectiveness for point-of-care testing.

For Treponema pallidum, the electronic reader showed sensitivities of 86.5% and 92.4%, with very high specificities (99.1% and 99.0%), suggesting it is a reliable tool for diagnosing syphilis alongside HIV testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory Evaluation of a Smartphone-Based Electronic Reader of Rapid Dual Point-of-Care Tests for Antibodies to Human Immunodeficiency Virus and Treponema pallidum Infections. Herbst de Cortina, S., Bristow, CC., Humphries, R., et al.[2019]

The Bio-Rad Syphilis IgG EIA test demonstrated a high agreement rate of 96.2% with the CAPTIA Syphilis-G test in screening for syphilis, indicating its efficacy as a reliable screening tool.

As a confirmatory test, the Bio-Rad assay showed a sensitivity of 97.8% and specificity of 100%, making it a highly accurate method for confirming syphilis infections, with potential for improved sensitivity by adjusting the cut-off for equivocal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Bio-Rad syphilis IgG test performed on the CODA system for serologic diagnosis of syphilis. Tholcken, CA., Woods, GL.[2019]

The Xpert HIV-1 VL assay shows high correlation with established reference standards for measuring viral load in HIV-positive patients, with a pooled Pearson correlation of 0.94, indicating it is a reliable testing method.

This assay requires minimal training and infrastructure, making it particularly suitable for resource-limited settings where rapid and accessible viral load testing is essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of the Xpert HIV-1 Viral Load Assay: a Systematic Review and Meta-analysis. Nash, M., Huddart, S., Badar, S., et al.[2019]

A study evaluating seven treponemal assays for syphilis diagnosis using 303 serum samples found that these tests performed comparably well, with agreement rates between 95.4% and 98.4% when compared to the FTA assay, which is considered the gold standard.

The Trep-ID EIA showed the highest agreement with a consensus of multiple tests, suggesting it may be a reliable option for clinical laboratories looking to implement treponemal testing for syphilis screening or confirmation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treponema-specific tests for serodiagnosis of syphilis: comparative evaluation of seven assays. Binnicker, MJ., Jespersen, DJ., Rollins, LO.[2021]

The FDA approved the OraQuick Rapid HIV-1 Antibody Test on November 7, 2002, allowing trained personnel to use it as a quick point-of-care diagnostic tool for HIV-1, providing results in as little as 20 minutes.

OraQuick detects antibodies in fingerstick whole blood specimens and is categorized as a moderate complexity test, making it accessible for rapid HIV testing in various healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approval of a new rapid test for HIV antibody. [2008]

A study involving 1029 participants found that multi-disease test kits for HIV showed high sensitivity (91.1% to 100%) and specificity (99.5% to 100%), indicating they are reliable for detecting HIV.

The performance of HIV tests using oral fluid was particularly noteworthy, demonstrating that non-invasive testing methods can be effective in diagnosing HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparisons of New HIV Rapid Test Kit Performance. Fisher, DG., Hess, KL., Reynolds, GL., et al.[2020]

Citations

1. cepheid.com cepheid.com/en-NL/tests/blood-virology-womens-health-sexual-health/xpert-hiv-1-viral-load-xc.html

Xpert ® HIV-1 Viral Load XC Xpert HIV-1 Viral Load XC: Next Generation Molecular Testing for Monitoring Viral Load and HIV-1 Infection.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4866899/

Diagnostic Accuracy of the Point-of-care Xpert® HIV-1 Viral ... In summary, the Xpert® HIV-1 VL showed good correlation with an established laboratory-based viral load assay, and could be a reliable tool for clinic-based ...

3. cepheid.com cepheid.com/en-DK/tests/blood-virology-womens-health-sexual-health/xpert-hiv-1-qual-xc.html

Xpert ® HIV-1 Qual XC A molecular point-of-care test that delivers actionable results in around 90 minutes. ... Highly sensitive, timely results for effective patient management and ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1386653219302446

Evaluation of the performance of the Cepheid Xpert HIV‐1 ... Xpert VL detected 97.9 % of established infections, and specificity was 99.80 %. •. Xpert VL detected 90 % and 98.5 % of early and later acute infections, ...

5. cepheid.mediaroom.com cepheid.mediaroom.com/2024-04-03-Cepheid-Announces-World-Health-Organization-Prequalification-of-Xpert-HIV-1-Qualitative-Test

Cepheid Announces World Health Organization ... Xpert HIV-1 Qual XC provides extended strain coverage by including two gene targets for the identification of HIV-1 infections - ...

6. web-support.cepheid.com web-support.cepheid.com/Package%20Insert%20Files/Xpert%20HIV-1%20Qual-1/Xpert%20HIV-1%20Qual-1%20ENGLISH%20Package%20Insert%20301-3048%2C%20Rev%20L.pdf

Xpert HIV-1 Qual The HIV-1 Qual assay is intended to aid in the diagnosis of HIV-1 infection in conjunction with clinical presentation and other laboratory markers. The assay is ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5503760/

High Sensitivity and Specificity of the Cepheid Xpert® HIV ... Fourteen of 15 PCR positive samples tested positive by Cepheid POC, yielding a sensitivity of 93.3% (95%CI: 68.1–99.8%). Baseline viral load among positive ...