Point-of-Care Tests for HIV Diagnosis

(EHPOC Trial)

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

408 Participants Needed

Trial Summary

What is the purpose of this trial?

This study proposes to investigate the performance of existing and new technologies for HIV diagnosis, one of the key strategies for Ending the HIV Epidemic in the U.S. Current, Standard-of-Care (SOC) diagnostic techniques have extended turn-around-times (TATs) that result in loss of patients to follow up due to delays in laboratory procedures. In this scenario, patients that are at a high-risk for HIV have the potential to continue transmission, making it difficult to end the epidemic. Rapid, Point-of-Care (POC) HIV viral load (VL) testing alleviates this problem by reducing TATs that allow providers to test for HIV infection and link patients to antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) during the same clinical visit, and subsequently, suppress VL, prevent HIV infection, and reduce its transmission among high-risk populations. The study proposes that evaluating the performance of new and existing POC technologies is needed to provide updated information to HIV test providers operating in different populations and settings and improve linkage to HIV treatment and prevention services. The study hypothesizes that: A. Determining the performance characteristics of HIV POC tests will inform optimal testing strategies in different populations and settings B. The use of HIV RNA POC tests will improve linkage to HIV treatment and prevention services: i. Improve early diagnosis of HIV ii. Reduce the time to ART initiation iii. Facilitate timely and appropriate referral for prevention services

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 data supports the effectiveness of the treatment Cepheid GeneXpert HIV-1 Qual POC HIV VL test and other point-of-care tests for HIV diagnosis?

The Xpert HIV-1 VL assay, part of the GeneXpert system, shows high accuracy in measuring HIV viral load, with strong agreement with reference tests, making it effective for use in resource-limited settings. The OraQuick Rapid HIV-1 Antibody Test is also highly sensitive and specific, providing reliable results for HIV diagnosis. ^{1 2 3 4 5}

Is the OraQuick Rapid HIV-1 Antibody Test safe for humans?

The OraQuick Rapid HIV-1 Antibody Test has been approved by the FDA for use by trained personnel, indicating it meets safety standards for human use. It is a simple, rapid test that provides results quickly and has been categorized as moderate complexity, suggesting it is safe when used correctly. ^{2 4 6 7 8}

How is the Point-of-Care Tests for HIV Diagnosis treatment different from other treatments?

This treatment is unique because it combines multiple rapid point-of-care tests that can detect HIV and syphilis simultaneously, providing same-day results and enabling immediate treatment. It includes tests like the OraQuick, which can use oral fluid instead of blood, making it less invasive and more accessible, especially in resource-limited settings. ^{2 4 9 10 11}

Research Team

Matthew Hamill, MBChB, Ph.D

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Findings from Research

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]

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]

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 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 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]

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]

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 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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the BioPlex 2200 syphilis system as a first-line method of reverse-sequence screening for syphilis diagnosis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Analysis of False-Negative Human Immunodeficiency Virus Rapid Tests Performed on Oral Fluid in 3 International Clinical Research Studies. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Treponema-specific tests for serodiagnosis of syphilis: comparative evaluation of seven assays. [2021]

4. England pubmed.ncbi.nlm.nih.gov

OraQuick ADVANCE Rapid HIV-1/2 antibody test. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Performance of the Xpert HIV-1 Viral Load Assay: a Systematic Review and Meta-analysis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Field performance evaluation of dual rapid HIV and syphilis tests in three antenatal care clinics in Zambia. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States 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. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Comparisons of New HIV Rapid Test Kit Performance. [2020]

11. Canada pubmed.ncbi.nlm.nih.gov

Laboratory evaluation of two point-of-care test kits for the identification of infectious syphilis. [2022]