Prevention Programme - Microbicides.

Lead Research Organisation: University College London

Abstract

The focus of this programme is to develop female controlled methods to prevent HIV which are safe, effective and affordable. |This large project brings together several experts in a partnership across Europe and Africa in the microbicide field. A microbicide is a product used vaginally to prevent infection by HIV or other sexually transmitted infections (STIs). A particular microbicide (PRO 2000/5) was selected after being tested in the laboratory and tested for safety. Once found to be safe, studies were undertaken by African partners to prepare for a large trial. This multi-centre Phase III trial began in October 2005 and recruitment closed in August 2008. 9385 women were enrolled from the following sub-Saharan African sites, in South Africa (Johannesburg, Soweto and Orange Farm, Durban, Tongaat, Verulam Isipingo, Africa Centre), Tanzania (Mwanza), Uganda (Masaka), Zambia (Mazabuka). The last visit took place in September 2009. Unfortunately, we demonstrated conclusively that PRO 2000/5 vaginal gel did not prevent HIV infection. This was disappointing as promising results were reported earlier in 2009 in an independent smaller trial, which we now know were due to chance.|We are now concentrating on the more potent anti-retroviral microbicides (anti-retrovirals are specific for HIV and used for treatment).

Technical Summary

The focus of this programme is to develop female controlled methods to prevent HIV which are safe, effective and affordable. |In the absence of an effective vaccine to prevent the spread of HIV-infection and the continuing HIV pandemic, which is particularly devastating in sub-Saharan Africa there is an urgent need to develop alternative methods of prevention. Women in sub-Saharan Africa are particularly vulnerable being unable in most instances to negotiate the use of condoms with their partners. |A central objective is the development and clinical assessment of candidate microbicides for the prevention of vaginally acquired HIV infection. The CTU is jointly co-ordinating the multi-disciplinary Microbicides Development Programme with Imperial College at St Marys Hospital, London.||The initial work focused on testing the safety of 2 candidate microbicides both in Europe (Antwerp and the UK) and in Africa (Uganda). In parallel to these trials, Feasibility studies were conducted in 6 African sites, to inform the design and size of a Phase 3 trial to assess two active products. A short Pilot study using placebo gel was conducted to validate the procedures planned for the main trial, and a final evaluation of the pre-clinical and clinical data was performed in August 2004 to select the product and concentration. A large Phase 3 trial of low and hig dose PRO 2000/5 vaginal gel began recruiting in 2005. CTU coordinated the development of the protocol, case record forms, database, monitoring, analyses and oversight (Trial Management Group, Trial Steering Committee and Data and Safety Monitoring Committee meetings).||Between October 2005 and August 2008 9385 women were enrolled from the following sub-Saharan African sites, in South Africa (Johannesburg, Soweto and Orange Farm, Durban, Tongaat, Verulam and Isipingo, Africa Centre), Tanzania (Mwanza), Uganda (Masaka), and Zambia (Mazabuka). Women were followed for at least 12 months (up to 24months in Uganda) and were asked to insert the gel pre-sex.||The trial assessed two doses of PRO2000/5 (2% and 0.5%) each in comparison with a placebo. In February 2008 the 2% gel was discontinued on the recommendation of the Independent Data Monitoring Committee as there was no more than a small chance of demonstrating benefit according to the original statistical plan.||Recruitment closed on the 15th of August 2008 and follow up will continue until August 2009. The study database was locked on the 1st November 2009 and the results were reviewed by the Senior Investigators, Trial Steering and Independent Data Monitoring Committees as well as two independent referees appointed by MRC prior to release of the result in December 2009. Unfortunately neither 0.5% nor 2% PRO 2000/5 reduced the incidence of HIV when compared to placebo gel.||The next scientific questions are focused around the more potent anti-retroviral microbicides, and MDP is preparing for the results of the CAPRISA 004 trial of tenofovir 1% vaginal gel which will report in July 2010. In anticipation of significant but moderate protection we are conducting a further pilot of daily placebo gel, the Top-Up study in 5 sub-Saharan countries: Uganda (Masaka), Tanzania (Mwanza), South Africa (Durban), and Zambia (Mazabuka) all of which participated in the Phase 3 trial, plus Mozambique (Maputo and Manhica) where they have successfully completed a Feasibility study. Three methods of collecting in the used applicators are being explored: daily, weekly and every 4 weeks at the clinic visits. Top-Up has been enrolling since June 2010 and is expected to report early 2011.

Organisations

Publications

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Baeten J (2016) Welcome to the preexposure prophylaxis revolution. in Current opinion in HIV and AIDS

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Cairns G (2016) The European preexposure prophylaxis revolution. in Current opinion in HIV and AIDS

 
Title Alien Sex Club Exhibition, Liverpool, 21st Nov. 2015 - event artist Susanna Hewlett, event scientist Prof. Sheena McCormack 
Description Multi-artistic product which was created by John Walter who is funded by Wellcome Trust to do a PhD. The exhibition is entitled the Alien Sex Club and there were two main exhibitions, one in London and one in Liverpool. 
Type Of Art Artistic/Creative Exhibition 
Year Produced 2015 
Impact Raising awareness of HIV, STIs, PrEP 
 
Title CHAARM video filming - 28th April 2014 
Description An explanatory video has been produced with the aim of presenting the CHAARM project and its main goal. It explains what are microbicides and it shows why is important to develop alternative prevention methods, such as new combination of microbicides, for controlling the risk of HIV infection. Professor Sheena McCormack is featured in the video. 
Type Of Art Film/Video/Animation 
Year Produced 2014 
Impact This film aimed to increase the profile of microbicides in Europe. 
URL http://chaarm.eu/content/newsroom
 
Title Contribution to video filming to feature on MRC CTU at UCL website 
Description Professor Sheena McCormack featured in the video 'The Gold Standard: What are randomised controlled trials and why are they important?' available at http://www.ctu.mrc.ac.uk/resources/multimedia/ 
Type Of Art Film/Video/Animation 
Year Produced 2014 
Impact The film aimed to broaden understanding of clinical trials for lay and non-expert audiences. 
URL http://www.ctu.mrc.ac.uk/resources/multimedia/
 
Title Filming for Goldsmith's University BA Media student graduation documentary, 13th Jan. 2014 
Description This was a documentary created by students and built around the personal experience of a close friend of theirs who had recently been diagnosed with HIV and who was considering participation in a research study. 
Type Of Art Film/Video/Animation 
Year Produced 2014 
Impact The film was well received at the graduation ceremony. 
 
Title PROUD documentary and Voices of Participants premiere 1st July 2015, The Cinema Museum, SE11, London. 
Description PROUD documentary and Voices of Participants premiere, The Cinema Museum, SE11, London. Launched 1st July 2015 
Type Of Art Film/Video/Animation 
Year Produced 2015 
Impact Raising awareness of PrEP amongst gay men and promoting debate. The film was also produced for German audiences with subtitles. 
URL https://vimeo.com/132412294
 
Title Participation in making of 'PrEP17' film 'The coming of age of PrEP' a film by Nicholas Feustel 
Description Film and participation in public discussions about the use of PrEP in MSM, under the banner of 'PrEP17: The coming of age of PrEP'. Film showing / discussion events in the UK/internationally as a follow-on from the PROUD trial documentary and Voices of Participants films, capturing the widespread use of PrEP obtained via the internet (self-purchased) and the contribution of this to declining HIV infections in gay men. 
Type Of Art Film/Video/Animation 
Year Produced 2017 
Impact Increased education of PrEP in the community resulting in increased access to PrEP by those who could afford to purchase their own, and increased agitation for access via the health service. Importantly the film portrayed the accelerated decline in new HIV infections that has followed increasing confidence in and use of PrEP that was sparked off by the PROUD study result. 
URL http://prepster.info/prep17/
 
Description 'PEP and PrEP: the science behind the strategies', NHIVNA Study Day, 6th March 2013, London
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
Impact Empowered clinical nurse specialists to talk to their HIV positive patients about treatment as prevention.
 
Description ADPH (Association of Directors of Public Health) / PHE Sexual Workshop, St. Bride's Foundation, Fleet Street, 5th October 2015, attended by Prof. Sheena McCormack
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
Impact PROUD was particularly relevant to this audience of public health experts who will influence the implementation in the event that the NHS approves PrEP. PROUD and IPERGAY were two trials conducted in men who have sex in men, in UK and France respectively. Both showed that Truvada was extremely effective at preventing HIV, whether given daily or before and after sex, and both had very high rates of HIV in the control group - much higher than expected based on surveillance data. The trials reported in 2015, and caused tremendous excitement amongst the clinical community and MSM. Disseminating these results to Directors of Public Health was crucial to preparing them for a national PrEP programme.
 
Description Chelsea & Westminster Directorate teaching session, 15th July 2015 PROUD and PrEP in clinic
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
Impact Chelsea and Westminster Hospital (CWH) Directorate teaching session, 15th July 2015 The CWH clinics see a large number of HIV negative men who have sex with men, and were a key partner in the PROUD study recruiting more than 1 in 5 of the study participants. The results of the PROUD study revealed a sub-population of MSM with particularly high HIV incidence, in whom PrEP was extremely effective. Ever since the results were reported in February 2015 MSM have been coming into clinics requesting PrEP. Following my talk, the Dean Street team decided to launch a PrEP clinic to see what the demand was. This started in September 2015 and has been fully booked since launch.
 
Description European AIDS Clinical Society (EACS) guidelines v8 presented at Barcelona, 22-23 Oct. 2015.
Geographic Reach Multiple continents/international 
Policy Influence Type Membership of a guideline committee
Impact Version 8 of the clinical guidelines contained guidance on pre-exposure prophylaxis for the first time. Professors Molina and McCormack were invited to join the committee to draft this section.
URL http://www.eacsociety.org/guidelines/eacs-guidelines/eacs-guidelines.html
 
Description European PrEP Group
Geographic Reach Asia 
Policy Influence Type Influenced training of practitioners or researchers
Impact This group was initiated and is coordinated by Sheena McCormack to provide a forum for exchange of knowledge and sharing tools (surveys, data collection forms, protocols etc) in order to accelerate research into pre-exposure prophylaxis (PrEP) in Europe. Although there have been multiple clinical trials assessing PrEP, none of these were conducted in European populations prior to 2012 when iPerGay and PROUD launched in France and the UK.
 
Description Minister for Public Health visited 56 Dean Street, 16th July 2015
Geographic Reach National 
Policy Influence Type Implementation circular/rapid advice/letter to e.g. Ministry of Health
Impact Minister of Public Health for England and Wales visited 56 Dean Street and Dean Street Express to see how efficient the screening service is now that it is automated with the largest CEPHEID machine in Europe in situ in the Express, 16th July 2015. Opportunity to explain that behaviour takes a long time to change, but in the meantime we can reduce the time from diagnosis to treatment, and PrEP can reduce the risk of HIV whilst people are in a period of risk.
URL http://www.chelwest.nhs.uk/services/hiv-sexual-health/clinics/dean-street-express
 
Description PROUD Briefing paper Pre-exposure Prophylaxis to prevent HIV among MSM in the UK, Sept 2015
Geographic Reach National 
Policy Influence Type Implementation circular/rapid advice/letter to e.g. Ministry of Health
Impact PROUD was a game changer for PrEP for two reasons. Firstly Truvada was more effective at preventing HIV in this open-label trial than in previously reported placebo-controlled trials, and secondly the trial schedule mirrored routine practice with quarterly visits, whereas previous trials had followed a monthly schedule. The study was conducted in men who have sex with men attending sexual health clinics in England. Policy work is ongoing towards an NHS decision in June 2016.
URL http://www.proud.mrc.ac.uk/97173/97177/proud_results_policy_brief_final
 
Description PROUD presentation, Dean Street clinic, 11th June 2014
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
Impact Increased awareness of PrEP and facilitated referral of gay men at risk of acquiring HIV for behavioural interventions.
 
Guideline Title WHO PrEP Implementation guidelines (draft)
Description PROUD trial citation in WHO PrEP Implementation guidelines, 2015
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in clinical guidelines
Impact PROUD was a game changer for PrEP for two reasons. Firstly Truvada was more effective at preventing HIV in this open-label trial than in previously reported placebo-controlled trials, and secondly the trial schedule mirrored routine practice with quarterly visits, whereas previous trials had followed a monthly schedule. The study was conducted in men who have sex with men attending sexual health clinics in England.
URL http://www.proud.mrc.ac.uk/97173/97177/report_on_public_involvement_meetings_with_prep_users_enrolle...
 
Description Presentation on PROUD at BASHH / PHE Ordinary General Meeting (OGM), 13th March 2015 (David Dolling)
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
Impact This was the first national presentation following the public release of the results of the PROUD study at an international conference the month before. The results had a considerable impact on practitioners for two reasons. Firstly the rate of HIV was much higher than expected based on routine clinic data, demonstrating that the men who came forward to take part were exactly who we should be giving PrEP to. Secondly, PrEP proved extremely effective at preventing HIV, in spite of high levels of other sexually transmitted infections which the clinical community suspected would undermine the biological efficacy.
 
Description Regulatory meeting, Paris, 25-26 Jan 2015
Geographic Reach National 
Policy Influence Type Participation in a advisory committee
Impact Under pressure from French activists, Gilead had submitted an application to use Truvada as PrEP on a named patient basis in 2013. ANSM, the French Regulatory Authority, was considering this and was aware that there were two European trials, IPERGAY (France) and PROUD (UK) that were about to report at a forthcoming conference (February 2015). ANSM requested that I attend in my role as Chief Investigator of PROUD, to present the study design and the baseline characteristics, in order to prepare them to better understand the result.
 
Description Scientific Advisory Group to EMA regarding the dapivirine vaginal ring application, 3rd Dec. 2018
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in a advisory committee
 
Description Statistics/Data Management training course for staff working on Tamovac II, Dar es Salaam, Tanzania 24-28 Nov. 2014
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
Impact The training was given by Dr Claire Cook (Data Scientist) and Dr. Adrian Cook (Statistician) of MRC CTU at UCL. This was a capacity building exercise planned for data management staff within the Tamovac II EDCTP network and took place in Dar es Salaam (1 week duration). Staff attended from sites in Mozambique and Dar. Other one to one mentoring in Statistics and remote training by webex from MRC CTU at UCL staff through the 'Statistics for non-Statisticians' course was also been given during the duration of the Tamovac II grant which had been of benefit to the ongoing development of staff. The training was well received by all who attended. The MRC CTU at UCL Tamovac II budget also funded 'Open Clinica' data management training at 2 sites in Tanzania.
 
Description Update to PrEP Position Statement on BHIVA website (14th Sept. 2015)
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
Impact The update to the Position Statement provided more detail for practitioners who are trying to advise and monitor people who have purchased their own drug to use as PrEP.
URL https://www.bhiva.org/documents/Publications/PrEP_BHIVA_BASHH_Update_14September15_Final.pdf
 
Description Weekly departmental academic meeting, Courtyard Clinic, St. George's Hospital Teaching session, 19th August 2015 PrEP and PROUD
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
Impact St George's were not a partner in the PROUD study, but they do see HIV negative men who have sex with men who are at risk and who would benefit from PrEP. The results of the PROUD study revealed a sub-population of MSM with particularly high HIV incidence, in whom PrEP was extremely effective. Ever since the results were reported in February 2015 MSM have been coming into clinics requesting PrEP.
 
Description CUTHIVAC (European Commission Collaborative Project - Large Scale Integrating Project)
Amount £324,810 (GBP)
Funding ID 241904 
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 01/2010 
End 12/2015
 
Description Clinical Trial/Capacity Building - Tamovac II
Amount £450,651 (GBP)
Funding ID IP.07.33112.001 
Organisation Sixth Framework Programme (FP6) 
Department European and Developing Countries Clinical Trials Partnership
Sector Public
Country European Union (EU)
Start 11/2009 
End 11/2014
 
Description Clinical trial Collaboration - UKHVC
Amount £491,380 (GBP)
Funding ID 083844 
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 04/2008 
End 03/2016
 
Description EDCTP2 (RIA2016V - Vaccines for povery related diseases): 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' (PrEPVacc)
Amount € 14,999,954 (EUR)
Funding ID RIA2016V - 1644 
Organisation Sixth Framework Programme (FP6) 
Department European and Developing Countries Clinical Trials Partnership
Sector Public
Country European Union (EU)
Start 01/2018 
End 12/2022
 
Description HOME PEPSE: 'The role of home packs of HIV post-exposure prophylaxis for sexual exposure to improve the speed and appropriate uptake of PEPSE in high risk individuals' (Guy's and St. Thomas's NHS Foundation Trust)
Amount £9,279 (GBP)
Organisation St Thomas' Hospital 
Sector Hospitals
Country United Kingdom
Start 06/2015 
End 11/2017
 
Description PANTHEON - A comprehensive assessment of the cost effectiveness of HIV prevention and testing strategies, including HIV self-testing, among men who have sex with men (MSM) in the UK. (NIHR Programme Development grant)
Amount £2,000,000 (GBP)
Funding ID RP-PG-1212-20006 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 01/2016 
End 12/2020
 
Description TRANSVAC
Amount € 1 (EUR)
Funding ID TNA1204-5 - HIV_vaccine_breakthrough 
Organisation European Commission 
Department Seventh Framework Programme (FP7)
Sector Public
Country European Union (EU)
Start 07/2012 
End 09/2013
 
Title EV03 Clinical Study Report 
Description Report of Phase IIa trial of 3xDNA/1xNYVAC compared to 2xDNA/2xNYVAC that demonstrated benefit of third DNA prime. 
Type Of Material Improvements to research infrastructure 
Provided To Others? No  
Impact Trials continue with 3xDNA priming 
 
Title MucoVac2 Clinical Study Report 
Description The contents of a Clinical Study Report are defined in the International Conference on Harmonisation of technical reports E3 guideline. The report summarises the rationale, design, safety and efficacy data collected, data and trial management structures, as well as the primary and secondary analyses and a line listing of all adverse events that occured during the trial. 
Type Of Material Improvements to research infrastructure 
Year Produced 2014 
Provided To Others? Yes  
Impact Providing the report has helped other groups to draft their reports. 
 
Title PROUD pilot study protocol 
Description The PROUD study protocol was developed by the MRC CTU at UCL team. The PROUD pilot study protocol defines the following study: PRe-exposure Option for reducing HIV in the UK: an open-label randomisation to immediate or Deferred daily Truvada for HIV negative gay men. The protocol includes participant information sheets, informed consent forms and CRFs. 
Type Of Material Model of mechanisms or symptoms - human 
Year Produced 2013 
Provided To Others? Yes  
Impact The PROUD pilot study has been conducted under protocol v1.1, 1.2.1, and now 1.3. 
URL http://www.proud.mrc.ac.uk/study_protocol.aspx
 
Title PROUD study One-to-one Interview guide 
Description The PROUD study Social Science Advisory Group developed the PROUD one-to-one (or in-depth interview) guide in order to interview participants enrolled in the PROUD pilot study 
Type Of Material Improvements to research infrastructure 
Year Produced 2013 
Provided To Others? Yes  
Impact The one-to-one guide will be used throughout the pilot study to collect qualitative data on study acceptability, PrEP experiences, PrEP adherence and the impact of PrEP on sexual behaviour 
URL http://www.proud.mrc.ac.uk/social_science_study_component.aspx
 
Title Protocol for the CUTHIVAC preventative trial CUTHIVAC_001 
Description The protocol which had been developed for a Phase I clinical trial running in London has been shared with another team within the CUTHIVAC consortium who are planning a trial using the same routes of vaccination in Peru. 
Type Of Material Improvements to research infrastructure 
Provided To Others? No  
Impact The protocol relates to a clinical trial in healthy humans. 
 
Title Quantitative assay for the measurement of binding antibodies against CN54rgp140 
Description Technology transfer between Imperial College and collaborating institutions within Tanzania (MUHAS, MMRC). Training was carried out involving members of the Imperial and MRC teams. 
Type Of Material Technology assay or reagent 
Provided To Others? No  
Impact The assay will allow the quantitative assessment of an important endpoint in several trials using common reagents and so direct comparison of results across trials which would be extremely valuable. 
 
Title CUTHIVTHER study database 
Description Therapeutic vaccine trial database. 
Type Of Material Database/Collection of data 
Provided To Others? No  
Impact Generation of reports for safety monitoring by the Trial Management Group and Independent Data Monitoring Committee 
 
Title Cuthivac 002 study database 
Description HIV vaccine trial database 
Type Of Material Database/Collection of data 
Provided To Others? No  
Impact Generation of reports for safety monitoring by the Trial Management Group and Independent Data Monitoring Committee 
 
Title PROUD participant database 
Description The database was developed by the MRC CTU at UCL team to allow study participants to remotely record sexual and adherence behaviour on daily diaries and monthly questionnaires. 
Type Of Material Database/Collection of data 
Provided To Others? No  
Impact The database has allowed real time data collection directly from study participants 
 
Title PROUD study database 
Description The PROUD database was developed by the MRC CTU at UCL data team and allows data to be entered remotely from each of the 13 PROUD study clinics as well as directly at CTU. 
Type Of Material Database/Collection of data 
Provided To Others? No  
Impact The database has facilitated real time data entry at each PROUD study clinic and supported data management. 
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation Eurovacc Foundation
Country Switzerland 
Sector Charity/Non Profit 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation Gilead Sciences, Inc.
Country United States 
Sector Private 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation Imperial College London
Country United Kingdom 
Sector Academic/University 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation International AIDS Vaccine Initiative (IAVI)
Country Global 
Sector Charity/Non Profit 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation Karolinska Institute
Country Sweden 
Sector Academic/University 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation Lausanne University Hospital (CHUV)
Country Switzerland 
Sector Hospitals 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation Ludwig Maximilian University of Munich (LMU Munich)
Country Germany 
Sector Academic/University 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation Medical Research Council of South Africa (MRC)
Country South Africa 
Sector Public 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation Muhimbili University of Health and Allied Sciences
Country Tanzania, United Republic of 
Sector Academic/University 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation National Institute for Medical Research, Tanzania
Country Tanzania, United Republic of 
Sector Public 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation National Institute of Health, Mozambique
Country Mozambique 
Sector Public 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation Uganda National Health Research Organisation
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation University of KwaZulu-Natal
Department KwaZulu-Natal Research Institute for Tuberculosis and HIV (K-RITH)
Country South Africa 
Sector Charity/Non Profit 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description Dr. Sarah Joseph collaboration with Chriss Geldmacher: Epitope mapping project 
Organisation UK HIV Vaccine Consortium (UKHVC)
Country United Kingdom 
Sector Academic/University 
PI Contribution Jointing drafted the application and contributed to the design of the study. UKHVC supplied samples for cross comparison studies between other trials.
Collaborator Contribution Expert in the technology needed for the project. Major financial contribution to the project.
Impact Preliminary results presented data to UKHVC - analysis ongoing
Start Year 2014
 
Description European HIV Vaccine Alliance (EHVA) 
Organisation National Institute of Health and Medical Research (INSERM)
Department Inserm Transfert
Country France 
Sector Public 
PI Contribution 40 partners have signed a research collaboration agreement (European Commission funded project 1st Jan 2016-31st Dec 2020). The EHVA program will develop a multidisciplinary vaccine platform (MVP) in the fields of prophylactic and therapeutic vaccines Trial protocols currently in development. Attendance at launch meeting and workpackage meetings/teleconferences. CTU providing trial management and statistical support.
Collaborator Contribution Amongst the 40 partners within the collaboration, there is expertise in immunology, virology, structural biology, viral vectors, statistics, computational and clinical science. Specific objectives within the collaboration are to build up as below, a: 1) Discovery platform - generation of novel vaccine candidates in the field of prophylactic and therapeutic vaccines inducing potent neutralizing and non-neutralizing antibody and T-cell responses. 2) Immune profiling platform - to rank novel and benchmark existing vaccine candidates in pre-clinical and human clinical trials through validated, qualified and standardized immunological assays and using advanced technologies in the profiling of the immune responses. 3) Data Management/Integration/Down-Selection Platform - to provide powerful statistical tools for the analysis and interpretation of complex data and algorithms for the selection of vaccine candidates at different stages of pre-clinical and clinical vaccine development. 2) Clinical trials platform - the primary goal is the acceleration of clinical development of novel vaccine candidates and the early prediction of failure of vaccine candidates.
Impact Country specific regulatory/ethics approvals for the therapeutic vaccine/monoclonal antibody trial are now available in Switzerland and UK and in process in France, Germany, Italy and Spain. The first joint Trial Steering and Independent Data Monitoring Committee took place in June 2018 and the first participant was enrolled on 20 February 2019. This is a multi-disciplinary collaboration.
Start Year 2016
 
Description European PrEP Group 
Organisation August Pi i Sunyer Biomedical Research Institute
Department Hospital Clinic of Barcelona
Country Spain 
Sector Hospitals 
PI Contribution I coordinate this group which convenes quarterly by teleconference to provide an update of PrEP related activities in several European countries: Belgium, Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Russia, Spain and the UK.
Collaborator Contribution Ongoing PrEP related activities such as surveys amongst potential users and providers, advocacy, policy.
Impact Up to date knowledge of PrEP activities in Europe including sharing tools and data, and coordination of efforts on advocacy. Notes of teleconference calls. Some members met at a July 2016 workshop held in the Windsor, UK for which a report is being developed.
Start Year 2013
 
Description European PrEP Group 
Organisation Charité - University of Medicine Berlin
Department Praxis Jessen2 and Kollegen
Country Germany 
Sector Academic/University 
PI Contribution I coordinate this group which convenes quarterly by teleconference to provide an update of PrEP related activities in several European countries: Belgium, Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Russia, Spain and the UK.
Collaborator Contribution Ongoing PrEP related activities such as surveys amongst potential users and providers, advocacy, policy.
Impact Up to date knowledge of PrEP activities in Europe including sharing tools and data, and coordination of efforts on advocacy. Notes of teleconference calls. Some members met at a July 2016 workshop held in the Windsor, UK for which a report is being developed.
Start Year 2013
 
Description European PrEP Group 
Organisation CheckpointLX
Country Portugal 
Sector Hospitals 
PI Contribution I coordinate this group which convenes quarterly by teleconference to provide an update of PrEP related activities in several European countries: Belgium, Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Russia, Spain and the UK.
Collaborator Contribution Ongoing PrEP related activities such as surveys amongst potential users and providers, advocacy, policy.
Impact Up to date knowledge of PrEP activities in Europe including sharing tools and data, and coordination of efforts on advocacy. Notes of teleconference calls. Some members met at a July 2016 workshop held in the Windsor, UK for which a report is being developed.
Start Year 2013
 
Description European PrEP Group 
Organisation Copenhagen University Hospital
Country Denmark 
Sector Hospitals 
PI Contribution I coordinate this group which convenes quarterly by teleconference to provide an update of PrEP related activities in several European countries: Belgium, Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Russia, Spain and the UK.
Collaborator Contribution Ongoing PrEP related activities such as surveys amongst potential users and providers, advocacy, policy.
Impact Up to date knowledge of PrEP activities in Europe including sharing tools and data, and coordination of efforts on advocacy. Notes of teleconference calls. Some members met at a July 2016 workshop held in the Windsor, UK for which a report is being developed.
Start Year 2013
 
Description European PrEP Group 
Organisation GGD Amsterdam
Country Netherlands 
Sector Public 
PI Contribution I coordinate this group which convenes quarterly by teleconference to provide an update of PrEP related activities in several European countries: Belgium, Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Russia, Spain and the UK.
Collaborator Contribution Ongoing PrEP related activities such as surveys amongst potential users and providers, advocacy, policy.
Impact Up to date knowledge of PrEP activities in Europe including sharing tools and data, and coordination of efforts on advocacy. Notes of teleconference calls. Some members met at a July 2016 workshop held in the Windsor, UK for which a report is being developed.
Start Year 2013
 
Description European PrEP Group 
Organisation Institute of Tropical Medicine Antwerp
Country Belgium 
Sector Academic/University 
PI Contribution I coordinate this group which convenes quarterly by teleconference to provide an update of PrEP related activities in several European countries: Belgium, Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Russia, Spain and the UK.
Collaborator Contribution Ongoing PrEP related activities such as surveys amongst potential users and providers, advocacy, policy.
Impact Up to date knowledge of PrEP activities in Europe including sharing tools and data, and coordination of efforts on advocacy. Notes of teleconference calls. Some members met at a July 2016 workshop held in the Windsor, UK for which a report is being developed.
Start Year 2013
 
Description European PrEP Group 
Organisation Moscow Regional AIDS Centre
Country Russian Federation 
Sector Public 
PI Contribution I coordinate this group which convenes quarterly by teleconference to provide an update of PrEP related activities in several European countries: Belgium, Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Russia, Spain and the UK.
Collaborator Contribution Ongoing PrEP related activities such as surveys amongst potential users and providers, advocacy, policy.
Impact Up to date knowledge of PrEP activities in Europe including sharing tools and data, and coordination of efforts on advocacy. Notes of teleconference calls. Some members met at a July 2016 workshop held in the Windsor, UK for which a report is being developed.
Start Year 2013
 
Description European PrEP Group 
Organisation National Institute for Infectious Diseases (Lazzaro Spallanzani IRCCS)
Department Department of Epidemiology
Country Italy 
Sector Public 
PI Contribution I coordinate this group which convenes quarterly by teleconference to provide an update of PrEP related activities in several European countries: Belgium, Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Russia, Spain and the UK.
Collaborator Contribution Ongoing PrEP related activities such as surveys amongst potential users and providers, advocacy, policy.
Impact Up to date knowledge of PrEP activities in Europe including sharing tools and data, and coordination of efforts on advocacy. Notes of teleconference calls. Some members met at a July 2016 workshop held in the Windsor, UK for which a report is being developed.
Start Year 2013
 
Description European PrEP Group 
Organisation Nye Pluss
Country Norway 
Sector Public 
PI Contribution I coordinate this group which convenes quarterly by teleconference to provide an update of PrEP related activities in several European countries: Belgium, Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Russia, Spain and the UK.
Collaborator Contribution Ongoing PrEP related activities such as surveys amongst potential users and providers, advocacy, policy.
Impact Up to date knowledge of PrEP activities in Europe including sharing tools and data, and coordination of efforts on advocacy. Notes of teleconference calls. Some members met at a July 2016 workshop held in the Windsor, UK for which a report is being developed.
Start Year 2013
 
Description European PrEP Group 
Organisation Paris Diderot University
Country France 
Sector Academic/University 
PI Contribution I coordinate this group which convenes quarterly by teleconference to provide an update of PrEP related activities in several European countries: Belgium, Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Russia, Spain and the UK.
Collaborator Contribution Ongoing PrEP related activities such as surveys amongst potential users and providers, advocacy, policy.
Impact Up to date knowledge of PrEP activities in Europe including sharing tools and data, and coordination of efforts on advocacy. Notes of teleconference calls. Some members met at a July 2016 workshop held in the Windsor, UK for which a report is being developed.
Start Year 2013
 
Description European PrEP Group 
Organisation Portuguese Group of Activists Treatments for HIV/AIDS Pedro Santos (GAT)
Country Portugal 
Sector Charity/Non Profit 
PI Contribution I coordinate this group which convenes quarterly by teleconference to provide an update of PrEP related activities in several European countries: Belgium, Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Russia, Spain and the UK.
Collaborator Contribution Ongoing PrEP related activities such as surveys amongst potential users and providers, advocacy, policy.
Impact Up to date knowledge of PrEP activities in Europe including sharing tools and data, and coordination of efforts on advocacy. Notes of teleconference calls. Some members met at a July 2016 workshop held in the Windsor, UK for which a report is being developed.
Start Year 2013
 
Description European PrEP Group 
Organisation Positive Voices
Country Greece 
Sector Charity/Non Profit 
PI Contribution I coordinate this group which convenes quarterly by teleconference to provide an update of PrEP related activities in several European countries: Belgium, Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Russia, Spain and the UK.
Collaborator Contribution Ongoing PrEP related activities such as surveys amongst potential users and providers, advocacy, policy.
Impact Up to date knowledge of PrEP activities in Europe including sharing tools and data, and coordination of efforts on advocacy. Notes of teleconference calls. Some members met at a July 2016 workshop held in the Windsor, UK for which a report is being developed.
Start Year 2013
 
Description European PrEP Group 
Organisation Public Health England
Country United Kingdom 
Sector Public 
PI Contribution I coordinate this group which convenes quarterly by teleconference to provide an update of PrEP related activities in several European countries: Belgium, Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Russia, Spain and the UK.
Collaborator Contribution Ongoing PrEP related activities such as surveys amongst potential users and providers, advocacy, policy.
Impact Up to date knowledge of PrEP activities in Europe including sharing tools and data, and coordination of efforts on advocacy. Notes of teleconference calls. Some members met at a July 2016 workshop held in the Windsor, UK for which a report is being developed.
Start Year 2013
 
Description European PrEP Group 
Organisation San Paolo Hospital
Country Brazil 
Sector Hospitals 
PI Contribution I coordinate this group which convenes quarterly by teleconference to provide an update of PrEP related activities in several European countries: Belgium, Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Russia, Spain and the UK.
Collaborator Contribution Ongoing PrEP related activities such as surveys amongst potential users and providers, advocacy, policy.
Impact Up to date knowledge of PrEP activities in Europe including sharing tools and data, and coordination of efforts on advocacy. Notes of teleconference calls. Some members met at a July 2016 workshop held in the Windsor, UK for which a report is being developed.
Start Year 2013
 
Description European PrEP Group 
Organisation St. James's Hospital, Dublin
Country Ireland 
Sector Hospitals 
PI Contribution I coordinate this group which convenes quarterly by teleconference to provide an update of PrEP related activities in several European countries: Belgium, Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Russia, Spain and the UK.
Collaborator Contribution Ongoing PrEP related activities such as surveys amongst potential users and providers, advocacy, policy.
Impact Up to date knowledge of PrEP activities in Europe including sharing tools and data, and coordination of efforts on advocacy. Notes of teleconference calls. Some members met at a July 2016 workshop held in the Windsor, UK for which a report is being developed.
Start Year 2013
 
Description European PrEP Group 
Organisation University College Dublin
Department School of Medicine and Medical Science
Country Ireland 
Sector Academic/University 
PI Contribution I coordinate this group which convenes quarterly by teleconference to provide an update of PrEP related activities in several European countries: Belgium, Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Russia, Spain and the UK.
Collaborator Contribution Ongoing PrEP related activities such as surveys amongst potential users and providers, advocacy, policy.
Impact Up to date knowledge of PrEP activities in Europe including sharing tools and data, and coordination of efforts on advocacy. Notes of teleconference calls. Some members met at a July 2016 workshop held in the Windsor, UK for which a report is being developed.
Start Year 2013
 
Description HOME PEPSE: 'The role of home packs of HIV post-exposure prophylaxis for sexual exposure to improve the speed and appropriate uptake of PEPSE in high risk individuals' (Guy's and St. Thomas's NHS Foundation Trust) 
Organisation Guy’s & St Thomas’ Charity
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution CTU role through our PROUD trial Social Scientist will be to conduct in depth interviews in a participant sub-set and probe for barriers and facilitators to reducing the risk of HIV, determine perceptions of risk and PEPSE need and check that the participant understands the evidence provided regarding effectiveness. Interviews will be with MSM about their experiences in the HOME PEPSE study. Qualitative audio file recordings (written participant consent to be gained prior to data collection) will be imported into NVivo, a qualitative data analysis package and coded using a combination of audio and transcribed textual coding using a predefined coding framework.
Collaborator Contribution St. Thomas's through Dr. Julie Fox, have designed the research protocol are taking the lead in managing the trial.
Impact CTU social scientist to work more fully on this project during 2016.
Start Year 2015
 
Description Microbicides Development Programme (MDP) and CONRAD tenofovir project 
Organisation Eastern Virginia Medical School
Department Contraception Research and Development (CONRAD)
Country United States 
Sector Academic/University 
PI Contribution Our research team developed research proposals to conduct a phase II clinical trial of tenofovir gel in either vaginal ring or tablet form, and an open-label wait listed design of tenofovir gel with Microbicides Development Programme partners in Uganda and Mozambique. Funding application currently being drafted for submission to EDCTP by 15th March 2016: 'A pragmatic, randomised open-label wait-listed trial to evaluate the effectiveness of tenofovir to reduce the risk of HIV acquisition among women involved in transactional and commercial sex in Mozambique, Rwanda, Tanzania and Uganda.
Collaborator Contribution CONRAD invited Professor Sheena McCormack to develop research proposals for CONRAD's Microbicide APS Objective 1 (MAPS1) which was successfully funded
Impact Full funding application to EDCTP 15th March 2016, but not funded.
Start Year 2013
 
Description PANTHEON: A comprehensive assessment of the cost-effectiveness of HIV prevention and testing strategies, including HIV self-testing, among men who have sex with men (MSM) in the UK 
Organisation Chelsea and Westminster Hospital NHS Foundation Trust
Country United Kingdom 
Sector Public 
PI Contribution We have contributed to the clinical trial methodology, manage the clinical trial operations including conduct of the analyses.
Collaborator Contribution The partners contribute to the qualitative data collection, the mathematical modelling and the health economics as wel as clinical and community expertise.
Impact Contract signature of partners. Discussions surrounding study database, recruitment and analysis. Funding provided by NIHR. Fully enrolled to SELPHI trial Q1 2018. Recruitment to the study was through an advertising campaign that directed individuals to the study website has now exceeded the target of 10,000 and the registration page is closed. The website remains open as a resource for the public and Selphi participants.
Start Year 2014
 
Description PANTHEON: A comprehensive assessment of the cost-effectiveness of HIV prevention and testing strategies, including HIV self-testing, among men who have sex with men (MSM) in the UK 
Organisation City, University of London
Country United Kingdom 
Sector Academic/University 
PI Contribution We have contributed to the clinical trial methodology, manage the clinical trial operations including conduct of the analyses.
Collaborator Contribution The partners contribute to the qualitative data collection, the mathematical modelling and the health economics as wel as clinical and community expertise.
Impact Contract signature of partners. Discussions surrounding study database, recruitment and analysis. Funding provided by NIHR. Fully enrolled to SELPHI trial Q1 2018. Recruitment to the study was through an advertising campaign that directed individuals to the study website has now exceeded the target of 10,000 and the registration page is closed. The website remains open as a resource for the public and Selphi participants.
Start Year 2014
 
Description PANTHEON: A comprehensive assessment of the cost-effectiveness of HIV prevention and testing strategies, including HIV self-testing, among men who have sex with men (MSM) in the UK 
Organisation King's College Hospital NHS Foundation Trust (NCH)
Country United Kingdom 
Sector Academic/University 
PI Contribution We have contributed to the clinical trial methodology, manage the clinical trial operations including conduct of the analyses.
Collaborator Contribution The partners contribute to the qualitative data collection, the mathematical modelling and the health economics as wel as clinical and community expertise.
Impact Contract signature of partners. Discussions surrounding study database, recruitment and analysis. Funding provided by NIHR. Fully enrolled to SELPHI trial Q1 2018. Recruitment to the study was through an advertising campaign that directed individuals to the study website has now exceeded the target of 10,000 and the registration page is closed. The website remains open as a resource for the public and Selphi participants.
Start Year 2014
 
Description PANTHEON: A comprehensive assessment of the cost-effectiveness of HIV prevention and testing strategies, including HIV self-testing, among men who have sex with men (MSM) in the UK 
Organisation London School of Hygiene and Tropical Medicine (LSHTM)
Country United Kingdom 
Sector Academic/University 
PI Contribution We have contributed to the clinical trial methodology, manage the clinical trial operations including conduct of the analyses.
Collaborator Contribution The partners contribute to the qualitative data collection, the mathematical modelling and the health economics as wel as clinical and community expertise.
Impact Contract signature of partners. Discussions surrounding study database, recruitment and analysis. Funding provided by NIHR. Fully enrolled to SELPHI trial Q1 2018. Recruitment to the study was through an advertising campaign that directed individuals to the study website has now exceeded the target of 10,000 and the registration page is closed. The website remains open as a resource for the public and Selphi participants.
Start Year 2014
 
Description PANTHEON: A comprehensive assessment of the cost-effectiveness of HIV prevention and testing strategies, including HIV self-testing, among men who have sex with men (MSM) in the UK 
Organisation Public Health England
Country United Kingdom 
Sector Public 
PI Contribution We have contributed to the clinical trial methodology, manage the clinical trial operations including conduct of the analyses.
Collaborator Contribution The partners contribute to the qualitative data collection, the mathematical modelling and the health economics as wel as clinical and community expertise.
Impact Contract signature of partners. Discussions surrounding study database, recruitment and analysis. Funding provided by NIHR. Fully enrolled to SELPHI trial Q1 2018. Recruitment to the study was through an advertising campaign that directed individuals to the study website has now exceeded the target of 10,000 and the registration page is closed. The website remains open as a resource for the public and Selphi participants.
Start Year 2014
 
Description PANTHEON: A comprehensive assessment of the cost-effectiveness of HIV prevention and testing strategies, including HIV self-testing, among men who have sex with men (MSM) in the UK 
Organisation Royal Free London NHS Foundation Trust
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution We have contributed to the clinical trial methodology, manage the clinical trial operations including conduct of the analyses.
Collaborator Contribution The partners contribute to the qualitative data collection, the mathematical modelling and the health economics as wel as clinical and community expertise.
Impact Contract signature of partners. Discussions surrounding study database, recruitment and analysis. Funding provided by NIHR. Fully enrolled to SELPHI trial Q1 2018. Recruitment to the study was through an advertising campaign that directed individuals to the study website has now exceeded the target of 10,000 and the registration page is closed. The website remains open as a resource for the public and Selphi participants.
Start Year 2014
 
Description PANTHEON: A comprehensive assessment of the cost-effectiveness of HIV prevention and testing strategies, including HIV self-testing, among men who have sex with men (MSM) in the UK 
Organisation University College London Hospitals NHS Foundation Trust
Country United Kingdom 
Sector Public 
PI Contribution We have contributed to the clinical trial methodology, manage the clinical trial operations including conduct of the analyses.
Collaborator Contribution The partners contribute to the qualitative data collection, the mathematical modelling and the health economics as wel as clinical and community expertise.
Impact Contract signature of partners. Discussions surrounding study database, recruitment and analysis. Funding provided by NIHR. Fully enrolled to SELPHI trial Q1 2018. Recruitment to the study was through an advertising campaign that directed individuals to the study website has now exceeded the target of 10,000 and the registration page is closed. The website remains open as a resource for the public and Selphi participants.
Start Year 2014
 
Description PrEP IMPACT trial 
Organisation Public Health England
Country United Kingdom 
Sector Public 
PI Contribution As an experienced PrEP trial PI from the UK PROUD trial, I am active in providing support/knowledge to the operations of the PrEP IMPACT trial and I also recruit patients to the trial from my HIV/sexual health clinic at Dean Street (C&W) London.
Collaborator Contribution PrEP is a new way for people to reduce their risk of acquiring HIV. 147 sites across England have recruited over 11,532 participants who are at a high risk of HIV.. The sample size has now been doubled in an attempt to meet demand.
Impact https://www.prepimpacttrial.org.uk/ Recruitment to the trial is underway and there continues to be a high demand amongst the community for participation.
Start Year 2017
 
Description PrEP IMPACT trial 
Organisation St Stephen's Clinical Research
PI Contribution As an experienced PrEP trial PI from the UK PROUD trial, I am active in providing support/knowledge to the operations of the PrEP IMPACT trial and I also recruit patients to the trial from my HIV/sexual health clinic at Dean Street (C&W) London.
Collaborator Contribution PrEP is a new way for people to reduce their risk of acquiring HIV. 147 sites across England have recruited over 11,532 participants who are at a high risk of HIV.. The sample size has now been doubled in an attempt to meet demand.
Impact https://www.prepimpacttrial.org.uk/ Recruitment to the trial is underway and there continues to be a high demand amongst the community for participation.
Start Year 2017
 
Title CutHIVTher trial 
Description Full title: 'A randomised phase I/II study to assess the safety and immunogenicity of the DNA-GTU vaccine administered by two novel methods compared to placebo in HIV-infected patients on antiretroviral therapy.' Vaccine administered trancutaneously or through electroporation (enhanced intramuscular delivery). Trial participants: 30 HIV infected male and female volunteers aged 18-45 years who have been on ART for at least 6 months with 2 or more HIV plasma viral load measurements; 50 copies HIV RNA/ml prior to enrolment. Funding provided through the European Commission CUTHIVAC grant. 
Type Therapeutic Intervention - Vaccines
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2015
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Analysis still to be done, trial fully recruited and participants in follow up. 
URL http://www.hra.nhs.uk/news/research-summaries/cuthivther-001/
 
Title CutHIVac 001 trial 
Description Full title: 'A phase I clinical trial to assess the safety and immunogenicity of three HIV GTU MultiHIV DNA immunisations administered via the Intramuscular, Intradermal and Transcutanous routes in healthy male and female volunteers. Trial participants: 30 male and female volunteers aged 18-45 years old who are at low risk of HIV infection. Funding provided through the European Commission CUTHIVAC grant. 
Type Preventative Intervention - Nutrition and Chemoprevention
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2016
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Participants meeting took place January 2016. Analysis ongoing. 
URL http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14858
 
Title DNA HIV CN54 prime followed by NYVAC C boost 
Description DNA plasmid dervied from clade C CN54 which has been through Phase I and IIa trials. Significant benefit was gained from three primes (reported at CROI Feb10). 
Type Preventative Intervention - Nutrition and Chemoprevention
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2009
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Benefits of third DNA demonstrated in terms of broader and stronger immune responses. 
URL http://www.isrctn.com/ISRCTN20946776
 
Title Pre-exposure prophylaxis for HIV infection (PROUD trial) 
Description PROUD is designed to address an unique question regarding Truvada-PrEP, namely the effectiveness when people know they are on a drug that reduces HIV, as this may lead people to increase their risk and as a consequence expose themselves to more HIV and sexually transmitted infections (STI). Gay men are randomised to have access to daily oral Truvada at enrolment or after one year of follow-up, and all participants have access to the standard prevention package throughout. Truvada as PrEP has been licensed as PrEP in the USA and this is a pilot study. Funding provided through: MRC Clinical Trials Unit at UCL, Public Health England, and Gilead Sciences. 544 study participants currently in active follow up. The PROUD trial reported at the Conference for Retroviruses and Opportunistic Infections (CROI), February 2015 http://www.croiwebcasts.org/console/player/25539?mediaType=audio& 
Type Preventative Intervention - Nutrition and Chemoprevention
Current Stage Of Development Small-scale adoption
Year Development Stage Completed 2015
Development Status Under active development/distribution
Clinical Trial? Yes
Impact PROUD was a game changer for PrEP for two reasons. Firstly Truvada was more effective at preventing HIV in this open-label pilot phase than in previously reported placebo-controlled trials, and secondly the trial schedule mirrored routine practice with quarterly visits, whereas previous trials had followed a monthly schedule. The study was conducted in men who have sex with men (MSM) attending sexual health clinics in England. When PROUD announced the decision to offer PrEP to those whose access was deferred, IPERGAY asked their Data Monitoring Committee to advise them what to do in their placebo-controlled trial which was also being conducted in MSM, in France. It transpired that Truvada was equally effective when MSM were advised to take drug before and after sex. This caused tremendous excitement when the results were presented back to back at an international conference, and the excitement sparked enthusiasm across Europe. In November 2015 the French regulatory authority approved the use of Truvada as PrEP on a named patient basis, and the French Minister of Health announced at the end of the same month that the costs of the drug would be fully reimbursed by the social security system. NHS England is about to issue a Commissioning Policy for public consultation. 
URL http://www.proud.mrc.ac.uk
 
Title UK HVC Spoke3 
Description Clade C DNA Clade C MVA Clade C rgp140 GLA 
Type Therapeutic Intervention - Vaccines
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2015
Development Status Actively seeking support
Clinical Trial? Yes
Impact Completion of healthy volunteer HIV vaccine trial, evaluating products developed through the Wellcome Trust funded UK HVC. 
URL http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14173
 
Title PROUD participant database mobile application 
Description The MRC CTU at UCL data team developed a mobile application to allow study participants to remotely access the PROUD participant database from mobile smart devices. 
Type Of Technology Webtool/Application 
Year Produced 2014 
Impact The application was developed in response to participants requests for remote access to the database from smart devices and therefore was a direct response to study participants requests. 
 
Description #trialsmatter Twitter Q&A, 20th May 2015 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Q&A on International Clinical Trials day. As well as a range of trialists there were participant/patients and community organisation representatives answering questions as quickly as possible!
#trialsmatter Twitter Q&A, 20th May 2015
Year(s) Of Engagement Activity 2015
 
Description 'Controlling the HIV Epidemic with Antiretrovirals: Having the Courage of our Convictions' (Paris, 1st October 2015). Prof. Sheena McCormack panel speaker: 'Early PrEP implementation: perspectives from the field' session 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Brief talks followed by a debate. The Chief Investigators of PROUD and IPERGAY were advocating for more activism in Europe to draw government attention to the rising HIV incidence in key populations and the need to implement PrEP.

xxx
Year(s) Of Engagement Activity 2015
 
Description 'HIV Ways of Knowing symposium', Homerton University Hospital, 1st October 2014 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Health professionals
Results and Impact Dr. Iain Reeves mentioned the PROUD trial within a session on "Treatment an intervention research"
Attended by Liz Brodnicki, PROUD Trial Manager

-
Year(s) Of Engagement Activity 2014
 
Description 'PEP and PrEP: the science behind the strategies', NHIVNA Study Day, 6th March 2013, London 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The talk resulted in questions and discussion which provided helpful insights into the way that clinics work around the country.

The most result was the realisation that clinical nurse specialists lacked confidence to talk to their HIV positive patients about treatment as prevention. The reason for this was consultant ambivalence regarding the evidence. There is no ambivalence about the evidence and I hope that the nurses who attended left with that key message, empowered to have discussions with their patients in future.
Year(s) Of Engagement Activity 2013
 
Description 'Rectal Microbicides: the bottom line on HIV Prevention', 17th Sept. 2014 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Participants in your research and patient groups
Results and Impact Coordinated by the PROUD team, hosted by THT, London, and faciliated by Jim Pickett, Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago.
Generated discussion about future HIV prevention options - especially PrEP and rectal microbicides

Lots of questions/discussion to be taken on board for future rectal microbicide study design/acceptability.
Report in draft for circulation
Year(s) Of Engagement Activity 2014
 
Description 'The Young People's Panel Discussion on HIV', Twentieth Century Fox Screening Rooms, Soho, 24th Sept. 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Media (as a channel to the public)
Results and Impact It was an event flagged in QX, funded by Monument Trust, and organised through a collaboration between 56 Dean Street and QX which focused on young people and HIV prevention. There was a film, a brief update on PrEP and PROUD and a panel discussion which was then opened up to the floor - all in the 20th Century Fox building in Soho Square.

Presentations from Dr Alan McOwan and Professor Sheena McCormack of 56 Dean Street on PrEP and the PROUD study respectively.

The panel discussion was illuminating, highlighting how important stigma still was for a generation that has become sexually active during a period when HIV was a treatable condition. There was a lively discussion following the panel and an opportunity to set the record straight with respect to the reasons for chosing PrEP and the benefits. There were several PROUD participants in the room who spoke eloquently about the alleviation from anxiety and the guilt as taking PrEP is a way to be responsible about the health of self and partner at times when a condom is not used.
Year(s) Of Engagement Activity 2014
 
Description 15th European AIDS Conference (EACS), Barcelona, 22-23 Oct. 2015. Prof. Sheena McCormack plenary presentation 'PrEP - from Science to Implementation' 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact An opportunity to place PrEP in the context as there have been so many clinical trials in diverse populations, the majority of which demonstrate effectiveness. The evidence for efficacy is clear, and two European trials in gay men demonstrate the potential to dramatically influence the epidemic in Europe.

A call to action for clinicians and community to lobby European governments to implement PrEP as a matter of urgency for key populations at risk of catching HIV.

xxx
Year(s) Of Engagement Activity 2015
 
Description 22nd Annual BHIVA Conference, Manchester 19-22 April 2016. Oral presentation by Dr. Monica Desai 'Baseline predictors of HIV Infection in the no-PrEP group in the PROUD trial' 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Dr. Monica Desai (PROUD team) gave a 10min presentation on 21st April 2016 during the BHIVA Manchester conference (Abstract O24).
http://www.bhiva.org/documents/Conferences/2016Manchester/Presentations/160421/MonicaDesai.pdf
Year(s) Of Engagement Activity 2016
URL http://www.bhiva.org/160421MonicaDesai.aspx
 
Description ADPH (Association of Directors of Public Health) / PHE Sexual Workshop, St. Bride's Foundation, Fleet Street, 5th October 2015 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact The Directors of Public Health and other members of the audience are responsible for oversight of commissioning of sexual health and family planning services. This was an opportunity to promote PrEP and the potential impact this could have on the HIV epidemic. One public health expert from Jersey told me that she would implement a PrEP service on return for individuals travelling to high prevalence countries for holiday or work.

xxx
Year(s) Of Engagement Activity 2015
 
Description AIDS Impact Conference, 2013 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Authors: Mitzy Gafos, Robert Pool, Sheena McCormack, Jonathan Elford
Title: Exploring women's use of microbicides without their partner's knowledge: experiences from a predominantly rural area of KwaZulu-Natal, South Africa
Conference: AIDS Impact
Dates: 29th Sept to 2nd Oct 2013
Location: Barcelona, Spain
Presented to approximately 75 people

Academic discussion about presentation of relevance to manuscript development
Year(s) Of Engagement Activity 2013
URL http://www.aidsimpact.com/2013/
 
Description ASSHH Conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Authors: Mitzy Gafos, Robert Pool, Sheena McCormack, Jonathan Elford
Title: Interpreting the interplay between biomedical knowledge and communication
Conference title: Association for the Social Sciences and Humanities in HIV (ASSHH)
Dates: 7th to 10th July 2013
Location: Paris, France
Presented to audience of approximately 15 people

Made contact with two relevant researchers for future collaborations
Year(s) Of Engagement Activity 2013
URL http://asshhconference.org/
 
Description AVAC PReP communications group annual meeting (April 2013) 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact The AVAC annual meeting was held from 2nd to 4th April 2013 in New York, USA, to discuss PrEP, microbicides and vaccine media and communications work. The workshop was attended by advocates, researchers, and communications experts.

The meeting was an opportunity to share updates on the PROUD PrEP study and discuss future microbicide research.
Year(s) Of Engagement Activity 2013
 
Description Advocates Guide to the R4P Conference - webinar, 6th Nov. 2014 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The webinar was organised to provide feedback on R4P Conference, the first international HIV prevention conference to bring vaccines, microbicides and PREP together. I was asked to speak specifically on the take home messages regarding prevention for gay men in Europe following the iPerGay and PROUD announcements. These two trials reported early due to interim analyses demonstrating that PrEP was highly effective in reducing the risk of HIV in an event driven regimen (iPerGay) and taking acccount of any change in risk behaviours (PROUD).
There was also feedback regarding a number of Good Participatory Practice presentations after which I was able to make the point that Community Engagement has always been at the heart of preparing for large HIV prevention trials.

I was emailed after the webinar by researchers and Communtiy Advocates who agreed with the points I had made.
Year(s) Of Engagement Activity 2014
 
Description An update on the PROUD pilot study, Dr. Monica Desai, presented at BASHH OGM, London, 14th April 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Health professionals
Results and Impact Well received talk, lots of questions.

Increase in requests for information.
Year(s) Of Engagement Activity 2014
 
Description CHAARM video filming, 28th April 2014 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Prof. Sheena McCormack was filmed for the video which has been posted at http://chaarm.eu/content/newsroom
An explanatory video has been produced with the aim of presenting the CHAARM project and its main goal. It explains what are microbicides and it shows why is important to develop alternative prevention methods, such as new combination of microbicides, for controlling the risk of HIV infection. Video posted 25th July 2014.

This film aimed to increase the profile of microbicides in Europe.
Year(s) Of Engagement Activity 2014
URL http://chaarm.eu/content/newsroom
 
Description CROI conference, 2013 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Presented to an audience of approximately 300 people.
CROI conference, 3-6 March 2013, Atlanta.
Title: Hormonal Contraception and Risk of HIV: An analysis of MDP 301
Authors:Angela Crook et al

Presentation was discussed at the conference press conference - discussion fed into development of a manuscript
Year(s) Of Engagement Activity 2013
 
Description CROI presentation by Prof. Sheena McCormack of PROUD results 24.02.15 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact CROI presentation of PROUD results 24.02.15 in a session that included the IPERGAY trial results too - two European randomised trials of Truvada as PrEP, conducted in gay men, both showing an 86% reduction in HIV acquisition. They were heralded as the most important results of the conference, and likened to the 1996 conference when triple therapy was shown to effectively control viral replication in people living with HIV.
Year(s) Of Engagement Activity 2015
 
Description CUTHIVAC 001 trial participants meeting, St. Mary's hospital, London 15th Feb 2016 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Study participants or study members
Results and Impact Presentation of the results to the healthy volunteer participants on this HIV vaccine trial.
Year(s) Of Engagement Activity 2016
 
Description Career pathways in Population Health 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Postgraduate students
Results and Impact 60 students mainly from public health attended this careers day organised by the Royal Society of Medicine. I gave a talk entitled 'Big questions in clinical trials'.

Several students sought individual career advice following the talk.
Year(s) Of Engagement Activity 2013
 
Description Clinic Seminar, April 2013 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Local
Primary Audience Health professionals
Results and Impact 40 healthcare professionals from 56 Dean Street clinic attended this talk on PrEP and PROUD.

Healthcare professionals seeing gay men at risk of HIV have referred these men to the PROUD study team.
Year(s) Of Engagement Activity 2013
 
Description Conference on Retroviruses and Opportunistic Infections (CROI), Boston , USA 22-25 Feb 2016. Presentation 'STI control in the era of PrEP' given by Prof. Sheena McCormack 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact An opportunity to emphasise that other sexually transmitted infections were increasing prior to PrEP introduction due to social changes. PrEP offers the chance to improve control of other STIs through regular screening, early diagnosis, prompt treatment and enhanced contact tracing of partners.

The Symposium Title was 'Innovations in PrEP.'
Year(s) Of Engagement Activity 2016
URL http://www.croiwebcasts.org/console/player/29561?mediaType=podiumVideo&
 
Description Dr Sarah Joseph invited to give a special lecture to third year medical studies on HIV vaccines at Kings College 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Undergraduate students
Results and Impact Talk sparked interest and discussion about HIV vaccines among students.

-
Year(s) Of Engagement Activity 2014
 
Description Dr. Catherine Montgomery presented 'Events, Looks, Data: Friction and Lubrication' at a meeting: New Methodologies for Interdisciplinarity in HIV and Related Health Fields, 25th June 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Dr. Catherine Montgomery presented: 'Events, Looks, Data: Friction and Lubrication in Clinical Trials', referring to MDP301 trial data in her presentation.

Attended by 35 people

-
Year(s) Of Engagement Activity 2014
 
Description Dr. Catherine Montgomery presented at a seminar on interventional trials in developing countries: Who is the 'trial community' and why does it matter? 7th April 2014, University College London 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Dr. Montgomery presented anthropological work from her PhD on the successes and challenges of working in Mazabuka, broadly covering:

- the MDP philosophy of capacity building, incl. local ownership of data, training, etc.
- the challenges of bringing men on board
- rumours and problems with misreporting at the end of the trial
- the trial as an intervention in its own right: how not just trial participants, but staff, investigators and communities at many levels can be changed in the process of conducting research
- presented also the capacity building outputs of MDP to present (numbers of higher degrees etc)

Seminar aimed at clinical academics in medicine with the aim to provide them with practical advice and educate.
Year(s) Of Engagement Activity 2014
 
Description Dr. Mitzy Gafos attendance at the AVAC Communications Working Groups meeting on 30th April and 1st May, New York 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Discuss communications needs of HIV prevention

Inform communication priorities for coming year
Year(s) Of Engagement Activity 2014
 
Description Dr. Mitzy Gafos led an Adherence Workshop, 29th Sept 2014 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact We identified the need to engage a broader audience and are working towards a national conference

We shared experiences, circulated data collection tools and posted a report of the meeting
Year(s) Of Engagement Activity 2014
 
Description Dr. Mitzy Gafos oral presentation on behalf of the PROUD Study: 'The changing language of HIV prevention', Barts hospital, 18th June 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Health professionals
Results and Impact Increased awareness among healthcare providers and Q&A session

Increased interest in the PROUD study
Year(s) Of Engagement Activity 2014
 
Description Dr. Mitzy Gafos presentation to UK-CAB (HIV Treatment Advocates Network): The Changing Landscape of Biomedical HIV Prevention Research, 25th April 2014, Birkbeck College, London 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact The meeting had 26 attendees, a third of whom came from outside London.
UK-CAB HIV treatment advocates network.
CAB 50: Looking backwards, moving forward

Feedback from Mitzy's session was rated excellent by over 50% and good by the rest. Audience feedback was that the presentation was good, engaging and that it enhanced their understanding.



Audience reported an improvement to their understanding following Mitzy's presentation
Year(s) Of Engagement Activity 2014
URL http://www.ukcab.net/meetings/presentations/
 
Description Dr. Mitzy Gafos presentation: Why New Methods? meeting: New Methodologies for Interdisciplinarity in HIV and Related Health Fields, Goldsmith's University, 25th June 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Presented methods used for data collection in microbicide and PrEP trials to data and advocated for the incorporation of new methods

Increased awareness of microbicide and PrEP studies and data tools applied
Year(s) Of Engagement Activity 2014
URL http://www.gold.ac.uk/sociology/research-centres/unitofplay/events/#d.en.62868
 
Description Dr. Mitzy Gafos presented at the MRC CTU at UCL General Staff meeting, 1st July 2014 - update on the PROUD pilot study 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Increased awareness of PROUD study and generated discussed

Increased awareness among CTU members
Year(s) Of Engagement Activity 2014
 
Description Dr. Mitzy Gafos presented: 'An update on Pre-Exposure Prophylaxis (PrEP)' Burrell Street, St. Thomas' at Burrell Street clinic, St. Thomas', London 6th November 2013 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Health professionals
Results and Impact Shared information about PROUD and the eligibility criteria and enrollment targets

Motivated for increased referral of eligible participants from health care providers
Year(s) Of Engagement Activity 2013
 
Description Dr. Mitzy Gafos presented: 'User perspectives, acceptability and adherence', WHO meeting, 25th March 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact The presentation was part of a 'Stakeholder Consultation on Priority Implementation Research to Inform Development of WHO Normative Guidance on Topical Pre-Exposure Prophylaxis'; input contributed to shaping a policy document.

Raised discussion regarding the role of self reported adherence data and the need to consider tools, such as BMQ, to predict adherence
Year(s) Of Engagement Activity 2014
 
Description Dr. Sarah Joseph attendance at Cuthivac annual Collaborators meeting, Nov 2013, Regensburg 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Progress updates on Cuthivac Consortium workpages.

-
Year(s) Of Engagement Activity 2013
 
Description Dr. Sarah Joseph attendance at Symposium on therapeutic vaccines/activators of HIV eradication, 12th Dec 2013 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Discussion about therapeutic vaccines research priorities

Informed the design of the current and future research applications
Year(s) Of Engagement Activity 2013
 
Description Dr. Sue Fleck presented at a Careers Conference, University of East London, 2nd April 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Undergraduate students
Results and Impact Well attended presentation ~100 attendees. Lots of questions and an attentive audience.
Presentation title: Working for Research Funding Organisations, Job Opportunities for Science Graduates at the Medical Research Council (MRC) Clinical Trials Unit (CTU) @ University College London (UCL)


Requests for further information.
Year(s) Of Engagement Activity 2014
 
Description EDCTP HIV Stakeholders meeting, Sep 2013 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact There were about 100 delegates from Africa, Europe and the US that attended this meeting. The majority were senior and influential academics or from normative agencies.

I am uniquely privileged to be working in microbicides, vaccines and PrEP to reduce the risk of HIV, and across the spectrum of product development from Phase I through to implementation. This was a excellent opportunity to provide a perspective balanced by the breadth and depth of my clinical trial experience.
Year(s) Of Engagement Activity 2013
URL http://www.edctp.org
 
Description Engagement of PROUD trial participants / sharing of information through trial the PROUD trial website www.proud.mrc.ac.uk 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact We engage with study participants, the media, academics and anyone interested in PrEP/HIV research through the study website which we regularly update.

Increase in enquiries relating to the PROUD trial.
Year(s) Of Engagement Activity 2012,2013,2014
URL http://www.proud.mrc.ac.uk
 
Description European AIDS Treatment Group (EATG), Brussels meeting 23-25 Jan 2015 to bring treatment advocates up to speed on HIV prevention topics. Prof. Sheena McCormack presented PrEP. 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Patients, carers and/or patient groups
Results and Impact At this point in time the treatment activist community was aware that there were two European trials with results that had led them to change much earlier than expected to offer participants at risk of HIV active treatment (Truvada as PrEP).

At this meeting there was an opportunity to explain why the two trials, PROUD and IPERGAY were designed so differently, and to describe the baseline characteristics. PROUD was an open-label design in which participants were randomised to receive PrEP immediately or after 12 months follow-up. The regimen offered was daily Truavda. IPERGAY was placebo-controlled, and the regimen was double dose before sex, and daily through to 2 doses after sex.
Year(s) Of Engagement Activity 2015
 
Description European Chemsex Forum 6-8 April 2016, London. Presentation by Prof. Sheena McCormack 'PrEP and ChemSex: Looking forward...' 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Gave a presentation on 'PrEP and ChemSex: Looking forward...' 7th April (15mins)
Year(s) Of Engagement Activity 2016
URL http://www.profbriefings.co.uk/chemsex2016/chemsex16prog.html
 
Description Extensive enagement with media (radio, TV, online and print) for distribution of PROUD trial results, February 2015 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact The PROUD trial results release in February 2015 received extensive coverage. Selected articles are below:

RADIO
Prof. Sheena McCormack (BBC5live breakfast 26 minutes in) http://www.bbc.co.uk/programmes/b0536kw9
PROUD trial participant interview http://www.bbc.co.uk/programmes/p02ksq13
Prof. Sheena McCormack, Dr. Mitzy Gafos and a trial participant (BBC5live 1:37 hours in) http://www.bbc.co.uk/programmes/b0536kwf#auto
Dr. Mitzy Gafos (BBC radio4 today programme) http://www.bbc.co.uk/programmes/p02ks961
Dr. Mike Brady +Edwin Bernard, HIV Justice network (LBC Sheila Fogarty) http://chirb.it/s7krdg
Dr. Mitzy Gafos - BBC world service 7.50am
Dr. Amanda Clarke - BBC radio Sussex
Prof. Sheena McCormack http://www.newstalk.com/player/shows/Moncrieff/80813/the_game_changing_drug_which_prevents_hiv


TV
Dr. Mike Brady + ppt (Rob Shepherd) http://news.sky.com/story/1433828/hiv-drug-game-changer-hopes-for-gay-men
Dr. Richard Gilson - BBC4 news at 7pm
Dr. Mitzy Gafos - Sky news live 3.30pm, BBC news 9.30am

ONLINE/PRINT
http://www.bbc.co.uk/news/health-31622337
http://www.bhiva.org/BHIVA-calls-for-rapid-assessment-of-PrEP-funding.aspx
http://www.europeanpharmaceuticalreview.com/29661/news/industry-news/proud-study-shows-pre-exposure-prophylaxis-is-highly-protective-against-hiv-infection/
http://www.aidsmap.com/Pre-exposure-prophylaxis-PrEP-stops-86-of-HIV-infections-in-PROUD-study/page/2947319/
http://news.sky.com/story/1433828/hiv-drug-game-changer-hopes-for-gay-men
http://www.avac.org/press-release/avac-calls-rapid-response-new-arv-based-hiv-prevention-data
http://www.cityam.com/210243/how-stop-spread-hiv-scientists-may-have-solved-problem-truvada
http://www.heraldscotland.com/news/health/preventative-hiv-drug-effective.119254681
http://www.independent.co.uk/life-style/health-and-families/health-news/hiv-pill-scientists-hail-discovery-of-gamechanger-that-cuts-the-risk-of-infection-among-gay-men-by-86-10068091.html#
http://www.itv.com/news/2015-02-25/drug-cuts-hiv-risk-by-87/
http://www.nhs.uk/news/2015/02February/Pages/Game-changer-HIV-drug-cuts-infection-risk-by-86-per-cent.aspx
http://www.nhs.uk/news/2015/02February/Pages/Game-changer-HIV-drug-cuts-infection-risk-by-86-per-cent.aspx
http://www.nzherald.co.nz/lifestyle/news/article.cfm?c_id=6&objectid=11408338
http://www.pinknews.co.uk/2015/02/24/proud-study-finds-prep-reduces-risk-of-hiv-infection-by-86/
http://www.reuters.com/article/2015/02/24/us-health-aids-prep-idUSKBN0LS2EV20150224
http://www.theguardian.com/society/2015/feb/24/daily-pill-truvada-cuts-spread-of-hiv-by-86-study-shows
http://www.ucl.ac.uk/news/news-articles/0215/250215-PROUD-pre-exposure-prophylaxis-protects-against-HIV
http://www.ucl.ac.uk/news/news-articles/0215/250215-PROUD-pre-exposure-prophylaxis-protects-against-HIV
http://www.who.int/hiv/mediacentre/news/croi2015-arvnews/en/
Year(s) Of Engagement Activity 2015
 
Description Gus Cairns, PROUD Community Engagement Group member and PROUD TSC Co-Chair provided a radio interview to www.voiceofrussia.com/uk on 10th Feb. 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Shared information about PrEP

Increased awareness of PrEP
Year(s) Of Engagement Activity 2014
 
Description Help Make History website www.helpmakehistory.mrc.ac.uk to increase interest in public participation in vaccine trials/information sharing 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Increase in number of registrants to Help Make History database of potential participants to vaccine trials. Increase in number of direct enquiries relating to participation in vaccine trials.

Registration to the Help Make History database of potential participants to vaccine trials has increased, along with the number of direct enquiries. Cuthivac 001 trial is now fully enrolled (as of 6th Nov 2014) as as direct result of this engagement, along with profiling of vaccine recruitment on social media.
Year(s) Of Engagement Activity 2012,2013,2014
URL http://www.helpmakehistory.mrc.ac.uk
 
Description Inaugural lecture 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact About 200 people from a range of disciplines and including the general public and school children attended and it was an opportunity to raise awareness of the ongoing HIV epidemic, the dramatic advances in biomedical interventions for the prevention of HIV and the importance of behaviour.

The lecture was videoed and posted on YouTube and tweeted.
Year(s) Of Engagement Activity 2013
 
Description Interview on PrEP on The Victoria Derbyshire show (TV). Prof. McCormack attending by skype, 7th June 2016 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Interview on PrEP on The Victoria Derbyshire show (TV). Prof. McCormack attending by skype, 7th June 2016, Yusef Azad (NAT) in person.
http://www.bbc.co.uk/programmes/p03xkmw9
Year(s) Of Engagement Activity 2016
URL https://twitter.com/victorialive/status/740123270108696578
 
Description Invited speaker at international conference, Oct 2013 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Health professionals
Results and Impact Several hundred delegates attended the plenary session 'ART for prevention - roll it out?' at the European AIDS Clinical Society 2013 held in Belgium.

This provided an opportunity to raise awareness of PrEP in Europe. The only two countries with ongoing PrEP activitieis in Europe are France and the UK, and yet this intervention is highly relevant to the European epidemic which is focused in MSM and drug users.
Year(s) Of Engagement Activity 2013
URL http://www.eacsociety.org
 
Description Invited speaker for CHAARM symposium 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Health professionals
Results and Impact About 200 people attended this symposium which was part of the European AIDS Clinical Society 2013 programme. I was invited to outline the Current status of Microbicide Trials.

The symposium sparked interest from the media leading to interviews.
Year(s) Of Engagement Activity 2013
URL http://chaarm.eu/content/newsroom
 
Description Invited speaker: 'HIV pre-exposure prophylaxis as a public health intervention: where are we in 2016', and panel Chair. BASHH Annual Conference 10-12 July, Oxford. 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact BASHH Annual Conference 10-12 July, Oxford.
Prof. Sheena McCormack invited speaker: 'HIV pre-exposure prophylaxis as a public health intervention: where are we in 2016' (15mins); Plenary Session 3 & Access to PrEP panel (Chair)
Year(s) Of Engagement Activity 2016
URL http://www.bashh.org/BASHH/Education/BASHH_Annual_Conference/BASHH_Annual_Conference_2016/BASHH/Educ...
 
Description Invited to Population Council select group dinner discussion on anti-LGBT legislation in Africa, London, 17th June 2014 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact I was able to contribute very little except to emphasise that MRC was commited to equality and diversity but also to protecting the safety of employees, and that the anti-gay legislation created a tension in this regard as the safety of MRC employees could be jeopardised by speaking out against the government legislation.
The take home message for me is that it is the electorate that is ultimately responsible for encouraging politicians to pursue the anti-gay legislation and this speaks to a fundamental structural problem that requires further investigation to better understand the underlying factors before a comprehensive strategy can be proposed.

Good contacts with diverse organisations made, and a better understanding of the constraints under which HIV testing and STI screening are conducted in several countries in Africa.
Year(s) Of Engagement Activity 2014
 
Description Invited to serve on Abstract Review Committee for BHIVA/BASSH 3rd joint conference (1-4th April 2014) 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact -
Year(s) Of Engagement Activity 2014
URL http://www.bashh.org/BASHH/Education/BASHH_Spring_Conference/BASHH_BHIVA_Conference_2014/BASHH/Educa...
 
Description Invited to speak at PrEP and PEPSE panel, BHIVA Autumn Conference, London, 9-10th Oct. 2014 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Health professionals
Results and Impact BHIVA Interactive Clinical Conundrums: PrEP and PEPSE, 10th October 2014
Panel: Professor Sheena McCormack, MRC CTU at UCL and Dr Andy Williams, Barts Health NHS Trust, London


-
Year(s) Of Engagement Activity 2014
 
Description Italian Conference on AIDS, Riccione, Italy, 17-19.05.15. Prof. McCormack invited to give a lecture on PROUD results and to participate to a Round Table: 'PrEP: is it the right time to act?' 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Discussion (in Italian with translation) revealed support from clinicians and community for PrEP but difficulties in navigating the current Italian system in which prevention services in general are under-resourced and seemingly not a government priority.
Year(s) Of Engagement Activity 2015
 
Description LGF Community Workshop 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Regional
Primary Audience Health professionals
Results and Impact The audience of about 50 was drawn mainly from community organisations, although there were commissioners of public health, healthcare professionals form clinics and other academics present. My talk was on PrEP and PROUD, the UK Pilot study of PrEP.

The talks were followed by working groups tasked with thinking of positive and negative aspects to PrEP. It was helpful to have this feedback to better understand what the challenges to roll-out are likely to be.
Year(s) Of Engagement Activity 2012
 
Description Lecture to medical students at Guys and St Thomass 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Undergraduate students
Results and Impact I gave an overview of HIV vaccines to medical students, highlighting the work of the UKHVC

Course organiser invited Sarah Joseph to give lecture to medical students on HIV vaccines as part of their virology moduel.
Year(s) Of Engagement Activity 2012,2013
 
Description Letter to The Times newspaper editor on PrEP 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Letter to The Times, Editor:
Written as below:

Dear Sir,

A drug now exists that prevents HIV: pre-exposure prophylaxis (PrEP). When taken correctly, it is near 100% effective. But NHS England is standing in the way of utilising this remarkable breakthrough to tackle the HIV epidemic.

After 18 months of delays and false starts, David Cameron has now committed NHS England to giving an answer on PrEP imminently.

As the decision looms, arguments against PrEP are running out of steam. Men accessing the drug in trials haven't shown an increase in STIs. The NHS spends 50 times more on HIV treatment than prevention.

PrEP, alongside condom use, has enormous potential to reduce HIV transmission. It is available in the US, France and Kenya and soon in Australia. The Government must now make PrEP available to people at high risk in England. Every day this is delayed, at least seven people will be infected with HIV.

We anticipate a long overdue answer on 31st May, when NHS England will decide if PrEP should be considered for funding. This could be a critical turning point in the fight against HIV - it must not pass us by.

Yours sincerely,

Deborah Gold, Chief Executive, National AIDS Trust Ian Green, Chief Executive, Terrence Higgins Trust Professor Sheena McCormack, PROUD trial Chief Investigator Dr Elizabeth Carlin, President, British Association for Sexual Health and HIV Dr David Asboe, Chair, British HIV Association Matthew Hodson, Chief Executive, GMFA - the gay men's health charity Marion Wadibia, Chief Executive, NAZ Tom Doyle, Chief Executive, Yorkshire MESMAC Rob Cookson, Deputy Chief Executive, LGBT Foundation Allan Anderson, Chief Executive, Positively UK Gus Cairns, European AIDS Treatment Group Monty Moncrieff, Chief Executive, London Friend Mark A. Santos, Director, Positive East Caspar Thomson, Executive Director, NAM Dr Greg Ussher, Chief Executive, METRO Ben Collins, ReShape Dr Will Nutland and Marc Thompson co-founders PrEPster Greg Owen and Alex Craddock, co-founders, iwantprepnow.co.uk Michelle Ross, co-Founder cliniQ Silvia Petretti, Memory Sachikonye and Paul Clift, UK Community Advisory Board Sophie Strachen, Trustee, Sophia Forum Dan Glass, ACT UP LONDON (AIDS Coalition To Unleash Power) Simon Collins, Director, HIV i-Base Robert Fieldhouse, Editor, BASELINE Magazine Lisa Power, MBE
Year(s) Of Engagement Activity 2016
 
Description MMCI, PrEP and Vax Comms call, 4th Feb. 2014 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Health professionals
Results and Impact Mitzy Gafos joined call for update on injectables

-
Year(s) Of Engagement Activity 2014
 
Description MTN 'Creating Desire for Microbicides' meeting, Arlington, USA, 13-14th May 2014 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Prof. Sheena McCormack invited to speak about PROUD at the meeting. Title of presentation: The PROUD Study: Creating desire for PrEP in the UK. This was an opportunity to promote the wait-listed design for assessment of products. The absence of placebo facilitates a more honest dialogue between participant and clinician, and means that participants are taking the product for themselves, not just for the study.

The audience understood why this design was the only one that could address the real-world effectiveness of PrEP in which participants were motivated to take a drug they knew would work, but less motivated to use condoms to reduce their risk of HIV.
Year(s) Of Engagement Activity 2014
URL http://www.mtnstopshiv.org/2014cd
 
Description Media - AIDSMap article: 'The road to PrEP: trials, regulation and roll-out', 25th June 2012 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Interview with article author

Media dissemination of information about PrEP/PROUD
Year(s) Of Engagement Activity 2012
URL http://www.aidsmap.com/The-road-to-PrEP-trials-regulation-and-rollout/page/2403757/
 
Description Media - Interview with The Times for article: Trial of pill to prevent HIV could lead to rise in promiscuity, scientists admit; published 8th Feb 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist

Media dissemination of information about PrEP/PROUD
Year(s) Of Engagement Activity 2014
URL http://www.thetimes.co.uk/tto/health/news/article4000861.ece
 
Description Media - Interview for BBC 5 Live for radio article: 14th July 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.scoop.it/t/mrc-news/?tag=HIV%2FAIDS
 
Description Media - Interview for Daily Mail article: 'Wonder drug' which can reduce HIV risk by 92% could be offered on the NHS, published 17th Oct 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.dailymail.co.uk/health/article-2796900/wonder-drug-reduce-hiv-risk-92-offered-nhs-landmar...
 
Description Media - Interview for Dirtyboyz for article July 2014 issue (pp. 54-55) 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
 
Description Media - Interview for Independent article: NHS to offer tablet which can reduce HIV risk by 90%; published 16th Oct 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.independent.co.uk/life-style/health-and-families/health-news/nhs-to-offer-tablet-which-ca...
 
Description Media - Interview for QX Magazine for article: PrEP Yourself; published 22nd Oct 2014. 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.qxmagazine.com/feature/prep-yourself/
 
Description Media - Interview for article in The Guardian supplement The Scene: Help make history by volunteering for HIV vaccine clinical trials; published 2nd Aug 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Prof. Robbin Shattock interviewed, article created promoting recuitment to HIV vaccine trials.

Increase in requests for participation in Cuthivac 001 HIV vaccine trial, fully recruited as of 6th Nov 2014.
Year(s) Of Engagement Activity 2014
 
Description Media - Interview with Baseline for article PrEP: Next Step?, published 10th July 2013 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist

Media dissemination of information about PrEP/PROUD
Year(s) Of Engagement Activity 2013
URL http://www.baseline-hiv.co.uk/hiv-articles/2013/7/10/prep-next-step
 
Description Media - Interview with Baseline for article: Prep- Gets Real?, published 5th Nov 2013 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist

Media dissemination of information about PrEP/PROUD
Year(s) Of Engagement Activity 2013
URL http://www.baseline-hiv.co.uk/hiv-articles/2013/11/5/prep-gets-real
 
Description Media - Interview with Mancunian Matters for article: 'The anti-HIV drug cure-all? Gay Manchester men offered pill to prevent infection in ground-breaking trial', published 15th Oct 2013 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist

Media dissemination of information about PrEP/PROUD
Year(s) Of Engagement Activity 2013
URL http://www.mancunianmatters.co.uk/content/151059198-anti-hiv-drug-cure-all-gay-manchester-men-offere...
 
Description Media - Interview with QX Magazine for article: PREP: A new pill in the fight against HIV, published 4th July 2013 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist

Media dissemination of information about PrEP/PROUD
Year(s) Of Engagement Activity 2013
URL http://www.qxmagazine.com/feature/prep-a-new-pill-in-the-fight-against-hiv/
 
Description Media - Interview with Radio Russia for radio/online article: HIV prevention drug goes on trial in the UK, broadcast 10th Feb 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist

Media dissemination of information about PrEP/PROUD
Year(s) Of Engagement Activity 2014
URL http://voiceofrussia.com/uk/news/2014_02_10/HIV-prevention-drug-goes-on-trial-in-the-UK-3396/
 
Description Media - Interview with Shmu radio, Aberdeen for World AIDS Day, 1st Dec 2013. 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist

Media dissemination of information about PrEP/PROUD
Year(s) Of Engagement Activity 2013
 
Description Media - Interview with The Daily Mail for article: 'Pressure grows on NHS to make new HIV wonder drug available for those at risk', published 17th May 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.dailymail.co.uk/news/article-2631219/Call-HIV-pill-gay-men-risk-infection-available-NHS.h...
 
Description Media - Interview with The Independent for article: 'Make new HIV protection pill available on the NHS, say sexual health campaigners', published 16th May 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.independent.co.uk/life-style/health-and-families/health-news/make-new-hiv-protection-pill...
 
Description Media - Interview with The Lancet for article: Uptake of PrEP for HIV slow among MSM, published 1st Feb 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist

Media dissemination of information about PrEP/PROUD
Year(s) Of Engagement Activity 2014
URL http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)60137-9/fulltext
 
Description Media - Interview with The Times for article: Coming soon: the daily pill that can protect against HIV; published 17th Oct 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.thetimes.co.uk/tto/health/news/article4239078.ece
 
Description Media - Interview with Under the Rainbow on Pure 107.8FM (LGBT community radio station, Stockport), 24th October 2013 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist

Media dissemination of information about PrEP/PROUD
Year(s) Of Engagement Activity 2013
 
Description Media - Interview with i-Base for article: The little blue pill that can stop HIV: UK PROUD study, article published 22nd Nov 2013 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist

Media dissemination of information about PrEP/PROUD
Year(s) Of Engagement Activity 2013
URL http://i-base.info/the-little-blue-pill-that-can-stop-hiv/
 
Description Media - Interview with trial participant writing an article for The Gay UK: So Why Are So Many Gay Men Opposed To PrEP? published 16th Oct 2014. 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Interview with PROUD trial participant who wanted to write an article.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.thegayuk.com/magazine/4574334751/So-Why-Are-So-Many-Gay-Men-Opposed-To-PrEP/8625632
 
Description Media - PROUD trial poem on YouTube, Prof. Sheena McCormack, 25th Sept 2013 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact A well documented and viewed artistic interpretation of the PROUD trial Informed Consent sheet.
Very well received.

661 YouTube hits as of 13th Nov 2014 and well publicised on social media. Increase in requests for information and participation in the PROUD trial.
Year(s) Of Engagement Activity 2013
URL http://www.youtube.com/watch?v=hXxr01cgb_M
 
Description Media - QX Magazine article: The Young People's Discussion Of HIV: A Review, published 1st Oct 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact • The Young People's Discussion of HIV was assembled by QX as part of Soho sexual health clinic 56 Dean Street's Gay Men's Wellbeing Programme, sponsored by the Monument Trust. Lots of discussion, this article arose and a further article with QX pending for Dec 2014.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.qxmagazine.com/feature/the-young-peoples-discussion-of-hiv/
 
Description Media - article AIDSMap/NAM: PROUD UK PrEP study completes enrolment - first data give participants' background and risk factors, published 9th April 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Article by PROUD Community Engagement Group member/TSC Co-Chair.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.aidsmap.com/page/2845218/
 
Description Media - article for AIDSMap/NAM: High effectiveness seen in English PrEP trial; published 16th Oct 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Article produced by Gus Cairns (co-chair of the PROUD Trial Steering Committee)/Community Engagement Group member.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.aidsmap.com/High-effectiveness-seen-in-English-PrEP-trial/page/2912952/
 
Description Media - article for HIV I-Base: UK PROUD study to provide PrEP earlier than expected: planned follow-up in this HIV prevention study to continue for two years; article published 16th Oct 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Article written by independent member of the PROUD IDMC (Simon Collins).

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://i-base.info/uk-proud-study-to-provide-prep-earlier-than-expected/
 
Description Media - article for Huffington Post: This New HIV Prevention Drug Could Soon Be Available To Those At Risk Of Infection On The NHS; published 17th Oct 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Article written (featured quotations previously mentioned in a Daily Mail article).

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.huffingtonpost.co.uk/2014/10/17/drug-breakthrough-hiv-prevention_n_6002650.html
 
Description Media - article in AIDSmap/NAM: European CDC cautious about PrEP; published 18th July 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Article written by PROUD Trial Steering Committee co-Chair/Community Engagement Group member.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.aidsmap.com/European-CDC-cautious-about-PrEP/page/2891977/
 
Description Media - article in Gay Star News: UK to be offered pill that reduces HIV risk by up to 90%; published 17th Oct 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Article featured some quotations from interviews with other journalists published in other journals.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.gaystarnews.com/article/uk-be-offered-pill-reduces-hiv-risk-90171014
 
Description Media - article in International Business Times: HIV 'Breakthrough' Drug Reduces Risk of Infection by up to 92%: What is Truvada?; published 17th Oct 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Article written.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.ibtimes.co.uk/hiv-aids-breakthrough-drug-reduces-risk-infection-by-92-what-truvada-147055...
 
Description Media - article in The Australian: Groundbreaking HIV pill developed in UK;published 17th Oct 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Article used quotations from interviews featured in other journals.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.theaustralian.com.au/news/health-science/groundbreaking-hiv-pill-developed-in-uk/story-e6...
 
Description Media - article in The Guardian: 'Honestly, it's a revolution. It's so great taking control', published 24th Sept 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Article on Truvada with comments from PROUD trial participant.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.theguardian.com/society/2014/sep/24/truvada-hiv-aids-you-tell-us
 
Description Media - article in The Guardian: Can this HIV drug help to end 30 years of blighted lives? 29th Sept 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Article: Terrence Higgins Trust quoted (Cary James).

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.theguardian.com/commentisfree/2014/sep/29/new-hiv-drug-truvada-gay-men-us-nhs
 
Description Media - article on HIV I-Base: Q and A on PrEP in the UK and changes to the HIV PROUD study; published 17th Oct. 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Q&A article written.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://i-base.info/qa-on-prep-in-the-uk-and-changes-to-the-hiv-proud-study/
 
Description Media - article on www.BHIVA.com: Second European PrEP study is closed early due to high effectiveness; published 29th Oct. 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Article provided by Gus Cairns, PROUD Trial Steering Committee co-Chair.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.bhiva.org/News.aspx?NewsID=f83f28a9-80f6-415f-8039-c5d35dbe483c
 
Description Media - article on www.HIVandHepatitis.com: High Effectiveness Seen in English PrEP Trial, All Will Be Offered Truvada; published 17th Oct. 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Article produced in collaboration with AIDSmap.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://www.hivandhepatitis.com/hiv-prevention/hiv-prep/4890-high-effectiveness-seen-in-english-prep-...
 
Description Media - article on www.RT.com: HIV drug cutting transition risk 90% may be offered on NHS; published 17th Oct 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Interview with journalist.

Media dissemination of information about PrEP/PROUD.
Year(s) Of Engagement Activity 2014
URL http://rt.com/uk/196816-drug-reduce-hiv-nhs/
 
Description Media: Boyz article titled 'PrEP Up' 27 November 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact The article increased awareness of PrEP

No impact to date
Year(s) Of Engagement Activity 2014
URL http://www.joomag.com/magazine/boyz-magazine-1213/0609721001417000705?short
 
Description Media: DW.DE Radio: Truvada Trials (27th November 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Increased awareness of PrEP - PROUD and IPERGAY

No impact yet
Year(s) Of Engagement Activity 2014
URL http://www.dw.de/program/s-1452-9798
 
Description Media: Interview to contribution to article: The Truvada Wars; BMJ 24th June 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Health professionals
Results and Impact Prof. Sheena McCormack interviewed by Julia Belluz 16th April 2014 for an article that Julia went on to have published in the BMJ.
Article title: The Truvada Wars (published 24th June 2014).

BMJ2014;348 doi:http://dx.doi.org/10.1136/bmj.g38111 (Published 24 June 2014)
Cite this as: BMJ 2014; 348:g3811


Increased awareness
Year(s) Of Engagement Activity 2014
URL http://www.bmj.com/content/348/bmj.g3811
 
Description Mentoring of British Commonwealth Fellow (Ugandan statistician) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact A British Commonwealth Fellow attended some mentoring at our Unit, including attending a TaMoVac trial management teleconference in 2015. The mentee asked lots of questions about how we ran trials and we equally learnt from her about perceptions of HIV treatment/prevention in Uganda. Dr. Sue Fleck talked to her about Trial Management issues in HIV Prevention trials.

The mentee attended various sessions at CTU and would take her learning back to her workplace.
Year(s) Of Engagement Activity 2015
 
Description Microbicides lecture, AIDS module, 2013 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Health professionals
Results and Impact This talk is embedded in the AIDS 3174 module offered by the LSHTM to their post-graduate students.

Not all the audience had heard of microbicides at the outset, and very few were aware of the current status of the trials, or the relevance of the oral PrEP studies to development of these topical agents.
Year(s) Of Engagement Activity 2013
 
Description Mitzy Gafos on behalf of the PROUD Study presented: 'An Update on the PROUD study of Pre-Exposure Prophylaxis (PrEP)', 5th June 2014, MRC Glasgow 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact -
Year(s) Of Engagement Activity 2014
 
Description Mitzy Gafos on behalf of the PROUD Study presented: 'PPI: Involving Participants in the PPI strategy of the PROUD study' at a Participant Engagement workshop, MRC CTU at UCL, 17th June 2014 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Presented experiences of involving study participants in PPI activities

Increased discussion about the role of study participants in PPI
Year(s) Of Engagement Activity 2014
 
Description Mitzy Gafos presented An Update on PROUD to the European AIDS Treatment Group (EATG) Webinar 2: PrEP on 24-11-2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Initiated discussion about PrEP in Europe

Linkage with European advocates
Year(s) Of Engagement Activity 2014
URL http://www.avac.org/event/eatg-webinar-2-pre-exposure-prophylaxis
 
Description Mitzy Gafos presented on "PrEP- is the time right?" Update on the PROUD study to the Wessex BASHH Regional Clinical Network Group Meeting 19-11-2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact The presentation generated a discussion about PrEP roll out in the UK - providers wanted more information about cost effectiveness, toxicity, resistance and targeting of PrEP in the NHS (15 doctors and health advisers present)

The presentation will be shared around the group
Year(s) Of Engagement Activity 2014
 
Description Mitzy Gafos presented: 'An update on Pre-Exposure Prophylaxis (PrEP)' to the BASHH North Thames Branch meeting, London, 20th November 2013 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Media (as a channel to the public)
Results and Impact Raised awareness and interest in the PROUD study

-
Year(s) Of Engagement Activity 2013
 
Description Moncrieff show, Ireland. Prof. Sheena McCormack interviewed on PrEP research, 5th March 2015 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Q&A on popular Irish radio show on PrEP and the results of PROUD in particular.
Year(s) Of Engagement Activity 2015
 
Description National AIDS Manual/AIDS Vaccine Advoacy Coalition Webinar on Microbicides 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact About 80 people attended this webinar.

The slides and audio are available on the NAM and AVAC websites.
Year(s) Of Engagement Activity 2013
URL http://www.avac.org/ht/display/EventDetails/i/49094/TPL/MatDetails/pid/351
 
Description National AIDS Manual/AIDS Vaccine Advocacy Coalition Webinar 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact 80 people joined the webinar, and the slides and audio are available on the NAM/AVAC websites.

Positive feedback from the organisers.
Year(s) Of Engagement Activity 2013
URL http://www.avac.org/ht/display/EventDetails/i/49928/TPL/MatDetails/pid/351
 
Description National AIDS Manual/AVAC teleconference (9th May 2013) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Presented to a group of advocates, community members and researchers on "Social Science Research in PrEP"

Provided update on PROUD
Year(s) Of Engagement Activity 2013
 
Description Oral presentation by Richard Stack: PrEP and PROUD, SSHA Annual Conference 21st Sept 2013 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Invited presentation prepared by MRC and given by a PROUD researcher to 80 delegates at the SSHA conference.
Conference: SSHA Annual Conference
21st September 2013, London
Title: PREP and PROUD

Increased awareness among Sexual Health Advisers about PROUD. Disseminated healthcare workers survey at the conference.
Year(s) Of Engagement Activity 2013
 
Description PROUD Community Engagement Group (CEG) meeting, 9th April 2014 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact Discussed progress on enrollment, participant involvement meetings and end of study plans

Shared information including recent BHIVA presentation slides
Year(s) Of Engagement Activity 2014
 
Description PROUD Community Engagement (CEG) meeting, 3rd Sept 2014. 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Agreed plans for the HTA application, PPI payment policy and participant reimbursement policy

Informed the submission of the HTA trial funding application
Year(s) Of Engagement Activity 2009,2014
 
Description PROUD Community Engagement Group (CEG) meeting, 14th Oct. 2014 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Updated CEG members of the IDMC recommendation in confidence and developed a dissemination strategy for the discontinuation of the deferred study arm

Supportive statements from CEG members once IDMC recommendation released on 16th October 2014
Year(s) Of Engagement Activity 2014
 
Description PROUD Community Engagement Meeting, Jun 2014 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Type Of Presentation Workshop Facilitator
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact 14th June 2013 - We invited a range of stakeholders from community organisations working with gay men, representatives from the gay press and gay dating agencies such as Grindr. We facilitated discussions about The workshop focused on discussing three key issues: Lack of knowledge/awareness of PrEP; risk awareness; and Improving awareness about PrEP

Approximately 16 people attended the workshop. The outcomes were summarised in a meeting report for internal use. Outcomes informed the subsequent messaging stategy and resulted in the development of a position statement on PrEP from the community groups who attended.
Year(s) Of Engagement Activity 2013
URL http://www.proud.mrc.ac.uk/PDF/PrEP%20Community%20Statement.pdf
 
Description PROUD PPI article: Involving 'seldom heard' groups in HIV research, INVOLVE website, November 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Article posted on the INVOLVE website, November 2014 to raise awareness of PROUD PPI work.

To early to assess the impact of this article.
Year(s) Of Engagement Activity 2014
URL http://www.invo.org.uk/involving-seldom-heard-groups-in-hiv-research/
 
Description PROUD Participant Involvement Meeting (1st), 12th Nov. 2013 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Attendees: 8 study participants - only one or two from out of London
Call notes: Six of the eight participants joined by phone and two joined on-line.
Topic: What about after the PROUD pilot study? A discussion about what the next steps should be in terms of finding the most appropriate ways of making PrEP available in the UK
Presentation given entitled 'Future Options for PROUD'
Presentation and meeting notes published on the PROUD website www.proud.mrc.ac.uk

Discussed reasons for slow recruitment that helped inform recruitment strategy
Discussed next steps for PrEP in the UK which helped inform future planning
Year(s) Of Engagement Activity 2013
URL http://www.proud.mrc.ac.uk/patient_and_public_involvement.aspx
 
Description PROUD Participant Involvement Meeting (2nd), 19th March 2014 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Participants in your research and patient groups
Results and Impact Topic: Future HIV prevention research priorities: a discussion about research priorities in the event that PROUD demonstrates benefits of PrEP in the UK
Future HIV prevention research priorities presentation
17 study participants with representation from Dean St (8), John Hunter (3), Barts (2), St Thomas's (2), MMC (1), Homerton (1)
Meeting presentation and notes published on http://www.proud.mrc.ac.uk/patient_and_public_involvement.aspx

Discussed acceptability of clinical trial designs (especially use of placebo and deferred arm) and research priorities which informed strategic thinking about next clinical research priorities for HIV prevention research
Year(s) Of Engagement Activity 2014
URL http://www.proud.mrc.ac.uk/pdf/Report%20on%20Second%20Participant%20Involvement%20Meeting_19March201...
 
Description PROUD Participant Involvement Meeting (3rd): 9th Sept 2014 in person meeting and 11th Sept 2014 teleconference 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Participants in your research and patient groups
Results and Impact Date: 9th September 2014 (in-person) and 11th September 2014 (teleconference)
Location: MRC CTU (Aviation House) and by phone
Facilitator: Mitzy Gafos
Topic: Study design and data collection tools for a larger PROUD trial.
Attendees: 12 study participants (10 in-person and 2 on teleconference) with representation from Barts, Dean St, John Hunter, Mortimer Marker, St Mary's, and St Thomas's.
Discussed 6 questions in 3 breakout groups

Informed study thinking on the following topics: PrEP access post follow-up, clinical trial design, clinical trial study visits, clinical trial data collection methods, PPI payment, and participant reimbursement policy
Year(s) Of Engagement Activity 2014
URL http://www.proud.mrc.ac.uk/patient_and_public_involvement.aspx
 
Description PROUD documentary and Voices of Participants premiere 1st July 2015, The Cinema Museum, SE11, London 
Form Of Engagement Activity A broadcast e.g. TV/radio/film/podcast (other than news/press)
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact PROUD documentary and Voices of Participants premiere, The Cinema Museum, SE11, London. Launched 1st July 2015.

Further screenings around the UK have taken place during 2015 and also a German-language screening as part of Hamburg Gay Pride 28th August 2015. See http://www.proud.mrc.ac.uk/films for more information.

The screenings have been well attended and well received, with numerous requests for further information following each event.
Year(s) Of Engagement Activity 2015
URL http://www.proud.mrc.ac.uk/films
 
Description PROUD interview for radio show 'Newstalk' (Pat Kenny Show), 1st February 2016. 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Popular Irish radio show, with a reach beyond Ireland. Interviewed about PrEP and PROUD and policy in the UK, and relevance of this for Ireland.
Year(s) Of Engagement Activity 2016
URL http://www.newstalk.com/listen_back/13240/24871/01st_February_2016_-_The_Pat_Kenny_Show_Part_2/
 
Description PROUD presentation, Dean Street clinic, 11th June 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Health professionals
Results and Impact Prof. Sheena McCormack presented to the Health Advisors at Dean Street clinic. Health Advisors are the frontline staff that speak to gay men most at risk of catching HIV, and those that have just found out they have HIV infection. I was invited to provide an update on the PROUD study.

Increased knowledge amongst staff, and improved my understanding of access to behavioural interventions facilitating future referrals for participants on the PROUD study.
Year(s) Of Engagement Activity 2014
 
Description PROUD presentation/update to London (NW) CLRN Infectious Diseases and Microbiology Specialty Group Open Meeting, 4th Dec. 2013 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Health professionals
Results and Impact Well attended.
Very helpful update on the anticipated changes to the CLRN especially the interactions with NHS Trusts.

Informed the group about the PROUD trial and developments in PrEP, to promote better understanding amongst healthcare professionals.
Year(s) Of Engagement Activity 2013
 
Description PROUD study update presentation to the UK CAB (MG) 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact My presentation was one of four presentations about PrEP. The sessions generated discussion about future access to PrEP. A number of the CAB members are also members of the Clinical Reference Group (CRG) who will be involved with the review of PrEP in the future.

The group identified a series of questions that they intended to present to Gilead including the cost of Truvada and licensing of Truvada at the EMA.
Year(s) Of Engagement Activity 2015
URL http://www.ukcab.net/meetings/next-meeting/
 
Description Participation in Community seminar 'Community Conversation on understanding new HIV prevention data and what it all means'; took place during CROI Conference, 25th Feb 2015 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Third sector organisations
Results and Impact Participation in Community seminar 'Community Conversation on understanding new HIV prevention data and what it all means' ; took place during the CROI Conference, 25th Feb 2015. The two European trials had caused excitement amongst community organisation, tempered by the lack of benefit seen in the vaginal gel trial conducted in South Africa.
Year(s) Of Engagement Activity 2015
 
Description Plenary presentation 'The madness of HIV prevention trials' 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation keynote/invited speaker
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The talk highlighted the challenges encountered in the conduct of HIV prevention trials. The answer can be disappointing because these issues were not overcome, or because the product did not work.

xxx
Year(s) Of Engagement Activity 2015
 
Description PrEP Trial Designs in Europe meeting, Windsor, 4-5/07/16 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The 'PrEP Trial Designs in Europe meeting', Windsor, 4-5/07/16 was an ANRS/MRC organised workshop involving 65 researchers, predominantly from Europe, but with some attendees also from the US, Russia and Israel. Attended by researchers, clinicians, regulatory & some pharma company reps.
Year(s) Of Engagement Activity 2016
 
Description PrEP Twitter Q&A, World AIDS Day 1st December 2015. Participation by Prof. Sheena McCormack 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact As well as the questions that spontaneously arrived, there were questions already prepared designed to raise awareness. The Chief Investigator, a member of the Community Engagement Group and a PROUD participant took part in #PROUDQandA
Year(s) Of Engagement Activity 2015
URL https://storify.com/MRCCTU/world-aids-day-q-a-prep-and-the-proud-study
 
Description PrEP and PROUD plenary at18th Annual BASHH Conference for SAS Doctors Working in Sexual Health. Warwick University, 5th Sept. 2015 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact An opportunity to reach a broader audience of practitioners working in sexual health, some of whom had not heard of PrEP before and very few of whom were overseeing PrEP or even aware of the PROUD study.

xxx
Year(s) Of Engagement Activity 2015
 
Description PrEP and PROUD talk to Gilead Sciences, Holborn, London, 13th May 2015 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Industry/Business
Results and Impact Talk on PrEP focusing on the two recently reported European trials - PROUD and IPERGAY. The discussion included how negotiations between Gilead (who have a monopoly on the market for PrEP and hepatitis C treatment, both of which are highly effective and both grossly over-charged) and governments in the interests of public health.
Year(s) Of Engagement Activity 2015
 
Description PrEP feature on the Victoria Derbyshire show, BBC Radio 5 Live, 14th July 2016 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact PrEP feature on the Victoria Derbyshire show, BBC Radio 5 Live, 14th July 2016
Year(s) Of Engagement Activity 2016
 
Description Prepster event at The Eagle, London on 19th March 2016. Showing of PROUD film and panel discussion of PrEP experts 
Form Of Engagement Activity A broadcast e.g. TV/radio/film/podcast (other than news/press)
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Over a hundred and fifty people turned up for the Prepster event at The Eagle London on 19th March 2016.

The evening was hosted by Prepster co-founder Will Nutland and started with a showing of Nicholas Feustel's short film about the PROUD PrEP trial https://vimeo.com/132412294 followed by a panel discussion of PrEP experts including;
?Nicholas Feustel - film maker Georgetown Media and PrEP activist
?Marc Thompson - PrEPster co-founder and Peer Mentor at Positively UK
?Sheena McCormack - PROUD study + Dean Street
?Mike Brady - Medical Director, Terrence Higgins Trust
?Greg Owen - I Want PrEP Now
Year(s) Of Engagement Activity 2016
URL https://vimeo.com/132412294
 
Description Prepster http://prepster.info/ and the LGBT Foundation, Manchester organised a showing of Nicholas Feustel's short film on the PROUD PrEP trial followed by a discussion with a panel of PrEP experts. 
Form Of Engagement Activity A broadcast e.g. TV/radio/film/podcast (other than news/press)
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Prepster http://prepster.info/ and the LGBT Foundation organised an evening showing in Manchester of Nicholas Feustel's short film on the PROUD PrEP trial followed by a discussion with a panel of PrEP experts.

Dr. Will Nutland (Prepster) hosted a panel of:

Yusef Azad, Director of Strategy - National AIDS Trust
Rob Cookson, Deputy Chief Executive - LGBT Foundation
Alex Craddock, Co-Founder - I Want PrEP Now
Sheena McCormack - PROUD Study + Dean St London
Chris Ward, Consultant Locum - The Hathersage Centre
Year(s) Of Engagement Activity 2016
URL https://vimeo.com/132412294
 
Description Presentation by Gus Cairns to UK CAB: Who accesses PrEP? PROUD study baseline data analysis, 24th October 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact UK-CAB 52: Sexual health and HIV

Well received presentation

-
Year(s) Of Engagement Activity 2014
URL http://www.ukcab.net/wp-content/uploads/2014/10/PROUD-study-pilot-baseline-data.pdf
 
Description Prof. Helen Rees webinar for AVAC on HC and HIV during which she referenced MDP data,10th March 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact -
Year(s) Of Engagement Activity 2014
 
Description Prof. McCormack attendance at MTN Phase 3 Rectal Microbicide Design meeting, Washington DC, 18-19.02.15 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact A workshop to review the available data on tenofovir rectal gel and the options for the final stage of evaluation, one of which is the immediate deferred design used to demonstrate the effectiveness of daily oral Truvada in PROUD.
Year(s) Of Engagement Activity 2015
 
Description Prof. McCormack participation in a Press meeting 24.02.15 during the CROI conference on PROUD trial results 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Invited to the Press meeting at CROI 24.02.15 following presentation of the PROUD results. The media was excited about the two European trials that both reported a 86% reduction in HIV (the largest reported to date), and asked why European governments were not responding to these impressive results.
Year(s) Of Engagement Activity 2015
 
Description Prof. Robin Shattock presented at the All-Party Parliamentary Group meeting focussed on AIDS, TB and Malaria, 25th Feb 2014 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact Professor Robin Shattock, Faculty of Medicine, Department of Medicine, Imperial College. Chairman of Mucosal infection and immunity and member of IAVI's Scientific Advisory Committee. Prof. Shattock addressed resistance to ARVs, therapeutic vaccines, the role of PrEP and the development of preventive vaccines.



Prof. Robin Shattock presented the challenges with resistance to ARVs which led on to discussions about why additional prevention options including microbicides and vaccines are needed. Slides on the UK HIV Resistance Database were presented also. Greater understanding gained by the APPG.
Year(s) Of Engagement Activity 2014
URL http://www.lstmliverpool.ac.uk/events/february-2014/25-feb-all-party-parliamentary-group-on-malaria-...
 
Description Prof. Sheena McCormack featured on BBC2 TV for The Victoria Derbyshire programme, discussing the 'Chemsex' scene, 2nd July 2015. 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Prof. Sheena McCormack provided content for BBC2 TV programme 'Chemsex' which aired 2nd July 2015.
Watch it at http://www.bbc.co.uk/iplayer/episode/b060pr3k/victoria-derbyshire-02072015

Also featured on BBC Radio 4; an article for BBC Online, Attitude and Gay Time.
Was 'Pick of the Day' in the Telegraph and the Evening Standard featured. Previewed in the Radio Times and the story was featured on 'Today', Radio 4.
Year(s) Of Engagement Activity 2015
 
Description Prof. Sheena McCormack participation in a 'HIV in Europe' meeting, 9-11 Dec 2015, Wilton Park, UK 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact The intended purpose was to identify barriers to access to prevention and treatment services for HIV in order to tackle the rising epidemic of HIV in Europe.
Prof. Sheena McCormack spoke on PrEP within session 3 of the programme 'Policy and programme implications for a new era of HIV treatment and prevention.'
Year(s) Of Engagement Activity 2015
 
Description Prof. Sheena McCormack presented at Terrence Higgins Trust meeting, Royal College of Physicians, London, 22nd June 2015 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact THT talk, Royal College of Physicians, London, 22nd June 2015 focused on PrEP and placing it in context with other interventions to prevent HIV, and providing a vision of the impact PrEP could have on the epidemic.
Year(s) Of Engagement Activity 2015
 
Description ReShape General Meeting (London, 9th Nov. 2015) 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Third sector organisations
Results and Impact This group was initiated by an activist from the AIDS treatment era of the 1980s and 1990s to bring third sector individuals and others interested in supporting a more active approach to lobbying for better access to treatment and prevention services in the UK. These services are threatened by the fragmentation that the 2013 Health and Social Welfare Act has caused by shifting responsibility for sexual health to Local Authorities, thereby separating HIV and STI prevention and treatment from HIV care.

xxx
Year(s) Of Engagement Activity 2015
 
Description Sex, Drugs and MSM 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Health professionals
Results and Impact About 100 participants from academic insitutions, healthcare and community organisations attended this workshop in Birmingham (Lakeside Centre) which was organised by the BASHH Special Interest Group for MSM. My talks was entitled 'PrEP and PEP'.

Stimulated discussion regarding universal access to PrEP in the UK.
Year(s) Of Engagement Activity 2013
URL http://www.bashh.org
 
Description South African AIDS Conferece 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Poster Presentation
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Authors: Kristin Fladseth, Mitzy Gafos, Marie-Louise Newell, Nuala McGrath
Title: More equitable gender norms are associated with higher levels of condom use at last sex among HIV+ve men and women: rural KwaZulu-Natal, South Africa
Conference: South African AIDS Conference
Date:18th - 21st June 2013
Location: Durban, South Africa

Scientific discussion relevant for manuscript development
Year(s) Of Engagement Activity 2013
URL http://www.saaids.co.za/
 
Description South East HIV Nurses Regional meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Regional
Primary Audience Health professionals
Results and Impact I was invited to give a talk on PrEP to this regional meeting of nurses and health advisors. About 50 people attended and the talk stimulated lively discussion.

Several members of the audience told me that my talk had made them think again about the value of PrEP in the UK setting.
Year(s) Of Engagement Activity 2012
 
Description South Yorkshire HIV Clinical Network meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Regional
Primary Audience Health professionals
Results and Impact About 60 people from various disciplines attended this meeting at which I was asked to talk on 'Will PrEP reduce HIV in the UK?'

There was a lively debate and very helpful exchange regarding the challenges faced in engaging gay men in South Yorkshire.
Year(s) Of Engagement Activity 2013
 
Description The Network for Multidisciplinary Studies on ARV-Based HIV Prevention (NEMUS). Prof. Sheena McCormack participated in webinar presented by Prof. Jean-Michel Molina: PrEP in MSM: How data from Ipergay fit in the context, 28th April 2015 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The Network for Multidisciplinary Studies on ARV-Based HIV Prevention (NEMUS) run educational webinars to update professionals and community organisations regarding the latest research. Sheena McCormack who was Chief Investigator on the PROUD study participated as an expert in the discussion that followed a presentation by Prof. Jean-Michel Molina: PrEP in MSM: How data from IPERGAY fit in the context.
Year(s) Of Engagement Activity 2015
 
Description UKHVC spoke003 results presentation to participants, at CTU, 13th July 2015 evening 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Study participants or study members
Results and Impact UKHVC spoke003 results presentation to participants, at CTU, 13th July 2015 evening
Year(s) Of Engagement Activity 2015
 
Description Use of Social Media for recruitment to HIV prevention research projects: Cuthivac 01 trial 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Use of Twitter and Facebook for information sharing and to stimulate recruitment to the Cuthivac 01 vaccine study.

An increase in enquiries. Both studies now fully enrolled.
Year(s) Of Engagement Activity 2013,2014
 
Description Victoria Derbyshire show, Prof. Sheena McCormack and Yusef Azad (NAT) interview on PrEP and NHS commissioning, 7th June 2016 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Victoria Derbyshire show interview with Sheena & Yusef Azad (National AIDS Trust) regarding PrEP, announcement by NHS that they were not the commissioner and NAT's decision to take NHS to court, 7th June 2016
Year(s) Of Engagement Activity 2016
 
Description Weekly departmental academic meeting, Courtyard Clinic, St. George's Hospital, Sexual Health & HIV dept. Prof. Sheena McCormack talk on PrEP/PROUD (London, 19th August 2015) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact An opportunity to promote PrEP to an audience that was familiar with the science but not yet acting on it. Practitioners were encouraged to speak to attendees at the sexual health clinic about PrEP in order to have a more informative discussion about sex, and risks to determine whether PrEP would be a useful addition for each individual.

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Year(s) Of Engagement Activity 2015
 
Description World AIDS Day talk, St. Anne's Church, Soho, 1st Dec. 2013 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact This was a moving occasion as people reminisced about the 30 years of the AIDS epidemic. I was asked to talk about what it had meant for me as a clinician and researcher. I recalled how my role started as palliative care for young, vibrant individuals who were destined to die an untimely death, how we scarcely dared believe in the efficacy of triple therapy, and how exciting it was now to have new ways in which to use these same drugs in HIV negative individuals to prevent HIV. In particular I recalled the courage, humour and integrity demonstrated by patients I had had the privilege to look after in the early years.

Several members of the audience were appreciative of the perspective I had been able to provide. Two students from Goldsmith's University approached me and asked me to take part in a documentary film that they were making.
Year(s) Of Engagement Activity 2013,2014