CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 224 enrolled
Drug / intervention
Cepheid GeneXpert HIV-1 Qual POC HIV VL test +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04793750
NCT04793750N/ACompleted

Ending the HIV Epidemic Through Point-of-Care Technologies (EHPOC): Performance Evaluation of Novel POC HIV Tests in Baltimore

Johns Hopkins University·interventional·Posted Mar 11, 2021·Updated Apr 23, 2026

In Brief

A clinical study evaluating Cepheid GeneXpert HIV-1 Qual POC HIV VL test, DPP HIV-Syphilis test system, and 1 other intervention for HIV Infections and Syphilis. Completed, enrolled 224 participants across 3 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 11, 2021
Enrollment StartAug 18, 2021
Primary CompletionFeb 28, 2025
Study CompletionMar 31, 2025
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 5.3 years ago

Interventions

Cepheid GeneXpert HIV-1 Qual POC HIV VL testother

POC Nucleic acid-based test for HIV RNA.

DPP HIV-Syphilis test systemother

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

OraQuickother

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