NHS PrEP Impact trial to double in size after gay men turned away

PrEP Impact trial: Man holding a pill used for Pre-Exposure Prophylaxis (PrEP) to prevent HIV infection (Stock photo) NHS England has backed plans to double the size of the PrEP Impact trial for HIV-preventing drugs, after gay and bisexual men were turned away from trial sites that reached capacity.

The health body proposed a massive expansion of the trial that gives at-risk groups access to Pre-Exposure Prophylaxis (PrEP) drug Truvada, which can drastically reduce the risk of being infected with HIV if taken daily.

Sexual health charities had warned that clinics are being forced to turn away people asking for PrEP, as the trial places allocated for men who have sex with men rapidly ran out in some parts of the country.

According to the PrEP Impact trial website , recruitment at 40 of the 135 trial centres is currently closed to gay and bisexual men. All of the sites remain open for other groups, including at-risk heterosexuals, trans men and trans women. NHS England: PrEP Impact trial uptake ‘exceeded initial expert predictions’

In a new statement on Friday, NHS England backed calls to double the number of places on the trial, making the HIV prevention pills available for a total of 26,000 people in England.

The initial trial had provided just 10,000 places, with a previous expansion taking the number of places available to 13,000.

NHS England said: “The speed of recruitment and demand for PrEP has significantly exceeded initial expert predictions.”

The body continued: “The trial researchers now consider that more places should be made available.

“They argue that recruitment needs to reach a ‘steady state’ in order to ensure the trial can robustly and scientifically inform the design and rollout of a full national programme in partnership with local authorities.”

The decision is set to be approved by the trial’s Programme Oversight Board on January 15. PrEP Impact trial: Man holding a pill used for Pre-Exposure Prophylaxis (PrEP) to prevent HIV infection. John Stewart, Director of Specialised Commissioning at NHS England said: “Through the PrEP trial, over 10,000 people are already receiving access to this important HIV prevention measure. “The trial researchers have submitted a case for increasing trial places and NHS England will play its part in delivering on this recommendation by committing to fund additional places in line with existing funding arrangements.

“This will help ensure the learning from the trial is robust enough to fully inform the planning of a national PrEP programme… for the future, as well as protecting more people from HIV right now.” HIV-preventing PrEP drugs must have ‘long-term home’

The announcement was welcomed by campaigners, who stressed that the drugs should be available to all who need them, as they are in Scotland.

Debbie Laycock, Head of Policy and Public Affairs at Terrence Higgins Trust, said: “We fully support the request and welcome NHS England’s commitment to ensure that significantly more people at risk of HIV in England are able to access PrEP.

“Now every effort must be made by all parties to ensure access to these additional places happens as soon as possible because PrEP has a crucial role to play in ending new HIV infections in the UK.”

Laycock added: “This decision will be a decisive moment on the road to giving PrEP a long-term home.” “We know of people who have been turned away from trial sites and then gone on to contract HIV.”

— Will Nutland, co-founder of PrEPster Will Nutland, co-founder of campaign group PrEPster said: “It became clear very early on that demand for the trial would rapidly outstrip the places available. We know of people who have been turned away from trial sites and then gone on to contract HIV.

“Given all the international evidence on the efficacy of PrEP it’s the right move for places on the Impact trial in England to be significantly increased, and PrEPster welcomes today’s commitment from NHS England.”