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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT04793750
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Cepheid GeneXpert HIV-1 Qual POC HIV VL test — DIAGNOSTIC_TEST
    POC Nucleic acid-based test for HIV RNA.
  • DPP HIV-Syphilis test system — DIAGNOSTIC_TEST
    POC Tests for antibodies to HIV 1/2 and Treponema pallidum.
  • OraQuick — DIAGNOSTIC_TEST
    POC oral fluid swab test for HIV 1/2 antibodies.

Study Details

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

Key Dates

Start date
Aug 18, 2021
Status verified
Apr 2026
Primary completion
Feb 28, 2025
Completion
Mar 31, 2025

Study Design

Enrollment
224 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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.
  • Active Comparator: SOC HIV Testing
    Participants will receive routine standard of care HIV testing.

Primary Outcome Measure

Participants Linked Either to Care (PrEP or ART) [ Time Frame: 12 Weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Johns Hopkins Hospital Emergency Department (JHHED)BaltimoreMaryland21287-
The Baltimore City Health Department (BCHD) Health and Wellness Center, Sexual Health ClinicsBaltimoreMaryland21217-
The John G. Bartlett Specialty Practice (JGBSP)BaltimoreMaryland21287-

Find similar trials in Baltimore, MD

By condition
HIV
By specialty
Infectious disease
By research site
Johns Hopkins Hospital Emergency Department (JHHED)· Baltimore, MDThe Baltimore City Health Department (BCHD) Health and Wellness Center, Sexual Health Clinics· Baltimore, MDThe John G. Bartlett Specialty Practice (JGBSP)· Baltimore, MD

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