The Self‐Testing AfRica (STAR) Initiative: accelerating global access and scale‐up of HIV self‐testing

Abstract

Introduction HIV self‐testing (HIVST) was first proposed as an additional option to standard HIV testing services in the 1980s. By 2015, two years after the first HIVST kit was approved for the American market and the year in which Unitaid invested in the “HIV Self‐Testing AfRica (STAR) Initiative,” HIVST remained unexplored with negligible access in low‐ and middle‐income countries (LMIC). However, rapid progress had been made. This commentary outlines the interlinked market, regulatory and policy barriers that had inhibited product development and kept HIVST out of LMIC policy. We detail the components of STAR that enabled rapid HIVST scale‐up, including critical investments in implementation, research, market forecasting, and engagement with manufacturers and regulators. Discussion The STAR Initiative has generated crucial information about how to distribute HIVST products effectively, ethically and efficiently. Service delivery models range from clinic‐based distribution to workplace and partner‐delivered approaches to reach first‐time male testers, to community outreach to sex workers and general population “hotspots.” These data directly informed supportive policy, notably the 2016 WHO guidelines strongly recommending HIVST as an additional testing approach, and regulatory change through support for WHO prequalification of the first HIVST kit in 2017. In July 2015, only two countries had national HIVST policies and were implementing HIVST. Three years later, 59 countries have policies, actively implemented in 28, with an additional 53 countries reporting policies under development. By end‐November 2018 several quality‐assured HIVST products had been registered, including two WHO prequalified tests. STAR Initiative countries have drafted regulations governing in vitro diagnostics, including HIVST products. With enabling policies, pre‐qualification and regulations in place, donor procurement of kits has increased rapidly, to a forecasted estimate of 16 million HIVST kits procured by 2020. Conclusions The STAR Initiative provided a strong foundation to introduce HIVST in LMICs and allow for rapid scale‐up based on the wealth of multi‐country evidence gathered. Together with sustained coordination and acceleration of market development work, HIVST can help address the testing gap and provide a focused and cost‐effective means to expand access to treatment and prevention services.

Evaluation of a mobile application to support HIV self-testing in Johannesburg, South Africa

“…The OraQuick HIVST kit (Orasure Technologies Inc., Bethlehem, USA) was used for the study as it had already undergone full evaluation and was approved for use in South Africa. 32 In a private room at a clinic, participants were asked to navigate the app and perform the HIVST with no assistance, whilst the HCW observed the process and recorded any deviations from the app instructions. Following the test, the HCW asked the participant a number of questions to obtain feedback on the app design and willingness to use an app for HIVST in future.…”

Reaching the second 90

“…HIVST expanded in Africa through policy and market changes catalyzed by the STAR (Self-Testing Africa) Initiative and endorsed by WHO in 2016. With the expansion of HIVST in six southern African countries through the STAR Initiative, multiple concerns were raised with regards to linkage to confirmatory testing and ART following HIVST [30]. Documentation of linkage is important as many studies show that expanded access to diagnosis through HIVST does not necessarily increase ART uptake [31,32 ▪▪ ,33].…”

To thine own test be true: HIV self‐testing and the global reach for the undiagnosed

“…Offering commentary on the use of HIVST, Ingold et al . focus on the broader policy environment in LMIC, market development for HIVST kits, the STAR programme experience and its positioning for HIVST scale‐up . As part of the intervention, the STAR programme engaged with manufactures and stakeholders at the country and multilateral levels to create demand, assess viability of HIVST as a route to diagnosis and research delivery methods.…”

“…Ingold et al . also touch on outstanding challenges to be addressed and present a call to action to maintain momentum in bringing HIVST to scale .…”