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

Williams, Owain David, Dean, Judith Ann, Harting, Kim, Bath, Kate and Gilks, Charles F. (2016) Implications of the on-line market for regulation and uptake of HIV self-testing in Australia. AIDS Care, 1-6. doi:10.1080/09540121.2016.1200716

Author Williams, Owain David
Dean, Judith Ann
Harting, Kim
Bath, Kate
Gilks, Charles F.
Title Implications of the on-line market for regulation and uptake of HIV self-testing in Australia
Journal name AIDS Care   Check publisher's open access policy
ISSN 0954-0121
Publication date 2016-06-23
Sub-type Article (original research)
DOI 10.1080/09540121.2016.1200716
Open Access Status Not Open Access
Start page 1
End page 6
Total pages 6
Place of publication Abingdon, Oxon, United Kingdom
Publisher Routledge
Collection year 2017
Language eng
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.
Keyword HIV self-testing
HIV home-testing
On-line purchasing
Medical device regulation
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: HERDC Pre-Audit
School of Public Health Publications
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Created: Wed, 27 Jul 2016, 16:09:13 EST by Judith Dean on behalf of School of Public Health