Prevention Programme - Microbicides

Lead Research Organisation: MRC Clinical Trials Unit

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

10 25 50

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

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

publication icon
Crook AM (2012) Statistical and methodological issues in microbicide trial design. in Best practice & research. Clinical obstetrics & gynaecology

publication icon
Hayes R (2010) HIV prevention research: taking stock and the way forward. in AIDS (London, England)

publication icon
McCormack S (2010) Microbicides: where are we now and what next? in HIV Therapy

publication icon
McCormack SM (2014) Biomedical prevention: state of the science. in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

publication icon
Richard Stack (Senior Health Adviser - 56 Dean Street) (2013) 'PROUD Study / PrEP( Pre-exposure prophylaxis for HIV) in the UK' in SSHA conference 2013

publication icon
Shattock RJ (2011) AIDS. Turning the tide against HIV. in Science (New York, N.Y.)

publication icon
Stone A (2006) Microbicides: stopping HIV at the gate. in Lancet (London, England)

publication icon
Stone AB (2013) Microbicides from a regulatory perspective. in AIDS (London, England)

 
Description CMO Seminar on future public health policy for HIV research
Geographic Reach National 
Policy Influence Type Participation in advisory committee
Impact As a result of the seminar the CMO wrote to all GPs advising them to test patients presenting with glandular fever symptoms for HIV. The legalisation of self-testing was also raised and subsequently the CMO announced that the law would be changed from April 2014.
 
Description Consultation on Standards of Care in HIV prevention trials
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
Impact Followed on from review of standards of care and prevention which MDP participated in. Presentation available to other practitioners. Report of meeting.
 
Description Consultation on Standards of Care in HIV prevention trials
Geographic Reach Africa 
Policy Influence Type Participation in a advisory committee
 
Description Entry in the EDCTP Annual Report 2013 (published June 2014)
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
Impact The MDP301 project which EDCTP co-funded was chosen as an example of good practice. EDCTP funding allowed microbicides to be introduced into Mozambique for the first time, with training of clinicians and researchers largely undertaken by the team from the University of Witswatersrand in Johannesburg.
URL http://www.edctp.org/annualreport2013
 
Description Europrise Steering Committee
Geographic Reach Europe 
Policy Influence Type Participation in advisory committee
 
Description FHI 360 Gender Analysis in Microbicides
Geographic Reach Africa 
Policy Influence Type Membership of a guidance committee
 
Description FHI 360 Male Engagement in Microbicides
Geographic Reach Africa 
Policy Influence Type Membership of a guidance committee
URL http://pdf.usaid.gov/pdf_docs/pa00k11w.pdf
 
Description Good Participatory Practice Guideline
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in other policy documents
Impact The methods we developed for community engagement made use of participatory methodology. This has not previously been used in HIV prevention trials to our knowledge. It provided a mechanism for feedback that led to improvement in recruitment, retention and adherence, but most importantly ensured that the trial was conducted to the highest ethical standards in consultation with the community.
 
Description Good Participatory Practice Guidelines: case studies
Geographic Reach Africa 
Policy Influence Type Influenced training of practitioners or researchers
Impact Shared to research staff as lessons to improve implementation of GPP
URL http://www.avac.org/implementation-tools
 
Description House of Lords Select Committee chaired by Lord Fowler
Geographic Reach Multiple continents/international 
Policy Influence Type Gave evidence to a government review
Impact Following this consultation home testing for HIV was became legal (April 2014)
 
Description Quick Working Group to coordinate Phase III microbicide trials
Geographic Reach Africa 
Policy Influence Type Participation in a advisory committee
 
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 Stakeholder Consultation on Priority Implementation Research to Inform Development of WHO Normative Guidance on Topical Pre-Exposure Prophylaxis
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in advisory committee
URL http://www.conrad.org/news-meetings-35.html
 
Description WHO/UNAIDS ethical conduct of HIV prevention trials guidelines
Geographic Reach Multiple continents/international 
Policy Influence Type Membership of a guidance committee
Impact Published UNAIDS 2008
 
Description WHO/UNAIDS ethical conduct of HIV prevention trials guidelines
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in advisory committee
Impact The updated guidelines have been disseminated to research groups internationally and have influenced the dialogue between researchers and communities, facilitating joint ownership of large research projects even in resource limited settings.
 
Description PROUD trial: Medical Research Council Clinical Trials Unit Core funds, Gilead Sciences Inc., Health Protection Agency (HPA) / Public Health England (PHE)
Amount £4,851,440 (GBP)
Funding ID
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 03/2012 
End 12/2016
 
Description CISM, Mozambique (Mo-Jo) 
Organisation Manhiça Health Research Centre (CISM)
Country Mozambique 
Sector Charity/Non Profit 
PI Contribution Provision of research tools (protocol, CRFs, database), assistance with training and monitoring. Implementation of the first ever microbicide study in Mozambique (Top Up). Coordination and support for analyses.
Collaborator Contribution This partnership was facilitated through an EDCTP award. CISM contributed through the work completed under this award (see outputs).
Impact Completed Feasibility Study in Mozambique (published) Completed Pilot Study (Top Up) and gained multi-centre experience as a result. South to South networking and capacity building facilitated through RHRU in Johannesburg for the Feasibility Study component. Conference abstracts and manuscript in preparation.
Start Year 2008
 
Description CONRAD (USAID funding) Top Up 
Organisation Eastern Virginia Medical School
Department Contraception Research and Development (CONRAD)
Country United States 
Sector Academic/University 
PI Contribution We drafted the protocol, CRFs, and documentation, designed and implemneted the local and combined database, completed initiation training with all clinical centres, organised shipments of gel with CONRAD, monitored through to close-out three of the five centres by the end of 2010, and held monthly Trial Management Group calls. We closed the database and extracted the final analysis files and coordinated the preparation of conference abstracts and poster presentations.
Collaborator Contribution CONRAD/East VIrginia Medical School supplied placebo gel for Top Up and funded one of the MDO clinical partners (University of Zambia) to conduct the study.
Impact The Top Up analysis has been presented at conferences and a manuscript is being prepared. Five centres in five countries in Sub-Saharan Africa took part in this study of daily gel.
Start Year 2009
 
Description Europrise 
Organisation ALTA
Country Italy 
Sector Private 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation European AIDS Treatment Group (EATG)
Country European Union (EU) 
Sector Public 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation GlaxoSmithKline (GSK)
Country Global 
Sector Private 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation Institute of Tropical Medicine Antwerp
Country Belgium 
Sector Academic/University 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation Karolinska Institute
Country Sweden 
Sector Academic/University 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation King's College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation Lund University
Country Sweden 
Sector Academic/University 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation National Institute for Biological Standards and Control (NIBSC)
Country United Kingdom 
Sector Public 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation Novartis
Country Global 
Sector Private 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation Robert Koch-Institut
Country Germany 
Sector Public 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation St George's University of London
Department Division of Clinical Sciences
Country United Kingdom 
Sector Academic/University 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation University of Siena
Country Italy 
Sector Academic/University 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation University of Verona
Country Italy 
Sector Academic/University 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation University of York
Country United Kingdom 
Sector Academic/University 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Grant application for a clinical trial (PROUD trial) 
Organisation Chelsea and Westminster Hospital NHS Foundation Trust
Country United Kingdom 
Sector Public 
PI Contribution Coordination. Primary responsibility for application and drafting trial documents (protocol, information sheet, informed consent etc)
Collaborator Contribution Joint application to NIHR/HTA for a large HIV prevention trial. Supported by a range of activities across these partnerships: modelling, behavioural data collection, health economics, audit of HIV testing and behavioural interventions in clinics. Joint application to NIHR/HTA for a large HIV prevention trial. Supported by a range of activities across these partnerships: modelling, behavioural data collection, health economics, audit of HIV testing and behavioural interventions in clinics. Joint application to NIHR/HTA for a large HIV prevention trial. Supported by a range of activities across these partnerships: modelling, behavioural data collection, health economics, audit of HIV testing and behavioural interventions in clinics.Joint application to NIHR/HTA for a large HIV prevention trial. Supported by a range of activities across these partnerships: modelling, behavioural data collection, health economics, audit of HIV testing and behavioural interventions in clinics.
Impact Grant application Audit report Development of mathematical model of transmission Sigma panel report
Start Year 2011
 
Description Grant application for a clinical trial (PROUD trial) 
Organisation London School of Hygiene and Tropical Medicine (LSHTM)
Country United Kingdom 
Sector Academic/University 
PI Contribution Coordination. Primary responsibility for application and drafting trial documents (protocol, information sheet, informed consent etc)
Collaborator Contribution Joint application to NIHR/HTA for a large HIV prevention trial. Supported by a range of activities across these partnerships: modelling, behavioural data collection, health economics, audit of HIV testing and behavioural interventions in clinics. Joint application to NIHR/HTA for a large HIV prevention trial. Supported by a range of activities across these partnerships: modelling, behavioural data collection, health economics, audit of HIV testing and behavioural interventions in clinics. Joint application to NIHR/HTA for a large HIV prevention trial. Supported by a range of activities across these partnerships: modelling, behavioural data collection, health economics, audit of HIV testing and behavioural interventions in clinics.Joint application to NIHR/HTA for a large HIV prevention trial. Supported by a range of activities across these partnerships: modelling, behavioural data collection, health economics, audit of HIV testing and behavioural interventions in clinics.
Impact Grant application Audit report Development of mathematical model of transmission Sigma panel report
Start Year 2011
 
Description Grant application for a clinical trial (PROUD trial) 
Organisation University College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Coordination. Primary responsibility for application and drafting trial documents (protocol, information sheet, informed consent etc)
Collaborator Contribution Joint application to NIHR/HTA for a large HIV prevention trial. Supported by a range of activities across these partnerships: modelling, behavioural data collection, health economics, audit of HIV testing and behavioural interventions in clinics. Joint application to NIHR/HTA for a large HIV prevention trial. Supported by a range of activities across these partnerships: modelling, behavioural data collection, health economics, audit of HIV testing and behavioural interventions in clinics. Joint application to NIHR/HTA for a large HIV prevention trial. Supported by a range of activities across these partnerships: modelling, behavioural data collection, health economics, audit of HIV testing and behavioural interventions in clinics.Joint application to NIHR/HTA for a large HIV prevention trial. Supported by a range of activities across these partnerships: modelling, behavioural data collection, health economics, audit of HIV testing and behavioural interventions in clinics.
Impact Grant application Audit report Development of mathematical model of transmission Sigma panel report
Start Year 2011
 
Description Hormonal contraception and risk of HIV acquistion: individual participant data analysis 
Organisation FHI 360
Country United States 
Sector Charity/Non Profit 
PI Contribution We provided data from the MDP301 dataset to the team at FHI as part of the individual participant data analysis to assess the association between hormonal contraception and the acquisition of HIV. As MDP301 was the largest dataset (over 8000 women) it was very influential. The Trial Statistician for MDP301 had to prepare the dataset for export.
Collaborator Contribution Import of the data and analysis using marginal structural models.
Impact An oral presentation at CROI 2014 and a manuscript which has been submitted. The analysis will be used by WHO when considering the next revision to their guidelines.
Start Year 2012
 
Description IPM Close Out 
Organisation International Partnership for Microbicides (IPM)
Country United States 
Sector Charity/Non Profit 
PI Contribution We designed the trial, drafted the protocol, CRFs, other documentation including the analysis plan, designed and implemented the database locally and centrally, wrote the necessary statsitical programmes, completed training, on site and central monitoring, analyses, statistical reports x3, drafted and submitted manuscript for peer-review, managed communications, oversaw the management of the award completing quarterly reports to donors.
Collaborator Contribution Advice on the appointment of a commercial research organistation to assist with the completion of trial close-out visits and archiving.
Impact Close out monitoring reports. The collaboration is multi-disciplinary (clinical, biostatisticians, data scientists, trial managers, product developers) but the same disciplines are represented in MDP and IPM other than the industry partner (Endo) in MDP.
Start Year 2009
 
Description MDP: Microbicides Development Programme 
Organisation Imperial College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Coordination of clinical studies and governance of programme, the latter in partnership with Imperial College. Data management, analysis and report writing for clinical studies.
Collaborator Contribution Imperial College conducted experiments to better understand the mechanism of action of PRO2000, managed Phase I clinical trials, and the governance of the programme, the latter in partnership with MRC CTU. Indevus provided product for the trials. St George's conducted experiments to aid selection of candidate microbicides. University of Barcelona coordinated the social science. University of Southampton coordinated the community engagement. LSHTM conducted mathematical modelling and assisted with the Phase III trial statistical analysis plan, as well as co-managing one of the clinical research centres. The other partners managed clinical research centres in which clinical and social science studies were conducted.
Impact Publications as listed. Safety and efficacy data on PRO2000 vaginal gel, as reported in the Lancet paper (McCormack et al, 2010). Use of mixed methods to collect and interpret adherence data as described in PlosOne papers (Pool et al, 2011). Conference and workshop presentations to disseminate to the scientific audience and policy makers. Webinar calls organised through the Global Campaign for Microbicides and the AIDS Vaccine Advocacy Coalition to reach community organisations.
 
Description MDP: Microbicides Development Programme 
Organisation Indevus Pharmaceuticals, Inc.
Country United States 
Sector Private 
PI Contribution Coordination of clinical studies and governance of programme, the latter in partnership with Imperial College. Data management, analysis and report writing for clinical studies.
Collaborator Contribution Imperial College conducted experiments to better understand the mechanism of action of PRO2000, managed Phase I clinical trials, and the governance of the programme, the latter in partnership with MRC CTU. Indevus provided product for the trials. St George's conducted experiments to aid selection of candidate microbicides. University of Barcelona coordinated the social science. University of Southampton coordinated the community engagement. LSHTM conducted mathematical modelling and assisted with the Phase III trial statistical analysis plan, as well as co-managing one of the clinical research centres. The other partners managed clinical research centres in which clinical and social science studies were conducted.
Impact Publications as listed. Safety and efficacy data on PRO2000 vaginal gel, as reported in the Lancet paper (McCormack et al, 2010). Use of mixed methods to collect and interpret adherence data as described in PlosOne papers (Pool et al, 2011). Conference and workshop presentations to disseminate to the scientific audience and policy makers. Webinar calls organised through the Global Campaign for Microbicides and the AIDS Vaccine Advocacy Coalition to reach community organisations.
 
Description MDP: Microbicides Development Programme 
Organisation London School of Hygiene and Tropical Medicine (LSHTM)
Country United Kingdom 
Sector Academic/University 
PI Contribution Coordination of clinical studies and governance of programme, the latter in partnership with Imperial College. Data management, analysis and report writing for clinical studies.
Collaborator Contribution Imperial College conducted experiments to better understand the mechanism of action of PRO2000, managed Phase I clinical trials, and the governance of the programme, the latter in partnership with MRC CTU. Indevus provided product for the trials. St George's conducted experiments to aid selection of candidate microbicides. University of Barcelona coordinated the social science. University of Southampton coordinated the community engagement. LSHTM conducted mathematical modelling and assisted with the Phase III trial statistical analysis plan, as well as co-managing one of the clinical research centres. The other partners managed clinical research centres in which clinical and social science studies were conducted.
Impact Publications as listed. Safety and efficacy data on PRO2000 vaginal gel, as reported in the Lancet paper (McCormack et al, 2010). Use of mixed methods to collect and interpret adherence data as described in PlosOne papers (Pool et al, 2011). Conference and workshop presentations to disseminate to the scientific audience and policy makers. Webinar calls organised through the Global Campaign for Microbicides and the AIDS Vaccine Advocacy Coalition to reach community organisations.
 
Description MDP: Microbicides Development Programme 
Organisation MRC/UVRI Uganda Research Unit on AIDS
Country Uganda 
Sector Public 
PI Contribution Coordination of clinical studies and governance of programme, the latter in partnership with Imperial College. Data management, analysis and report writing for clinical studies.
Collaborator Contribution Imperial College conducted experiments to better understand the mechanism of action of PRO2000, managed Phase I clinical trials, and the governance of the programme, the latter in partnership with MRC CTU. Indevus provided product for the trials. St George's conducted experiments to aid selection of candidate microbicides. University of Barcelona coordinated the social science. University of Southampton coordinated the community engagement. LSHTM conducted mathematical modelling and assisted with the Phase III trial statistical analysis plan, as well as co-managing one of the clinical research centres. The other partners managed clinical research centres in which clinical and social science studies were conducted.
Impact Publications as listed. Safety and efficacy data on PRO2000 vaginal gel, as reported in the Lancet paper (McCormack et al, 2010). Use of mixed methods to collect and interpret adherence data as described in PlosOne papers (Pool et al, 2011). Conference and workshop presentations to disseminate to the scientific audience and policy makers. Webinar calls organised through the Global Campaign for Microbicides and the AIDS Vaccine Advocacy Coalition to reach community organisations.
 
Description MDP: Microbicides Development Programme 
Organisation Manhiça Health Research Centre (CISM)
Country Mozambique 
Sector Charity/Non Profit 
PI Contribution Coordination of clinical studies and governance of programme, the latter in partnership with Imperial College. Data management, analysis and report writing for clinical studies.
Collaborator Contribution Imperial College conducted experiments to better understand the mechanism of action of PRO2000, managed Phase I clinical trials, and the governance of the programme, the latter in partnership with MRC CTU. Indevus provided product for the trials. St George's conducted experiments to aid selection of candidate microbicides. University of Barcelona coordinated the social science. University of Southampton coordinated the community engagement. LSHTM conducted mathematical modelling and assisted with the Phase III trial statistical analysis plan, as well as co-managing one of the clinical research centres. The other partners managed clinical research centres in which clinical and social science studies were conducted.
Impact Publications as listed. Safety and efficacy data on PRO2000 vaginal gel, as reported in the Lancet paper (McCormack et al, 2010). Use of mixed methods to collect and interpret adherence data as described in PlosOne papers (Pool et al, 2011). Conference and workshop presentations to disseminate to the scientific audience and policy makers. Webinar calls organised through the Global Campaign for Microbicides and the AIDS Vaccine Advocacy Coalition to reach community organisations.
 
Description MDP: Microbicides Development Programme 
Organisation Medical Research Council of South Africa (MRC)
Country South Africa 
Sector Public 
PI Contribution Coordination of clinical studies and governance of programme, the latter in partnership with Imperial College. Data management, analysis and report writing for clinical studies.
Collaborator Contribution Imperial College conducted experiments to better understand the mechanism of action of PRO2000, managed Phase I clinical trials, and the governance of the programme, the latter in partnership with MRC CTU. Indevus provided product for the trials. St George's conducted experiments to aid selection of candidate microbicides. University of Barcelona coordinated the social science. University of Southampton coordinated the community engagement. LSHTM conducted mathematical modelling and assisted with the Phase III trial statistical analysis plan, as well as co-managing one of the clinical research centres. The other partners managed clinical research centres in which clinical and social science studies were conducted.
Impact Publications as listed. Safety and efficacy data on PRO2000 vaginal gel, as reported in the Lancet paper (McCormack et al, 2010). Use of mixed methods to collect and interpret adherence data as described in PlosOne papers (Pool et al, 2011). Conference and workshop presentations to disseminate to the scientific audience and policy makers. Webinar calls organised through the Global Campaign for Microbicides and the AIDS Vaccine Advocacy Coalition to reach community organisations.
 
Description MDP: Microbicides Development Programme 
Organisation St George's University of London
Country United Kingdom 
Sector Academic/University 
PI Contribution Coordination of clinical studies and governance of programme, the latter in partnership with Imperial College. Data management, analysis and report writing for clinical studies.
Collaborator Contribution Imperial College conducted experiments to better understand the mechanism of action of PRO2000, managed Phase I clinical trials, and the governance of the programme, the latter in partnership with MRC CTU. Indevus provided product for the trials. St George's conducted experiments to aid selection of candidate microbicides. University of Barcelona coordinated the social science. University of Southampton coordinated the community engagement. LSHTM conducted mathematical modelling and assisted with the Phase III trial statistical analysis plan, as well as co-managing one of the clinical research centres. The other partners managed clinical research centres in which clinical and social science studies were conducted.
Impact Publications as listed. Safety and efficacy data on PRO2000 vaginal gel, as reported in the Lancet paper (McCormack et al, 2010). Use of mixed methods to collect and interpret adherence data as described in PlosOne papers (Pool et al, 2011). Conference and workshop presentations to disseminate to the scientific audience and policy makers. Webinar calls organised through the Global Campaign for Microbicides and the AIDS Vaccine Advocacy Coalition to reach community organisations.
 
Description MDP: Microbicides Development Programme 
Organisation University of Barcelona
Country Spain 
Sector Academic/University 
PI Contribution Coordination of clinical studies and governance of programme, the latter in partnership with Imperial College. Data management, analysis and report writing for clinical studies.
Collaborator Contribution Imperial College conducted experiments to better understand the mechanism of action of PRO2000, managed Phase I clinical trials, and the governance of the programme, the latter in partnership with MRC CTU. Indevus provided product for the trials. St George's conducted experiments to aid selection of candidate microbicides. University of Barcelona coordinated the social science. University of Southampton coordinated the community engagement. LSHTM conducted mathematical modelling and assisted with the Phase III trial statistical analysis plan, as well as co-managing one of the clinical research centres. The other partners managed clinical research centres in which clinical and social science studies were conducted.
Impact Publications as listed. Safety and efficacy data on PRO2000 vaginal gel, as reported in the Lancet paper (McCormack et al, 2010). Use of mixed methods to collect and interpret adherence data as described in PlosOne papers (Pool et al, 2011). Conference and workshop presentations to disseminate to the scientific audience and policy makers. Webinar calls organised through the Global Campaign for Microbicides and the AIDS Vaccine Advocacy Coalition to reach community organisations.
 
Description MDP: Microbicides Development Programme 
Organisation University of KwaZulu-Natal
Country South Africa 
Sector Academic/University 
PI Contribution Coordination of clinical studies and governance of programme, the latter in partnership with Imperial College. Data management, analysis and report writing for clinical studies.
Collaborator Contribution Imperial College conducted experiments to better understand the mechanism of action of PRO2000, managed Phase I clinical trials, and the governance of the programme, the latter in partnership with MRC CTU. Indevus provided product for the trials. St George's conducted experiments to aid selection of candidate microbicides. University of Barcelona coordinated the social science. University of Southampton coordinated the community engagement. LSHTM conducted mathematical modelling and assisted with the Phase III trial statistical analysis plan, as well as co-managing one of the clinical research centres. The other partners managed clinical research centres in which clinical and social science studies were conducted.
Impact Publications as listed. Safety and efficacy data on PRO2000 vaginal gel, as reported in the Lancet paper (McCormack et al, 2010). Use of mixed methods to collect and interpret adherence data as described in PlosOne papers (Pool et al, 2011). Conference and workshop presentations to disseminate to the scientific audience and policy makers. Webinar calls organised through the Global Campaign for Microbicides and the AIDS Vaccine Advocacy Coalition to reach community organisations.
 
Description MDP: Microbicides Development Programme 
Organisation University of Southampton
Country United Kingdom 
Sector Academic/University 
PI Contribution Coordination of clinical studies and governance of programme, the latter in partnership with Imperial College. Data management, analysis and report writing for clinical studies.
Collaborator Contribution Imperial College conducted experiments to better understand the mechanism of action of PRO2000, managed Phase I clinical trials, and the governance of the programme, the latter in partnership with MRC CTU. Indevus provided product for the trials. St George's conducted experiments to aid selection of candidate microbicides. University of Barcelona coordinated the social science. University of Southampton coordinated the community engagement. LSHTM conducted mathematical modelling and assisted with the Phase III trial statistical analysis plan, as well as co-managing one of the clinical research centres. The other partners managed clinical research centres in which clinical and social science studies were conducted.
Impact Publications as listed. Safety and efficacy data on PRO2000 vaginal gel, as reported in the Lancet paper (McCormack et al, 2010). Use of mixed methods to collect and interpret adherence data as described in PlosOne papers (Pool et al, 2011). Conference and workshop presentations to disseminate to the scientific audience and policy makers. Webinar calls organised through the Global Campaign for Microbicides and the AIDS Vaccine Advocacy Coalition to reach community organisations.
 
Description MDP: Microbicides Development Programme 
Organisation University of Zambia
Country Zambia 
Sector Academic/University 
PI Contribution Coordination of clinical studies and governance of programme, the latter in partnership with Imperial College. Data management, analysis and report writing for clinical studies.
Collaborator Contribution Imperial College conducted experiments to better understand the mechanism of action of PRO2000, managed Phase I clinical trials, and the governance of the programme, the latter in partnership with MRC CTU. Indevus provided product for the trials. St George's conducted experiments to aid selection of candidate microbicides. University of Barcelona coordinated the social science. University of Southampton coordinated the community engagement. LSHTM conducted mathematical modelling and assisted with the Phase III trial statistical analysis plan, as well as co-managing one of the clinical research centres. The other partners managed clinical research centres in which clinical and social science studies were conducted.
Impact Publications as listed. Safety and efficacy data on PRO2000 vaginal gel, as reported in the Lancet paper (McCormack et al, 2010). Use of mixed methods to collect and interpret adherence data as described in PlosOne papers (Pool et al, 2011). Conference and workshop presentations to disseminate to the scientific audience and policy makers. Webinar calls organised through the Global Campaign for Microbicides and the AIDS Vaccine Advocacy Coalition to reach community organisations.
 
Description MDP: Microbicides Development Programme 
Organisation University of the Witwatersrand
Department Reproductive Health and HIV Research Unit (RHRU) Witwatersrand
Country South Africa 
Sector Academic/University 
PI Contribution Coordination of clinical studies and governance of programme, the latter in partnership with Imperial College. Data management, analysis and report writing for clinical studies.
Collaborator Contribution Imperial College conducted experiments to better understand the mechanism of action of PRO2000, managed Phase I clinical trials, and the governance of the programme, the latter in partnership with MRC CTU. Indevus provided product for the trials. St George's conducted experiments to aid selection of candidate microbicides. University of Barcelona coordinated the social science. University of Southampton coordinated the community engagement. LSHTM conducted mathematical modelling and assisted with the Phase III trial statistical analysis plan, as well as co-managing one of the clinical research centres. The other partners managed clinical research centres in which clinical and social science studies were conducted.
Impact Publications as listed. Safety and efficacy data on PRO2000 vaginal gel, as reported in the Lancet paper (McCormack et al, 2010). Use of mixed methods to collect and interpret adherence data as described in PlosOne papers (Pool et al, 2011). Conference and workshop presentations to disseminate to the scientific audience and policy makers. Webinar calls organised through the Global Campaign for Microbicides and the AIDS Vaccine Advocacy Coalition to reach community organisations.
 
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
 
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 AVAC Tenofovir gel working group (TGWG) 
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 AVAC TGWG host regular teleconferences with advocates and scientists. I provide regular updates to the international group of approximately 100 members internatinally on teleconferences.



Produced a document summarising 'frequently asked questions' about tenofovir gel.
Year(s) Of Engagement Activity 2010,2011,2012
 
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 APPG HIV/AIDS - Sheena McCormack 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? Yes
Primary Audience Policymakers/politicians
Results and Impact The session was well attended (~100) by MPs, civil society leadership and the general public, particularly students. There were several questions, with a focus on access which seemed premature.

There was an opportunity to reinforce the urgent need for prevention options, particularly for women in sub-Saharan Africa, and to ensure people understood that the researchers really did not know if the candidate microbicide would protect.
Year(s) Of Engagement Activity 2007
 
Description AVAC PrEP communications working group 
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 AVAC PrEP communications group host regular teleconferences with advocates, scientists and funders. I provide regular updates to the international group of approximately 60 members internatinally on teleconferences.


Discussed the PROUD pilot study planned in the UK.
Year(s) Of Engagement Activity 2012
 
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 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 Consultation on Standards of Prevention, Kampala 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Primary Audience Policymakers/politicians
Results and Impact My talk described the different ways in which MDP partners consulted key stakeholders in order to decide what the most appropriate standard of care should be locally.
Presentation available on request.

The representative from the SA competent authority stated that MDP had set the gold standard for consultation.
Year(s) Of Engagement Activity 2009
 
Description Dissemination of MDP301 results to civil society groups 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Primary Audience Public/other audiences
Results and Impact I presented the results using a powerpoint presentation, and then took questions. The questions are typed in and facilitated by the conference chair.

Unfortunately the candidate microbicide, PRO2000, did not prevent HIV acquisition. This was very disappointing for the field as an earlier trial reported 30% protection. Although this was not statistically significant, it did raise hopes and expectations that MDP301 would be a positive result.
Year(s) Of Engagement Activity 2009
 
Description Dissemination of MDP301 results to the media 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Primary Audience Media (as a channel to the public)
Results and Impact MRC Press Office coordinated the approach to journalists they work closely with and who are known to be interested in HIV/AIDS. I briefly described the results during a telephone interview and answered questions.

This interaction led to a series of well written balanced articles on the day of release, 14th December 2009.
Unfortunately, the coverage on the internet from a Zambian journalist a week later was inaccurate and sensational. This was very difficult to control and quickly escalated as it was picked up by newspapers and radio stations in more than one country in Africa, which gave the accusations credibility.
Year(s) Of Engagement Activity 2009
 
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 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. 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 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 Institute of Development Studies discussion forum on urbanisation, gender and health 
Form Of Engagement Activity Participation in an activity, workshop or similar
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 This was an online three day discussion from 29-31 Jan 2013 involving approximately 40 people working in research, policy development and service delivery - with a focus on Kenya and South Africa. IDS will produce a report of the discussion for DFID.

Made contact with people working in a range of organizations mainly in South Africa.

Oct 2013 - update - a report entitled "Urbanisation, gender and health" has now been published and is available at http://interactions.eldis.org/
Year(s) Of Engagement Activity 2010,2013
URL http://interactions.eldis.org/
 
Description Institute of Medical Research, Papua New Guinea 
Form Of Engagement Activity A talk or presentation
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 IMR of Papua New Guinea are conducting microbicide feasibility work. Two MDP representatives presented findings from the MDP 301 trial to an audience of approximately 40 scientists and talked at a workshop of approximately 15 social scientists on social science techniques in HIV prevention research.

Informed their research plans.
Year(s) Of Engagement Activity 2012
 
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 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 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 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 Microbicide Media Communications Initiative (MMCI) 
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 MMCI host regular teleconferences with advocates. I provide regular updates to the international group of approximately 100 members on teleconferences.

Developed a series of key messages in advance of the AIDS conference 2012.
Year(s) Of Engagement Activity 2010,2011,2012
 
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 NAM/AVAC PrEp workshop 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact Through questions, I was able to point out to this mixed audience which included civil society and media, the challenge of rolling out anti-retroviral drugs for prevention when we are failing to meet the needs of positive individuals in sub-Saharn Africa, and that the vast majority of women in this setting are not at risk every day and unlikely to want to take a pill a day to protect them from a much less frequent risk of acquiring HIV.

During the breaks it was clear from feedback that several members of the audience were not previously aware of the needs of the target population, and challenges of roll-out.
Year(s) Of Engagement Activity 2009
 
Description NAT meeting - Precious Lunga 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Primary Audience Public/other audiences
Results and Impact 30 people attended. Precious gave a 15m talk describing our work in MDP incuding documentation of the challenges faced by women in Africa with respect to HIV testing and the positive reception of gel by women and their partners. There were a lot of questions.

Nothing of note, but some myths about gel were dispelled - eg that women from countries where dry sex was the practice will not like using gel (they do), and that women would likely hide gel use from their partners (they don't).
Year(s) Of Engagement Activity 2007
 
Description NY Times - Donald McNeil and Celia Dugger 
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 I was interviewed by Donald and Celia following release of the CAPRISA 004 result, during the AIDS conference and a few weeks later on the phone.

Donald McNeil was very appreciative of my explanation of the confidence interval.
I had the opportunity to explain to both journalists the challenges ahead for implementation, the complexity of the dual dosing regimen in CAPRISA, and the closing gap to collect placebo-controlled comparison of a single dose of tenofovir applied prior to sex.
Year(s) Of Engagement Activity 2010
 
Description Presentation at the UK HIV Community Advisory Board meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact approx 50 advocates attended an all day meeting. Presentation "why is it so difficult to find an effective HIV vaccine" followed by an introduction to the Help make History website for healthy HIV vaccine trial volunteers

Interest shown in helping develop future studies
Year(s) Of Engagement Activity 2009
 
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. 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 Stakeholder consultation in Zambia 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Primary Audience Public/other audiences
Results and Impact Following the accusations against the research team in Zambia, the Director of Public Health requested a public consultation inviting the local Chiefs, participants, Community Advisory Group members, the media, researchers and other stakeholders to hear the results of both MDP301 and the preceding HPTN035 microbicide trial studying PRO2000. I helped the local team to prepare for this, attended in the audience and answered questions.

Confirmation that there was a need and support for further microbicide research in Zambia.
The political situation was already complicated with no Pharmacy Board in place following a change in government in 2008, and the Permanent Secretary of Health under investigation for corruption.
This meeting was a turning point, but nonetheless approval to conduct further research continued to be witheld for other prevention initiatives, including our own. Whilst the other research groups have abandoned their plans, MDP remained in order to demonstrate microbicide research was still possible, and approval for the Top Up study of placebo gel materialised at the end of 2010.
Year(s) Of Engagement Activity 2010
 
Description UK CAB Educational Talk (Oct 2012) 
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 The talk was entitled "Drug development in relation to PrEP and the PROUD study." It was an hour long educational talk for around 20 members of UK CAB representing patient groups. The session encouraged questions throughout and the final 15 minutes took the opportunity to describe the PROUD study, in particular the design. Participants were engaged and we discussed the difficulties a deferred design may present. (David Dolling)

Feedback from the meeting was positive and the session was highly rated.
Year(s) Of Engagement Activity 2012
 
Description UK PrEP eWorking Group 
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 Established eGroup
Held three conference calls and two meetings.
Continued dissemination of relevant clinical trial results with interpretation.


Constructive feedback on the concerns of the UK clinicians, community organisations, commissioners with respect to PrEP.
Input to design of proposed trial and dosing regimens.
Continued support.
Year(s) Of Engagement Activity 2011
 
Description US Institute of Medicine Review of HIV prevention trials 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Primary Audience Public/other audiences
Results and Impact I gave a talk with slides to the IoM panel which is open to the public. The panel members asked several questions and were particularly intersted in our preparatory work for the Phase III microbicide trial, and the integrated social science. They asked especially about the triangulation of several methods to assess adherence to gel.

The IoM recommendations mirrored the work already completed in MDP ie collection of cohort data to accurately assess HIV incidence, careful mapping of comunities, behaviours and attitudes, piloting the gel and trial tools, triangulating different measurements of adherence.
Year(s) Of Engagement Activity 2007
 
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