HIV self-test approval an important step forward

Burnet Institute

29 November, 2018

Burnet Head, Public Health, Professor Mark Stoové

Burnet Institute welcomes the approval of Australia’s first HIV self-testing device as an important step towards making access to HIV testing easier and more convenient, discovering undiagnosed HIV, and getting people on treatment.

Undiagnosed HIV, which has remained largely static in Australia over recent years, is the major driver of HIV transmission in Australia, and enhancing the frequency of testing through self-testing will help address this key barrier to HIV elimination.

While Australia has made impressive gains in HIV prevention and accelerating people diagnosed with HIV into care and treatment, over 10 percent of Australians with HIV are unaware of their status.

Burnet Head of Public Health, Professor Mark Stoové said the approval by the Therapeutic Goods Administration of an Australian-made and designed finger-prick device by Atomo Diagnostics will have a direct and positive impact on the rate of testing and early diagnosis.

“The key priority at the moment for HIV in Australia is undiagnosed HIV, and to address this we need to enhance the frequency of HIV testing,” Professor Stoové said.

“The rate of testing in Australia for gay men, the key risk population, has remained relatively unchanged for five years, and less than 20 percent of gay men most at risk are adhering to national guidelines that recommend they test up to four times a year.

“We want to get people diagnosed as early in their infection as possible, and ensure people access treatment as early as possible.

“People who are on treatment and virally suppressed do not pass the virus on to others and we know that early treatment leads to better health outcomes.”

The approval of the self-test device coincides with the launch of Burnet’s new Flagship HIV project focused initially in Victoria to investigate ways to increase the coverage of self-testing and regular testing in ways that link people to care.

The new TGA-approved HIV self-test kits and support will be accessible online, and the project will investigate the efficacy and feasibility of distribution through community health services and clinics, and through peer distribution.

“It is important that we prepare for the introduction of self-tests and have systems in place to maximise the prevention and clinical benefits of this new technology,” Professor Stoové said.

Victorians who stand to benefit most from self-testing include:

  • People at risk of HIV who don’t have access to high caseload services situated primarily in inner Melbourne
  • Immigrant communities, particularly young Asian gay men who experience a range of barriers to negotiating Australia’s health system
  • Gay men who test regularly but find it difficult to test at recommended frequencies of up to four times per year.

“People in rural Victoria or outer Melbourne often need to attend typical community general practices to access HIV testing and can sometimes experience stigma and discomfort in disclosing their risk practices in these settings,” Professor Stoové said.

“Our data shows that people who attend non-specialist general practices for HIV testing attend less regularly and are, on average, diagnosed later in their infection.”

Compounding this issue is the extra pressure placed on high caseload clinics in Melbourne since the subsidised availability of HIV prevention medication PrEP in April 2018.

Having to manage the dispensing and renewal of scripts for PrEP every three months has created capacity issues at some HIV specialist clinics.

“The beauty of self-testing is that it would not only increase the number and frequency of tests that occur, but also take pressure off those services,” Professor Stoové said.

Find out more about Burnet’s work in HIV and support our HIV research.

Contact Details

For more information in relation to this news article, please contact:

Professor Mark A Stoové

Head of Public Health




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