NCT04793750: EHPOC

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

Completed NA Last updated 5 November 2025

What this trial tests

NA trial testing Cepheid GeneXpert HIV-1 Qual POC HIV VL test in HIV Infections in 419 participants. Completed in 31 March 2025.

Timeline

18 August 2021

Primary endpoint
28 February 2025

31 March 2025

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	419
Start date	18 August 2021
Primary completion	28 February 2025
Estimated completion	31 March 2025
Sites	3 locations across United States

Drugs / interventions tested

• Cepheid GeneXpert HIV-1 Qual POC HIV VL test
• DPP HIV-Syphilis test system
• OraQuick

Conditions studied

• HIV Infections — all drugs for HIV Infections →
• Syphilis — all drugs for Syphilis →

Sponsor

Johns Hopkins University

Who can join

18 and older, any sex, with HIV Infections or Syphilis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evaluating the impact of point-of-care HIV viral load assessment on linkage to care in Baltimore, MD: a randomized controlled trial.
   Bayan MH, Smalls T, Boudreau A, Mirza AW, et al · · 2023 · cited 2× · PMID 37658305 · DOI 10.1186/s12879-023-08459-7
2. Next-Day HIV Viral Load Test Result and Linkage to Care Among Persons Living With or at Risk of HIV: A Randomized Clinical Trial.
   Hamill MM, Bayan MH, Boudreau A, Ramdeep N, et al · · 2025 · PMID 41400951 · DOI 10.1001/jamanetworkopen.2025.48380