CD4-link: improving access to HIV care in underserves areas with a home-based, mail-in CD4 count test

Active Project Grant Awarded Last action

Award ID
R41MH138179
Recipient
Awarding agency
Obligated
$898,186

Award facts

Assistance listing
93.242 Mental Health Research Grants
Completion date 91% complete
Originally
Place of performance
Louisiana, USA

Award details come from USAspending.gov.

Description

Abstract
HIV infection remains a pervasive global health challenge, necessitating improved early diagnosis, swift access to care, and consistent monitoring for people living with HIV (plwh) to reduce new transmissions. However, a substantial GAP persists in connecting and retaining individuals in the healthcare system, particularly in under-served regions. The analysis of blood CD4+ t cell numbers plays a central role in healthcare monitoring of plwh, alongside measures of HIV load. To our knowledge, no commercially available home- based mail-in CD4 count tests exist. The development of such a test would alleviate barriers to HIV testing and monitoring, such as the need for travel to clinics and concerns about stigma, especially in underserved areas. Founded in louisiana, a state grappling with a high incidence of new HIV cases, spotted tech is committed to addressing this challenge. The overarching goal is to improve HIV monitoring, healthcare management, and facilitate rapid linkage-to-care in underserved areas by reducing the need for clinic visits. The primary OB- jective of this proposal is to develop an innovative CD4 count test - the CD4-link kit - where blood is self- collected in the form of a dried blood spot (DBS) on filter paper and mailed to a lab for CD4 count analysis. The central hypothesis is that the implementation of the CD4-link kit in louisiana will yield evidence of feasibility and usability for the health monitoring of plwh. To test this hypothesis, three aims will be pursued: aim 1 focuses on assay development, optimizing solutions allowing for optimal cell recovery from DBS, and assessing DBS sample stability under various storage and transportation conditions. Aim 2 involves in-house test validation to assess precision and accuracy. In aim 3, field testing at four louisiana HIV clinics will involve collecting finger stick blood samples and comparing their CD4 counts to those from fresh whole blood (gold standard). The CD4-link kit is poised to stand out as the first-of-its-kind, addressing a notable GAP in current testing AP- proaches; traditionally, CD4+ t cell absolute counts are accessible only through clinic visits. The underlying rationale for its development is to empower individuals to assess their CD4 counts from the comfort of their homes, alleviating the burden of travel for those in underserved areas. This innovation holds particular significance as IT empowers people living with HIV (plwh) to actively seek and maintain HIV care, thereby improving health, fostering early intervention, and ultimately contributing to a reduction in HIV transmission.

Transactions

Action Obligated Date
Amendment $0
Amendment $0
Amendment $0
Amendment $0
Amendment $449,093
Original award $449,093

Quick answers

Who received award R41MH138179?

R41MH138179 was awarded to Spotted TECH LLC by National Institute of Mental Health (National Institutes of Health) on September 16, 2024.

How much is award R41MH138179 worth?

$898,186 has been obligated on R41MH138179.

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