Implications of the on-line market for regulation and uptake of HIV self-testing in Australia

Abstract

Self-Testing for HIV (HIVST) is widely recognised as a feasible and effective means of increasing rates of testing and detection of HIV, particularly in non-testing and infrequent testing populations. Currently in Australia, the only means of accessing this technology is to purchase unregulated products on-line. A search of available on-line distributers was purposefully performed from the perspective of an English-speaking individual, with no clinical background or specific understanding of HIV testing practices, seeking to determine their HIV status. Purchased kits were assessed against a structured extraction tool based on the Australian Therapeutic Goods Administration (TGA) HIV testing clinical performance guidelines. In total, eight HIVST kits were purchased from seven different distributers. Analysis of the purchased kits and linked websites revealed that none met the TGA's requirements for HIV testing kits intended for home use; none also conformed to the additional recommendations for information, quality and links to services developed from this study's review of HIVST associated literature. People seeking HIVST kits are able to purchase sub-standard products that ill-serve their needs, and do so at a time of great personal vulnerability. The fact that Australians are willing to purchase and use these sub-standard products indicates HIVST is in demand. Health policy and models of service are needed in order to ensure people have access to a safe and effective registered device at prices that enable equity of access to all Australians, particularly those most at risk of HIV. Other countries awaiting access to regulated HIVST devices also need to consider the potential implications. Collaboration between manufacturers, distributers, regulatory bodies, service providers and the community is needed globally in order to ensure HIVST is embedded into testing methods in a manner that does not disrupt but rather safely and effectively increases HIV testing rates.

Online HIV Self-Testing (HIVST) Dissemination by an Australian Community Peer HIV Organisation: A Scalable Way to Increase Access to Testing, Particularly for Suboptimal Testers

“…With respect to the issue of cost and potential financial barriers, this project provided HIVST kits free of charge. Sale of HIVST kits is likely to have limited capacity to meet the need of those who want self-testing as, consistent with previous Australian [ 15 , 28 ] and international [ 41 ] research, many (50.8%) of the study participants indicated that they would not be willing to pay for an HIVST kit. In 2019, the TGA approved the Atomo Diagnostics™ rapid diagnostic finger-prick test in Australia for use as a self-test.…”

“…Understanding of how to implement innovative dissemination models will support HIVST implementation science. Such models need to include mechanisms of choice for accessing peer and clinician support pre- and post-testing, along with pathways facilitating early linkage to care and support of those with a reactive HIVST result to confirmatory testing [ 15 , 28 ]. A particular strength of HIVST is the capacity for internet-based service delivery, especially among people known to have embraced online technologies [ 29 ] and wanting discrete choice [ 30 ].…”

Regulation of HIV self‐testing in Malawi, Zambia and Zimbabwe: a qualitative study with key stakeholders

“…Manufacturers lack incentives to innovate further product development and prices for existing products remain high due to lack of competition . For end users, the delays could result in the proliferation and use of unregulated low quality tests and ultimately incorrect HIV screening results and loss of consumer confidence .…”

Economic evaluation of alternative testing regimes and settings to detect undiagnosed HIV in Australia

“…Costs incurred by the health system include: consult length; staff salary; consult costs including Medicare Benefits Schedule rebates from the publicly funded universal health care system operated by the Commonwealth of Australia Department of Human Services; test costs; and confirmatory laboratory testing for reactive results. Costs were calculated from the health care provider's perspective, with the exception of HIVST, which was based on the retail price of the test kit established elsewhere [19].…”