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.
Organisations
- London Sch of Hygiene and Trop Medicine, United Kingdom (Lead Research Organisation)
- Universite Montpellier (Collaboration)
- National Institute for Medical Research (Collaboration)
- Academic Medical Center (Collaboration)
- Kilimanjaro Christian Medical Centre (KCMS) (Collaboration)
- University of Ouagadougou (Collaboration)
- Medical Research Council (Collaboration)
- MRC/UVRI Uganda Research Unit on AIDS, Uganda (Collaboration)
- International Center for Reproductive Health (ICRH) (Collaboration)
Publications
Allen CF
(2007)
Validity of coital diaries in a feasibility study for the Microbicides Development Programme trial among women at high risk of HIV/AIDS in Mwanza, Tanzania.
in Sexually transmitted infections
Baisley K
(2009)
Bacterial vaginosis in female facility workers in north-western Tanzania: prevalence and risk factors.
in Sexually transmitted infections
Everett DB
(2009)
Suitability of simple human immunodeficiency virus rapid tests in clinical trials in community-based clinic settings.
in Journal of clinical microbiology
Everett DB
(2007)
Low specificity of the Murex fourth-generation HIV enzyme immunoassay in Tanzanian adolescents.
in Tropical medicine & international health : TM & IH
Lees S
(2010)
Comparison of sexual behavior data collected using a coital diary and a clinic-based interview during a microbicide pilot study in Mwanza, Tanzania.
in Sexually transmitted diseases
Mabey D
(2006)
Prospective, multi-centre clinic-based evaluation of four rapid diagnostic tests for syphilis.
in Sexually transmitted infections
McCormack S
(2010)
PRO2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): a phase 3, randomised, double-blind, parallel-group trial.
in Lancet (London, England)
| 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 | 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 | Netherlands |
| 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 | Netherlands |
| 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 | 06/2009 |
| 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 | Public |
| 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 | Public |
| 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 | Academic/University |
| 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 | 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 | 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 |