Long shot?: In April next year, South Africa plans to start rolling out an anti-HIV jab, taken only twice a year, that could end Aids in the country within 14 to 18 years. But is our public health system equipped to keep track of millions, who are on the shot? (Unsplash)
In April next year, South Africa plans to start rolling out an anti-HIV jab, taken only twice a year, that could end Aids in the country within 14 to 18 years — if enough people take it.
The once-every-six-months shot, called lenacapavir (LEN), works 100% of the time to stop young women from getting HIV through sex. Of the about 400 people in South Africa who still get infected with HIV each day — 122 of them are teen girls and young women.
The jab works almost as well for other groups and is likely to get registered by our medicines regulator in October or November.
LEN is a form of PrEP — pre-exposure prophylaxis — which is when medicine normally used to treat people who are infected with HIV is used to stop HIV-negative people from getting the virus.
But for our LEN roll-out to be successful — so for it to result in ending Aids as a public health threat in South Africa — the government would need to buy and distribute millions of doses of the jab over the next two decades, modelling studies show.
The health department would also need to convince HIV-negative people who face a high chance of getting the virus to use the shot for as long as they need it; in other words: they would need to create demand for it.
With cheaper generics that will come to the market in 2027, the health department will likely be able to increase the number of doses — enough to phase in just over 450 000 people over two years — it will be buying with Global Fund money.
But is our public health system equipped to keep track of hundreds of thousands of people, let alone millions, who are on the shot — and for how long they stay on it?
We do a deep dive.
What can — and can’t — our health system count?
Let’s start with the daily HIV prevention pill, also called oral PrEP.
LEN won’t be South Africa’s first HIV prevention meds. Public clinics started to roll out a daily anti-HIV pill in 2016. By April this year, 1.9 million people had used it at least once.
But while 97% of primary healthcare facilities stock the pill, and the health department keeps track of how many people have started to use it, data for how long and how consistently those who get the pill from government clinics use it, rolls in much slower.
People who get the pill from government clinics get a month’s supply when they start, and if they test HIV negative when they return to the clinic for a refill, they get enough anti-HIV pills for three months, according to health department guidelines.
Counting how many people start using the pill is a relatively straightforward process. But the electronic patient tracking system — Tier.Net — that the health department uses makes it difficult to keep track of people who stop and restart HIV prevention medication.
“But keeping track of people stopping and restarting PrEP medication isn’t just difficult in South Africa — most countries struggle with it,” says Hasina Subedar, a senior HIV prevention technical advisor. That’s because the systems that have, over the years, been used to track HIV-infected people’s use of treatment, are now often also used to monitor HIV-negative people’s use of HIV prevention medication, and the rules for HIV treatment and HIV prevention medication are different.
Here’s why.
Like the HIV prevention pill, HIV treatment needs to be taken daily, but unlike HIV prevention medication, treatment for an HIV-infected person needs to be taken lifelong. So, when a patient misses a clinic visit for a refill of their prescription, systems like Tier.Net signals it as a problem.
With the prevention pill, however, people can stop and start their medication. Someone could, for instance, stop taking the pill because their HIV infection risk has gone down, so not because they’ve “failed”.
Scientists call this effective use. Systems like Tier.Net would therefore need to be adjusted to follow effective use over time.
With LEN’s roll-out on the horizon, the health department will require a system that can track both daily HIV prevention pills and 6-monthly injections properly and that also keeps records accurate when people switch between pills and injections or move to different clinics.
Do we know how to track if people take the pill each day?
From studies, we know that many people, especially young women, struggle to take the pill every day. And when someone skips doses, their chances of contracting HIV increase.
But to track how consistently people are taking their pills is also difficult to do — and, again, not just in South Africa.
To know this, health workers could either ask someone if they took it each day or check patients’ pill containers to see if all the meds have been used. Theoretically, people’s blood can also be tested, to see the level of the drug in it. But such tests are costly and are therefore not done routinely at public clinics. It’s mostly only something that is done in studies, Subedar says.
And, checking containers, and asking patients to tell health workers if they took their pill each day, isn’t straightforward either.
Studies show users who self-report often give nurses the wrong information. A Nigerian PrEP study among men who have sex with men, for example, showed two-thirds of men reported perfect pill use, but blood tests revealed far fewer had protective drug levels.
“Prevention has always been a numbers game,” says Mitchell Warren, who heads up the health advocacy organisation Avac, which advocates for HIV prevention options globally. “We hand out a million condoms, a million PrEP pills and assume protection. But people lie about sex and drugs. They tell you what you want to hear.”
And users who skip doses sometimes throw away the pills to make a container look empty.
Will LEN be easier to track than the pill?
So, will LEN use, that only needs to be recorded once every six months, be easier to track than the daily pill?
Well, yes and no.
What makes consistent LEN use easier to track than the daily pill, is the fact that LEN doesn’t require a user to take doses at home; once someone gets their shot at a clinic, the dose is done.
“With injectables, once it’s in, it’s in,” explains Linda-Gail Bekker, head of the Desmond Tutu Health Foundation at the University of Cape Town.
“But with pills, people can still fail to take it consistently at home. And when people miss follow-ups, protection can quietly slip away.”
Bekker also led the trial that showed LEN fully protects young women against getting HIV through sex.
But, even in the case of LEN, tracking patients who stop or restart and, reminding them of 6-monthly follow-up visits, will need a data system that can do this.
Although Tier.Net is electronic, it’s not a patient record system, it only records selected HIV data, while an electronic patient record records all a patient’s health information.
Why SA needs an electronic patient record system to track PrEP use
Only the Western Cape has an electronic patient record system. Other provinces mostly use paper records, which means when patients get their HIV prevention medicine from different clinics, the original clinic they used might record them as having stopped PrEP, because they did not let the clinic know that they were moving to another one.
The Western Cape, on the other hand, is able to pick up if someone who got their medicine at one clinic, has gone to a different facility in the province to get a refill. But, because its electronic system is limited to that province only, they can only be tracked within the province.
If a patient who lives in the Eastern Cape, but works in the Western Cape, for example, goes home and gets their PrEP from there over a holiday, the Western Cape wouldn’t know.
A national electronic medical record system would let the national health department follow people across clinics, showing whether they’d really stopped taking the pill or LEN or simply moved on to another clinic to get their meds.
An important part of this electronic record is a “unique patient identifier”. This is a number given to each patient that ties together their different clinic records. In theory, it would allow clinics to share information so that no one’s care falls through the cracks when they move.
But more than a decade after the government first promised such a system, it’s still stuck in a pilot phase, leaving PrEP’s tracking gap unsolved.
One solution could be to create a system like the Electronic Vaccination Data System (EVDS), which South Africa used during the Covid-19 pandemic to register and track people’s vaccinations. The system could be adapted to track LEN injections instead. It could also be used to send automated reminders when someone is due for their next injection and health workers would be able to see who is returning on time and who might have stopped.
During Covid the EVDS might have seemed like a basic registry. But, in reality, it was a national data backbone that logged every shot given, verified people’s ID numbers, synced with health databases and sent real-time updates from thousands of vaccination sites.
A PrEP version could, in theory, send reminders when someone’s next injection is due and show health workers who’s keeping up or has stopped. A system like the one used to track the Covid vaccinations could offer a solution for PrEP.
How did LEN studies track effective use?
To measure effective LEN use during a study (called PURPOSE 1), in which around 2 100 women were offered the injection for over a period of one year, Bekker and her researchers kept tabs on something called “annual persistence”.
The “persistence” that was tracked was whether study participants came back on time for their next injection. In other words, did they “persist”?
For LEN, this was a straightforward measurement — show up, and you’re protected; miss a visit, and there are gaps.
A cohort tracker used in another study — Project PrEP conducted by Wits RHI — recorded when participants started, restarted or changed to a different PrEP medication.
A cohort tracker looks at information about a patient or a group of people — who all started something at the same time, for instance, PrEP — over time, showing how they’re doing as time goes by.
But the method used in the study is far too labour-intensive for the public system, says Subedar. “We need something that can do the same job, but without adding extra work for health workers or patients.”
The challenge now for the health department is finding a middle ground.
“If we get this right, LEN could change the trajectory of the epidemic,” Bekker says. “But it will only happen if we learn quickly from the data and make the system strong enough to deliver.”
This story was produced by the Bhekisisa Centre for Health Journalism. Sign up for the newsletter.