Vaginal microbicides for the prevention of HIV transmission

Lead Research Organisation: Imperial College London
Department Name: Dept of Medicine

Abstract

Abstracts are not currently available in GtR for all funded research. This is normally because the abstract was not required at the time of proposal submission, but may be because it included sensitive information such as personal details.

Publications

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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 IAPAC Consensus Statement, 2013
Geographic Reach Multiple continents/international 
Policy Influence Type Membership of a guidance committee
 
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 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 Capacity Building - Tz Ug
Amount £73,455 (GBP)
Organisation Sixth Framework Programme (FP6) 
Department European and Developing Countries Clinical Trials Partnership
Sector Public
Country European Union (EU)
Start 05/2007 
End 02/2011
 
Description Clinical Trial/Capacity Building - MoJo
Amount £1,687,570 (GBP)
Funding ID CT.2005.33070.003 
Organisation Sixth Framework Programme (FP6) 
Department European and Developing Countries Clinical Trials Partnership
Sector Public
Country European Union (EU)
Start 05/2007 
End 12/2010
 
Description Clinical Trial/capacity building - Afrevac
Amount £193,790 (GBP)
Funding ID CT.2006.33111.001 
Organisation Sixth Framework Programme (FP6) 
Department European and Developing Countries Clinical Trials Partnership
Sector Public
Country European Union (EU)
Start 03/2008 
End 03/2012
 
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 MRC Programme Grant/DfID: Microbicides Development Programme
Amount £41,829,957 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start  
End 12/2010
 
Description Network of Excellence
Amount £134,664 (GBP)
Funding ID 037611 
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 01/2007 
End 12/2011
 
Description Networking - Project Management
Amount £20,904 (GBP)
Organisation Sixth Framework Programme (FP6) 
Department European and Developing Countries Clinical Trials Partnership
Sector Public
Country European Union (EU)
Start 04/2006 
End 04/2008
 
Description Networking/Capacity Building - Biomarkers
Amount £31,269 (GBP)
Funding ID IP.2007.33070.001 
Organisation Sixth Framework Programme (FP6) 
Department European and Developing Countries Clinical Trials Partnership
Sector Public
Country European Union (EU)
Start 04/2009 
End 01/2013
 
Title MDP301 database 
Description MDP301 databases set up in 6 research centres in sub-Saharan Africa as well as the combined database held at MRC CTU. The data could be extracted into Access and easily manipulated by the local investigators. 
Type Of Material Database/Collection of Data/Biological Samples 
Provided To Others? No  
Impact Over 60 conference abstracts submitted by African investigators who were able to extract and analyse their own data, most of which led to scholarships and some of which won awards such as best conference poster. 
 
Title Triangulation of adherence data and reconciliation 
Description Adherence data were collected by self-report, diaries and returned used applicators. During part 1 of the IDI there was a further self-report, followed by a review of the quantitative data and reconciliation to obtain the most accurate estimate of adherence to a coitally dependent vaginal gel. 
Type Of Material Database/Collection of Data/Biological Samples 
Year Produced 2008 
Provided To Others? Yes  
Impact This method was recommended by the Institute of Medicine Review of HIV prevention trials 2008, and subsequently adopted by several research groups. It is frequently referenced as the gold standard in the absence of a biomarker for adherence. 
 
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 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 IPM 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 cleaned and closed the database, extracted and analysed data and coordinated the preparation of conference abstracts and posters.
Collaborator Contribution IPM is a not for profit product developer of microbicides. They provided financial support to MDP which is funded mainly through MRC/DFID with some support from EDCTP. IPM made comments on the protocol and provided financial support to enable the clinical research centres to enrol and follow particiaptns. IPM is committed to daily microbicides (as opposed to intermittent, coitally dependent dosing).
Impact Conference abstracts and posters comparing the three different methods of collecting in the used applicators (daily, weekly or at the monthly visit).
Start Year 2009
 
Description IPM Top Up 
Organisation International Partnership for Microbicides (IPM)
Country United States 
Sector Charity/Non Profit 
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 cleaned and closed the database, extracted and analysed data and coordinated the preparation of conference abstracts and posters.
Collaborator Contribution IPM is a not for profit product developer of microbicides. They provided financial support to MDP which is funded mainly through MRC/DFID with some support from EDCTP. IPM made comments on the protocol and provided financial support to enable the clinical research centres to enrol and follow particiaptns. IPM is committed to daily microbicides (as opposed to intermittent, coitally dependent dosing).
Impact Conference abstracts and posters comparing the three different methods of collecting in the used applicators (daily, weekly or at the monthly visit).
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
 
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 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 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 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 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 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 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 Feedback on Microbicides 2012 conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach Local
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Talk was given as part of regular seminar series to ~80 members of the clinical trials unit.

The seminar generated interested as there have been many exciting development in the field which impact other work within the unit.
Year(s) Of Engagement Activity 2012
 
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 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 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 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 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 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 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 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 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