At the start of December 2016, NHS England announced funding for a large scale PrEP trial in England. The announcement said that the trial would be a joint initiative between NHS England and Public Health England (PHE), to start early in the 2017-2018 financial year, and that there would be at least 10,000 participants in the trial over the next three years.
When the announcement was made, PrEPster and iwantPrEPnow made a statement welcoming the trial. Since then, members of @teamprepster, along with other HIV prevention advocates, have attended meetings with PHE to help inform the trial.
As of the end of February 2017, the information we have on the trial is as follows:
- 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
- The trial protocols (the paper thats outline how the trial will be undertaken) have been submitted to the relevant regulatory bodies
- 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.
(N.B. wording above has been edited from the draft criteria)
- Recruitment to the trial will be accompanied by a communications strategy. HIV advocates are pushing to ensure that the communications strategy ensures 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 how to enrol on it.
- The trial in unlikely to start recruitment until at least July 2017
- Prescribing centres (i.e. trial sites) will be sexual health clinics across England. No decision has currently been taken on the trial sites and it is understood that sites will include urban and rural sites, in a range of clinics.
- There will be no placebo arm of the trial. That is: everyone who is provided with drug will be given real PrEP.
@teamPrEPster, and other HIV advocate groups, will be keeping a watchful eye on development of the trial, not least to ensure that there are no further delays to its implementation.