Development of Mwanza Intervention Trials Unit as a centre of excellence in HIV/STI prevention research

Lead Research Organisation: London Sch of Hygiene and Trop Medicine
Department Name: Epidemiology and Population Health

Abstract

Worldwide about 33 million adults and children are infected with the HIV virus that causes AIDS, and the number continues to grow each year. Sub-Saharan Africa continues to be the worst affected region, accounting for around two-thirds of all cases. Although there is no cure for HIV/AIDS, use of drugs called antiretrovirals can keep the infection under control and prevent it from developing into full-blown AIDS. A lot of progress has been made in the past five years in making such treatment available to more HIV-infected people in Africa who need it. However, there are still a lot of new HIV infections occurring each year, and this means that the number of people needing treatment will continue to increase. Unless we can find effective ways of preventing new infections, it is going to be very difficult and costly to provide lifelong treatment for an ever-increasing number of patients.

Only a few methods have been proven to be effective in preventing HIV infection and so we urgently need to find new methods. Several such methods are now in the pipeline and these will have to be tested carefully in well-designed trials to make sure they work. Scientists from the London School of Hygiene and Tropical Medicine have been doing research for many years with colleagues at the National Institute for Medical Research (NIMR) in Mwanza, Tanzania, to find effective ways of controlling HIV. In 2006, MRC provided initial funding to this group to set up a new trials unit in Mwanza, called the Mwanza Intervention Trials Unit. The aim of the unit is to develop as a centre of excellence in East Africa for trials of new methods to control HIV and other sexual health problems.

During the past three years, the unit has been set up and a building has been constructed to house it on the campus of NIMR in Mwanza. We have appointed a Scientific Director who is a respected Tanzanian scientist to lead the unit, and other senior staff have been recruited. We are now seeking funds to support the continued development of the unit. During the next few years we plan to carry out a range of trials looking at different methods of controlling HIV and other sexually transmitted infections. We will also be developing a comprehensive training programme so that the unit can help to develop capacity to conduct research in Africa.

Technical Summary

The global HIV pandemic continues to grow and the number of new HIV infections each year greatly exceeds the number of HIV-infected patients starting antiretroviral treatment (ART). Unless effective HIV prevention efforts can reduce the incidence of new infections, it will become increasingly difficult to sustain treatment services for all who need them. New prevention methods of proven effectiveness are urgently needed but there is a dearth of clinical trial centres in Africa equipped to carry out trials of such interventions to the highest standards.

Recognising this need, the MRC made a special award to the London School of Hygiene and Tropical Medicine (LSHTM) in 2006 to support the establishment of the Mwanza Intervention Trials Unit (MITU) in Mwanza, Tanzania. This new trials facility was established as a joint initiative of LSHTM and the Tanzanian National Institute for Medical Research (NIMR), building on a long history of successful collaborative research between these two institutions on the prevention and control of HIV and other sexually transmitted infections (STIs). The MRC award funded the construction of purpose-built premises for the new unit and contributed to the initial core costs of the unit. Key senior staff of the unit have been appointed including a Scientific Director and Senior Research Administrator. The new unit was officially opened by the Tanzanian Minister of Health in July 2009.

The unit?s mission is to contribute to improving health through the development and evaluation of interventions against HIV and other health problems by conducting research, including clinical trials, to the highest international standards; to enhance the capacity to carry out such research in Tanzania and the East African region; and to contribute to the translation of research findings into health policy.

Although the unit aims to be self-sufficient with core costs supported through indirect cost recovery on research grants, some ongoing core support will be needed during the initial period of development. This application seeks funding for such support during the three years from the end of the initial award in April 2010. During this period, the unit will continue to conduct randomised trials of promising interventions against HIV and other STIs, including trials of vaginal microbicides, use of ART for HIV prevention, community-based behavioural interventions and human papillomavirus (HPV) vaccination. In addition, the unit will develop a comprehensive programme of capacity building including short courses, MSc and PhD training, staff mentoring and postdoctoral fellowships.

Publications

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Callahan R (2015) Pregnancy and contraceptive use among women participating in the FEM-PrEP trial. in Journal of acquired immune deficiency syndromes (1999)

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Calvert C (2013) Risk factors for unplanned pregnancy among young women in Tanzania. in The journal of family planning and reproductive health care

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Francis JM (2017) Ethanol Concentration of Traditional Alcoholic Beverages in Northern Tanzania. in Journal of studies on alcohol and drugs

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Francis JM (2014) Systematic review and meta-analysis: prevalence of alcohol use among young people in eastern Africa. in Tropical medicine & international health : TM & IH

 
Description Consultations meeting for EDCTP in Lisbon, Portugal
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in advisory committee
 
Description Review results from trials of use of antiretroviral drugs for HIV prevention
Geographic Reach Africa 
Policy Influence Type Participation in a national consultation
 
Description Scientific Technical Committee meeting attendance
Geographic Reach National 
Policy Influence Type Membership of a guidance committee
 
Description Technical resource person
Geographic Reach National 
Policy Influence Type Participation in a national consultation
 
Description Technical working group on alcohol policy
Geographic Reach Africa 
Policy Influence Type Gave evidence to a government review
 
Description Workshop to review vaginal microbicide research findings and state of the field
Geographic Reach Africa 
Policy Influence Type Participation in a national consultation
 
Description cervical cancer vaccination
Geographic Reach National 
Policy Influence Type Participation in a national consultation
 
Description American Jewish World Service - Intervention with Microfinance for AIDS and Gender Equity (IMAGE) replication trial in Tanzania
Amount £1,395,348 (GBP)
Organisation American Jewish World Service (AJWS) 
Sector Charity/Non Profit
Country United States
Start 08/2011 
End 01/2016
 
Description Associations between HPV and HIV and preparation for trial of HPV vaccination for HIV prevention in Tanzania and South Africa
Amount £106,861 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 02/2014 
End 10/2014
 
Description EDCTP Strategic Primer Grant: Preparing for clinical trials of interventions to improve the reproductive health of adolescent girls in sub-Saharan Africa.
Amount € 512,624 (EUR)
Organisation Sixth Framework Programme (FP6) 
Department European and Developing Countries Clinical Trials Partnership
Sector Public
Country European Union (EU)
Start 12/2012 
End 11/2014
 
Description GSK - HPV-021 Post Trial Vaccination
Amount £9,869 (GBP)
Organisation GlaxoSmithKline (GSK) 
Sector Private
Country Global
Start 01/2011 
End 11/2011
 
Description H3Africa
Amount £120,000 (GBP)
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 09/2014 
End 08/2016
 
Description IPM - Microbiocides Development Programme(MDP) Phase III Clinical trial MDP301: Supplementary Funding for the Top-Up Substudy
Amount £25,000 (GBP)
Organisation International Partnership for Microbicides (IPM) 
Sector Charity/Non Profit
Country United States
Start 03/2010 
End 02/2012
 
Description MRC - Improving the health systems response to chronic diseases in Africa.
Amount £2,303,109 (GBP)
Funding ID G1002650 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 11/2011 
End 10/2015
 
Description MRC - Operational study documenting existing health practices for the provision of Cotrimoxazole Preventive Therapy
Amount £4,020 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 05/2011 
End 10/2011
 
Description MRC PHIND scheme
Amount £151,265 (GBP)
Funding ID MR/R00255X/1 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 09/2017 
End 02/2019
 
Description Mapping of fishing communities and of health services currently available in fishing communities, situated on the shores of Lake Victoria in Tanzania
Amount $12,807 (USD)
Organisation International AIDS Vaccine Initiative (IAVI) 
Sector Charity/Non Profit
Country Global
Start 05/2013 
End 08/2013
 
Description UICC - HPV Pilot Demonstration Project
Amount £9,583 (GBP)
Organisation Union for International Cancer Control 
Sector Private
Country Switzerland
Start 02/2011 
End 02/2012
 
Title Computer server 
Description We have purchased new computer server for storage of data collected in studies. 
Type Of Material Improvements to research infrastructure 
Year Produced 2018 
Provided To Others? No  
Impact We have now additional computer space to store data collected in our studies. 
 
Title Introduced use of OpenClinica for data management 
Description This is an open source and GCP-compliant data management system which was introduced in all our studies in 2010 
Type Of Material Improvements to research infrastructure 
Year Produced 2014 
Provided To Others? Yes  
Impact This system have helped to standardise data management systems across our studies 
 
Title Laboratory facility improvements 
Description We have expanded our laboratory facilities by developing a new laboratory sample archive unit, biosafety level 3 laboratory, and development of capacity for isolation and preservation of peripheral blood mononuclear cells, and HIV viral genotyping 
Type Of Material Improvements to research infrastructure 
Provided To Others? No  
Impact Improved laboratory infrastructure have allowed to expansion of the range of research studies conducted at our centre 
 
Title New lab techniques introduced for studying vaginal microbiome 
Description New lab techniques have been developed to study vaginal flora and how this influences the risk of HIV 
Type Of Material Improvements to research infrastructure 
Provided To Others? No  
Impact This have helped us to work in this new area of work to identify the role of vaginal microbiome in HIV transmission. 
 
Title Use of android tablets for data collection 
Description We have purchased android tablets which will be used in collecting data in a large clinical trial we are conducting in Tanzania 
Type Of Material Improvements to research infrastructure 
Provided To Others? No  
Impact We expect this system will allow us to collect more accurate data and contribute in more timely data analysis 
 
Title Use of electronic devices in collecting data 
Description We programmed PDAs to collect data in our large population survey 
Type Of Material Improvements to research infrastructure 
Provided To Others? No  
Impact This helped our team to collect more accurate data and minimise time required to clean the data after the survey 
 
Description Collaboration with South African Medical Research Council 
Organisation Medical Research Council of South Africa (MRC)
Country South Africa 
Sector Public 
PI Contribution We applied for research funding as part of the South African and UK Mental Health research scheme
Collaborator Contribution South African MRC contributed funds for this project and we collaborated with senior scientists at this institution in developing the proposal.
Impact No outputs at this point
Start Year 2018
 
Description Institute of Tropical Medicine 
Organisation University of Liverpool
Department Institute of Translational Medicine
Country United Kingdom 
Sector Academic/University 
PI Contribution Grant holder for EDCTP grant: Preparing for clinical trials of interventions to improve the reproductive health of adolescent girls in sub-Saharan Africa.
Collaborator Contribution Oversight and coordination of project
Impact Project currently in progress
Start Year 2012
 
Description Kenya Medical Research Institute 
Organisation Kenyan Institute for Medical Research (KEMRI)
Country Kenya 
Sector Public 
PI Contribution Provided contributions as part of the Lake Victoria Health Research Consortium
Collaborator Contribution Contributed in development of research agenda for the Lake Victoria Health Research Consortium
Impact We are working together in developing new proposals for funding
Start Year 2013
 
Description Lake Victoria Consortium for Health Research 
Organisation International AIDS Vaccine Initiative (IAVI)
Country Global 
Sector Charity/Non Profit 
PI Contribution We have been working together to develop proposals to seek funding to study the epidemiology of HIV among fishing communities in East Africa. We hope to develop interventions with will be evaluated in Kenya, Tanzania and Uganda. We have applied for funding in the PHIND scheme to do formative work in preparation for a larger grant.
Collaborator Contribution Our partners have been working in developing proposals and also in conference calls and face to face meetings.
Impact So far the main output have been development and submission of the PHIND proposal which is under review. This is a multi-disciplinary team comprised of epidemiologists, social scientists, and laboratory scientists
Start Year 2013
 
Description Research project to develop intervention to reduce harmful alcohol use 
Organisation Medical Research Council of South Africa (MRC)
Country South Africa 
Sector Public 
PI Contribution We have developed a proposal funded by MRC as part of the PHIND scheme
Collaborator Contribution Our partner was involved in development of the proposal and now in its implementation after being funded by the MRC
Impact So far no outputs from this collaboration
Start Year 2017