Mwanza Intervention Trials Facility

Lead Research Organisation: London Sch of Hygiene and Trop Medicine
Department Name: Infectious and Tropical Diseases

Abstract

We propose to establish a dedicated Intervention Trials Facility in Mwanza, Tanzania aimed at strengthening the capacity of Tanzania and the East African region to participate in HIV intervention trials. The Facility will be established by LSHTM working in close partnership with the Tanzanian National Institute for Medical Research (NIMR). It will provide a platform to meet local and regional needs, facilitate future research programmes funded by MRC, DFID, Wellcome Trust and other agencies, and help to leverage further capacity building support, for example from EDCTP.

Technical Summary

We propose to establish a dedicated Intervention Trials Facility in Mwanza, Tanzania aimed at strengthening the capacity of Tanzania and the East African region to participate in HIV intervention trials. The Facility will be established by LSHTM working in close partnership with the Tanzanian National Institute for Medical Research (NIMR). It will provide a platform to meet local and regional needs, facilitate future research programmes funded by MRC, DFID, Wellcome Trust and other agencies, and help to leverage further capacity building support, for example from EDCTP.

Publications

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Everett DB (2007) Low specificity of the Murex fourth-generation HIV enzyme immunoassay in Tanzanian adolescents. in Tropical medicine & international health : TM & IH

 
Description Findings of MDP301 trial
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in other policy documents
Impact Clear negative results of MDP301 trial of Pro2000 have provided firm basis to focus future microbicide research on antiretroviral-based microbicides
 
Description HSV-2 trial results
Geographic Reach Africa 
Policy Influence Type Participation in a national consultation
Impact This was the first trial in the world to demonstrate that acyclovir had no effect on HIV incidence and the results have recently been published in the New England Journal of Medicine. The impact on policy being that this intervention would not now be seen as useful.
 
Description MEMA Kwa Vijana Further Survey workshops attended by policymakers.
Geographic Reach Africa 
Policy Influence Type Participation in a national consultation
Impact Impact on policymakers in Tanzania through their attendance at workshops.
 
Description EDCTP - Clinical trials/capacity building grants (Capacity development and strengthening in preparation for HIV vaccine trials in Tanzania and Burkina Faso)
Amount £2,000,000 (GBP)
Organisation Sixth Framework Programme (FP6) 
Department European and Developing Countries Clinical Trials Partnership
Sector Public
Country European Union (EU)
Start  
 
Description EDCTP - Clinical trials/capacity building grants (Site preparation and capacity strengthening for trials of vaginal microbicides in Tanzania and Uganda)
Amount £2,000,000 (GBP)
Organisation Sixth Framework Programme (FP6) 
Department European and Developing Countries Clinical Trials Partnership
Sector Public
Country European Union (EU)
Start  
 
Description GSK - Clinicial trials
Amount £898,104 (GBP)
Organisation GlaxoSmithKline (GSK) 
Sector Private
Country Global
Start  
 
Description IPM - Project Grant (Biomarkers for Microbicide Development)
Amount £84,021 (GBP)
Organisation International Partnership for Microbicides (IPM) 
Sector Charity/Non Profit
Country United States
Start 07/2009 
End 06/2011
 
Description MRC Research Grant (Intravaginal practices in Tanzania and Uganda: Relationships with the vaginal microenvironment and HIV)
Amount £604,172 (GBP)
Funding ID G0701039 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start  
 
Description MRC research grant (Development of Mwanza Intervention Trials Unit as a centre of excellence in HIV/STI prevention research)
Amount £1,090,982 (GBP)
Funding ID G0901756 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 01/2010 
End 12/2013
 
Description Wellcome Trust Project Grant (Delivery, uptake and acceptability of HPV vaccination in Tanzanian girls)
Amount £431,687 (GBP)
Funding ID 090318 
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start  
 
Title Leukocyte Morphology Slide 
Description A smear of the cell pellet of the cervicovaginal lavage specimen. The smear is prepared similarly to a blood film, fixed with methanol, stained and read by a technician proficient in doing manual differentials. The technician records the type and count of white blood cells present in the smear. 
Type Of Material Database/Collection of Data/Biological Samples 
Provided To Others? No  
Impact Currently undergoing evaluation. 
 
Title Vaginal Practice Pictoral Diary 
Description Pictorial data collection tool in which participants record their vaginal practice and sexual history daily. 
Type Of Material Data analysis technique 
Provided To Others? No  
Impact Submitted paper to Sexually Transmitted Diseases "Vaginal practices diary: development of a pictorial data collection tool for sensitive behavioural data" 
 
Description Center for Proverty-related Communicable Diseases 
Organisation Academic Medical Center
Country Netherlands 
Sector Academic/University 
PI Contribution Technical support (epidemiology and biostatistics)
Collaborator Contribution Monitoring of clinical trials; data management expertise; ethical and regulatory requirements advice
Impact Strengthening research capacity in East African region.
 
Description Clinical trial: Microbicides Development Programme 
Organisation Medical Research Council (MRC)
Department Microbicides Development Programme
Country United Kingdom 
Sector Public 
PI Contribution PI for Mwanza field site; statistical input to trial
Collaborator Contribution Collaborative involvement in Phase III trial of Pro2000 vaginal microbicide
Impact Successful completion and publication of MDP301 Phase III trial; further publications in progress; capacity building in partner sites in Africa; development of proposal for MDP302 trial
 
Description ICRH 
Organisation International Center for Reproductive Health (ICRH)
Country Belgium 
Sector Charity/Non Profit 
PI Contribution Providing biostatistical expertise and training.
Collaborator Contribution Coordinate an EDCTP-funded project: Characterisation of novel microbicide safety biomarkers in East and South Africa
Impact Strengthening research capacity in Africa.
Start Year 2009
 
Description Kilimanjaro Christian Medical Centre (KCMS) 
Organisation Kilimanjaro Christian Medical Centre (KCMS)
Country Tanzania, United Republic of 
Sector Hospitals 
PI Contribution Coordinated an EDCTP-funded project: Capacity development and strengthening in preparation for HIV vaccine trials in Tanzania and Burkina Faso
Collaborator Contribution Research expertise: distribution of viral genotypes among high-risk and general populations; Role of co-morbidities in HIV pathogenesis and clinical course of HIV disease; Models of delivering care and treatment for people living with HIV/AIDS
Impact Strengthening research capacity in Africa.
Start Year 2008
 
Description MRC Clinical Trials Unit 
Organisation Medical Research Council (MRC)
Department MRC Clinical Trials Unit
Country United Kingdom 
Sector Public 
PI Contribution Technical support (epidemiology and biostatistics)
Collaborator Contribution Monitoring of clinical trials; data management expertise; ethical and regulatory requirements advice.
Impact Strengthening research capacity in East African region.
 
Description MRC/UVRI Uganda Research Unit on AIDS 
Organisation MRC/UVRI Uganda Research Unit on AIDS
Country Uganda 
Sector Public 
PI Contribution Technical support (epidemiology and biostatistics)
Collaborator Contribution Provided experience in Phase I/II clinical trials; colposcopy expertise; lab expertise; financial and administrative capacity building support.
Impact Strengthening research capacity in East African region.
 
Description NIMR Mwanza Centre 
Organisation National Institute for Medical Research, Tanzania
Department Mwanza Intervention Trials Unit (MITU)
Country Tanzania, United Republic of 
Sector Public 
PI Contribution Technical (epidemiological, statistical, clinical, research) and administrative support.
Collaborator Contribution Providing laboratory and logistical infrastructure and support.
Impact Strengthening research capacity in Africa; scientific publications; joint research grants
 
Description University of Montpellier 
Organisation University of Montpellier
Department Laboratory of Bacteriology and Virology Montpellier
Country France 
Sector Academic/University 
PI Contribution Coordinated an EDCTP-funded project: Capacity development and strengthening in preparation for HIV vaccine trials in Tanzania and Burkina Faso
Collaborator Contribution Providing technical support in the area of laboratory capacity building and conducting proposed laboratory assays
Impact Strengthening research capacity in Africa
Start Year 2008
 
Description University of Ouagadougou 
Organisation University of Ouagadougou
Country Burkina Faso 
Sector Academic/University 
PI Contribution Coordinated an EDCTP-funded project: Capacity development and strengthening in preparation for HIV vaccine trials in Tanzania and Burkina Faso
Collaborator Contribution Providing south-south capacity building and exchange of technical expertise with Africian collaborators
Impact Strengthening research capacity in Africa
Start Year 2008
 
Description HSV-2 trial dissemination activities 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact Dissemination of the results from the trial: "Clinical epidemiology of HSV-2 and the impact of HSV suppressive therapy to reduce HIV incidence in high risk women, Tanzania" through workshops, international conferences and meetings and publications in scientific journals.

Dissemination of the results from the trial: "Clinical epidemiology of HSV-2 and the impact of HSV suppressive therapy to reduce HIV incidence in high risk women, Tanzania" through workshops. Increased awareness about the association between HIV and HSV-2 in trial participants, scientists and health care workers in Tanzania.
Year(s) Of Engagement Activity 2009
 
Description MEMA Kwa Vijana Further Survey dissemination activities 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Primary Audience Policymakers/politicians
Results and Impact Dissemination of the results from the "MEMA Kwa Vijana Further Survey" (Adolescent Sexual and Reproductive Health intervention) through international and regional workshops.
Year(s) Of Engagement Activity 2009
 
Description Produced MITU biennial report 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact Produced the first MITU biennial report.

Distributed to researchers, research collaborations, funding organisations and the media.
Year(s) Of Engagement Activity 2009
 
Description Scientific symposium: HIV Prevention - Where Now? 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact The symposium included keynote presentations reviewing the research evidence on major approaches to HIV prevention in adults and focused on the prevention of heterosexual transmission of HIV in Africa. There was discussion of research gaps, future directions and methodological approaches. The media were present.

An article on the symposium featured in "Tanzania AIDS Week in Review".
Year(s) Of Engagement Activity 2009
 
Description Workshop: MDP301 trial of Pro2000 microbicide gel 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Primary Audience Participants in your research and patient groups
Results and Impact Subsantial proportion of women participating in trial attended dissemination workshops

NA
Year(s) Of Engagement Activity 2010