HIV InfectionsEHPOCNCT04793750
Ending the HIV Epidemic Through Point-of-Care Technologies (EHPOC)
A study testing Cepheid GeneXpert HIV-1 Qual POC HIV VL test, DPP HIV-Syphilis test system and OraQuick in people with HIV Infections and Syphilis, run by Johns Hopkins University at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Syphilis
- What is being tested?
- Cepheid GeneXpert HIV-1 Qual POC HIV VL test, DPP HIV-Syphilis test system and OraQuick
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Aug 2021to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Aged 18 years or older
- Living with or at high risk for HIV (MSM/transgender; injection drug use (IDU); known STI or being screened for STI; part of a high STI prevalence network [e.g., in the Sexual Health clinic])
- Willing to undergo phlebotomy and collection of oral fluid samples
- Willing to complete a questionnaire
- Willing to have laboratory results shared with the clinician(s) associated with their care
- Willing to attend follow-up visits
- Willing for samples to be transferred to the CDC for analysis and storage
Who cannot join
- Aged <18 years
- Unwilling to undergo study procedures
- Any other reason deemed pertinent by the study team
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Baltimore City Health Department (BCHD) Health and Wellness Center, Sexual Health Clinics
Baltimore, Maryland, 21217
Johns Hopkins Hospital Emergency Department (JHHED)
Baltimore, Maryland, 21287
The John G. Bartlett Specialty Practice (JGBSP)
Baltimore, Maryland, 21287
About this study
Official title: Ending the HIV Epidemic Through Point-of-Care Technologies (EHPOC): Performance Evaluation of Novel POC HIV Tests in Baltimore
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:
- Determining the performance characteristics of HIV POC tests will inform optimal testing strategies in different populations and settings
- The use of HIV RNA POC tests will improve linkage to HIV treatment and prevention services:
- Improve early diagnosis of HIV ii. Reduce the time to ART initiation iii. Facilitate timely and appropriate referral for prevention services
Read the detailed description
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:
- Determining the performance characteristics of HIV POC tests will inform optimal testing strategies in different populations and settings.
- 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.
- Conditions
- HIV Infections, Syphilis
- Being tested
- Cepheid GeneXpert HIV-1 Qual POC HIV VL test, DPP HIV-Syphilis test system, OraQuick
- Keywords
- HIV, point-of-care, standard-of-care, POC, SOC, Syphilis, Viral load, VL, ART, antiretroviral therapy, PrEP, pre-exposure prophylaxis, PEP, post-exposure prophylaxis, Ending the HIV epidemic, EHE, human immunodeficiency virus, POC VL, sexually transmitted diseases (STDs), sexually transmitted infections (STIs)
- Medical subject headings
- HIV Infections, Syphilis, Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cepheid GeneXpert HIV-1 Qual POC HIV VL testDiagnostic test
POC Nucleic acid-based test for HIV RNA.
DPP HIV-Syphilis test systemDiagnostic test
POC Tests for antibodies to HIV 1/2 and Treponema pallidum.
OraQuickDiagnostic test
POC oral fluid swab test for HIV 1/2 antibodies.
| Study group | Role | What they receive |
|---|---|---|
| POC HIV VL Testing | Experimental | Participants will receive the standard of care tests (DPP HIV-Syphilis Test System, OraQuick) plus the HIV POC VL test. Receives: Diagnostic Test: Cepheid GeneXpert HIV-1 Qual POC HIV VL test; Diagnostic Test: DPP HIV-Syphilis test system; Diagnostic Test: OraQuick |
| SOC HIV Testing | Active comparator | Participants will receive routine standard of care HIV testing. Receives: Diagnostic Test: DPP HIV-Syphilis test system; Diagnostic Test: OraQuick |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Weeks
Secondary outcomes (2)
HIV: Time to Linkage to Either PrEP or ART
Measured: 12 Weeks
Participants Reporting Condom-less Sex
This will be used to assess HIV 'knowledge' - behavioral change (awareness/risk behavior change).
Measured: Day 0 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start18 Aug 2021
- Primary completion28 Feb 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Roche Molecular Systems, Inc, Cepheid
- Responsible party
- Sponsor
- Investigators
- Matthew Hamill, MBChB, Ph.D, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793750
- Sponsor's protocol ID
- IRB00274090
- Acronym
- EHPOC
- Status last verified
- Apr 2026
- First submitted
- 8 Mar 2021
- Last updated
- 23 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Stekler JD, Violette LR, Clark HA, McDougal SJ, Niemann LA, Katz DA, Chavez PR, Wesolowski LG, Ethridge SF, McMahan VM, Cornelius-Hudson A, Delaney KP. Prospective Evaluation of HIV Testing Technologies in a Clinical Setting: Protocol for Project DETECT. JMIR Res Protoc. 2020 Jan 27;9(1):e16332. doi: 10.2196/16332.
PubMed 32012115Patel P, Bennett B, Sullivan T, Parker MM, Heffelfinger JD, Sullivan PS; CDC AHI Study Group. Rapid HIV screening: missed opportunities for HIV diagnosis and prevention. J Clin Virol. 2012 May;54(1):42-7. doi: 10.1016/j.jcv.2012.01.022. Epub 2012 Feb 29.
PubMed 22381919Miller WC, Rosenberg NE, Rutstein SE, Powers KA. Role of acute and early HIV infection in the sexual transmission of HIV. Curr Opin HIV AIDS. 2010 Jul;5(4):277-82. doi: 10.1097/COH.0b013e32833a0d3a.
PubMed 20543601Cohen MS, Smith MK, Muessig KE, Hallett TB, Powers KA, Kashuba AD. Antiretroviral treatment of HIV-1 prevents transmission of HIV-1: where do we go from here? Lancet. 2013 Nov 2;382(9903):1515-24. doi: 10.1016/S0140-6736(13)61998-4. Epub 2013 Oct 23.
PubMed 24152938Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Cottle L, Zhang XC, Makhema J, Mills LA, Panchia R, Faesen S, Eron J, Gallant J, Havlir D, Swindells S, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano DD, Essex M, Hudelson SE, Redd AD, Fleming TR; HPTN 052 Study Team. Antiretroviral Therapy for the Prevention of HIV-1 Transmission. N Engl J Med. 2016 Sep 1;375(9):830-9. doi: 10.1056/NEJMoa1600693. Epub 2016 Jul 18.
PubMed 27424812Agutu CA, Ngetsa CJ, Price MA, Rinke de Wit TF, Omosa-Manyonyi G, Sanders EJ, Graham SM. Systematic review of the performance and clinical utility of point of care HIV-1 RNA testing for diagnosis and care. PLoS One. 2019 Jun 27;14(6):e0218369. doi: 10.1371/journal.pone.0218369. eCollection 2019.
PubMed 31246963Opollo VS, Nikuze A, Ben-Farhat J, Anyango E, Humwa F, Oyaro B, Wanjala S, Omwoyo W, Majiwa M, Akelo V, Zeh C, Maman D. Field evaluation of near point of care Cepheid GeneXpert HIV-1 Qual for early infant diagnosis. PLoS One. 2018 Dec 27;13(12):e0209778. doi: 10.1371/journal.pone.0209778. eCollection 2018.
PubMed 30589900Leon SR, Ramos LB, Vargas SK, Kojima N, Perez DG, Caceres CF, Klausner JD. Laboratory Evaluation of a Dual-Path Platform Assay for Rapid Point-of-Care HIV and Syphilis Testing. J Clin Microbiol. 2016 Feb;54(2):492-4. doi: 10.1128/JCM.03152-15. Epub 2015 Dec 9.
PubMed 26659215Tilchin C, Schumacher CM, Psoter KJ, Humes E, Muvva R, Chaulk P, Checkley W, Jennings JM. Human Immunodeficiency Virus Diagnosis After a Syphilis, Gonorrhea, or Repeat Diagnosis Among Males Including non-Men Who Have Sex With Men: What Is the Incidence? Sex Transm Dis. 2019 Apr;46(4):271-277. doi: 10.1097/OLQ.0000000000000964.
PubMed 30870326Girometti N, Gutierrez A, Nwokolo N, McOwan A, Whitlock G. High HIV incidence in men who have sex with men following an early syphilis diagnosis: is there room for pre-exposure prophylaxis as a prevention strategy? Sex Transm Infect. 2017 Aug;93(5):320-322. doi: 10.1136/sextrans-2016-052865. Epub 2016 Oct 19.
PubMed 28729516Solomon MM, Mayer KH, Glidden DV, Liu AY, McMahan VM, Guanira JV, Chariyalertsak S, Fernandez T, Grant RM; iPrEx Study Team. Syphilis predicts HIV incidence among men and transgender women who have sex with men in a preexposure prophylaxis trial. Clin Infect Dis. 2014 Oct;59(7):1020-6. doi: 10.1093/cid/ciu450. Epub 2014 Jun 13.
PubMed 24928295Delaney KP, Branson BM, Uniyal A, Phillips S, Candal D, Owen SM, Kerndt PR. Evaluation of the performance characteristics of 6 rapid HIV antibody tests. Clin Infect Dis. 2011 Jan 15;52(2):257-63. doi: 10.1093/cid/ciq068.
PubMed 21288853Stekler JD, O'Neal JD, Lane A, Swanson F, Maenza J, Stevens CE, Coombs RW, Dragavon JA, Swenson PD, Golden MR, Branson BM. Relative accuracy of serum, whole blood, and oral fluid HIV tests among Seattle men who have sex with men. J Clin Virol. 2013 Dec;58 Suppl 1(0 1):e119-22. doi: 10.1016/j.jcv.2013.09.018.
PubMed 24342471O'Neal JD, Golden MR, Branson BM, Stekler JD. HIV nucleic acid amplification testing versus rapid testing: it is worth the wait. Testing preferences of men who have sex with men. J Acquir Immune Defic Syndr. 2012 Aug 1;60(4):e117-20. doi: 10.1097/QAI.0b013e31825aab51.
PubMed 22772351CDC: Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. In. Edited by Laboratories CfDCaPaAoPH: Centers for Disease Control and Prevention and Association of Public Health Laboratories; 2014.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ending the HIV Epidemic Through Point-of-Care Technologies (EHPOC): Performance Evaluation of Novel POC HIV Tests in Baltimore
- ClinicalTrials.gov ID
- NCT04793750
- Acronym / sponsor ID
- EHPOC / IRB00274090
- Conditions
- HIV Infections, Syphilis
- Keywords
- HIV, point-of-care, standard-of-care, POC, SOC, Syphilis, Viral load, VL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Roche Molecular Systems, Inc, Cepheid
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Posted 22 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determining the performance characteristics of HIV POC tests will inform optimal testing strategies in different populations and settings
- The use of HIV RNA POC tests will improve linkage to HIV treatment and prevention services:
- Improve early diagnosis of HIV ii. Reduce the time to ART initiation iii. Facilitate timely and appropriate referral for prevention services
Detailed description
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:
- Determining the performance characteristics of HIV POC tests will inform optimal testing strategies in different populations and settings.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POC HIV VL Testing | Experimental | Diagnostic Test: Cepheid GeneXpert HIV-1 Qual POC HIV VL test, Diagnostic Test: DPP HIV-Syphilis test system, Diagnostic Test: OraQuickParticipants will receive the standard of care tests (DPP HIV-Syphilis Test System, OraQuick) plus the HIV POC VL test. |
| SOC HIV Testing | Active comparator | Diagnostic Test: DPP HIV-Syphilis test system, Diagnostic Test: OraQuickParticipants will receive routine standard of care HIV testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years or older
- Living with or at high risk for HIV (MSM/transgender; injection drug use (IDU); known STI or being screened for STI; part of a high STI prevalence network [e.g., in the Sexual Health clinic])
- Willing to undergo phlebotomy and collection of oral fluid samples
- Willing to complete a questionnaire
- Willing to have laboratory results shared with the clinician(s) associated with their care
Key exclusion criteria (3 listed)
- Aged <18 years
- Unwilling to undergo study procedures
- Any other reason deemed pertinent by the study team
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 |
|---|---|---|
| Cepheid GeneXpert HIV-1 Qual POC HIV VL testPOC Nucleic acid-based test for HIV RNA. | Diagnostic test | POC HIV VL Testing |
| DPP HIV-Syphilis test systemPOC Tests for antibodies to HIV 1/2 and Treponema pallidum. | Diagnostic test | POC HIV VL Testing, SOC HIV Testing |
| OraQuickPOC oral fluid swab test for HIV 1/2 antibodies. | Diagnostic test | POC HIV VL Testing, SOC HIV Testing |
Primary outcome
Participants Linked Either to Care (PrEP or ART)
Time frame: 12 Weeks
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.
2 secondary outcomes
HIV: Time to Linkage to Either PrEP or ART
Time frame: 12 Weeks
Participants Reporting Condom-less Sex
Time frame: Day 0 and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32012115Stekler JD, Violette LR, Clark HA, McDougal SJ, Niemann LA, Katz DA, Chavez PR, Wesolowski LG, Ethridge SF, McMahan VM, Cornelius-Hudson A, Delaney KP. Prospective Evaluation of HIV Testing Technologies in a Clinical Setting: Protocol for Project DETECT. JMIR Res Protoc. 2020 Jan 27;9(1):e16332. doi: 10.2196/16332.
- Background: PubMed 22381919Patel P, Bennett B, Sullivan T, Parker MM, Heffelfinger JD, Sullivan PS; CDC AHI Study Group. Rapid HIV screening: missed opportunities for HIV diagnosis and prevention. J Clin Virol. 2012 May;54(1):42-7. doi: 10.1016/j.jcv.2012.01.022. Epub 2012 Feb 29.
- Background: PubMed 20543601Miller WC, Rosenberg NE, Rutstein SE, Powers KA. Role of acute and early HIV infection in the sexual transmission of HIV. Curr Opin HIV AIDS. 2010 Jul;5(4):277-82. doi: 10.1097/COH.0b013e32833a0d3a.
- Background: PubMed 24152938Cohen MS, Smith MK, Muessig KE, Hallett TB, Powers KA, Kashuba AD. Antiretroviral treatment of HIV-1 prevents transmission of HIV-1: where do we go from here? Lancet. 2013 Nov 2;382(9903):1515-24. doi: 10.1016/S0140-6736(13)61998-4. Epub 2013 Oct 23.
- Background: PubMed 27424812Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Cottle L, Zhang XC, Makhema J, Mills LA, Panchia R, Faesen S, Eron J, Gallant J, Havlir D, Swindells S, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano DD, Essex M, Hudelson SE, Redd AD, Fleming TR; HPTN 052 Study Team. Antiretroviral Therapy for the Prevention of HIV-1 Transmission. N Engl J Med. 2016 Sep 1;375(9):830-9. doi: 10.1056/NEJMoa1600693. Epub 2016 Jul 18.
- Background: PubMed 31246963Agutu CA, Ngetsa CJ, Price MA, Rinke de Wit TF, Omosa-Manyonyi G, Sanders EJ, Graham SM. Systematic review of the performance and clinical utility of point of care HIV-1 RNA testing for diagnosis and care. PLoS One. 2019 Jun 27;14(6):e0218369. doi: 10.1371/journal.pone.0218369. eCollection 2019.
- Background: PubMed 30589900Opollo VS, Nikuze A, Ben-Farhat J, Anyango E, Humwa F, Oyaro B, Wanjala S, Omwoyo W, Majiwa M, Akelo V, Zeh C, Maman D. Field evaluation of near point of care Cepheid GeneXpert HIV-1 Qual for early infant diagnosis. PLoS One. 2018 Dec 27;13(12):e0209778. doi: 10.1371/journal.pone.0209778. eCollection 2018.
- Background: PubMed 26659215Leon SR, Ramos LB, Vargas SK, Kojima N, Perez DG, Caceres CF, Klausner JD. Laboratory Evaluation of a Dual-Path Platform Assay for Rapid Point-of-Care HIV and Syphilis Testing. J Clin Microbiol. 2016 Feb;54(2):492-4. doi: 10.1128/JCM.03152-15. Epub 2015 Dec 9.
- Background: PubMed 30870326Tilchin C, Schumacher CM, Psoter KJ, Humes E, Muvva R, Chaulk P, Checkley W, Jennings JM. Human Immunodeficiency Virus Diagnosis After a Syphilis, Gonorrhea, or Repeat Diagnosis Among Males Including non-Men Who Have Sex With Men: What Is the Incidence? Sex Transm Dis. 2019 Apr;46(4):271-277. doi: 10.1097/OLQ.0000000000000964.
- Background: PubMed 28729516Girometti N, Gutierrez A, Nwokolo N, McOwan A, Whitlock G. High HIV incidence in men who have sex with men following an early syphilis diagnosis: is there room for pre-exposure prophylaxis as a prevention strategy? Sex Transm Infect. 2017 Aug;93(5):320-322. doi: 10.1136/sextrans-2016-052865. Epub 2016 Oct 19.
- Background: PubMed 24928295Solomon MM, Mayer KH, Glidden DV, Liu AY, McMahan VM, Guanira JV, Chariyalertsak S, Fernandez T, Grant RM; iPrEx Study Team. Syphilis predicts HIV incidence among men and transgender women who have sex with men in a preexposure prophylaxis trial. Clin Infect Dis. 2014 Oct;59(7):1020-6. doi: 10.1093/cid/ciu450. Epub 2014 Jun 13.
- Background: PubMed 21288853Delaney KP, Branson BM, Uniyal A, Phillips S, Candal D, Owen SM, Kerndt PR. Evaluation of the performance characteristics of 6 rapid HIV antibody tests. Clin Infect Dis. 2011 Jan 15;52(2):257-63. doi: 10.1093/cid/ciq068.
- Key Strategies in the PlanLink provided by the sponsor.
- Quick Mary land HIV StatisticsLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Matthew Hamill, MBChB, Ph.D principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cepheid GeneXpert HIV-1 Qual POC HIV VL test, DPP HIV-Syphilis test system and OraQuick in people with HIV Infections and Syphilis, run by Johns Hopkins University at 3 sites in United States.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 23 Apr 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 United States. 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?
Yes. Results are posted in the registry (first posted 22 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Linked Either to Care (PrEP or ART) (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04793750, which also lists 24 linked publications.
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 23 Apr 2026.