Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04793750
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2021-03-08
Brief Title:
Ending the HIV Epidemic Through Point-of-Care Technologies EHPOC
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Ending the HIV Epidemic Through Point-of-Care Technologies EHPOC Performance Evaluation of Novel POC HIV Tests in Baltimore
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EHPOC
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 US 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
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
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 201920 it was estimated that more than 160000 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 adultadolescent HIV diagnosis rates per 100000 in 2018 tied with Mississippi Among people living with HIV in Maryland in 2019 the Centers for Disease Control and Prevention CDC estimated that 892 had been diagnosed and that 3830 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 ie 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 AntigenAntibody AgAb 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 AgAb 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
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 ie 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 AntigenAntibody AgAb 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 AgAb 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None