Enrolling Sites

University of Cape Town Lung Institute (UCTLI), Cape Town, South Africa

The SAMRC Unit on Child and Adolescent Health focuses on key health concerns affecting children and adolescents in Africa. A primary focus is on child lung health and the intersection of infection with emergence of chronic non-communicable diseases, addressing lung health from birth through adolescence. Studies focus on the origin and risk factors for acute and chronic lung disease and the impact of acute disease on child health and on development of chronic disease.

The goals and objectives of research at the Unit are to translate clinical research and basic science evidence into improving diagnosis prevention and management of specific priority childhood diseases that shape child health across Africa with a focus on pneumonia, tuberculosis, HIV-associated lung diseases and chronic illnesses such as asthma, all of which are the major cause of childhood mortality and morbidity globally and are contributors to under-5 mortality in Africa.

Specific Objectives:

· To expand and strengthen research and collaborations in child health to improve health in South Africa and the region.

· To develop a translational, cutting edge research program focused on childhood diseases including national priorities such as pneumonia, HIV and TB.

· To investigate the impact of early exposures including infectious diseases on child health and on the development of chronic disease.

· To increase understanding of the risk factors, host responses and long term outcome of early childhood illness.

· To enhance the health of children and adolescents by developing new strategies for diagnosis, management and prevention of diseases.

· To provide a platform for the training of clinician scientists in child health.

· To promote implementation of research findings into policy and practice.

National Institute of Medical Research-Mbeya Medical Research Centre (NIMR-MMRC), Mbeya, Tanzania

NIMR-Mbeya Medical Research Centre (NIMR-MMRC) Tanzania is both a basic research centre with advanced immunology and molecular biology facilities, and a trial site with state-of-the art TB and CP accredited safety laboratory.

NIMR-MMRC conducts both TB, HIV, Helminths researches and other tropical diseases of public health importance. It conducts GCP-compliant HIV Vaccine, TB drug and diagnostic trials and basic research programmes on biomarkers as well as several trials on new diagnostics and interventions in the health system.

MMRC has experience from multiple population based cohort studies, enrolling and following-up 20.000 individuals over 7 years

http://www.mmrp.org/

Dr Christina Manyama is a Clinical Research Coordinator and Sub Investigator at NIMR – Mbeya Medical Research Center (NIMR-MMRC). She works on the daily study management and study conduct procedures.

Dr Christina is a medical doctor holding a Masters Degree in Clinical Trials from London School of Hygiene and Tropical Medicine. She has long experience of working with clinical trials for seven years at NIMR-MMRC. She has been working as an investigator in TB drugs development trials and TB/HIV trials in general.

Currently Christina is a head of unit for clinical trials at NIMR-MMRC.

The main area of her interest is clinical trials both in the TB and HIV fields, focussing on TB drugs and vaccine development

Contact: cmanyama@nimr-mmrc.org

Issa Sabi, MD, MMed is a Paediatrician and Research Scientist at the National Institute for Medical Research (NIMR) and serves as Sub Investigator for the RaPaed-AIDA-TB project. He is the Head for the Department of Tuberculosis and Emerging Diseases at NIMR-Mbeya Medical Research Center supporting various TB and HIV research projects ranging from drugs trials, vaccine trials, diagnostics studies, and observational studies.

Dr Sabi has over 9 years’ experience of being involved in national and multinational research projects. His current work focuses on evaluation on new TB diagnostics in children including his recently published work on evaluation of Xpert MTB/RIF Ultra assay for the Diagnosis of TB in Children.

Recent HIV works focuses on PMTCT interventions and on the evaluation of Point of Care (PoC) tests for early infant HIV diagnosis. In addition to the RaPaed-AIDA-TB project he is currently supporting the EDCTP funded project LIFE which aims at evaluating if HIV testing at birth (using PoC tests) followed by immediate neonatal HIV treatment initiation may lead to lesser infant sickness, HIV progression or even death as compared to the current standard of care.

Dr Sabi is a member of the Childhood TB Technical Working Group in Tanzania; a member of National TB operational research coordinating committee; and a member of Paediatric Association of Tanzania (PAT).

He received his Medical Degree from Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania; Master of Medicine degree from the Catholic University of Health and Allied Sciences, Mwanza, Tanzania and is currently pursuing his PhD at the LMU Centre for International Health at the University of Munich, Germany.

Contact: isabi@nimr-mmrc.org

Dr Nyanda is a project/principal investigator on RaPaed-AIDA-TB at NIMR Mbeya Medical Research Centre (NIMR-MMRC) and currently the Centre Director at the same site. He oversees activities related to all research Tasks at NIMR-MMRC.

He is a medical doctor, holding a Master Degree in Tropical and Infectious Diseases from Liverpool School of Tropical Medicine UK, and PhD from LMU Centre for International Health at Ludwig-Maximilians-Universität, Munich. Dr Nyanda has more than 9 years of experience in managing clinical trials, diagnostic and operational studies as a Coordinator, Principal Investigator, Clinical Trial Manager at institutional and national levels in cross-functional and multicultural and international environment. He has recognizable experience in research of new TB drugs and diagnostics as well as emerging diseases, with strong expertise in ICH-GCP guidelines.

Furthermore, his main areas of research interest are in infectious diseases in particular TB, ranging from diagnostics, therapeutic to operational/implementation research. He has published over 22 publications dealing particularly with TB, HIV and selected infectious diseases.

Contact: nelias@nimr-mmrc.org

The recruitment site for RaPaed study in Malawi is the Queen Elizabeth Central hospital (QECH), a major public health facility for Blantyre city.

It has a specialist children’s A&E department that sees over 95 000 children per year of which, on average, 25 000 cases are admitted. As well as direct attendance, QECH receives referrals from the principal health centres within Blantyre.

Laboratories for the RaPaed study are set up at CoM. The TB diagnostics laboratory (cat 3) and is running to GCLP standards.

The site leads are Dr Marriott Nliwasa (CoM) and Prof Liz Corbett. The other co-investigators are Dr George Chagaluka (Paediatrician) and Dr Robina Semphere (Study physician).

The Malawi HIV/TB research group’s research programme includes i) Intervention trials of early diagnosis of HIV & TB at community and primary care level (SCALE, PROSPeCT and XACT-TB Trials), including health economics; ii) TB diagnostics and clinical management - evaluation of new diagnostics in adults and children (EDCTP funded TB RaPaed TB study), early mortality on TB treatment, and HIV clinical epidemiology; iii) Phase 3 Therapeutic trials including investigation of surrogate markers of TB treatment, drug interactions, pharmacomimetrics and genomics (EDCTP funded PanACEA II); and iv) Social determinants of health seeking for chronic cough and TB, Masculinity, Individual and societal consequences following self-testing for HIV.