Point-of-Care Tests for HIV Diagnosis
(EHPOC Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Disqualifiers: Under 18, Unwilling, Others
No Placebo Group
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.
12345Is 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.
24678How 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.
2491011Eligibility 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.
+4 more
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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: POC HIV VL TestingExperimental Treatment3 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 TestingActive Control2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Baltimore City Health Department (BCHD) Health and Wellness Center, Sexual Health ClinicsBaltimore, MD
Johns Hopkins Hospital Emergency Department (JHHED)Baltimore, MD
The John G. Bartlett Specialty Practice (JGBSP)Baltimore, MD
Loading ...
Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
Centers for Disease Control and PreventionCollaborator
References
Evaluation of the BioPlex 2200 syphilis system as a first-line method of reverse-sequence screening for syphilis diagnosis. [2021]Despite recent technological advances, the diagnosis of syphilis remains a challenging enterprise. Actually, most high-volume laboratories have adopted the "reverse algorithm" due several factors, including the potential to automate testing. Recently, immunoassays processed on random-access systems have been proposed as screening tests. The purpose of this study was to evaluate diagnostic performances of BioPlex 2200 Syphilis IgG and BioPlex 2200 Syphilis IgM, tests based on Multiplex Flow technology, in comparison with the performance of Architect Syphilis TP, a chemiluminescent immunoassay for the detection of IgG and/or IgM anti-Treponema pallidum antibodies. A retrospective study was performed with a panel of 100 blood donor sera, a panel of 350 clinical and laboratory-characterized syphilitic sera, and 170 samples obtained from subjects with potentially interfering conditions. Moreover, 200 unselected samples submitted to the Microbiology Laboratory of St. Orsola Hospital in Bologna for routine screening for syphilis were evaluated. As confirmatory tests, T. pallidum hemagglutination and Western blot assays were used. Considering the IgG Western blot (WB) assay to be the gold standard method, BioPlex 2200 Syphilis IgG specificity was far higher than Architect Syphilis TP specificity (89.7% versus 78.4%, respectively), whereas the sensitivity was 100% for both automated methods. Compared to the IgM WB assay, BioPlex 2200 Syphilis IgM performed with a specificity of 94.9%, whereas the sensitivity was 84.8%. Considering the excellent ease of use and automation, the high sample throughput and its valuable analytical performances, BioPlex Syphilis 2200 IgG could represent a suitable choice for high-volume laboratories. BioPlex Syphilis 2200 IgM could be considered a good addition to IgG testing for uncovering active infections.
Analysis of False-Negative Human Immunodeficiency Virus Rapid Tests Performed on Oral Fluid in 3 International Clinical Research Studies. [2022]The OraQuick Advance Rapid HIV-1/2 Test is a point-of-care test capable of detecting human immunodeficiency virus (HIV)-specific antibodies in blood and oral fluid. To understand test performance and factors contributing to false-negative results in longitudinal studies, we examined results of participants enrolled in the Botswana TDF/FTC Oral HIV Prophylaxis Trial, the Bangkok Tenofovir Study, and the Bangkok MSM Cohort Study, 3 separate clinical studies of high-risk, HIV-negative persons conducted in Botswana and Thailand.
Treponema-specific tests for serodiagnosis of syphilis: comparative evaluation of seven assays. [2021]The diagnosis of syphilis is challenging and often relies on serologic tests to detect treponemal or nontreponemal antibodies. Recently, the Centers for Disease Control and Prevention and the Association of Public Health Laboratories proposed an update to the syphilis serology testing algorithm, in which serum samples are first tested using a treponema-specific test and positive samples are analyzed with a nontreponemal assay. The goal of this study was to compare the performance of seven treponemal assays (BioPlex 2200 syphilis IgG [Bio-Rad, Hercules, CA], fluorescent treponemal antibody [FTA] assay [Zeus Scientific, Raritan, NJ], Treponema pallidum particle agglutination [TP-PA; Fujirebio Diagnostics, Malvern, PA], Trep-Sure enzyme immunoassay [EIA; Phoenix Biotech, Oakville, Ontario, Canada], Trep-Chek EIA [Phoenix Biotech], Trep-ID EIA [Phoenix Biotech], and Treponema ViraBlot IgG [Viramed Biotech AG, Planegg, Germany]) using serum samples (n = 303) submitted to our reference laboratory. In addition to testing with these 7 assays, all samples were tested by a rapid plasma reagin (RPR) assay and a treponemal IgM Western blot assay (Viramed ViraBlot). Compared to the FTA assay as the gold standard, the evaluated treponemal tests demonstrated comparable levels of performance, with percent agreement ranging from 95.4% (95% confidence interval, 92.3 to 97.3) for the Trep-Sure EIA to 98.4% (96.1 to 99.4) for the Trep-ID EIA. Compared to a "consensus of the test panel" (defined as at least 4 of 7 treponemal tests being in agreement), the percent agreement ranged from 95.7% (92.7 to 97.5) for Trep-Sure to 99.3% (97.5 to 99.9) for Trep-ID. These data may assist clinical laboratories that are considering implementing a treponemal test for screening or confirmatory purposes.
OraQuick ADVANCE Rapid HIV-1/2 antibody test. [2019]Rapid HIV antibody tests represent a key development in the current diagnosis and management of HIV infection. The OraQuick ADVANCE Rapid HIV-1/2 antibody test (OraSure Technologies) has received US Food and Drug Administration approval on the basis of its performance characteristics and a subsequent Clinical Laboratory Improvement Amendments waiver based on its simplicity and accuracy. The test has been approved for use on oral mucosal transudate, whole blood or plasma. Clinical evaluation of the OraQuick ADVANCE Rapid HIV-1/2 antibody test has revealed high sensitivity and specificity. The test has many important applications, extending the opportunities for voluntary counseling and testing, and as a tool for the scale-up of antiretroviral therapy in resource-limited settings.
Performance of the Xpert HIV-1 Viral Load Assay: a Systematic Review and Meta-analysis. [2019]Viral load (VL) is the preferred treatment-monitoring approach for HIV-positive patients. However, more rapid, near-patient, and low-complexity assays are needed to scale up VL testing. The Xpert HIV-1 VL assay (Cepheid, Sunnyvale, CA) is a new, automated molecular test, and it can leverage the GeneXpert systems that are being used widely for tuberculosis diagnosis. We systematically reviewed the evidence on the performance of this new tool in comparison to established reference standards. A total of 12 articles (13 studies) in which HIV patient VLs were compared between Xpert HIV VL assay and a reference standard VL assay were identified. Study quality was generally high, but substantial variability was observed in the number and type of agreement measures reported. Correlation coefficients between Xpert and reference assays were high, with a pooled Pearson correlation (n = 8) of 0.94 (95% confidence interval [CI], 0.89, 0.97) and Spearman correlation (n = 3) of 0.96 (95% CI, 0.86, 0.99). Bland-Altman metrics (n = 11) all were within 0.35 log copies/ml of perfect agreement. Overall, Xpert HIV-1 VL performed well compared to current reference tests. The minimal training and infrastructure requirements for the Xpert HIV-1 VL assay make it attractive for use in resource-constrained settings, where point-of-care VL testing is most needed.
Approval of a new rapid test for HIV antibody. [2008]On November 7, 2002, the Food and Drug Administration announced approval of the OraQuick Rapid HIV-1 Antibody Test (OraSure Technologies, Inc., Bethlehem, Pennsylvania) for use by trained personnel as a point-of-care test to aid in the diagnosis of infection with human immunodeficiency virus type 1 (HIV-1). OraQuick is a simple, rapid test that can detect antibodies to HIV in fingerstick whole blood specimens and provide results in as little as 20 minutes [corrected]. The test has been categorized as moderate complexity under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). A second FDA-approved moderate-complexity rapid HIV test, Single Use Diagnostic System for HIV-1 (Abbott-Murex Inc., Norcross, Georgia), remains available in the United States for use with serum or plasma specimens.
Field performance evaluation of dual rapid HIV and syphilis tests in three antenatal care clinics in Zambia. [2022]This cross-sectional study of 3212 pregnant women assessed the field performance, acceptability, and feasibility of two dual HIV/syphilis rapid diagnostic tests, the Chembio DPP HIV-syphilis Assay and the SD Bioline HIV/syphilis Duo in antenatal clinics. Sensitivity and specificity for HIV and syphilis were calculated compared to the rapid Determine HIV-1/2 with Uni-Gold to confirm positive results for HIV and the Treponema pallidum particle agglutination assay for syphilis. RPR titers ≥1:4 were used to define active syphilis detection. Acceptability and feasibility were assessed using self-reported questionnaires. For Chembio, the HIV sensitivity was 90.6% (95%CI = 87.4, 93.0) and specificity was 97.2% (95%CI = 96.2, 97.8); syphilis sensitivity was 68.6% (95%CI = 61.9, 74.6) and specificity was 98.5% (95%CI = 97.8, 98.9). For SD Bioline, HIV sensitivity was 89.4% (95%CI = 86.1, 92.0) and specificity was 96.3% (95%CI = 95.3, 97.1); syphilis sensitivity was 66.2% (95%CI = 59.4, 72.4) and specificity was 97.2% (95%CI = 96.4, 97.9). Using the reference for active syphilis, syphilis sensitivity was 84.7% (95%CI = 76.1, 90.6) for Chembio and 81.6% (95%CI = 72.7, 88.1) for SD Bioline. Both rapid diagnostic tests were assessed as highly acceptable and feasible. In a field setting, the performance of both rapid diagnostic tests was comparable to other published field evaluations and each was rated highly acceptable and feasible. These findings can be used to guide further research and proposed scale up in antenatal clinic settings.
Evaluation of the Bio-Rad syphilis IgG test performed on the CODA system for serologic diagnosis of syphilis. [2019]The performance of the Bio-Rad Syphilis IgG EIA test as a "screen for syphilis" [testing first by EIA and then by the rapid plasma reagin (RPR) assay if the EIA was positive or equivocal] and as a confirmatory test was evaluated by comparing results to those obtained by CAPTIA Syphilis-G. Discrepancies were resolved by repeating both EIAs and/or the SeroDia TP-PA (a particle agglutination assay that replaced the microhemagglutination Treponema pallidum test). Both EIAs were totally automated, the Bio-Rad test using the AutoPrep instrument for pipetting and the CODA system to perform all of the steps required to complete the EIA and interpret results, and the CAPTIA test using the LabOTech(R) to accomplish both functions. Of 449 unselected sera submitted to "screen for syphilis," both EIAs agreed for 432 (96.2%) specimens: 395 negative, 36 positive, and one equivocal. Fifty-four specimens were positive or equivocal by one or both EIAs; 41 of these were RPR reactive. Three of these 41 were incorrectly called negative by Bio-Rad (sensitivity 92.7%), and there was 1 false-negative result by CAPTIA (sensitivity, 97.6%) (P, not significant). To further evaluate the Bio-Rad assay as a confirmatory test, 144 known RPR-reactive specimens were tested by both EIAs. Results agreed for 134 (93.1%): 123 positive, 11 negative. After resolving discrepancies, there were 3 false-negative and no false-positive results by Bio-Rad (sensitivity 97.8%, specificity 100%), and with CAPTIA there were no false-negative results and 1 false-positive (sensitivity 100%, specificity 91.7%) (P, not significant). The sensitivity of the Bio-Rad assay could be improved, without altering specificity, by lowering the cut-off value for equivocal results. In summary, the Bio-Rad Syphilis IgG EIA performed using the AutoPrep instrument and CODA system is a reliable, efficient method of syphilis testing.
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]Dual point-of-care tests for antibodies to human immunodeficiency virus (HIV) and Treponema pallidum allow for same-day testing and treatment and have been demonstrated to be cost-effective in preventing the adverse outcomes of HIV infection and syphilis. By recording and transmitting data as they are collected, electronic readers address challenges related to the decentralization of point-of-care testing.
Comparisons of New HIV Rapid Test Kit Performance. [2020]The development of rapid point-of-care tests for HIV infection has greatly reduced the problem of failure to return for test results. Test manufacturers are now developing test kits that can test for two or even three diseases at the same time, multiple-disease test kits. This study reports on the sensitivity and specificity of HIV tests when included on multi-disease test kits. 1029 participants were recruited from 2011 to 2014. HIV test kit sensitivities ranged from 91.1 to 100%, and the HIV test kit specificities from 99.5 to 100%. The two HIV kits which used oral fluid instead of blood performed well.
Laboratory evaluation of two point-of-care test kits for the identification of infectious syphilis. [2022]Label="Background" NlmCategory="UNASSIGNED">Syphilis is a sexually transmitted disease that can have atypical clinical presentations. Conventional laboratory tests to confirm the diagnosis are not rapid enough to affect clinical decision on treatment and contact tracing. Rapid point-of-care tests (POCT) can be useful for control of infectious diseases; however, no POCT for syphilis detection is currently available in Canada. The aim of this study is to evaluate two POCTs (RevealTM Rapid TP (Treponema pallidum) Antibody test and DPP® Syphilis Screen and Confirm test) for detection of infectious syphilis.