Impetus for change? The importance of targets and regulatory reform to ending HIV

HIV Australia | Vol. 13 No. 1 | April 2015

By Karen Price and Nicolas Parkhill

Five years out, targets that have been set for 2020 are looming larger in the consciousness of HIV policy makers, advocates, community educators and health workers.

Drawing on experience in NSW, it is reasonable to suggest that setting targets has the capacity to energise and revitalise the response to HIV, but only if those targets are accompanied by supportive environments and technological advancement.

This article explores some of the benefits of setting targets, and also some of the limitations that are hindering progress.

Setting targets is a way for jurisdictions to prioritise what matters within its health system.¹ Increasing healthcare costs mean that there is greater pressure on health organisations to be as efficient and effective as possible, and accountability is increasing in these fiscally constrained times.

The 2011 National Health Reform Agreement signed off by the Council of Australian Governments (COAG) was the most notable use of targets to drive performance in recent years.² These reforms introduced public accountability and reporting of performance in an unprecedented manner.

While robust arguments can be posited to suggest the success or otherwise of these reforms, one thing is irrefutable: targets, data collection and public reporting had an influence on the health system, focusing attention of administrators and health professionals alike.

Around this time, the world was learning of emerging evidence of the role that treatment could play in preventing new cases of HIV. The results from the HIV Prevention Trials Network’s HPTN052 study demonstrated a 96% reduction in HIV transmission in serodiscordant heterosexual couples.³

This ‘game-changing’ finding coincided with the arrival of a new state government in NSW, a government which – after 16 years in opposition – challenged the dominant markers of ‘success’ in containing HIV ; low and stable rates were not enough – they wanted to see reduction.⁴

The confluence of new scientific evidence, a new and bold government, and a willing sector saw NSW embrace an HIV Strategy that sought to capitalise on new understandings about the relationship between HIV treatment and HIV prevention – ‘Treatment as Prevention’ – to drive dramatic change.

The NSW HIV Strategy 2012 – 2015: A New Era,⁵ includes the following targets:

reduce the transmission of HIV among gay and other homosexually active men by 60% by 2015, and by 80% by 2020
reduce the average time between HIV infection and diagnosis from 4.5 years to 1.5 years by 2020
increase to 90% the proportion of people living with HIV on antiretroviral treatment, by 2020.

The NSW Government further illustrated its serious commitment to these strategic targets by taking the strong step of incorporating targets into the performance expectations of the public health system and relevant non-government organisations (NGOs), with performance targets for chief executives of the Local Health Districts (LHDs) directly linked to the Strategy. This has driven enormous change, particularly in the area of HIV testing.

The impetus for change saw a number of important developments.

Firstly, the target driven approach necessitated a change to data collection – and, importantly, more frequent data releases.

A government setting bold targets wants to know how the system is tracking on delivering on those goals. In the space of a year, HIV data went from an annual collection of data, reported well after the surveillance period ended, to quarterly data, issued weeks after the close of the quarter.

This timely feedback to the system has been invaluable, as has the growth in the sophistication and depth of data analysis.

Secondly, to its credit, the NSW Government heard the voices of community advocates who mounted a convincing argument that the overly cautious regulatory environment was holding back progress in NSW (and indeed Australia), and preventing the rollout of community rapid test services.

HIV rapid tests have been approved for use in community settings in comparable overseas countries for quite some time but in Australia, protracted Therapeutic Goods Administration (TGA) application and approval processes have undermined efforts to roll out community testing across Australian jurisdictions.

It was clear to all that to achieve the bold targets in the Strategy, more gay men needed to know their status and that for this to be possible, HIV testing needed to be faster and more convenient.

The regulatory environment was moving too slowly, so the NSW Government funded a trial, run by the Kirby Institute using the TGA research concessions. This meant that Local Health Districts and community partners could provide rapid HIV testing services in NSW for the first time.

Thirdly, use of new technology under the Kirby trial has allowed for development of more flexible and attractive service delivery models.

Over the course of the last 18 months, ACON has undertaken a process of service realignment and worked with our clinical partners to establish a network of HIV and sexually transmissible infections (STI) screening services in community-based settings across NSW.

Initially with one site, there are now four sites operating – including a permanent shop-front service on Oxford Street, Sydney’s iconic ‘gay strip’.⁶ Models in regional NSW involving peers, and ‘pop up’ testing sites have been trialled on World AIDS Day and at community events such as Tropical Fruits in Lismore.

Central to the seismic change to policy and services settings, has been ACON’s reconceptualisation of how it delivers peer-led, community-driven education programs, with recognition that a more sophisticated, longer-term dialogue with gay men is required.

One of the many outputs of this dialogue has been the development of ACON’s multi-award winning campaign platform – Ending HIV. Successive evaluation reports of the campaign have demonstrated a significant shift in community understanding, attitudes and behaviours when it comes to safe sex, testing and treatment – and crucially, regarding treatment as prevention science.

The planning and execution of these campaign phases have built upon each other, using modalities including social media, online platforms, physical spaces, community outreach, and population-wide high impact activations.

Key words for the NSW HIV sector are scale-up, innovation and advocacy. In a relatively short space of time, the HIV testing landscape has changed markedly, and the results have been dramatic, with significant increases in testing among gay men and other men who have sex with men sustained across these years,⁷and testing rates almost doubling from 2011 to 2014 across five Local Health Districts.

Targets, tools and regulatory reform

Despite such strong commitment from government and the sector, legislation and regulatory policy can create public health ‘road blocks’ – particularly when it comes to the early adoption of new technologies at scale.

While it would be reasonable to suggest that stronger scientific evidence and experience are producing broader-based support for ‘new ways of doing business’, there remains no real access in Australia to key innovations such as home testing kits and pre-exposure prophylaxis (PrEP).

The access that has been achieved to date has been largely granted through policy ‘workarounds’ by way of research trials. These are useful in the short-term but programming on this basis is, of course, unsustainable.

This situation effectively means that those working hard to achieve the promise indicated by the research, and backed by government strategy, are potentially being held fully accountable for outcomes for which we only have half the tools.

Regulatory barriers have created vulnerabilities and a situation that is difficult to imagine in comparable areas of public health.

Australia remains well behind comparable countries on HIV rapid testing:

To date only one HIV rapid test has been approved by the TGA for use in non-clinical community settings (the Alere Determine Antigen/Antibody test).
Issues including regulatory delays and lack of clarity regarding sensitivity criteria mean that manufacturers are not rushing to lodge TGA applications for HIV rapid tests. As yet, there have been no applications for approval of an HIV rapid test device for self-use/home use and it is unclear whether any manufacturers intend to lodge an application in the near future.
No rapid test has been listed on the Medicare Benefits Schedule and none is under consideration by the Medical Services Advisory Committee.

There is also a lag in responding to growing community awareness and demand for PrEP in Australia, fuelled by demonstration projects underway in NSW and Victoria, and overwhelmingly positive interim announcements made by the PROUD (UK) and IPERGAY (France) PrEP trials (full results of which are anticipated later in 2015).^8, ⁹

While it is understood that Gilead are likely to be applying to the TGA to have Truvada licensed as PrEP, the staged application process means that even if an application is lodged soon, a decision is unlikely to be made until mid-2016 at best. Pending TGA approval of Truvada as PrEP, Australian HIV specialists may prescribe Truvada as PrEP off-label.

National guidelines have been developed by ASHM (the Australasian Society for HIV Medicine) for clinicians prescribing PrEP.

Once the TGA has approved Truvada as PrEP, enhancing PrEP access will depend on Pharmaceutical Benefit Scheme (PBS) approval, but access is likely to remain severely limited given the likelihood that PBS eligibility criteria will be very narrow. Glaciers have been known to move faster … .

In the meantime, people are purchasing Truvada and other HIV antiretrovirals for use as PrEP from overseas via the internet, or over the counter during travel, and there is limited information available regarding dosage and timing.

The determination of gay men to take control of their sexual health by finding ways to get around regulatory blockages is of no surprise to ACON – gay men have been the key actors in HIV prevention for three decades.

It is entirely understandable that men want to take advantage of new ways of preventing HIV transmission – it is very much in keeping with gay men’s full commitment and participation in HIV prevention over almost 30 years.

What has compounded this frustrating situation is conflicting advice from the TGA as to whether there are legal restrictions in place that limit or stop community and other public health bodies advising people about how to access new evidence-based and effective biomedical prevention technologies.

The situation is beyond sense in that we were given to understand that any health organisation that had the audacity to assist its community members to look after their health by providing them with contemporary information on choosing the safest products and using them safely could potentially be penalised for doing so.

We have recently been advised that in fact we are free to provide such information – this is great but it is extremely frustrating that we were previously advised otherwise.

Conclusion: are targets enough?

The experience in NSW suggests that setting targets has been very helpful. The fact that those targets were embedded into the reporting arrangements across the sector was essential to giving them real effect.

The bold strategic direction, coupled with strong performance targets, data collection and public accountability for results has raised the profile and given priority to HIV, which remains a chronic and incurable disease that elevates the risk of cancer, cardiovascular disease, and diabetes.

However, setting targets can only achieve so much. Change in a range of other areas – including data collection and feedback, technology, service delivery models and community education and awareness must all play a role.

Without community mobilisation – in recognition that significant reductions in HIV transmission are possible – no change will occur, regardless of how bold the target or startling the science.

Advocacy has always been at the core of achievements in HIV over three decades. While the achievements in NSW over the past two years provide real cause for optimism, there are serious concerns that the counterproductive effect of the slow, expensive and hostile regulatory environment in Australia will circumvent public health, jurisdictional leadership and individual capacity.

2020 is looming large, and our community deserves a more supportive regulatory environment as it continues to fight HIV.

References

1 Bevan, G. (2006). Setting targets for health care performance: lessons from a case study of the English NHS. National Institute of Economic Review, Volume 197, No.1, 67–79. dx.doi.org/10.1177/002795010619700102

2 Patel, K. (2014, 29 May). Can we improve the health system with performance reporting? Deeble Institute issues brief no. 6. Deeble Institute for Health Policy Research for Health Policy Research, Australian Healthcare and Hospitals Association.

3 Cohen, M., Chen, Y., McCauley, M., Gamble, T., Hosseinipour. M., Kumarasamy, N., et al. (2011). Prevention of HIV-1 Infection with early retroviral therapy. New England Medical Journal, 365(6), 493–505. nejm.org/doi/full/10.1056/NEJMoa1105243

4 O’Donnell, D. (2013, 27 June). Policy Agendas and Path Dependency: A former bureaucrat accounts for the re-making of HIV in NSW. Brett Tindall Memorial Lecture, The Kirby Institute, Sydney, 13.

5 NSW Ministry of Health. (2012). The NSW HIV Strategy 2012 – 2015: A New Era. NSW Ministry of Health. Retrieved from: www.health.nsw.gov.au

6 See: endinghiv.org.au/nsw/test-more/a-test/

7 NSW Ministry of Health. (2015). NSW HIV Strategy 2012 – 2015 Data Report Q3, 2014. NSW Ministry of Health. Retrieved from: www.health.nsw.gov.au

8 For further information see: PROUD study media release (16 October 2014). Retrieved from: www.proud.mrc.ac.uk

9 For further information see: IPERGAY media release (29 October 2014). Retrieved from: www.ipergay.fr

Karen Price is the Director of HIV and Sexual Health at ACON.

Nicolas Parkhill is the Chief Executive Officer at ACON. ACON is a leading health promotion organisation in New South Wales specialising in HIV prevention and support, and lesbian, bisexual, transgender, and intersex health.