# Evaluation of New HIV Testing Technologies in Clinical Settings with High HIV Incidence

> **NIH ALLCDC U01** · UNIVERSITY OF WASHINGTON · 2020 · $1,677,722

## Abstract

PROJECT SUMMARY
HIV testing is the entry point into HIV prevention and care and therefore critical for reducing ongoing transmission
and morbidity. Although most people with HIV in the U.S. are aware of their infection, many are diagnosed late
and disparities in access to HIV testing services remain. Point-of-care (POC) HIV tests are recommended when
it is not feasible to conduct more sensitive laboratory-based HIV tests and can be useful in serving hard-to-reach
populations. However, currently FDA-approved POC tests are less effective at identifying early and acute HIV
infection, and antibody-based tests in particular can be affected by antiretroviral use for treatment or pre-
exposure prophylaxis. Recent developments in HIV testing have potential to improve diagnosis during acute HIV
infection; improve test performance in people taking antiretroviral medications for prevention and treatment; and
distinguish between recent and longer-term infections to focus interventions on networks of ongoing
transmission. Rigorous, comparative evaluations of the performance of the newest HIV tests in real world
settings are needed to inform their use in clinical care, outreach, and other settings. The project proposed for
this Cooperative Agreement will evaluate the diagnostic and clinical performance of the newest HIV testing
technologies and establish panels of data and specimens for evaluations of laboratory-based tests. We will
recruit people at high risk for HIV, taking antiretrovirals for prevention or treatment, with recent HIV infection, and
people with HIV who are not taking ART or have not achieved viral suppression into a cross-sectional study to
evaluate the relative sensitivity and specificity of the newest POC HIV tests compared to the CDC-recommended
laboratory algorithm (Aim 1). Participants from Aim 1 with discordant tests will be recruited into a longitudinal
study with frequent visits to evaluate the sensitivity of these tests during seroconversion (Aim 2). At study visits
for Aims 1 and 2, we will also evaluate the diagnostic and clinical performance of POC nucleic acid tests (Aim 3)
and collect matched demographic, behavioral, and clinical data to assess the impact of these factors on HIV test
performance (Aim 4). Finally, specimens will be collected from participants and matched with their demographic,
clinical, and behavioral data to support additional evaluations of laboratory-based HIV tests (Aim 5). Employing
a research team with substantive experience in HIV testing including POC and nucleic acid tests, pre-exposure
prophylaxis and HIV clinical care, HIV epidemiology, and public health programs and policy, this evaluation and
comparison of the newest HIV testing technologies will inform HIV testing guidelines and support health care
providers in deciding which tests to use in different settings and different populations.

## Key facts

- **NIH application ID:** 10145345
- **Project number:** 1U01PS005203-01
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** David A Katz
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** ALLCDC
- **Fiscal year:** 2020
- **Award amount:** $1,677,722
- **Award type:** 1
- **Project period:** 2020-09-30 → 2023-09-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10145345

## Citation

> US National Institutes of Health, RePORTER application 10145345, Evaluation of New HIV Testing Technologies in Clinical Settings with High HIV Incidence (1U01PS005203-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10145345. Licensed CC0.

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