title: 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.
authors.affiliation: a School of Public Health, Faculty of Medicine and Biomedical Sciences , The University of Queensland , Herston , Australia.
authors.forename: Owain David
authors.initials: OD
authors.lastname: Williams
authors.affiliation: a School of Public Health, Faculty of Medicine and Biomedical Sciences , The University of Queensland , Herston , Australia.
authors.forename: Judith Ann
authors.initials: JA
authors.lastname: Dean
authors.affiliation: a School of Public Health, Faculty of Medicine and Biomedical Sciences , The University of Queensland , Herston , Australia.
authors.forename: Kim
authors.initials: K
authors.lastname: Harting
authors.affiliation: a School of Public Health, Faculty of Medicine and Biomedical Sciences , The University of Queensland , Herston , Australia.
authors.forename: Kate
authors.initials: K
authors.lastname: Bath
authors.affiliation: a School of Public Health, Faculty of Medicine and Biomedical Sciences , The University of Queensland , Herston , Australia.
authors.forename: Charles F
authors.initials: CF
authors.lastname: Gilks
mesh_terms: D001315:Australia; D054626:Consumer Health Information / Q000592:standards; D059026:Diagnostic Self Evaluation; D015658:HIV Infections / Q000175:diagnosis*; D006291:Health Policy; D006301:Health Services Needs and Demand; D006801:Humans; D020407:Internet; D062307:Medical Device Legislation; D011933:Reagent Kits, Diagnostic / Q000191:economics / Q000592:standards*; D012648:Self Care
chemical_list: D011933:Reagent Kits, Diagnostic
keywords: HIV home-testing; HIV self-testing; medical device regulation; on-line purchasing