TIMELINE OF HIVST. Although momentum for implementation has built up only recently, HIVST as a testing method is not new. The idea has been discussed since early in the epidemic as a discreet and convenient option for those seeking to know their status. This table summarizes some of the major chronological milestones that led to its introduction as an innovative component of effective testing campaigns. Informal self-testing documented among health workers, and in some settings products were available in private sector pharmacies. 2012 The United States Food and Drug Administration (FDA) approves the first HIVST product.24 2015 While WHO encouraged countries to start exploring HIVST and provided advice for operational research, normative guidance was not yet available. August: Unitaid funds the STAR Initiative to undertake a comprehensive evaluation and implementation of HIVST in Southern Africa to provide the evidence and experience necessary to help make HIVST a reality. December: Unitaid’s first Landscape for HIV rapid diagnostic tests for HIV self-testing report finds that only three countries – France, the United Kingdom and the United States – have products approved for self-testing.26 2017 In July 2017, WHO prequalifies the first HIVST product previously approved by the FDA in 2012.28 Prequalification paves the way for purchase of self-testing products by international procurers for low-income countries. The Bill and Xxxxxxx Xxxxx Foundation (BMGF) with the Children’s Investment Fund Foundation (CIFF) begins to subsidize OraQuick HIVST kit, making it available at a price of US $2 in 50 LMICs. XXXXXX commits to procuring at least 1 million HIVST kits for COP18 The GF and Unitaid-supported Expert Review Panel for Diagnostics (EPRD) approves four blood-based HIVST rapid diagnostic tests (RDTs). 2019 WHO PQ prequalifies third and fourth HIVST kits, both are blood-based HIVST RDTs.30 WHO releases new guidance to optimize HIVST implementation, including effective, service delivery models, linkage to care and support tools.31 WHO policy update: 88 countries worldwide have adopted HIV self-testing policies, while many others are currently developing them. 2008 Kenya becomes the first country to release a national policy on HIVST.22 However, no products intended for self-testing were available outside research settings. Worldwide, lack of regulation and policies to permit HIVST limit the development of products for self-testing.23 2013 WHO and partners hold the first global co...
