The Slow Journey To Rapid Testing

Rapid Testing for HIV is the fastest way of diagnosing someone’s HIV status, and health and HIV organisations are keen to get rapid HIV testing up and running. But so far, it has not been approved for use in Australia. Rachel Cook reports.

Rapid testing was a breakthrough in HIV diagnosis. Particularly in countries where going to the doctor is not as affordable or as easy as it is in Australia. It’s a simple test that requires either a blood or saliva sample and the results are available within 30 minutes.  Although the test is available in London, several European and African countries, New Zealand, USA, Canada, PNG and Singapore, it is not available in Australia. For the VAC/GMHC the approval of this test would be a significant step in HIV prevention.

“The better we get at diagnosing undiagnosed HIV the better we prevent onward transmission of HIV,” Matt Dixon, executive director of VAC/GMHC told MCV.

“It’s about ease of access to testing and people being able to get a result in a very quick turnaround. It makes testing more attractive to them and removes a barrier of having to come back for a second appointment and also the psychological barrier of having to wait up to two weeks without knowing your result.”

In Australia, social research supports the attractiveness of same day results for people testing for HIV. Currently, people can wait up to two weeks for their results and while, according to Dixon, Australia “has done well” in reaching its targets for transmission in terms of sex workers, intravenous drug users and mother to child transmission, when it comes to reaching those targets for gay men,  there is still work to do.

“Australia signed up to achieve a 50% reduction in new sexual transmission of HIV by 2015,” Dixon says. “From 2006 to 2009 it was pretty stable at about 260 new infections in Victoria each year, but in 2010 it dips down to 235 infections and then in 2011 it went up to 280 new infections so it is bouncing about a bit.

“We are tracking this year a little bit lower than last year, so we are hoping that 2012 comes in at a lower rate than 2011, but still it’s a concern because we always want to drive our rates down.”

When news circulated about the widespread availability of rapid testing for HIV in other countries, Australian gay men wanted to know why it wasn’t available here. As often a first point of call organisation for gay men with questions about HIV, the VAC/GMHC has fielded a lot of these queries.

“Through a lot of different channels we’ve had questions and interest in it [rapid testing] over the years,” Dixon says. “People coming to our counseling services, people ask about it on our website. There’s lots of gay men who know about rapid testing in other countries and question why it’s not available for them here.”

Currently the test is going through the motions at the Therapeutic Goods Administration (TGA). While Dixon says he “wouldn’t be critical of the TGA and its process”, he also says that it does “seem like an extremely slow process.”

DR Mark Stoové from the Burnet Institute echoes Dixons concerns.

“It does seem to be taking its time, in the end and we don’t know how long it might take, it’s like, well how long is a price of string,” Stoové says.

However, Stoové also points out that there are several other factors, besides the TGA, that are holding things up.

“In terms of the logistics of getting something out there it has to be TGA approved,” Stoové says, “but things are not moving just because of the TGA, it’s also up to the jurisdictions who need to decide on the types of models they want to use and how it is to be funded. There is no MBS [Medicare Benefits Schedule] rebate for this testing, so at least in short term, those costs are born by jurisdictions.”

Whether or not the availability of rapid testing would encourage people to test more often is the subject of a randomised trial at the Melbourne Sexual Health Centre (MSHC).

The director of the MSHC, Professor Christopher Fairley, says:

“The rationale behind the study is that the more people test, the sooner they know whether they are HIV positive, the sooner they can go on treatment and the much less infectious they are. It’s all about improving the diagnosis so that we can reduce transmission.”

Dr Tim Read, a Sexual Health Physician at the MSHC, who is in charge of the study, is tracking how often gay men actually get tested for HIV. The study involves 400 men and is following them over a period of 18 months.

“The study is looking at how people are using HIV tests,” Read says. “We are also looking at the frequency of HIV testing. Half the people are randomly allocated to have access to a rapid HIV test and the other half are randomly allocated to conventional laboratory HIV testing.”

Read is tracking the participants via their contact with the clinic, email and sms. They also answer a questionnaire as to whether they have had a HIV test elsewhere. The study will finish in September with Read expecting the findings by late October.

Read says he believes the availability of rapid testing at the Melbourne Sexual Health Clinic would mean gay men would test more regularly.

“There is evidence to say these tests are very acceptable to gay men”, Read says, “It’s available in a lot of other countries and people from other countries sometimes express surprise that we don’t have them here.”

While Australia still waits for rapid testing to become available through medical clinics, in the US an advisory committee for the Food and Drug Administration (FDA) has recommended the approval of rapid testing for home use. The test is called OraQuick In-Home HIV Test and would be available over the counter.

When asked about the feasibility of rapid testing being made available in Australia a spokeswoman for the Department of Health and Ageing told MCV:
“Because of the serious nature of diseases such as HIV and the impact this can have on the community, the regulatory framework that currently applies in Australia requires that kits intended for use as self-testing (home-use) for those serious diseases cannot be legally supplied in this country.”

And so the wait continues…