“The end of AIDS” tune is premature and dangerous

By – Professor Francois Venter

It is strange to think of the progress we have made as a country since 2004, when the South African antiretroviral (ARV) programme rollout was started.

The success of the programme has been beyond some of our wildest dreams. A situation, where almost half a million people were dying every year, has been transformed. Over three million people are on safe treatment, life expectancy is up across the country (life expectancy is normal for people starting ARVs with CD4 counts above 350), and mother-to-child transmission has plummeted. The steps to accomplish this have been astounding, when you think about it – rolling out HIV testing, getting people ‘’staged’’ with CD4 counts, transitioning them to adherence interventions to get them started on ARVs, and keeping them in care, while reliably supplying the drugs and laboratory monitoring services.

The government has received much applause, both locally and internationally, for sustained political and financial support to the HIV programme since 2008, making it one of the few non-donor dependent programmes in Africa. The UNAIDS 90-90-90 targets have been embraced by the Department of Health as aspirational targets, and seem tantalisingly close. Data from the Africa Centre shows clear correlation with ARV coverage, and a decrease in new HIV infections. For the first time in decades, we have seen a decrease in TB numbers, almost certainly due to increased coverage of ARVs. All this, in a health system that can charitably be called less than optimal.

Treatment Action Campaign (TAC) march Pretoria, 2014. Photo: Treatment Action Campaign
Treatment Action Campaign (TAC) march Pretoria, 2014. Photo: Treatment Action Campaign

There are brave government officials who stood up during the denialist Mbeki administration period, who fought hard for a scientific approach, where cabinet did little to challenge their irrational President and his obdurate Minister of Health. Many of these same officials stayed on, and have supported the Zuma administration and current Health Minister Aaron Motsoeledi in giving us the world’s largest ARV programme. There are many unsung heroes in the struggle against AIDS denialism, and hopefully one day their story will be told.

However, to quote an old revolutionary: “Tell no lies…. Claim no easy victories”. We face huge challenges with sustaining the HIV response in South Africa, and we should not kid ourselves that the road to getting on top of the epidemic is even half-done. The rhetoric of agencies, suggesting the end of AIDS is around the corner, is grossly premature and very dangerous.

Two critical and vastly different factors have played a part in making our HIV response so effective:

Unprecedented community and civil society mobilisation. Led by the TAC, and quietly supported by many in government, the clashes with the state and the pharmaceutical industry kept the fight for better treatment front and centre of the AIDS response since 2000. Aided by researchers, clinicians, donors and a critical media, apathy on the part of the public was transformed into outrage at government’s initial denialism and subsequent anaemic support under Mbeki. Less acknowledged was the huge amount of community treatment literacy that was undertaken by civil society that prepared patients at a local and clinic level for taking treatment.

Resilience of ARVs. The spectre of mass ARV resistance and poor adherence never materialised. While ARV resistance is devastating at an individual level, and there may be a signal that certain drug classes now may have slightly reduced efficacy, the doomsayers have been proved wrong. Even the older regimens, associated with substantial irreversible toxicity, had people taking their treatment for years, a testament to the power of the medication and community support. Twelve years in, only a small percentage of people are on second and third line regimens.

These two factors allow us to look to the signals of where the HIV programme has challenges, and how we may start addressing these practically.

The UNAIDS 90-90-90 targets (ensure that 90% know their HIV status, 90% get ARVs and 90% are virally suppressed) provide a useful way to view these challenges. Here are a few of the major issues we need to address and some potential solutions, in no particular order, which may need to be tested by the current and next NSP.

HIV testing

While HIV testing is reaching a substantial number of people, the 90% knowing they are positive target is the biggest gap in the UNAIDS targets, and the NSP target of testing everyone annually will never be a reality with current testing models. Testing remains stuck in overloaded state facilities or in bureaucratic systems in the private sector.

New testing strategies have not been evident since the dawn of rapid testing over a decade ago, other than the Minister’s major push to test 15 million in 2010. There are lessons in this push, which got huge numbers of people tested and contributed to a surge of people accessing treatment (and a welcome rise in the average CD4 count at ARV initiation). The surge was largely driven by civil society, commercial pharmacies and donor programmes, often supported with the Department of Health (DoH) test kits; facility testing in traditional DoH clinics did not rise substantially.

It is probably not realistic to expect much more at traditional health facilities. Short of a major restructure and improved management of health staff, coupled with more resources, the burden of testing on these facilities will be significant.

Get everyone else involved in testing

The target setting in 2010 focused many minds outside of traditional facilities. It seems possible to set the first 90 as a target outside of clinics and hospitals – a similar campaign, but one that does not focus on the DoH clinics, but rather on workplaces, churches, schools, unions, sports clubs and others. There is nothing stopping the Minister from issuing this challenge, and insisting that the country’s sectors cooperate. How each sector gets people tested (in a way that respects human rights and legal requirements), and links them to care, could rest with the respective sector. A good start would be directing this challenge at the country’s biggest employer, the government. The Minister, as well as his officials have long and justifiably complained that other departments and parliament mouth rhetoric around HIV with no substance, leaving it a DoH issue. Imagine the Departments of Basic and Higher Education having to ensure all their teachers and students are tested, or the Department of Labour working with unions to get their members through the HIV pre and post-test counselling process, with DoH providing test kits.

Expand community and self-testing

There are some innovative testing models out there to be tried. Initial enthusiasm has been for community home testing, and this has been effective in finding undiagnosed HIV. However, subsequent waves of home testing by MSF in Africa, have demonstrated very low subsequent case finding, suggesting that these interventions are probably worth doing as a once off, but subsequent waves can be delayed. Self-testing is an innovative approach that has been shown to be safe and acceptable in several environments, including in a large study in Malawi. The World Health Organisation (WHO) is currently developing guidelines on self-testing, with several products on their way to commercial market. This may assist a lot in getting routine testing away from facilities, allowing pressured healthcare staff to play a role in confirming the diagnosis and starting ART, rather than testing healthy negatives.

Fix HIV testing quality assurance problems

Finally, an unpleasant elephant in the room is what WHO terms ‘’misdiagnosis’’, where incorrect HIV results are given to patients, undermining both testing and treatment programmes. While some high-profile cases have been due to the tests themselves, it is clear that most problems are seen with the health workers performing the test. The full extent of the problem is not known, although a simple enzyme-linked immunosorbent assay (ELISA) screening of new CD4 counts received by the National Health Laboratory Systems (NHLS) would solve the problem in a flash. Quality assurance programmes are needed at a facility level, to identify problem staff practices, with training and monitoring interventions triggered as needed. Again, this could be delegated to the NHLS as the monitor, if resourced adequately.

Money

The budget for the HIV response is huge in absolute terms. While certainly appropriate considering the burden of disease, and the effectiveness of ARVs, the fact that the National Treasury largely finances the programme makes it vulnerable to economic downturns, currency fluctuations and political distractions, means that trying to find cost savings is important. The national ARV bill will be over R10 billion by 2018; removing CD4 counts as an initiation criteria and testing everyone will drive it higher.

Get new drugs to decrease costs

Thankfully, new drugs that are safer, cheaper, and more robust are in the offing, and will hopefully substantially reduce the drug bill, while limiting transition to second and subsequent line therapy. With the right studies, these may be available by 2019 in the South African state sector.

But don’t forget the kids…

These new drugs are being tested on children, and harmonisation with adult regimens guards them from stock outs. The paediatricians need to ask what evidence will ensure maximum harmonisation with adult regimens, and what research needs to be done to give firm recommendations.

Missing in action 1: Men

If the treatment programme is disaggregated by 90-90-90 gender data, South African women are pretty much there, due partly to high testing rates in PMTCT programmes, and familiarity with clinics through contraception and childcare. Men, however, are under-tested and access ART far less than women. UNAIDS released data showing that South Africa has the worst gender imbalance in terms of access to ART in the world. Men present later and at a lower CD4 count, with poorer outcomes, and have poorer adherence in some studies. The rhetoric around young women’s vulnerability to HIV (which is real) obscures the fact that male lifetime risk of HIV approximates women’s – it just occurs over a longer life period. Unfortunately, precious little creative thought is apparent around improving male access to care.

Get to the workplace and get creative

Some quick wins seem possible – as male representation in the workplace far exceeds women’s, this is an easy place to start, perhaps with the HIV testing programmes discussed above. In addition, expanding clinic times to accommodate working people seems sensible. However, this does not reach unemployed men, a huge number of people. Self-testing has been shown to be very acceptable to men, but finding acceptable and validated tests will probably only occur next year, and may take time to enter the state sector. New and creative ways to access men are desperately needed, if any of the 90s are to be attained.

Linkage to care

The previous NSP called for the implementation of a single-patient identifier (SPI) for health databases, a concept ratified by the national DoH using the national ID number, but very poorly implemented so far. The previous call was on the back of multiple concerns about poor monitoring and evaluation of the programme, and the unknown number of people ‘’lost’’ to the programme (either through default, death or simply getting their treatment elsewhere). Interpretation of data is therefore almost completely speculative – terms like ‘’lost-to-follow-up”, which often come with implicit stigmatising judgements on patients in systems, are probably more accurately titled ‘’lost from our (very poor) systems of monitoring”. Commonly cited numbers like 30% lost at two years from programmes, seem implausible looking at the remarkable increase in life expectancy. While some patients indeed may fall off the system and die, it seems more likely that most simply migrate between clinics that have non-existent referral systems.

Decree the SPI

As a single, decisive implementation priority, it is hard to see one with more profound implications than the single-patient identifier. It already exists in the private sector through pharmacies, where medical aid information is pooled. Some provinces have resisted the call for a single identifier, citing confidentiality issues or the fact that a small number of people don’t have ID books. While these concerns are real, they are easily remedied with international standards around accessing relatively confidential data, and ensuring a ‘’plan B’’ is available for people without ID numbers that allows testing. There is huge loss in terms of programme monitoring, as well as individual patient harm where referral is not done and health care workers have to guess at optimal treatments, harms patients every day. Starting with the NHLS, a national directive that all laboratory tests have to have to be submitted with the ID number should be implemented, with a national programme telling facility health staff that a date has been set, and specimens will be discarded without the number. This is already done for some facilities, for other information like health worker contact details, so there is precedent. Facilities then should transfer their file numbering system to one using the single patient identifier, with future promise that some of these records will make their way to an electronic centralised system that is centrally accessible. Until this is done, arguing about the extent of linkage to care problems and possible solutions seems pointless.

Support the NHLS

South Africans may not appreciate what a huge resource a National Health Laboratory Service is (there are few of them anywhere in the world), and how it may assist us in understanding health issues way beyond just HIV. However, the poor support, especially from provinces, that the NHLS has had over the last few years, has severely undermined it. Brave people still work there, and we need it to function efficiently and cost effectively, to get HIV and broader health programmes the lab support they need.

SMS (or WhatsApp) the nation

Innovative cell-phone based approaches also look promising in linking patients to care, but implementation at a mass scale has yet to be implemented. In other fields, such as Home Affairs, there is constant information fed to the public after applications for documents like passports or ID books. Everyone is reminded about their dentist, their car service, or their unpaid Metro bills and traffic fines, and there seems no reason this couldn’t be extended to the public health system to alert patients to appointments, drug shortages, or changing clinic times.

Community engagement

It is hard not to be cynical about support to community organisations. Governments, donors and agencies trumpet at almost every opportunity about how important civil society and community organisations. However, when expenditure is analysed, precious little trickles down to these organisations. As an example, the TAC almost had to close its doors, due to lack of funding, and still battles to find adequate financial support. Communities are tasked with all manner of support to HIV programmes, from education on adherence to palliative care, almost all of it unpaid. Reports of government funding ‘’sweetheart’’ organisations that do not rock the boat or who are unaccountable, abound. Donors who have supported programmes that publicly criticise or embarrass government, often with good cause, have been berated at times by politicians and officials.

Set targets for budget allocations

Treatment literacy and community support are acknowledged to be important. In the same way as many budgets have ‘’X percent’’ allocated to issues such as HIV prevention, a percentage should be allocated for civil society and community support, and monitored as a performance indicator. Those funded should be held to reporting standards seen with other organisations, to ensure accountability.

Novel models of care

MSF have revolutionised delivery of drugs, with their (inadvertently misleadingly-titled) ‘’adherence clubs’’, centralised dispensing points for chronic medications with a strong focus on HIV. However, scale-up of this model has remained challenging, and provincial level buy-in is very variable. In addition, the national DoH have been experimenting with home delivery of chronic medications, although uptake is apparently slow. In Gauteng, vending machines are available on a pilot basis in a limited number of facilities, through a donor programme. The DoH has signalled the urgent need for ‘’decanting’’ of patients out of busy facilities.

Get innovative chronic disease dispensing to scale

It is heartening to see these new approaches, that both try to decongest facilities, as well as make access more convenient to patients. However, they need to go to scale, as only a small minority of the population currently enjoy access to these new models of care.

Don’t discount verticalised services

These are loathed by many health managers, who prefer the simplicity one-size-fits-all model of primary care. Unfortunately, it seems that for certain marginalised or smaller groups, this may be the most effective way to address health needs, especially HIV care. Experience with groups like MSM, sex workers and adolescents, as well as pregnant women, suggest that tailored approaches work, and future priority groups like transgender populations are likely to need them too.

Drug stock-outs

Civil society, in partnership with government, has been conducting a regular drug stock-out survey, in conjunction with a problem solving aspect, where reports of stock-outs are rapidly escalated and resolved, often within hours. Despite a rocky start to the relationship, the programme has yielded much information and fruitful collaboration, and two critical lessons:

  1. Fixed-dose combination tablets very rarely stock out

This was seen across the country, where stock-outs of adult first-line ARVs and TB treatment, both fixed-dose combination, were almost non-existent. Other drugs regularly stocked out, and despite (often heroic) problem solving by health care staff to get these medications, stock-outs of ARVs in alternative regimens and for children were common. This needs careful consideration by guideline committees, when considering regimens, especially for children, where alignment with the adult FDC would protect them from individual stock-outs.

Call centres work

Having a call centre that knows who to look up with information, and rapidly resolve issues, is feasible on a tight budget and a small number of staff. The ability of staff to resolve facility-level stock-outs (national DoH has made substantial progress with depot-level shortages) is remarkable. It does suggest that perhaps testing this with other facility headaches – staffing, waiting times, other stock problems – is an interesting and constructive model for improving staff and patient lives.

Tuberculosis

It’s difficult to overstate the catastrophe that remains South Africa’s biggest killer. Despite some evidence of decreased new cases, the numbers remain staggering, with an additional burden of multi-drug resistant TB (MDR-TB), and nowhere near the resources to control either. MDR-TB has a higher mortality than Ebola, but the amount of programmatic and political attention pales against a disease not seen in South Africa since 1995, but which commands resources and focus across the country. In the diagnosis and treatment of TB, South Africa leads the world in many aspects. The introduction of the new diagnostic, the GeneXpert in 2012 was an ambitious undertaking but its early trials showed that the GeneXpert did not result in a reduction of mortality from TB. This suggests health-systems weaknesses. While South Africa is leading the world in the implementation of new drugs for the treatment of MDR-TB, including bedaquiline, the implementation of decentralised care with adequate M&E for MDR-TB is patchy in many areas. The solution lies somewhere between using the latest advances in technology with improvement in the basic principles of TB control: find, test and cure.

Give TB more budget and proper support

While there is evidence of some movement in the TB world, partly on the back of the Minister’s own “TB 90-90-90”, the TB department needs the sort of energy, creativity and, most importantly, budget that HIV world has enjoyed for over a decade.

Deal with facility infection control

Worrying studies recently have shown health care workers at very high risk of TB, as well as data suggesting many MDR infections happen in hospitals and clinics. The lack of South African Medical Association (SAMA) and nursing union outrage at what is clearly an occupational disaster, is disturbing. Facility rebuilding is expensive, but needs to be adequately planned for. In the meantime, the various interventions around administrative and personal protections around TB really need more priority.

Get us better drugs and diagnostics

We are seeing the first hint of this, and the research community needs to get fully behind these studies, while demanding the resources to execute them quickly.

Missing in action 2: Young women, men who have sex with men (MSM) and sex workers

Politicians don’t like talking about sex. It’s a vote killer, especially in a conservative country such as South Africa. Unfortunately, young women remain at catastrophic risk of HIV, for reasons we don’t understand, but are likely to be a complex intersection of behaviour, social ills like gender-based violence, and biology. Interventions that work (condoms, proper sex education that includes access to contraception, and pre-exposure prophylaxis) are not available at schools, despite objective evidence that this is when the vast majority become sexually active, and where substantial HIV and other sexually transmitted disease occurs. Brave moves by the DoH to start extending PrEP services to sex workers and perhaps to MSM, as an HIV-prevention plan, are to be applauded, but the same bravery is needed for a much larger segment of society.

DBE needs courage

The Department of Basic Education needs to change its policy, and immediately allow meaningful reproductive education, contraception and condoms into schools. Parent, teacher and politician sensitivities need to be seen in the context of incidence rates of up to 8% at some of the KwaZulu-Natal sites.

Politicians need to change laws

In tandem, the excellent progress made by a partnership of the DoH and a wide slew of civil society organisations to address the health needs of sex workers in the new plan, which includes a focus on HIV prevention with immediate treatment and PrEP, is undermined by the continued criminalisation of sex work, with harassment by the police a daily reality. Again, it will take brave leadership to address this, but it is necessary.

Missing in action 3: Civil society and business

The Mbeki era controversy distracted us, and let a huge portion of our society off the hook on the AIDS response. Beyond a few public statements by leaders from the churches, unions and within business, precious little of substance has come from these groups (with the exception of some home-based church groups, and some work-based treatment programmes).

Set them a challenge

Challenges need to be issued across all these groups, to support the HIV response. Again, a national HIV testing programme would be a tangible expression of this, linked to accountable targets.

Distractions

It’s important to focus on what is important within the HIV programme. Much airtime has been given to the so-called ‘’non-communicable disease’’, both within the general health system and within HIV programmes. These conditions are often based on observational data from developed country populations, with increasingly questioned interventions. Well-meaning but evidence-free interventions, ranging from meaningless nutritional and exercise advice to mobile mammogram screening, have been adopted by various programme managers, and advocated by senior DoH staff. This despite the fact that TB remains the number one killer in the country, followed by other diseases of poverty.

Carefully evaluate screening programmes

It is remarkable to reflect on a statistic released in the last few years – that poorer Americans have witnessed a reduction in life expectancy in the last 30 years, and that this correlates clearly with increasing poverty. South Africans continue to die from under-nutrition and other diseases of poverty. Expensive screening programmes that use up the precious time healthcare staff need careful thought before being applied. In addition, health workers and the DoH need to understand that poverty reduction is probably going to make a far greater impact on health, especially when screening tests involve convoluted referral steps, invasive confirmation and relatively untested treatments. In addition, existing, evidence-based screening for TB is poorly done, and adding further layers of complexity to this seems a poor choice. Public health experts need to be better cheerleaders in this regard, and temper the disease-specific advocacy that has arisen within medicine. A basic income grant for poor people is likely to have a much greater impact on their health than a cholesterol screen or BMI check.

Prevention

Finally, but just as importantly – despite evidence of a downturn in infections in some surveys – HIV new infections continue to be around 1 000 a day. As mentioned above, some brave choices are needed in schools to address the epidemic among young women, and legal challenges to sex worker legislation are required. However, other interventions would help.

Support PrEP

Pre-exposure prophylaxis is complex, but it works. The current push is appropriate, but the group who most needs it, young women, will almost certainly not receive it using current models of care. Integrating PrEP into contraceptive, HIV testing and other programmes will require drive and creativity.

Support vaccine development

This is a long-term solution, but is looking more promising than a few years ago.

Stop getting distracted

Politicians are obsessed with people’s sex lives, disregarding home-grown evidence and insisting on supporting poorly thought-through programmes around concurrency and sugar daddies. We need focus on better relationships, gender violence and attention to condom provision and reproductive health, not billboards trumpeting often meaningless messages about who we have sex with.

Conclusions

Amílcar Cabral was a Guinea-Bissauan and Cape Verdean agricultural engineer, writer, and a nationalist thinker and political leader. He was also one of Africa’s foremost anti-colonial leaders (Wikipedia).

The full revolutionary quote by Cabral I referred to earlier in this article is: “Hide nothing from the masses of our people. Tell no lies. Expose lies whenever they are told. Mask no difficulties, mistakes, failures. Claim no easy victories…”

We can’t get complacent, with the empty promise from agencies of an ‘’AIDS-free generation” when our victories (in some cases) have been relatively easy, and many mistakes were dismissed.

Many of these problems (and solutions) are not specific to HIV. But HIV has allowed the whole area of health to be ambitious again, reconnecting with the energy that briefly arose after the Alma Alta Declaration on primary health care, but perhaps with more critical reflection (and resources to support it). It is an exciting time to be in the health field, especially in HIV, and people in South Africa rely on us to get it right.  

Professor Francois Venter is the Deputy Executive at Wits Reproductive Health & HIV Institute, Professor in the Department of Medicine at the University of the Witwatersrand.

Conflict of interest declaration

Prof Venter receives support to both his salary and programmes from a large number of donors, as well as from the pharmaceutical industry (including drug donations to research projects) and managed care organisations. He currently runs a large sex worker health programme, an HIV-self testing programme, and is working on research studies on the new drugs detailed above, as well as a programme looking at non-communicable diseases. The views expressed here are not necessarily of his organisation.

 

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