{"id":80600,"date":"2017-04-10T09:23:00","date_gmt":"2017-04-10T09:23:00","guid":{"rendered":"http:\/\/mostafa.openonline.co.uk\/?guid=ffd20b7e9e5e058aff7d9c41a42d10f7"},"modified":"2017-11-28T11:48:08","modified_gmt":"2017-11-28T11:48:08","slug":"government-response-update-on-prep-impact-trial-in-england","status":"publish","type":"post","link":"https:\/\/mostafa.openonline.co.uk\/?p=80600","title":{"rendered":"News story: Update on PrEP Impact trial in England"},"content":{"rendered":"<p><em>Updated:<\/em> Added latest update.<\/p>\n<div class=\"govspeak\">\n<h2 id=\"latest-update\">Latest update<\/h2>\n<p>A month on from the <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> 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 <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr>.<\/p>\n<p>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.<\/p>\n<p>An up to date list of participating clinics can be found on the <a rel=\"external\" href=\"https:\/\/www.prepimpacttrial.org.uk\/\">trial website<\/a> where people can find out if their local clinic is open to recruitment.<\/p>\n<p>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\u2019s ready. In order to avoid people travelling long distances to access <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr>, 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.<\/p>\n<p>The <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> Oversight Board held its latest meeting on 15 November 2017 where it welcomed Florence Labwo, the third lay member to join the group following a recent recruitment process.  Florence brings over 20 years\u2019 experience as a health and well-being advocate, specialising in sexual and public health and has worked extensively in the field of <abbr title=\"Human immunodeficiency virus\">HIV<\/abbr> prevention and support in East London.<\/p>\n<p>Issues raised and discussed at the Board included updates:<\/p>\n<ul>\n<li>from the trial Sponsor on progress so far with participant recruitment and site openings, along with future projections<\/li>\n<li>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<\/li>\n<li>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<\/li>\n<li>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<\/li>\n<li>about 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 the main objectives and to help actively manage the allocation of places between sites and different participant groups<\/li>\n<li>about the need for continued regular communication from the Board to stakeholders \u2013 it was agreed that going forward, stakeholder updates would be sent out within one week of Board meetings where possible<\/li>\n<li>about the 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<\/li>\n<li>on the launch of <abbr title=\"Public Health England\">PHE<\/abbr>\u2019s <abbr title=\"Human immunodeficiency virus\">HIV<\/abbr> Prevention Innovation Fund which includes a number of projects related to <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr>\n<\/li>\n<\/ul>\n<p>The Board will meet again on 19 December 2017 and a further update will follow after that date.<\/p>\n<p>For further information on the trial, visit the <a rel=\"external\" href=\"https:\/\/www.prepimpacttrial.org.uk\/\">trial website<\/a>.<\/p>\n<h2 id=\"previous-updates\">Previous updates<\/h2>\n<h3 id=\"october-2017\">3 October 2017<\/h3>\n<p>An update on the <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> trial following the Oversight Board meeting on 5 September 2017 is available on the <a rel=\"external\" href=\"https:\/\/www.england.nhs.uk\/commissioning\/spec-services\/npc-crg\/blood-and-infection-group-f\/f03\/prep-trial-updates\/\">NHS England website<\/a>.<\/p>\n<p>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 5 major cities.<\/p>\n<p>We had hoped everything would be in place for the trial to launch in early September 2017. It has not been possible to complete all the necessary steps to achieve this. We know this will be disappointing for all those eager to participate in this important research.<\/p>\n<p>We are working hard with all partner organisations to put the remaining pieces of the jigsaw into place. We hope the first clinics will open their doors in the next couple of weeks and are confident that the trial will be up and running by the end of October 2017.<\/p>\n<h3 id=\"august-2017\">21 August 2017<\/h3>\n<p>A list of questions and answers on the <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> impact trial is available on the <a rel=\"external\" href=\"https:\/\/www.england.nhs.uk\/commissioning\/spec-services\/npc-crg\/blood-and-infection-group-f\/f03\/prep-impact-trial-questions-and-answers\/\">NHS England website<\/a>.<\/p>\n<h3 id=\"july-2017\">26 July 2017<\/h3>\n<p>Two important meetings have taken place since our last update in June.<\/p>\n<p>On 29 June, the trial\u2019s Community Advisory Board met in London. The group is made up of representatives from community and voluntary groups representing people living with <abbr title=\"Human immunodeficiency virus\">HIV<\/abbr> and experts in <abbr title=\"Human immunodeficiency virus\">HIV<\/abbr> treatment and prevention.<\/p>\n<p>The group was originally set up to provide <abbr title=\"Public Health England\">PHE<\/abbr> with advice around the co-ordination of an <abbr title=\"Human immunodeficiency virus\">HIV<\/abbr>&#8211;<abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> public health implementation pilot. The group agreed that, now a large scale trial was being set up, it would become more focussed on providing advice and assurance to the trial. As well as a discussion about its future role and membership, the group:<\/p>\n<ul>\n<li>received an update on progress with setting up the trial<\/li>\n<li>reviewed and commented on the communications plan for the trial<\/li>\n<li>made a number of suggestions about how to ensure the trial engages effectively with communities represented by members and also those communities that may be less engaged with services<\/li>\n<\/ul>\n<p>On 14 July, the <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> Programme Oversight Board met. The Board received an update on progress with the trial drug procurement &#8211; a number of bids had been received by the closing date and these were now being reviewed in advance of a preferred bidder being selected. Timescales were on track to appoint a supplier by the beginning of August.<\/p>\n<p>The Board also received an assurance that the ethics committee approval was on track and that feedback on the trial budget had been addressed.<\/p>\n<p>The Board reviewed and discussed plans to ensure the readiness of <abbr title=\"Genitourinary medicine\">GUM<\/abbr> clinics participating in the trial. It was accepted that some clinics would be ready to start providing <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> sooner than others. However, members of the Board stressed the importance of ensuring that the first wave of participating clinics covered as wide a geographical area as possible and that other clinics came on stream as soon as possible afterwards.<\/p>\n<p>Finally, the Board agreed a set of <a rel=\"external\" href=\"https:\/\/www.england.nhs.uk\/commissioning\/spec-services\/npc-crg\/blood-and-infection-group-f\/f03\/prep-impact-trial-questions-and-answers\/\">questions and answers<\/a> to provide an update on trial progress to be sent out to stakeholders alongside the July stakeholder update. The list of questions and answers will be available on the trial website once it is operational. The next meeting of the Oversight Board is on 3 August and a further update will be provided in due course.<\/p>\n<p>For further information on the trial, please contact <a href=\"mailto:prepimpacttrial@ststcr.com\">prepimpacttrial@ststcr.com<\/a>.<\/p>\n<h3 id=\"june-2017\">20 June 2017<\/h3>\n<p>We continue to make progress preparing for the pre-exposure prophylaxis (<abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr>) Impact trial. The work being undertaken now will provide a solid base to deliver a robust study.  The <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> Programme Oversight Board provides governance to make sure the <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> trial is as good as it can be and that it progresses as planned.<\/p>\n<p>The Board met on 5 May and 2 June 2017, and below is an update on some of the main things that were discussed.<\/p>\n<p>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 (<abbr title=\"National Institute for Health Research\">NIHR<\/abbr>) for their input. Their constructive feedback at the June meeting will be incorporated into the final plans.<\/p>\n<p>The Programme Oversight Board subsequently approved the trial protocol and budget, subject to consideration and, where appropriate, inclusion of <abbr title=\"National Institute for Health Research\">NIHR<\/abbr>\u2019s suggestions, and once finalised the protocol will be submitted to a Research Ethics Committee for approval.<\/p>\n<p><abbr title=\"National Institute for Health Research\">NIHR<\/abbr> will continue to attend future meetings as advisors to the Board.<\/p>\n<p>A timeline for next steps will be produced by the trial team, co-ordinated by St Stephen\u2019s Clinical Research, part of St Stephen\u2019s AIDS Trust, who are working with researchers to co-ordinate and lead the trial.<\/p>\n<p>NHS England emphasised that the <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> 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 2017, 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 (<abbr title=\"Prior Information Notice\">PIN<\/abbr>) was published in the Official Journal of the European Union on 30 May 2017. The <abbr title=\"Prior Information Notice\">PIN<\/abbr> 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.<\/p>\n<p>Budget discussions focused on the maximum sum available (up to \u00a310 million) and the research and drugs costs.<\/p>\n<p><abbr title=\"Public Health England\">PHE<\/abbr> reported that all specialised genitourinary medicine clinics (that is, 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.<\/p>\n<p>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 <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> Programme Oversight Board and any working groups. Paul Martin of the <abbr title=\"Lesbian, gay, bisexual and transgender\">LGBT<\/abbr> Foundation has agreed to be an interim lay member until appointments are made.<\/p>\n<p>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.<\/p>\n<p>The <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> Programme Oversight Board will meet again in July 2017 and an update will follow.<\/p>\n<p>Contact <a href=\"mailto:prepimpacttrial@ststcr.com\">prepimpacttrial@ststcr.com<\/a> for further information on the trial.<\/p>\n<h3 id=\"april-2017\">10 April 2017<\/h3>\n<p>Considerable progress has been made in preparing for the <a href=\"https:\/\/www.gov.uk\/government\/news\/nhs-england-and-phe-extend-hiv-prevention-programme\"><abbr title=\"Human immunodeficiency virus\">HIV<\/abbr> pre-exposure prophylaxis (<abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr>) trial<\/a> that was announced by NHS England and <abbr title=\"Public Health England\">PHE<\/abbr> last December as a major extension to the  <a rel=\"external\" href=\"https:\/\/www.hivpreventionengland.org.uk\/about\/\">national <abbr title=\"Human immunodeficiency virus\">HIV<\/abbr> prevention programme<\/a>. The trial, called the <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> Impact Trial, will include at least 10,000 participants over the next 3 years and will answer important outstanding questions on the extent of need, uptake and duration of use of <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> in the setting of sexually transmitted infection (<abbr title=\"sexually transmitted infection\">STI<\/abbr>) clinics in England. Our aim is to have the trial started by the summer of 2017.<\/p>\n<p>The trial protocol is complete, trial participant eligibility criteria have been endorsed by experts in the field and by community representatives, and independent peer review has been conducted. The Medicines and Healthcare products Regulatory Agency (<abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr>) has been consulted about trial categorisation and a relevant opinion received.  Submission for ethics committee approval is imminent.<\/p>\n<p><abbr title=\"sexually transmitted infection\">STI<\/abbr> clinic attendees considered to be at high risk of acquiring <abbr title=\"Human immunodeficiency virus\">HIV<\/abbr> will be eligible to participate in the trial. Heterosexual and transgender individuals and gay men will be clinically risk-assessed as part of combination prevention and those at high risk offered <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr>. To ensure equity of access across the country, the trial sites will include as many as possible of the over 200 level-3 <abbr title=\"sexually transmitted infection\">STI<\/abbr> clinics.<\/p>\n<p>A number of <abbr title=\"sexually transmitted infection\">STI<\/abbr> clinics have expressed an interest in joining the trial. Site participation standards are being finalised and all level-3 <abbr title=\"sexually transmitted infection\">STI<\/abbr> clinics will be written to in the next 2 weeks enquiring about capacity, willingness to meet the standards and to be a trial site.  The likely trial site and per-participant costs are being assessed prior to detailed discussion with the trial management team which will include <abbr title=\"sexually transmitted infection\">STI<\/abbr> service provider representation.<\/p>\n<p><abbr title=\"Public Health England\">PHE<\/abbr>\u2019s Prevention Innovation Fund in 2017 to 2018 is seeking proposals that will address knowledge, awareness and understanding of <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> and other <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> related questions, especially in currently under-served populations in the community (e.g. higher-risk heterosexuals, black and minority ethnic group gay men and transgender communities).  To register interest in the fund please send an email with your name, email address and organisation name to <a href=\"mailto:hiv.prevention@phe.gov.uk\">hiv.prevention@phe.gov.uk<\/a>.<\/p>\n<p><abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> drug supply will be paid for and secured by NHS England.  Competitive procurement has begun and all relevant supplier-manufacturers have been written to.  A market engagement meeting is scheduled for later in April as part of this process.<\/p>\n<p>Overarching governance arrangements, in the form of a <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> Programme Oversight Board with joint leadership from <abbr title=\"Public Health England\">PHE<\/abbr> and NHS England, is in place to support the trial and to use the findings to prepare for a subsequent <abbr title=\"pre-exposure prophylaxis\">PrEP<\/abbr> programme.  Membership includes the Local Government Association (<abbr title=\"Local Government Association\">LGA<\/abbr>) and the Association of Directors of Public Health (<abbr title=\"Association of Directors of Public Health\">ADPH<\/abbr>).<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>In response to stakeholders, Public Health England (PHE) and NHS England have published an update on the PrEP Impact trial.<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"_links":{"self":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/80600"}],"collection":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=80600"}],"version-history":[{"count":5,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/80600\/revisions"}],"predecessor-version":[{"id":86725,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/80600\/revisions\/86725"}],"wp:attachment":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=80600"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=80600"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=80600"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}