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SITE LOCATIONS

The University of Cape Town (UCT), located in Cape Town, South Africa with major research initiatives in tuberculosis at the Institute of Infectious Diseases and Molecular Medicine (IDM) at UCT. The Institute of Infectious Disease and Molecular Medicine was established in 2004 as a cross-faculty postgraduate research institute based within the University of Cape Town (UCT). It is physically and administratively located within the Faculty of Health Sciences. IDM is an international centre of excellence where world-class scientists work together to tackle diseases of major importance in Africa, conducting basic, clinical and public health research that is leading-edge and relevant to the needs of African people. IDM comprised of 35 Full and 13 Associate Members, with 16 Affiliate Members from departments across UCT, and 12 Adjunct Members from other institutions. Working within our Members' laboratories and clinical research sites are approximately 400 scientific, technical and administrative staff, 70 postdoctoral fellows and 300 postgraduate students. The IDM conducts research at the laboratory-clinic-community interface by engaging a wide range of scientific and clinical disciplines. Collaborative research is an important focus for the IDM, with collaborators being based at 45 South African institutions, 34 African institutions in 18 African countries, and 336 institutions in 37 countries internationally. The IDM also has links to other institutions through 46 research consortia and 29 industrial partners.

 

Dr. Helen Cox is Site PI of the FEND-TB consortium site at UCT, and is a Wellcome Trust Intermediate Fellow in Public Health and Tropical Medicine specializing in drug-resistant tuberculosis, with expertise in TB diagnostics and treatment. Dr. Chad Centner is a microbiologist with dual appointments at the National Health Laboratory Service (NHLS) and University of Cape Town, and FENDTB reference testing will be performed in the NHLS laboratory under an existing collaborative arrangement. The Cape Town clinical team and PI have ongoing collaborative studies that recruit from Department of Health clinics in Khayelitsha and other locations. The Western Cape had approximately 45,000 TB cases notified in 2017 (incidence 681/100,000), including approximately 24,000 in Cape Town. Diagnostic studies by the UCT group have been conducted in the Khayelitsha sub-district, where 4088 new TB cases were diagnosed in 2017. Within the Khayelitsha sub-district there are 10 clinics; research infrastructure has been previously established in 3 of these clinics including infrastructure for clinic and community-based recruitment and follow-up. There is a long history of collaboration and support from the City of Cape Town and National TB Control Programs.

Makerere University, located in Kampala, Uganda, has been involved in international collaborative research on tuberculosis dating back to 1986, through a variety of NIH, WHO, CDC and non-governmental funding agency initiatives related to tuberculosis and HIV/AIDS. Many of the key investigators and leadership at Makerere University are principal investigators and site investigators in ongoing studies and clinical trials in tuberculosis and HIV/AIDS. Professor Moses Joloba (Dean of the School of Biomedical Sciences) is Site PI of the FEND-TB consortium site at Makerere University, with over 30+ years in tuberculosis research, training and leadership. Dr. Joloba also directs the Supranational TB Reference Laboratory, which is networked with all of the labs in the region. The Uganda clinical team has strong linkages with the

Kampala Capital City Authority TB program. Makerere University hosts the adult TB FEND-TB protocol and the pediatric TB FEND-TB protocol, with prior successful involvement in the NIAID Clinical Diagnostics Research Consortium (TB-CDRC) conducting several multi-center diagnostic evaluations (2009-2016), as well as recently completing a superiority study of Ultra Xpert II in pulmonary TB diagnosis.

 

Kisenyi Health Centre IV in Kampala is a sub-district level outpatient clinic with a designated TB/HIV clinic, established research infrastructure, and capacity to recruit adults and children. The Centre receives about 268 new TB suspects and 32 retreatment cases/month. Mulago National Referral Hospital receives an estimated 150 new TB suspects and 20 retreatment cases/month including adults and children. Mulago Hospital TB ward, a National TB treatment center and Centre of Excellence for MDR-TB care in Uganda, treats approximately 1200 drug susceptible and 150 MDR TB patients each year, with an estimated HIV prevalence of 50%. All three sites are government facilities that operate per the National TB program under the Ministry of Health. Baylor Uganda Children’s Clinical Center of Excellence (CCE), Kampala will be an additional site for recruitment of pediatric TB. Comprehensive clinical care is provided for more than 5000 HIV-positive children. In years 2017-2019, an average of 8 children < 5 years of age were diagnosed with

laboratory confirmed TB per year. The CCE will be a site for the pediatric protocol of FEND-TB.

The Universidad Peruana Cayetano Heredia (UPCH) in Lima, Peru, is a private non-profit university established in 1961. UPCH closely collaborates with the Ministry of Health and the Peruvian Direction of Prevention and Control of Tuberculosis (NTP). Dr Cesar Ugarte, UPCH site PI, is a member of the NTP National TB Expert Board that provides recommendations and guidance for evidence based decision making. Dr. Cesar Ugarte is Site PI of the FEND-TB consortium at the Instituto de Medicina Tropical Alexander von Humboldt at Universidad Peruana Cayetano Heredia (UPCH). Since 2015 Dr. Ugarte is the TB Research Unit Coordinator at IMTAvH, leading and overseen different TB studies. His interest has been with ongoing studies on molecularTB diagnosis and urine LAM studies and he is a member of the NTP National TB Expert

Board that provides recommendations and guidance for evidence-based decision making.

 

Participants will be recruited from primary health centers in San Juan de Lurigancho and La Victoria Districts (TB prevalence 168.6/100,000), and from three hospitals. Cayetano Heredia Hospital is a tertiary referral hospital that, in 2017, saw 16,000 TB suspects with an estimated TB prevalence of 55%. San Juan de Lurigancho Hospital and Huaycan Hospital are secondary referral hospitals that, in 2017, served approximately 10,000 and 5000 TB suspects, respectively.

The National Lung Hospital (NLH), located in Hanoi, Vietnam under the leadership of Dr. Nguyen Viet Nhung, NLH Director is a FEND-TB Consortium site in Asia. Professor Nhung has been working in the field of TB and TB/HIV diagnosis and treatment for more than 25 years. As the first Manager of the Vietnam National Tuberculosis (TB) Program and Director of the National Lung Hospital, Dr. Nhung and NLH have been actively participating in the development of strategic research on TB and lung diseases. NLH has been collaborating with universities and research centers from the United States, Australia, France, the Netherlands, South Korea, and Japan, including the TB Trials Consortium.

 

Affiliated performance sites include the Viet Tiep Hospital - Hai Phong and the Hai Phong Lung Hospital, all in Hanoi City. The first two hospitals (NLH and Viet Tiep Hospital) will provide patient recruitment and the Hai Phong Lung Hospital will provide related clinical laboratory facilities for the Adult TB protocol.