- June 2018 update
- March 2018 update
- January 2018 update
- November 2017 update
- September 2017 update
- June 2017 update
The PrEP Impact trial continues to recruit at pace with over 7,000 participants now recruited across 139 clinics. The Programme Oversight Board met on 26 April and 17 May and the following key issues were discussed:
- The Board received an update from the trial sponsor on the reallocation of places. This was an agreed action from the March Board meeting due to the fact that based on current recruitment rates it was not felt to be feasible to recruit 2,000 women and other people within the time period covered by the trial. The proposal was to reallocate approximately half of those places and this has now taken place. A number of these reallocated places are being held centrally by the trial Sponsor so that clinics can request more when they are approaching their allocation for places for gay and bisexual men. This meant that as of 17 May, of the 139 clinics participating in the trial, 138 are open to recruitment for gay and bisexual men. All bar one of the London clinics also remained open to recruitment.
- The board were updated by the trial Sponsor that after 30 years of research in the field of HIV/AIDS, the Trustees’ of St. Stephen’s AIDS Trust (SSAT) have decided to wind down SSAT and therefore also the subsidiary company St. Stephen’s Clinical Research (SSCR). The staff at SSAT/SSCR are currently working to ensure a seamless transfer of sponsorship of the trial to Chelsea and Westminster NHS Foundation Trust. The SSAT/SSCR team are continuing to deliver the trial in the interim period whilst arrangements to transfer the staff currently working on the trial across are completed. They should therefore continue to be the first point of contact for any queries. The Board received assurances that there will be no impact on the clinical delivery of the trial for participants or trial sites, all amendments will be primarily administrative. There would also be no impact on the supply of PrEP drug to current participants or delays in enrolling new participants as this was all being managed locally by individual clinics.
- The board received a proposal from the Trial Management Group to consider increasing the total number of places available for the trial from 10,000 to 13,000. The researchers consider that based on the data regarding the number and profile of those enrolled in the trial in the first six months, a greater number of participants is required to more accurately estimate the likely long term needs of a routinely commissioned PrEP programme. An increase in trial size will require resource commitments from commissioners. Local authority and NHS England commissioners were very supportive of the principle of an increase in the trial size. It was agreed that further work was required to finalise an agreement to increase the size. Given that across the country, places are still available to enroll new trial participants, the Board agreed to keep the situation under close review and ensure the final decision was taken as soon as possible after the transfer of sponsorship was complete. The Board agreed the final decision to increase the number of places could be taken by ‘Chairs action’ outside of a Board meeting if required.
- The Board received an update on work being led by members of the Community Advisory Board to raise awareness of PrEP particularly in women and other groups. Engagement events had taken place in Leeds and London with a range of attendees including GPs, sexual health service providers, community groups, prison workers and sex worker services. The feedback was very positive with the main take away messages being the need to integrate information about PrEP into the overall prevention messages, and the need for people to have more confidence in their own knowledge about PrEP to be able to do that. A full report from the events will be brought to a later Board meeting.
- The Board discussed the work to prepare for future commissioning arrangements. Commissioner members of the PrEP Oversight Board have met and identified key issues that will need to be addressed to progress the work. NHS England and local authorities will prepare for the work by compiling a list of their respective commissioning and contracting issues on which they need to take decisions and the data they will require to inform these decisions. This will help form the basis of a planning group that will be established to undertake the work on preparing for future commissioning. The first meeting of this group is expected to take place later in June.
The next meeting of the Board will take in July. A further update on progress will be shared after that meeting.
For further information on the trial please visit the trial website.
We are now five months on from the start of the PrEP Impact Trial and recruitment has reached the halfway mark with over 5,000 people across over 100 clinics enrolled on the trial and accessing PrEP as a result.
The PrEP Programme Oversight Board met on 22 February. The main item discussed at the Board was a proposal from the trial management group, developed with input from the trial’s Community Advisory Board to reallocate half of the approximately 2,000 trial places reserved for women and people from other high risk groups to gay and bisexual men. The reallocation was being proposed as it had become apparent since the trial started that the need amongst women and people from other high risk groups had been overestimated. Based on current recruitment rates and notwithstanding the work underway to raise awareness of PrEP in those groups, it would not be feasible to recruit 2,000 women and other people within the time period covered by the trial. The Board agreed to the reallocation proposal, and the revised allocations will be communicated to participating clinics by the trial sponsor as soon as possible.
The other main item discussed was a paper on potential future commissioning arrangements for PrEP. The Board agreed that given the speed at which the trial was recruiting it was important to start thinking about potential future commissioning arrangements now. The paper proposed the establishment of a new PrEP Commissioning Planning Group to plan the framework for the commissioning decisions to be made by NHS England and local authorities. The paper also set out the key issues that would need to be addressed to enable NHS England and local authorities to take the decisions on potential future PrEP commissioning for which they were responsible. Members discussed the proposed membership and raised the importance of ensuring service users and lay representatives were involved. The Board welcomed the paper and agreed that NHS England and local authority Board members would develop the proposals further, and report back at the next Board meeting which is in April. A further update will follow after that meeting.
For further information on the trial please visit the trial website
The PrEP Impact Trial continues to make good progress with over 3,200 participants enrolled in the first 12 weeks and over 65 clinics now open across a wide geographical area and in a number of towns and cities across England.
The PrEP Programme Oversight Board – which has representation from Local Authorities, Directors of Public Health, Public Health England, NHS England and lay members – had its latest meeting just before Christmas. The Board received a detailed update in the form of a dashboard from the trial sponsor and trial management group on participant recruitment and site allocations and continues to closely monitor progress.
The Board held further discussions on a set of principles to guide a process for re-allocating places between sites should there be higher than expected volumes of people wanting to participate in the trial in some areas and amongst certain groups. This work is continuing and the input of community groups through the Trial’s Community Advisory Board is proving to be invaluable. The Board agreed to review and further consider the principles at its February meeting once further work had been done on the proposals by the Trial Management Group.
Other key issues raised and discussed at the Board included:
- Approval to proceed with a piece of work to map activities being undertaken to raise awareness of PrEP, in particular amongst women, trans and Black African people who may be at high risk of HIV infection and to undertake further awareness raising work in the Spring/Summer to fill any gaps. This work will be led by community groups and lay representatives.
- A decision to update the trial website to make it clearer which sites were recruiting particular groups of participants.
- Further work on communications, and that the Frequently Asked Questions will be refreshed. The Board agreed that the key way for people to register for updates on the trial would be though the NHS England HIV Clinical Reference Group Stakeholder registration process. The trial website will link to these updates and the FAQs
- A review of the draft statistical plan for the trial which set out how data from and about the trial will be collected and reported. The Board made a number of suggestions for how this could be developed further.
The next Board meeting will be on 22 February and a further update will follow after that meeting.
For further information on the trial please visit the trial website.
Over a month on from the PrEP Impact trial starting to enroll its first participants, good progress is being made with over 1,900 people now enrolled on the trial and receiving PrEP.
Over 35 clinics including sites in London, Brighton, Cambridge, Norwich, Leicester, Nottingham, Sheffield, Leeds, Manchester, Liverpool and Durham are now open for trial recruitment. All participating clinics are expected to open by April 2018.
An up to date list of participating clinics can be found on the trial website where people can find out if their local clinic is open to recruitment.
Most sexual health clinics are expected to take part in the trial, so people will be able to enroll at a local clinic when it’s ready. In order to avoid people travelling long distances to access PrEP, we are currently working with clinics and community groups to ensure everyone has the latest information on the trial and is aware that clinics across the country will be opening soon.
The PrEP Oversight Board held its latest meeting on 15 November where it welcomed Florence Labwo, the third lay member to join the group following a recent recruitment process. Florence brings over 20 years’ experience as a health and well-being advocate, specialising in sexual and public health and has worked extensively in the field of HIV prevention and support in East London.
Issues raised and discussed at the Board included:
- An update from the trial Sponsor on progress so far with participant recruitment and site openings, along with future projections.
- An update on work to define the principles which will guide any future re-allocation of trial places, in the event of some clinics quickly filling their allotted places.
- An update from lay representatives which included a request for the website to include information on when a trial site has reached its full allocation of places for gay and bisexual men, but where there are still places available for other groups.
- An update from Local Authority commissioners who raised the importance of regular communication between the trial organisers and local sites to help address local issues or problems that might arise.
- The need for the Board to continue to receive frequent updates on trial progress given that recruitment was taking place very quickly. In future a dashboard will be produced showing progress against key objectives and to help actively manage the allocation of places between sites and different participant groups.
- The need for continued regular communication from the Board to stakeholders – it was agreed that going forward, stakeholder updates would be sent out within one week of Board meetings where possible.
- A request for a proposal to come to the next meeting on raising awareness of the trial in groups other than gay and bisexual men, to ensure that as diverse a range of participants can be recruited to the trial as possible.
- An update on the launch of Public Health England’s HIV Prevention Innovation Fund which includes a number of projects related to PrEP.
The Board will meet again on 19 December and a further update will follow after that date.
For further information on the trial please visit the trial trial website.
Since the last meeting, the multi-agency stakeholders involved in this trial have been working hard to put all the building blocks in place to enable the coordinated opening of the first trial sites across five major cities.
We had hoped everything would be in place for the trial to launch in early September. Unfortunately, it has not quite been possible to complete all the necessary steps to achieve this which we know will be disappointing for all those eager to participate in this important research. We are working hard with all partner organisations to put the remaining pieces of the jigsaw into place and whilst we hope the first clinics will open their doors in the next couple of weeks we are confident that the trial will be up and running by the end of October.
As the largest single study of its type in the world, the PrEP trial is complex, involving well in excess of 100 organisations ranging from sexual health clinics, local authority commissioners, research bodies, a drug manufacturer, as well as NHS England and Public Health England. The key building blocks to getting the trial off the ground are:
- Obtaining ethical approval of the clinical trial protocol (completed)
- Ensuring the drug supply is ready for distribution (completed)
- Completing trial site feasibility assessments (completed)
- Training of trial sites in trial protocol and associated activities (launched and ongoing)
- Individual trial sites securing local commissioner approval for participation in research (in progress)
- Individual trial sites securing local research governance assurance sign off (in progress)
Commissioners and researchers are agreed on the importance of having a good geographical spread of trial sites right from the start, particularly to manage potential demand in the early days. That is why the St Stephen’s Clinical Research (SSCR) trial team having been focusing efforts on making sure trial sites across London, Brighton, Manchester, Liverpool and Sheffield, coordinate to be amongst the first to open their doors to potential participants. The remaining clinics across the rest of the country will follow closely behind over the next few months.
The trial website will be continually updated with information on which clinics are involved and ready to enrol participants and we will continue to provide stakeholder updates to inform people of progress.
New lay members of the Board
The Board is delighted to welcome Roger Pebody and Rob Cookson as lay representatives, following the recruitment process led by NHS England and PHE.
Roger has been an Editor at NAM / aidsmap since 2008, producing patient information materials, as well as information for professionals on HIV prevention and the social impact of HIV. He is currently a member of UK-CAB, a network for community HIV treatment advocates in the UK, and co-chair of the community advisory group for the SELPHI study of self-testing. He was also a member of the community engagement group for the PROUD study of pre-exposure prophylaxis.
Rob Cookson has worked at LGBT Foundation for 10 years and was appointed Deputy Chief Executive in 2015. He has been involved in the GM Sexual Health Network and HIV Prevention England as a board member, and having worked within the voluntary and community sector for 18 years, he brings a wealth of experience in patient and public involvement.
The Board agreed that it will appoint a third lay member to represent participants from other community groups that are expected to enrol in the trial, including BME, women and transgender groups. For an application pack please email firstname.lastname@example.org.
We continue to make progress preparing for the pre-exposure prophylaxis (PrEP) Impact Trial. The work being undertaken now will provide a solid base to deliver a robust study. The PrEP Programme Oversight Board provides governance to make sure the PrEP trial is as good as it can be and that it progresses as planned.
The Board met on 5 May and 2 June 2017, and the following key points were discussed:
- To ensure the trial is robust, plans including the protocol, financial impact and measurement of results were shared with the National Institute for Health Research (NIHR) for their input. Their constructive feedback at the June meeting will be incorporated into the final plans.
The Programme Oversight Board subsequently approved the trial protocol and budget, subject to consideration and, where appropriate, inclusion of NIHR’s suggestions, and once finalised the protocol will be submitted to a Research Ethics Committee for approval.
NIHR will continue to attend future meetings as advisors to the Board.
- A timeline for next steps will be produced by the trial team, co-ordinated by St Stephen’s Clinical Research, part of St Stephen’s AIDS Trust, who are working with researchers to co-ordinate and lead the trial.
- NHS England emphasised that the PrEP trial is a top priority for the organisation and is leading the drug procurement for the trial. A pre-tender procurement supplier event was held in April, which was well attended by a number of manufacturers. Because of the value of the contract, EU procurement rules apply and as such the formal Prior Information Notice (PIN) was published in the Official Journal of the European Union on 30 May 2017. The PIN invites interested parties to submit applications to provide the drug for the trial. NHS England expects to be able to confirm the award of the final contract by 31 July 2017, meaning trial drugs could be available from early August, in readiness for the trial to begin once ethics approval is received and trial sites are prepared.
- Budget discussions focused on the maximum sum available (up to £10m) and the research and drugs costs.
- Public Health England reported that all specialised genitourinary medicine clinics (i.e. level 3 sexual health clinics) were written to with information on the trial and have received notification from only one clinic to opt out. All other respondents have demonstrated a willingness to be included as a trial site.
- The importance of including laypeople at all levels of governance and decision- making was discussed and agreed. A recruitment process is underway to ensure lay representation at future meetings of the PrEP Programme Oversight Board and any working groups. Paul Martin of the LGBT Foundation has agreed to be an interim lay member until appointments are made.
- The need to ensure regular communications with stakeholders was discussed and the Board committed to producing an update following each meeting. A frequently asked questions document to address some of the more detailed queries that have been received will be available shortly.
The PrEP Programme Oversight Board will meet again in July and an update will follow.