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

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04793750

Collaborator

Centers for Disease Control and Prevention (U.S. Fed)

408

Enrollment

Locations

Arms

35.4

Anticipated Duration (Months)

136

Patients Per Site

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

Determining the performance characteristics of HIV POC tests will inform optimal testing strategies in different populations and settings
The use of HIV RNA POC tests will improve linkage to HIV treatment and prevention services:

Improve early diagnosis of HIV ii. Reduce the time to ART initiation iii. Facilitate timely and appropriate referral for prevention services

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Syphilis	Diagnostic Test: Cepheid GeneXpert HIV-1 Qual POC HIV VL test Diagnostic Test: DPP HIV-Syphilis test system Diagnostic Test: OraQuick	N/A

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:

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

Study Type:

Interventional

Anticipated Enrollment :

408 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Aug 18, 2021

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Proportion of participants linked either to PrEP or ART [12 Weeks]
Proportion of participants linked to either PrEP or ART will be assessed. If test positive, then participant is referred for next day HIV ART start. If test negative, then participant is referred for next day HIV PrEP start.

Secondary Outcome Measures

HIV: time to linkage to either PrEP or ART [12 Weeks]
Time to linkage measured in days.
Syphilis: time to linkage to syphilis treatment [12 Weeks]
Time to linkage measured in days.
Change in proportion of participants reporting condom-less sex [Day 0 and Week 12]
This will be used to assess HIV 'knowledge' - behavioral change (awareness/risk behavior change).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Baltimore City Health Department (BCHD) Health and Wellness Center, Sexual Health Clinics	Baltimore	Maryland	United States	21217
2	Johns Hopkins Hospital Emergency Department (JHHED)	Baltimore	Maryland	United States	21287
3	The John G. Bartlett Specialty Practice (JGBSP)	Baltimore	Maryland	United States	21287