# CD4-LINK: Improving access to HIV care in underserves areas with a home-based, mail-in CD4 count test

> **NIH NIH R41** · SPOTTED TECH LLC · 2024 · $449,093

## Abstract

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.

## Key facts

- **NIH application ID:** 11008514
- **Project number:** 1R41MH138179-01
- **Recipient organization:** SPOTTED TECH LLC
- **Principal Investigator:** Marissa Fahlberg
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $449,093
- **Award type:** 1
- **Project period:** 2024-09-16 → 2026-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11008514

## Citation

> US National Institutes of Health, RePORTER application 11008514, CD4-LINK: Improving access to HIV care in underserves areas with a home-based, mail-in CD4 count test (1R41MH138179-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/11008514. Licensed CC0.

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