Highlighting and addressing barriers to widespread adaptation of HIV self-testing in the United States

ABSTRACT

Introduction

HIV self-testing (HIVST), whereby an individual performs and interprets their own rapid screening test at home, is another tool to increase the proportion of at-risk individuals who know their status. Globally, HIVST has rapidly been adopted through global partnerships to ensure equitable access to tests in low- and middle-income countries (LMIC).

Area Covered

This review discusses the regulatory burdens of HIV self-testing within the United States while examining the use of HIV self-tests on a global scale. While the United States only has one approved HIV self-test, numerous tests have been prequalified by the WHO.

Expert Opinion

Despite the US Food and Drug Administration (FDA) clearance of the first and only self-test in 2012, there have been no other tests that have undergone FDA consideration due to regulatory barriers. This, in turn, has stifled market competition. Despite existing evidence that such programs are an innovative approach to testing hesitant or hard-to-reach populations, high individual test cost and bulky packaging make large-scale, mail-out, and HIV self-testing programs expensive. COVID-19 pandemic has accelerated the public demand for self-testing – HIV self-test programs should capitalize on this to increase the proportion of at-risk people who know their status and are linked to care to contribute to ending the HIV epidemic.

KEYWORDS:

• HIV self-testing
• oral self-test
• blood self-test
• HIV
• HIVST
• home-testing

Article highlights

• HIV self-testing access has expanded globally, particularly in low- and middle-income countries.

• Regulatory barriers have dissuaded companies from applying for FDA approval for their HIV self-tests.

• HIV self-tests are an effective tool to reach hesitant-to-test populations.

• Distribution models in LMICs have shown the potential for HIV self-testing programs in the United States.

• HIV self-testing is an important component of ending the HIV epidemic which could be accelerated by regulatory reform.

Acknowledgments

We thankfully acknowledge Dr Kevin P. Delaney for his thoughtful comments and suggestions.

Declaration of Interest

YCM has received research grant support from Hologic, Cepheid, Roche, ChemBio, Becton Dickinson, miDiagnostics, and has provided consultative support to Abbott. The authors have no other 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 apart from those disclosed.

Reviewers Disclosure

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

Salary support from the National Institutes of Health [NIBIB U54EB007958 (YCM, SM), NIAID UM1AI068613 (YCM), and Fogarty International Center 5D43TW009771 (YCM)] and the US Centers for Disease Control U01PS005204 (YCM). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.