South Africa is home to dozens of HIV trials. Ethics committees require that people participating in these studies get access to a comprehensive HIV prevention package – so why are only some people getting PrEP?
More than 500 people have signed up since December to be part of the country’s largest HIV vaccine trial, but some experts are crying foul over what they say is unequal access to the HIV prevention pill among participants.
Researchers are testing what is likely the world’s best shot at an HIV vaccine in 15 sites across the country in a trial called HVTN 702. As part of the trial, about 5 000 participants will receive either a placebo or the vaccine, which contains artificial proteins created to “look” like HIV although they are not actually infectious. If the jab can trick participants’ bodies into developing a way to fight off HIV infection, it could ultimately cut people’s risk of contracting the virus by about half.
But only a portion of the several hundred people who have volunteered for the study are also getting the HIV prevention pill, also known as pre-exposure prophylaxis (PrEP).
PrEP can reduce a person’s risk of HIV infection by more than 90%, depending on how regularly it’s taken, studies have shown. PrEP is currently only freely available to sex workers in the public sector as well as a small number of other people as part of pilot projects, which will help the government to decide how to roll it out more broadly.
Only people in the HIV vaccine trial who live near these pilot projects are able to get PrEP for free. African Alliance for HIV Prevention founder Tian Johnson says that this unequal access to the drug is unfair and compromises study participants’ rights.
HIV prevention studies must comply with international ethical guidelines that require researchers to provide participants with HIV prevention information and services to reduce their risk of contracting the virus in their communities.
According to the United Nations Joint Programme on HIV and Aids (UNAids), people who volunteer for prevention trials should get counselling and “state-of-the-art HIV risk reduction methods”. But what this means in practice, beyond simply supplying condoms, often varies by study and depends on governments and resources, UNAids admits in a 2012 document.
In South Africa, HIV vaccine trial sites are not currently offering participants PrEP because rolling out the HIV prevention pill is yet to become a national policy.
Instead, trial cochair Linda-Gail Bekker says the trial refers people interested in PrEP to pilot projects, when possible, or to the private sector. A month’s course of PrEP costs about R263 at retailers such as Clicks, said Bekker, speaking at the national Aids conference in Durban last week.
“People who are able to access PrEP [through pilot projects] are lucky —luckier than those millions of other people in the country who aren’t near to [pilot sites]. This isn’t an issue for the vaccine sites to deal with — it’s an issue for the government.
“I think they [the government] are very seriously trying to weigh up how, when and to whom to offer PrEP. Given our health budget, it may mean careful redistribution of priorities,” Bekker explains.
Health department spokesperson Popo Maja maintains that the government is awaiting results from projects before deciding how to make PrEP more widely available, especially to young women who are at a high risk of HIV infection.
Keymanthri Moodley, the director of Stellenbosch University’s Centre for Medical Ethics and Law, says that, although sites are working to ensure access to PrEP, the equal treatment of trial participants is crucial.
She explains: “It is important that participants in a clinical trial investigating a new prevention option are offered a standard of care that includes all proven prevention options. This prevention package should be accessible in the same manner at all trial sites to ensure that participants are treated fairly.”
According to Johnson, this package should include PrEP and cover people’s access to it even after the trial concludes. Meanwhile, he argues there is more than enough evidence to support PrEP becoming widely available in the public sector — a step Kenya took in March.
He explains: “Advocates, now more than ever, need to stand up in defence of science and what science teaches us. What it has taught is that PrEP works.
“As clinical trial sites continue the important work of finding answers to ending HIV, advocates must be vigilant and hold trial sites and networks to account to meaningfully think about what their standard of care looks like when it comes to prevention.
“While being guided by national policies on PrEP … trials would do well to engage advocates to explore opportunities to accelerate the national PrEP agenda.”