Ending the HIV Epidemic Through Point-of-Care Technologies (EHPOC)

NCT04793750 | Completed Results FDA Device

• 1 other identifier: IRB00274090
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 3

Brief 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 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

Conditions

HIV Infections; Syphilis

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); STD; STI

Outcome Measures

Primary Outcomes (1)

• 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.

  12 Weeks

Secondary Outcomes (2)

• HIV: Time to Linkage to Either PrEP or ART

  12 Weeks

• Participants Reporting Condom-less Sex

  Day 0 and Week 12

Study Arms (2)

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.

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.

Diagnostic Test: DPP HIV-Syphilis test system; Diagnostic Test: OraQuick

Interventions

Cepheid GeneXpert HIV-1 Qual POC HIV VL test DIAGNOSTIC_TEST

POC Nucleic acid-based test for HIV RNA.

POC HIV VL Testing

OraQuick DIAGNOSTIC_TEST

POC oral fluid swab test for HIV 1/2 antibodies.

POC HIV VL Testing; SOC HIV Testing

DPP HIV-Syphilis test system DIAGNOSTIC_TEST

POC Tests for antibodies to HIV 1/2 and Treponema pallidum.

POC HIV VL Testing; SOC HIV Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Aged \<18 years
• Unwilling to undergo study procedures
• Any other reason deemed pertinent by the study team

Sponsors & Collaborators

• Johns Hopkins University: lead
• Centers for Disease Control and Prevention: collaborator
• Roche Molecular Systems, Inc: collaborator
• Cepheid: collaborator

Study Sites (3)

The Baltimore City Health Department (BCHD) Health and Wellness Center, Sexual Health Clinics

Baltimore, Maryland, 21217, United States

Location

Johns Hopkins Hospital Emergency Department (JHHED)

Baltimore, Maryland, 21287, United States

Location

The John G. Bartlett Specialty Practice (JGBSP)

Baltimore, Maryland, 21287, United States

Location

Related Publications (24)

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  PMID: 32012115 BACKGROUND

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  PMID: 22381919 BACKGROUND

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  PMID: 20543601 BACKGROUND

• Cohen 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.

  PMID: 24152938 BACKGROUND

• Cohen 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.

  PMID: 27424812 BACKGROUND

• Agutu 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.

  PMID: 31246963 BACKGROUND

• Opollo 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.

  PMID: 30589900 BACKGROUND

• Leon 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.

  PMID: 26659215 BACKGROUND

• Tilchin 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.

  PMID: 30870326 BACKGROUND

• Girometti 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.

  PMID: 28729516 BACKGROUND

• Solomon 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.

  PMID: 24928295 BACKGROUND

• Delaney 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.

  PMID: 21288853 BACKGROUND

• Stekler 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.

  PMID: 24342471 BACKGROUND

• O'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.

  PMID: 22772351 BACKGROUND

• CDC: 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.

  BACKGROUND

• Masciotra S, Luo W, Youngpairoj AS, Kennedy MS, Wells S, Ambrose K, Sprinkle P, Owen SM. Performance of the Alere Determine HIV-1/2 Ag/Ab Combo Rapid Test with specimens from HIV-1 seroconverters from the US and HIV-2 infected individuals from Ivory Coast. J Clin Virol. 2013 Dec;58 Suppl 1(Suppl 1):e54-8. doi: 10.1016/j.jcv.2013.07.002. Epub 2013 Aug 2.

  PMID: 23911678 BACKGROUND

• Delaney KP ES, Wesolowski L, Owen SM, Branson BM: Performance of the Geenius HIV-1/HIV-2 Assay in the CDC HIV testing algorithm. In: CROI 2015: 2015; Seattle, Washington; 2015.

  BACKGROUND

• Stevens W, Gous N, Ford N, Scott LE. Feasibility of HIV point-of-care tests for resource-limited settings: challenges and solutions. BMC Med. 2014 Sep 8;12:173. doi: 10.1186/s12916-014-0173-7.

  PMID: 25197773 BACKGROUND

• Mehta SD, Rothman RE, Kelen GD, Quinn TC, Zenilman JM. Clinical aspects of diagnosis of gonorrhea and Chlamydia infection in an acute care setting. Clin Infect Dis. 2001 Feb 15;32(4):655-9. doi: 10.1086/318711. Epub 2001 Feb 9.

  PMID: 11181134 BACKGROUND

• Rogers SM, Miller WC, Turner CF, Ellen J, Zenilman J, Rothman R, Villarroel MA, Al-Tayyib A, Leone P, Gaydos C, Ganapathi L, Hobbs M, Kanouse D. Concordance of chlamydia trachomatis infections within sexual partnerships. Sex Transm Infect. 2008 Feb;84(1):23-8. doi: 10.1136/sti.2007.027029. Epub 2007 Oct 2.

  PMID: 17911137 BACKGROUND

• Gaydos CA, Ako MC, Lewis M, Hsieh YH, Rothman RE, Dugas AF. Use of a Rapid Diagnostic for Chlamydia trachomatis and Neisseria gonorrhoeae for Women in the Emergency Department Can Improve Clinical Management: Report of a Randomized Clinical Trial. Ann Emerg Med. 2019 Jul;74(1):36-44. doi: 10.1016/j.annemergmed.2018.09.012. Epub 2018 Nov 2.

  PMID: 30392736 BACKGROUND

• Kelen GD, Hsieh YH, Rothman RE, Patel EU, Laeyendecker OB, Marzinke MA, Clarke W, Parsons T, Manucci JL, Quinn TC. Improvements in the continuum of HIV care in an inner-city emergency department. AIDS. 2016 Jan 2;30(1):113-20. doi: 10.1097/QAD.0000000000000896.

  PMID: 26731757 BACKGROUND

• Hamill MM, Bayan MH, Boudreau A, Ramdeep N, Rothman R, Eshleman SH, Bennett T, Sewell T, Demko ZO, Mirza A, Smalls TJ, Johnson N, Riggan B, Nielsen E, MacGowan RJ, Gonzalez-Jimenez N, Chavez PR, Delaney KP, Hsieh YH, Manabe YC. Next-Day HIV Viral Load Test Result and Linkage to Care Among Persons Living With or at Risk of HIV: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2548380. doi: 10.1001/jamanetworkopen.2025.48380.

  PMID: 41400951 RESULT

• Bayan MH, Smalls T, Boudreau A, Mirza AW, Pasco C, Demko ZO, Rothman RE, Hsieh YH, Eshleman SH, Mostafa HH, Gonzalez-Jimenez N, Chavez PR, Emerson B, Delaney KP, Daugherty D, MacGowan RJ, Manabe YC, Hamill MM. Evaluating the impact of point-of-care HIV viral load assessment on linkage to care in Baltimore, MD: a randomized controlled trial. BMC Infect Dis. 2023 Sep 1;23(1):570. doi: 10.1186/s12879-023-08459-7.

  PMID: 37658305 DERIVED

Related Links

• Key Strategies in the Plan
• Quick Mary land HIV Statistics

MeSH Terms

Conditions

HIV Infections; Syphilis; Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Slow Virus Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Matthew M. Hamill, MBChB, PhD
• Organization: Johns Hopkins School of Medicine

mhamill6@jhu.edu

4105509080

Study Officials

• Matthew Hamill, MBChB, Ph.D

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 11, 2021
• Study Start: August 18, 2021
• Primary Completion: February 28, 2025
• Study Completion: March 31, 2025
• Last Updated: April 23, 2026
• Results First Posted: April 22, 2026

Record last verified: 2026-04

Locations

US (3)