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

NCT04793750 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2026-04-23

Study results available
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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

Interventions

DIAGNOSTIC_TEST

Cepheid GeneXpert HIV-1 Qual POC HIV VL test

POC Nucleic acid-based test for HIV RNA.

DIAGNOSTIC_TEST

DPP HIV-Syphilis test system

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

DIAGNOSTIC_TEST

OraQuick

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

Sponsors & Collaborators

Principal Investigators

  • Matthew Hamill, MBChB, Ph.D · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-18
Primary Completion
2025-02-28
Completion
2025-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04793750 on ClinicalTrials.gov