Point-of-care urine tenofovir monitoring of adherence to drive interventions for HIV treatment and prevention

ABSTRACT

Introduction

Although effective antiretroviral and pre-exposure prophylaxis/PrEP regimens are available globally, adherence challenges persist. Objective measures of adherence can both measure adherence accurately and can be used to drive interventions. The first point-of-care pharmacologic adherence measure, urine tenofovir testing using a lateral flow assay, is now available.

Areas Covered

This review examines the ability of pharmacologic metrics of adherence to predict HIV and PrEP clinical outcomes and the past use of pharmacologic metrics of adherence as tools to drive adherence interventions. The success of preliminary studies using point-of-care adherence metrics to guide interventions is then discussed.

Expert Opinion

Large randomized clinical trials are now needed to test the impact of point-of-care adherence interventions on HIV and PrEP clinical outcomes, given promising results of the pilot studies summarized here. Hybrid implementation-effectiveness studies will be needed to examine optimal approaches to incorporating point-of-care testing into routine clinical care delivery, including in guiding resistance testing, adherence counseling, and delivery of other evidence-based adherence interventions. Given the ability of point-of-care tenofovir testing to be implemented in settings where viral load testing is not available, and at more frequent intervals due to its low cost, urine-based tenofovir assays have the potential to be highly scalable in diverse clinical settings.

KEYWORDS:

• Point-of-care
• Adherence
• Urine testing
• Interventions
• HIV virologic suppression
• PrEP

Article highlights

• Although effective antiretroviral therapy and PrEP are now available globally, adherence challenges persist.

• Pharmacologic metrics of adherence can measure pill-taking and can also be used to drive adherence interventions.

• Pilot data suggest that a point-of-care urine lateral flow assay can be used to improve HIV virologic suppression among adults with adherence challenges in Namibia and to improve PrEP adherence among young women using PrEP in Kenya.

• A large randomized clinical trial is needed to replicate these results and establish the role of point-of-care urine adherence testing to improve virologic suppression and PrEP adherence in diverse clinical settings.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have received an honorarium from Expert Review of Molecular Diagnostics for their review work but have no other relevant financial relationships to disclose.

Author contributions

Both authors have substantially contributed to the conception and design of the review article and interpreting the relevant literature and have contributed to writing the review article.

Additional information

Funding

This paper was funded by NIH/NIMH K23MH122286 (Spinelli) and NIH/NIAID R01AI152119 (Gandhi).