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.

KEYWORDS:

• HIV self-testing
• HIV home-testing
• on-line purchasing
• medical device regulation

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

The first and second authors are currently funded to undertake HIV self-testing-related research by the HIV Foundation of Queensland HIV Research and Program Grants 2015. This work was supported by this funding and additional funds from the Queensland HIV/STI Professorial Chair discretionary fund.