IMPACT trial

Bringing you information
on the new England PrEP IMPACT trial

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 it’s being co-ordinated by Public Health England (PHE).

Since that announcement, PrEPster and I Want PrEP Now (IWPN), along with other HIV prevention advocates, have attended meetings with PHE to help inform the trial. We will continue to engage as members of PHE’s Community Advisory Board.

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.

 

When?
The trial is due to commence “in the summer” of 2017.

We’re continuing to press NHSE and PHE for clarity on the start date. We’re concerned that the trial is already late in starting.

 

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.

 

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

Trial sites will be sexual health clinics across England. No final decision has been made on the trial sites and it is understood that sites will include urban and rural sites, in a range of 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?
There is currently no way of recruiting on to the site.

IWPN has started an email 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! https://www.iwantprepnow.co.uk/nhs-prep-trial

If you or someone you know thinks they need PrEP before the trial starts then find out how to buy PrEP online legally and safely HERE. Additionally, 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.

 

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.

Action to make this a diverse trial

HIV prevention advocates have raised concerns about how the trial will recruit a diverse group of people who need PrEP. Currently, PrEP is not available on the NHS in England and thousands of people are buying generic PrEP online. But to buy PrEP online you need the money to do so, and a safe address to have the PrEP delivered to – meaning that buying online is not an option for many people. That means that current PrEP use is skewed and only obtained by certain groups and networks of people – whilst others who might benefit from PrEP cannot easily get it.

 

A diverse trial should seek to include:

 

Gay and bisexual men in England have the highest incidence of HIV – and must continue to be key targets for PrEP education, awareness and access.
Black gay and bisexual men are twice as likely as white British men to have HIV. Research shows how they face barriers and obstacles to sexual health services in general and PrEP access in particular.
Over half the gay and bisexual men diagnosed with HIV were born outside the UK. Migrants have an enhanced vulnerability to HIV and face economic, cultural and language barriers to PrEP access and sexual health services.

 

African communities – especially those from sub-Saharan Africa – also have enhanced HIV incidence and would benefit from greater PrEP access. Yet many African women, for example, prefer to visit GPs (family doctors) for sexual health issues, rather than sexual clinics.
Some trans* people have enhanced vulnerability to HIV. Uncertainty about PrEP efficacy in trans* people and concerns about interaction with other medications, are among the obstacles to PrEP access.
Those who have little control over their sex lives and their sexual health – including people facing intimate partner violence – and those who find it hard to negotiate the sex that they want.

 

And thousands of people do not know that they are at risk of being exposed to HIV and who do not know that they could benefit from PrEP. This includes people who do not know about HIV risks, or do not believe or understand the sex they are having might expose them to HIV.

What could we do to build a diverse trial?

PrEPster, IWPN, and other HIV prevention advocates are pushing to ensure that the IMPACT trial’s communications strategy ensures that key populations are informed about the trial and know how they can enrol on it.

We think there are key actions that can be taken, especially by and through community organisations that are rooted in the communities that might benefit from PrEP.

 

These actions include:

 

Making links with GPs (family doctors) where key groups (such as African women) go for sexual health services and ensuring those GPs know about the trial.
Liaising with organisations that are not traditionally seen to do HIV prevention or sexual health work and telling them about the trial and how it might benefit the people they reach. This might include women’s advocacy organisations; refuges and hostels; gender based violence advocates; refugee, asylum and immigration organisations; drug and alcohol services; and youth organisations.
Community HIV prevention organisations linking with GPs and organisations (as above) and offering support directly to individuals considering starting on the trial. This might involve offering further face-to-face information and support; or offering to accompany participants to trial sites for enrolment and visits, or offering on-going support to trial participants.

 

Working with Gender Identity Clinics directly to inform them about the trial and the recruitment criteria, and build up better understanding of concerns about using PrEP - such as hormone interactions and evidence of PrEP efficacy in trans* people.
Building capacity in our community HIV prevention organisations so that volunteers and staff know about PrEP and the trial – especially smaller ones that reach populations that aren’t attending sexual health clinics or who will not see advertising for the trial.
Working with advocates in the adult sex industry to build knowledge about PrEP and how it might add additional protection during sex-without-condoms porn, for example.

 

Building alliances with others in the sex work industry to explore how PrEP might enable greater protection and control for some sex workers – especially those who have less control over their sex work.
Using the trial as a building block to educate about PrEP even if those reached do not go on the trial. Whilst PrEP is being talked about and used by urban gay men, the trial will be the first time that very many people learn about PrEP.
Ensuring that our activities to promote the trial over-serve sub-groups of people who might most benefit from PrEP but who might be least knowledgeable about it. This might include for example, Black and Asian gay men; younger people; and those not accessing commercial ‘scenes’ or gendered spaces or other spaces – such as faith communities – where much of the HIV prevention activity currently takes place.

 

Ensuring that information about the trial is available in languages other than English and in formats other than just written ones. This can include through talks and discussions, through short videos, radio programmes and through community targeted social media.