When NHS England announced at the start of December 2016 that they’d be funding a new large-scale PrEP trial, many people thought that they’d be able to access PrEP in the spring. More than 3 months later, and the trial has not even started to recruit. Dr Will Nutland from PrEPster.info gives an update about what’s going on with the trial.
Towards the end of last year – and following two court battles – NHS England finally announced that it would make PrEP available in England. The NHS committee that makes recommendations for funding of new services found that the evidence for PrEP was compelling enough for it to be made available on the NHS. But instead of going ahead and making PrEP widely available, NHS England instead decided to fund a trial, saying that there were “significant outstanding implementation questions” that needed to be answered.
The December announcement said that the trial would be a joint initiative between NHS England and Public Health England (PHE), and it would start early in the 2017-2018 financial year. The statement promised that there would be at least 10,000 participants in the trial over the next three years.
When the announcement of the trial was made, PrEPster and iwantPrEPnow (IWPN) made a statement welcoming the trial (http://prepster.info/2016/12/community-prep-advocates-respond-nhs-england-prep-announcement/). And since then, members of PrEPster, along with other HIV prevention advocates and organisations including THT and NAT, have attended meetings with PHE to help inform the trial.
Both PrEPster and IWPN have been inundated with queries from people wanting to start on the trial, and as of the end of February 2017, this is the information we have on the trial:
– It is possible that generic (i.e. cheaper) sources of PrEP might be used in the trial, allowing for more participants than if Truvada, at current cost price, is used.
– NHS England is about to start the procurement process for the PrEP drugs used in the trial, and the trial cannot start until this process is completed.
– The trial protocols (the papers that outline how the trial will be undertaken) have been submitted to the relevant regulatory bodies.
There has been much debate about who should get access to the trial, especially given that the demand for PrEP may exceed the places available. Right now, the eligibility criteria for the trial will likely include:
* cis-and transgender men who have sex with men and transgender women who are HIV negative, report sex without condoms in the past 3 months, and consider that they will do so again in the next 3 months;
* the HIV negative partner of an HIV positive person when the positive partner is not known to be virally suppressed (i.e. has a detectable viral load), and sex without condoms is anticipated;
* other populations, not in the groups above, including those having heterosexual sex, who are clinically assessed and considered to be at similar high risk of HIV acquisition.
Many HIV prevention advocates, including PrEPster and IWPN, are pushing to ensure that participation on the trial is as diverse as possible. Recruitment to the trial will be accompanied by a communications strategy and we’re pushing for that communications strategy to ensure that key populations, including Black gay men; African communities, especially women; sex workers; and people who don’t have English as a first language, are informed about the trial and know how to enrol on it.
Unlike some of the recent PrEP trials, everyone who enrols on the trial will get real PrEP: there will be no placebo arm of the trial.
One of the biggest questions about the trial is whether it will recruit people outside of big cities like London. The trial organisers say that prescribing centres (i.e. trial sites) will be sexual health clinics and that these will be across England (the trial will only operate in England), including urban and rural sites. Despite rumours, no decision has yet been taken on the trial sites.
Disappointingly, the trial is unlikely to start recruitment until at least July 2017. Whilst is takes time to set up such trials, every month that goes by without the trial starting is another month when more avoidable HIV infections will happen.
We’ll be keeping a watchful eye on development of the trial – and will be making a noise if there are any further delays.
Meanwhile, IWPN has started a mailing list for those interested in enrolling on the trial. The list provides regular updates on the trial – it does not guarantee a place on the trial!