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    Muhimbili Capacity Statement

    MUHIMBILI MEDICAL RESEARCH CENTRE

    Administration

    Muhimbili Research Centre started in 1968 when the East African Research Council (EARC) established the TB Reference Laboratory with the British Medical Research Council (BMRC) assistance. When the National Institute for Medical Research was established in 1979, it inherited the TB reference Laboratory. From its inception, it operated as a NIMR- Muhimbili Station until August 2005, when it became a centre with two research stations, Haydom (in Mbulu District) and one at Kilosa in Kilosa District. It jointly runs a BSL-1-3 laboratory for TB, the Central TB reference Laboratory with National Tuberculosis and Leprosy Control Program. The laboratory is located within the Central Pathology Laboratory building of the Muhimbili National Hospital.

     Research capacity

    Since 2005, the Centre has diversified its research focus from a disease-specific approach research, i.e. researching TB, HIV/AIDS and related illnesses, to a broader mandate that includes all health research at local, regional, zonal and national levels according to the National Health Research Priorities and Institutional mandate. The current research focus is on major research areas, which include; TB and TB/HIV co-infection; NCDs and Co and multimorbidity with infectious diseases including HIV and zoonotic diseases; Clinical trials; Diagnosis and laboratory sciences; Disease Surveillance and outbreak; Genetics and Molecular Biology; Bio-informatics; Health System and Policy Research; and Child and Maternal health.   The Centre has over 33 scientists trained in different disciplines at master’s and PhD levels. Over the years, several achievements have been attained.

    Main achievements: Some of the findings from research carried out at the centre have contributed to the formulation of national and global policies in the management, prevention and control of diseases.

    1. Guidelines for managing HIV and AIDS, Sixth Edition, October 2017 (www.nacp.go.tz/site/download/NATIONAL_DECEMBER_2017.pdf). Global Advanced HIV Disease Toolkit (TRIP experiences and materials contributed in the development process): (http://www.differentiatedcare.org/Resources/Resource-Library/Global-Advanced-HIV-DiseaseToolkit). The Centre has over 200 published papers in peer-reviewed journals, including The Lancet and the New England Journal of Medicine (NEJM); it is also leading the development and running of the ongoing multi-centre HIV and TB trial web database, the management system (the REDAMS database) in East Africa. The Centre has also won and successfully implemented several consultancies from national and international agencies, including NIH, USAID and PEPFAR programs.
    2. The WHO Guidelines for managing advanced HIV disease and rapid initiation of antiretroviral therapy: Under the leadership of NIMR-Muhimbili, the center implemented the trial entitled “Reduction of early mortality among HIV infected subjects starting antiretroviral therapy: a randomized trial” (The REMSTART trial/IP.2009.33011.003) was completed successful, published in the LANCET which shows a preventive package for Cryptococcal Meningitis that reduced mortality by 30%. REMSTART was among two trials selected through systematic review and contributed to the development of the WHO Guidelines for managing advanced HIV disease and rapid initiation of antiretroviral therapy (http://www.who.int/hiv/pub/guidelines/advanced-HIV-disease/en/), launched at launched at the 9th International AIDS Society (IAS) 2017
    3. The Tanzania National Guidelines for the Management f HIV and AIDS, Sixth 8 Edition, October 2017: As the leading centre of the REMSTART and the project on Translating Research (REMSTART package) into Practice (TRIP- EDCTP-CSA-2014) both funded by EDCTP, the centre influenced the change and revision of the guidelines for management of HIV and AIDS (www.nacp.go.tz/site/download/NATIONAL_DECEMBER_2017.pdf ), which includes screening for Cryptococci (pg 98) infection and pre-emptive treatment with fluconazole for asymptomatic HIV infected individuals with Cryptococci Infection.
    4. The WHO Guidelines for the Diagnosis, Prevention and Management of Cryptococci Disease in HIV-Infected Adults, Adolescents and Children, March 2018: As Country leading centre in a multi countries trial and through the international team NIMR Muhimbili published results of a trial for Advancing Cryptococci Treatment for Africa (ACTA; ISRCTN45035509) in the New England Journal of Medicine which shows relatively simple changes can save tens of thousands of lives a year. In the light of the new findings, the World Health Organisation (WHO) has issued new Cryptococci Disease guidelines (http://www.who.int/hiv/mediacentre/news/cryptococcaldisease- infographic/en/) recommending a one-week drug course basing on ACTAL trial findings.
    5. National Policy Guidelines for Collaborative TB/HIV Activities, 2016: We conducted several studies focusing at epidemiological and clinical issues related to TB and HIV infection (publication list) and also involved in capacity building for clinical research in TB (http://eaccr.org/). The results of these projects have contributed to a better understanding of interaction between HIV and TB in the country. The knowledge justifies the use of Anti- Retroviral Treatment in TB patients and contributed to the Collaborative TB/HIV Activities (http://www.ntlp.go.tz/resources/) of NTLP and National AIDS/HIV Program (NACP).
    6. Guidelines for Management of Multi Drug Resistant – TB in Tanzania; Second Edition, 2017: Through NIMR-Muhimbili, the group conducted TB drug resistance research and routine TB drug resistance surveillance team at the Central Tuberculosis Reference Laboratory (CTRL), and published several publications on TB drug resistance. The results of TB drug susceptibility testing has provided the knowledge that is useful to the monitoring of TB treatment and hence demonstrating the NTLP progress, and contributed to the national policy on TB dug resistance (http://www.ntlp.go.tz/resources/).
    7. Manual for the Management of Tuberculosis and Leprosy, Sixth Edition, 2013: Studies on validity of the Spot-Morning-Spot sputum specimen in the detection of AFB in TB patients and effects of delayed processing of sputum specimen on laboratory results (our publication list) had impact on initiation of the policy on spot-morning- spot collection of sputum specimens. The policy reduces diagnosis time from three to two days. In addition, the studies showed that increased transit time reduces viability of M. tuberculosis. This has strengthened the emphasis on securing effective transport of sputum to zonal and reference laboratories the country. These results contributed to the policy revision for specimen collection for diagnosis of TB in NTLP manual (http://www.ntlp.go.tz/resources/).
    8. Establishment of national one health unit/policy under Prime Minister Office: Through our research group, we have played a leading role in conducting research and coordinating networks (http://afriqueoneaspire.org/) on zoonotic diseases like bovine TB, and brucellosis (my publication list) in humans in collaboration with other sectors, and contributed the demonstration of add value of one health. The country has now established a special unit for coordinating one health issue under the office of prime minister (http://preparednessandresponse.org/countries/tanzania/).
    9. CTRL has been accredited on GeneXpert, AFB smear microscopy under ISO15189:2012 through SADCAS from 2019 to 2024, and in 2022 the scope was extended to include Line Probe Assay (LPA) and Culture

     

    List of completed and ongoing projects:

    1. Epidemiology, clinical, immunology and neuroradiological characteristics of Taenia solium cysticercosis in people with and without HIV/AIDS in Southern Highlands of Tanzania Mbeya and Iringa. (CYSTINET)
    2. Fluconazole plus flucytosine vs. fluconazole alone for cryptococcal antigen-positive patients identified through screening: Phase III randomized controlled trial. (EFFECT TRIAL)
    3. Sub EFFECT TRIAL (Pathophysiology and clinical outcomes of subclinical cryptococcal meningitis
    4. Assessment of Immunogenicity following administration of COVID-19 vaccines in Tanzania
    5. Multicenter, Phase 1/2a, double-blinded Randomized Controlled non-inferiority Trial to Assess Safety and Immunogenicity of TANCoV 1.3.20 SARS _CoV-2 vaccine in healthy participants in Tanzania. (TANCoV)
    6. The Impact of HIV infection on cancer treatment toxicity, tolerability, and survival among lung cancer patients in Tanzania; a prospective cohort study.
    7. Implementation and evaluation of nanopore sequencing for Tuberculosis, COVID-19, and WHO Antimicrobial Resistance Priority Pathogens.
    8. A randomized placebo-controlled double-blind phase III trial to determine the effects of metformin versus placebo on the incidence of diabetes in HIV-infected persons with pre-diabetes in Tanzania. Metformin Treatment for Africa. (META 3 trial)
    9. Controlling chronic diseases in Africa: development and evaluation of integrated community-based management for HIV-infection, diabetes and hypertension in Tanzania and Uganda. (INTE-COM)
    10. Lung cancer in East Africa in relation to HIV-1 infection: Epidemiological, Molecular characterization and Imaging. (U54 Study)
    11. Use of Point of Care HIV Viral Load Monitoring to Improve Viral Load Suppression among Children and Adolescents Living with HIV in East Africa. (POINT OF CARE)
    12. Tanzania Global Health Security Priorities – Advancing Efforts and Strategies to Protect and Improve Health Security. (TAGHESP)
    13. Chanjo Kwa Wakati – Leveraging community health workers and a responsive digital health system to improve vaccination coverage and timeliness in resource-limited settings.
    14. Assessment of the feasibility of Involving Community Health Workers in the Delivery of Tuberculosis Preventive Treatment with Family Approach Under Programmatic Conditions in Tanzania. (TPT)
    15. Addressing neonatal mortalities through Prolonged Immediate Kangaroo Mother Care in Bagamoyo Tanzania. (KMC)
    16. Capacity Building for Female Scientists in East Africa. (CaFe-SEA)
    17. Eastern Africa Consortium for Clinical Research 3. (EACCR 3)
    18. Moving Tanzania’s Clinical Research Ethics and Medicines Regulatory Capacity to the Next Level: Fostering Medicine Quality, Safety and GCP Clinical Trials. (ASCEND)
    19. Building resilient research ethics, Diagnostics, and medicines regulatory capacity during routine and public health emergency periods. (BREEDIME)
    20. Developing national and global agendas for the ethics of post-trial arrangements in low-middle income countries during pandemics/epidemics (Short title: Pandemic Ethics) Multi-country study GLOBVAC 3363383
    21. Co-designing neglected zoonosis intervention through One Health, education, and public-private partnership.
    22. SMS Campaign to Increase COVID-19 Vaccine Take-up in Tanzania.
    23. Afya yako: Countering Public Health Misinformation through Local media.
    24. Support to NTP activities for using digital technologies to support the TB response in Ta

    Currently, NIMR-Muhimbili has active funding from the EDCTP, EU, NIHR, World Bank, UNICEF, USAID (through Engender Health organisation), Global Fund, and the National Institute of Health. Being located at MUHAS and MNH, the centre has a pool of qualified research assistants from different disciplines, including medical doctors, social scientists, and psychologists, to mention a few. On average, the Centre has conducted about 40-45 research projects annually of different magnitudes and disciplines.

     

    Laboratory capacity

    The Muhimbili Medical Research Center (NIMR – MMRC), in collaboration with the National Tuberculosis Control Program (NTLP), jointly operate the Central Laboratory of Tuberculosis (TB) Tanzania (CTRL). This BSL3 laboratory is located within Muhimbili National Hospital (MNH) in the Central Pathology Laboratory (CPL) building. The laboratory has been accredited under the International Organization for Standardization (ISO) 15189 of 2012 since 2018. The laboratory is also accredited by the Southern African Development Community Accreditation Service (SADCAS) under ISO 15189 of 2012 since 2018 to date. The accredited scopes for the laboratory are AFB smear Microscopy, GeneXpert by Xpert MTB/RIF Ultra, conventional Mycobacterial Culture and Line probe assay (LPA)

     

    The laboratory is recognised by the Ministry of Health (MoH, Tanzania), SADCAS (South Africa) and the World Health Organization (WHO) as well as other renowned international organisations. The laboratory works in collaboration with other local and international laboratories, including, among others, the Uganda Supranational Reference Laboratory (Uganda SNRL), the Institute of Tropical Medicine, and the University of Antwerp, Belgium. The laboratory is actively engaged in: -monitoring the resistance of anti-TB drugs through Surveillance such as Drug Resistance Survey (DRS) or Prevalence Survey of Tuberculosis (PST), monitoring the quality of tuberculosis screening services through the Implementation of the External Quality Assurance System (EQA). The laboratory is currently on the brink of introducing sequencing using Oxford Nanopore Sequencing Technologies (ONT) for the detection of Mycobacterium species and drug resistance.