IMPACT trial

Bringing you information
on the new England PrEP IMPACT trial
- NEW UPDATE 27 OCTOBER 2017

At the start of December 2016, NHS England (NHSE) announced funding for a large scale PrEP trial in England. This is now called the IMPACT Trial and is being co-ordinated by Public Health England (PHE) and St Stephen’s AIDS Trust. On 3 August 2017, NHS England announced that procedures were in place for the Trial to start recruitment in September 2017. The Trial started recruitment in October 2017.

You can find our joint statement welcoming the trial HERE and the update we made in February 2017 HERE, along with PHE’s update HERE. Our statement from 3 August 2017 is HERE. PrEPster will continue to engage as members of the Trial’s Community Advisory Board.

The trial has released the following FAQs about the trial and at the Trial’s launch in October 2017, this website. As of October 2017, this is the most recent and up-to-date information available about the Trial.

When?
The first trial clinic started enrolling in October 2017 and all trial sites are expected to be enrolling participants by April 2018 at the very latest.

PrEPster will continue to push for all trials sites to start enrolment as soon as possible.

How many?
The trial will recruit at least 10,000 participants over three years. Participants must be over 16 to take part.

There will be no placebo arm of the trial. That is: everyone who is provided with drug will be given real PrEP.

How long?
Anyone recruited into the trial will need to attend their sexual health clinic trial site four times a year for as long as they are in the trial, in addition to a recruitment visit at the start of the trial.

The trial will start enrolling on a staggered basis. That is – not all clinics will open enrolment at the same time. Each clinic needs to undertake administrative processes and apply for local ethics approval before they can begin enrolment.

Where?
The trial is recruiting from urban and rural areas across England, in a range of clinics.

Trial sites will be sexual health clinics across England and it is expected that up to 200 clinics across England will take part. Details of participating clinics are on the IMPACT Trial website with status updates – including details of clinics that are closed to enrolment. PrEPster will also post regular updates on our Facebook page about enrolling clinics.

Only sexual health clinics will serve as trial sites. GPs (family doctors), community centres and voluntary organisations will NOT be trial sites (unless they offer a full sexual health service as part of their service centre).

How?
People interested in being part of the trial should contact their local clinic directly about involvement. Check the enrolment status of your clinic here.

There are eligibility criteria to be able to enrol on the trial (see below). That means that some current PrEP users and some people who want to use PrEP may not be allocated to the trial if they do not meet these criteria. PrEPster will continue to push for clinics to provide PrEP support services for people who are using PrEP but who do not get a trial place.

Each participating clinic will be allocated a set number of places for the trial. They will NOT be able to provide free PrEP once their allocated places are full. PrEPster, IWPN and other organisations are continuing to lobby NHS England for PrEP to be made available to everyone who is eligible and wants it. Check in with our TAKE ACTION page for ways to help make PrEP more widely available.

If the trial fills up – or someone wants PrEP but doesn’t meet the eligibility criteria – then buying online will remain one option of obtaining it. Find out how to buy PrEP online legally and safely HERE.

Who?
The current eligibility criteria will likely include (N.B. wording slightly edited from draft study protocol)

  • 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.