Development of a rapid enzymatic assay for point-of-care HIV drug level feedback
NIAID - National Institute of Allergy and Infectious Diseases
About This Grant
Project Summary/Abstract: Adolescent girls and young women (AGYW) in sub-Saharan Africa account for one in four new HIV infections globally. Antiretroviral (ARV) drugs can prevent and treat HIV, yet non-adherence among AGYW persists as a public health challenge due to biological, economic, and social barriers. High adherence measured via drug levels in biological specimens correlates with HIV treatment and prevention efficacy, and studies demonstrate that providing drug level feedback (DLF) paired with supportive counseling improves outcomes. Furthermore, AGYWs receiving oral or extended release ARVs (like monthly vaginal rings) desire regular real-time DLF, while their healthcare providers assert that DLF facilitates candid conversations about non-adherence. Additionally, DLF can assess the effectiveness of adherence-promoting interventions by providing an objective marker of drug exposure. Yet current DLF tests are slow, expensive, and centrally analyzed. To address the critical need for accessible and inexpensive HIV DLF for AGYW, we aim to develop rapid enzymatic assays to measure HIV drug levels in routine care settings like pharmacies or clinics. Our approach represents a paradigm shift in DLF because it measures ARVs based on their enzymatic activity, enabling rapid (<30 min) and inexpensive measurement. We will expand on prior work led by Dr. Olanrewaju (PI) which developed and validated the REverse transcriptase ACTivity (REACT) assay to measure tenofovir diphosphate (TFV-DP), a nucleotide reverse transcriptase inhibitor (NRTI) used in all approved oral PrEP regimens, and expanded REACT to detect the non-nucleoside reverse transcriptase inhibitors (NNRTIs). In this proposal, we will: (1) Calibrate REACT to operate at recently established TFV-DP thresholds that indicate oral PrEP efficacy among cisgender women. We will also optimize REACT in plasma to measure the NNRTIs doravirine (DOR), rilpivirine (RPV), and dapivirine (DPV) used in oral and long-acting HIV treatment and prevention regimens that are scaling up in high- burden settings. (2) Integrate the assay into the Harmony portable device (developed by Co-I Lutz) that can be deployed in routine care settings. We will freeze-dry reagents to eliminate the need for cold reagent storage, simplify assay setup, and enhance the platform’s usability. (3) Evaluate the sensitivity and specificity of REACT for DLF among AGYW using banked clinical samples. We will measure TFV-DP and FTC-TP in banked clinical samples collected from AGYW in a pharmacologic study led by Co-I Mugwanya (R01AI155086), DPV from banked samples collected in a PrEP delivery study among AGYW (R01HD108041) led by Co-I Pintye, and DOR and RPV from people living with HIV enrolled in the University of Washington Center for AIDS Research Enhanced Specimen Collection Service. Our multidisciplinary team at the University of Washington is uniquely qualified to complete this work given our expertise in enzymatic assays, point-of-care diagnostics, clinical validation, and implementation science.
Grant Summary
Development of a rapid enzymatic assay for point-of-care HIV drug level feedback is a NIAID - National Institute of Allergy and Infectious Diseases grant providing up to $670K for university, nonprofit, healthcare org. Applications are due 2031-04-30 (open). Check eligibility and apply with FindGrants.
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How to Apply
Up to $670K
2031-04-30
- 1Confirm your organization is eligible for Development of a rapid enzymatic assay for point-of-care HIV drug level feedback from NIAID - National Institute of Allergy and Infectious Diseases, checking organization type, location, and any population or project requirements.
- 2Gather the required documents and information, including your organization details, project plan, and budget figures.
- 3Draft your application narrative and budget addressing the funder's priorities and review criteria. FindGrants can draft each section for you to review and edit.
- 4Review every section against the requirements checklist, then export a submission-ready application pack and submit it to NIAID - National Institute of Allergy and Infectious Diseases before the deadline.
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Development of a rapid enzymatic assay for point-of-care HIV drug level feedback: Frequently Asked Questions
Who is eligible for the Development of a rapid enzymatic assay for point-of-care HIV drug level feedback?
Development of a rapid enzymatic assay for point-of-care HIV drug level feedback is offered by NIAID - National Institute of Allergy and Infectious Diseases and is generally open to university, nonprofit, healthcare org. It is open to organizations nationwide unless the funder specifies otherwise. Review the specific eligibility terms before applying, since funders set their own requirements around organization type, location, and the population or project being served.
How much funding does the Development of a rapid enzymatic assay for point-of-care HIV drug level feedback provide?
Development of a rapid enzymatic assay for point-of-care HIV drug level feedback provides up to $670K per award from NIAID - National Institute of Allergy and Infectious Diseases. Actual award sizes depend on the scope of your project, available program funds, and the number of applicants, so build a budget that reflects realistic, allowable costs rather than the maximum figure.
When is the Development of a rapid enzymatic assay for point-of-care HIV drug level feedback deadline?
Applications for Development of a rapid enzymatic assay for point-of-care HIV drug level feedback are due 2031-04-30 (open). Because deadlines can change, verify the date with the funder, NIAID - National Institute of Allergy and Infectious Diseases, and give yourself enough time to prepare a complete, competitive application before the close date.
How do you apply for the Development of a rapid enzymatic assay for point-of-care HIV drug level feedback?
To apply for Development of a rapid enzymatic assay for point-of-care HIV drug level feedback, confirm your eligibility, gather the required documents, and prepare a narrative and budget that address the funder's priorities. FindGrants guides you step by step and can draft each section, then exports a submission-ready application pack for this grant from NIAID - National Institute of Allergy and Infectious Diseases.