Accelerating Human Immunodeficiency Virus Self-Testing in the United States: A Call to Action

Human immunodeficiency virus (HIV) self-testing has emerged as a tool to increase the proportion of people to know their status. Since the first HIV self-test was approved in 2012 by the US Food and Drug Administration (FDA), global access to HIV self-tests has been bolstered by public-private partnerships to ensure equitable access in low- and middle-income countries. However, no company has applied for FDA clearance in a decade. We highlight the potential benefits to reclassifying HIV self-tests from class III to class II. Human immunodeficiency virus (HIV) self-testing is used to increase the proportion of people knowing their status. No company has applied for FDA clearance in a decade. We highlight potential benefits of reclassifying HIV self-tests from class III to class II.