An interventional study of Cepheid GeneXpert HIV-1 Qual POC HIV VL test and DPP HIV-Syphilis test system in HIV Infections and Syphilis, sponsored by Johns Hopkins University. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Diagnostic
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
The strategy for Ending the HIV Epidemic (EHE) includes four key strategies that together can end the HIV epidemic in the United States (US): Diagnose, Treat, Prevent, and Respond. Diagnosis is the gateway to all other interventions; it is the cornerstone of EHE. In 2019/20 it was estimated that more than 160,000 Americans are unaware of living with HIV. Early diagnosis coupled with rapid linkage to care is critical and can lead to improved individual and community health outcomes. Achieving this goal will require improved, more accessible, and routine HIV testing; immediately connecting people with HIV to care services; and connecting those without HIV to appropriate HIV prevention services. Maryland was ranked 6th among states and territories in adult/adolescent HIV diagnosis rates (per 100,000) in 2018, tied with Mississippi. Among people living with HIV in Maryland in 2019, the Centers for Disease Control and Prevention (CDC) estimated that 89.2% had been diagnosed and that \~3,830 people with HIV are undiagnosed.
Evaluation of existing and new POC HIV tests is needed to inform testing guidelines and provide updated information to HIV test providers. Characterizing the performance of POC tests can provide estimates for the window period for HIV detection (i.e., the time from HIV acquisition to the time that a diagnostic test becomes positive). The window period provides key information needed to interpret an initial positive test result and assess the risk of transmission to others. It may also help guide decisions about repeat testing and initiation of ART in those with HIV and prevention interventions, including PrEP and post-exposure prophylaxis (PEP) (in those without HIV).
During the window period for an HIV Antigen/Antibody (Ag/Ab) test, infected individuals may have non-reactive test results, falsely reassuring patients and providers. HIV RNA [or 'viral load' (VL)] assays have window periods that are approximately 10 days shorter than most HIV Ag/Ab tests, providing greater sensitivity for detection of early HIV infection. The use of HIV RNA detection platforms for HIV screening facilitates earlier diagnosis and more effective implementation of ART and PrEP. This may be especially useful in settings where the infection is acquired in persons using PrEP, since PrEP agents may suppress viral replication and delay antibody production.
The following hypotheses underpin the planned study:
A. Determining the performance characteristics of HIV POC tests will inform optimal testing strategies in different populations and settings.
B. Use of HIV RNA POC tests will improve linkage to HIV treatment and prevention services.
The implications of this CDC-sponsored research are important since this research could improve early diagnosis of HIV, reduce the time to ART initiation, and facilitate timely and appropriate referral for prevention services. Additionally, if someone is infected while using long-acting PrEP, or initiated PrEP while infected, the risk of resistance and side effects can be minimized; if the infection is missed. These are critical issues for EHE success.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 224 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive the standard of care tests (DPP HIV-Syphilis Test System, OraQuick) plus the HIV POC VL test.
Diagnostic Test: Cepheid GeneXpert HIV-1 Qual POC HIV VL test · Diagnostic Test: DPP HIV-Syphilis test system · Diagnostic Test: OraQuick
Participants will receive routine standard of care HIV testing.
Diagnostic Test: DPP HIV-Syphilis test system · Diagnostic Test: OraQuick
POC Nucleic acid-based test for HIV RNA.
POC Tests for antibodies to HIV 1/2 and Treponema pallidum.
POC oral fluid swab test for HIV 1/2 antibodies.
Participants Linked Either to Care (PrEP or ART)
The primary outcome of the study was linkage to care rate, defined as having at least one in-person or telehealth interaction with a clinical team about HIV ART or PrEP within the study follow-up period.
Time frame: 12 Weeks
HIV: Time to Linkage to Either PrEP or ART
Time frame: 12 Weeks
Participants Reporting Condom-less Sex
This will be used to assess HIV 'knowledge' - behavioral change (awareness/risk behavior change).
Time frame: Day 0 and Week 12
| Milestone | POC HIV VL Testing | SOC HIV Testing |
|---|---|---|
| Started | 113 | 111 |
| Completed | 113 | 111 |
| Not completed | 0 | 0 |
The primary outcome of the study was linkage to care rate, defined as having at least one in-person or telehealth interaction with a clinical team about HIV ART or PrEP within the study follow-up period.
| Participants | POC HIV VL Testing | SOC HIV Testing |
|---|---|---|
| Participants Linked Either to Care (PrEP or ART) | 51 | 50 |
| days | POC HIV VL Testing | SOC HIV Testing |
|---|---|---|
| HIV: Time to Linkage to Either PrEP or ART | 49 (5 to 91) | 74 (7 to 93) |
This will be used to assess HIV 'knowledge' - behavioral change (awareness/risk behavior change).
| participants | POC HIV VL Testing | SOC HIV Testing |
|---|---|---|
| Participants reporting condom-less sex at baseline | 63 | 70 |
| Participants reporting condom-less sex at week-12 | 28 | 34 |
Collected over From enrollment unitl end of follow-up, up to 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| POC HIV VL Testing | 0/113 (0%) | 0/113 (0%) | 16/113 (14.2%) |
| SOC HIV Testing | 0/111 (0%) | 0/111 (0%) | 25/111 (22.5%) |
| Event | POC HIV VL Testing | SOC HIV Testing |
|---|---|---|
| Adverse events noted per protocolGeneral disorders | 16/113 | 25/111 |
| Age, Customized(Participants) | POC HIV VL Testing | SOC HIV Testing | Total |
|---|---|---|---|
| Age group — Less than 25 | 10 | 8 | 18 |
| Age group — 25 - 40 | 55 | 42 | 97 |
| Age group — More than 40 | 48 | 61 | 109 |
| Sex: Female, Male(Participants) | POC HIV VL Testing | SOC HIV Testing | Total |
|---|---|---|---|
| Female | 50 | 38 | 88 |
| Male | 63 | 73 | 136 |
| Linked to care(Participants) | POC HIV VL Testing | SOC HIV Testing | Total |
|---|---|---|---|
| Linked to care | 51 | 50 | 101 |
| Not linked to care | 62 | 61 | 123 |
| Race/Ethnicity, Customized(Participants) | POC HIV VL Testing | SOC HIV Testing | Total |
|---|---|---|---|
| Race — Black or African American or Another Race | 77 | 74 | 151 |
| Race — White | 36 | 37 | 73 |
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