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

April 21, 2026 updated by: Johns Hopkins University

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:

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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:

A. Determining the performance characteristics of HIV POC tests will inform optimal testing strategies in different populations and settings.

B. 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 Type

Interventional

Enrollment (Actual)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21217
        • The Baltimore City Health Department (BCHD) Health and Wellness Center, Sexual Health Clinics
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital Emergency Department (JHHED)
      • Baltimore, Maryland, United States, 21287
        • The John G. Bartlett Specialty Practice (JGBSP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: POC HIV VL Testing
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
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.
Active Comparator: SOC HIV Testing
Participants will receive routine standard of care HIV testing.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV: Time to Linkage to Either PrEP or ART
Time Frame: 12 Weeks
12 Weeks
Participants Reporting Condom-less Sex
Time Frame: Day 0 and Week 12
This will be used to assess HIV 'knowledge' - behavioral change (awareness/risk behavior change).
Day 0 and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Centers for Disease Control and Prevention
Roche Molecular Systems, Inc
Cepheid

Investigators

  • Principal Investigator: Matthew Hamill, MBChB, Ph.D, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2021

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

March 31, 2025

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 11, 2021

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00274090

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Cepheid GeneXpert HIV-1 Qual POC HIV VL test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe