DMS # 72347-V1 EDCTP Report for the Regional Networks of Excellence Submission of individual reports per site will no longer be accepted by EDCTP. Project Coordinators are requested to submit ONE consolidated report per Network Call Scheme Report type Report Reporting period Capacity-building Annual fourth From [16th May 2012] To [15th May 2013] (Year 4) SECTION A: PROJECT PROFILE This information is used in the Project Profile published on the EDCTP website Project Coordinator Please provide a recent photograph for your profile Annex 1 Name: Prof. Pontiano Kaleebu EDCTP grant code CB.07.41700.001 Name of Network EACCR Grant title The East African Consortium for Clinical Research: A capacity-building network of excellence, training and mentorship in the conduct of clinical trials in Africa Coordinating Institution Email Address: [email protected] Uganda Virus Research Institute (UVRI) P.O Box 49 Entebbe (Uganda) 51-59 Nakiwogo Road Phone: +256 417704103 Country Uganda Total number of sites/institutions* 35 institutions Number of active sites contributing to this report 17 regional leading & 18 sister institutions continue to be active members Grant start and end date From Value of EDCTP grant 3.46 million euros 16th May 2009 To 31st December 2013 *only applies to sites with legal entity status EDCTP Reporting Template for the Regional Networks of Excellence Page 1 of 44 DMS # 72347-V1 1.1 List of collaborators Please provide details of the work package leaders and other collaborators on the grant, indicating their role in the project (for example, project coordinator, PhD and MSc supervisor, site PI, work package leader, etc). Where collaborators have more than one role, please provide details. Site/Institution Country 1. Uganda Virus Research institute Uganda 2. MRC/UVRI Research Unit Uganda 3. Kilimanjaro Christian Medical Centre (KCMC) Tanzania Active (Y/N)* Y Name of collaborator Prof. Pontiano Kaleebu Y Prof. Heiner Grosskurth Y Prof. Gibson Kibiki Y 4. MRC/UVRI Research Unit 5. Kenya Medical Research InstituteKilifi Uganda Prof. Alison Elliott Y Kenya Prof. Kevin Marsh Y 6. Uganda Virus Research Institute Uganda 7. Kenya Medical Reserach Institute Kenya Dr. Edward Katongole Mbidde Y Dr. Nobert peshu Y 8. University of Oxford 9. Ifakara Health Research InstituteIHI 10. Armauer Hansen Reserach Institute (AHRI) UK Dr. Trudie Lang Y Tanzania Dr. Abdulla Salim Y Ethiopia Dr. Abraham Aseffa EDCTP Reporting Template for the Regional Networks of Excellence Role in Network Area of expertise Gender Current email Overall Project Coordinator Former Director MRC/UVRI Unit & co-applicant Deputy Overall Project Coordinator Facilitator of capacity-building activities & coapplicant Co-applicant & Head of institution HIV Male Pontiano.Kaleebu@mrcug anda.org heiner.grosskurth@gmail. com HIV Male TB Male [email protected]/ [email protected] Immunology & Infectious Diseases Female [email protected] Malaria Male [email protected] Chairman EACCR Steering committee & Director, UVRI Malaria node coordinator HIV, Bioethics, oncology Male [email protected] Malaria Male [email protected] Member, EACCR Steering committee & training Member, EACCR Steering committee & Head of IHI Member, EACCR Steering committee & Head of site Malaria, clinical trials, Training (elearning) Malaria Female [email protected]. uk Male [email protected]/ [email protected] TB Male [email protected] Page 2 of 44 DMS # 72347-V1 Site/Institution 11. National Institute for Medical Research – Mwanza 12. National Institute for Medical Research – Mwanza 13. Armauer Hansen Reserach Institute (AHRI) 14. Muhimbili University of Health and Allied Sciences (MUHAS) 15. Institute of Endemic Diseases (IEND) 16. Muhimbili University of Health and Allied Sciences (MUHAS) 17. National Institute for Medical Research Dar es Salaam 18. National Institute for Medical Research – Muhimbili 19. National Institute for Medical Research – Muhimbili 20. Muhimbili University of Health and Allied Sciences(MUHAS) Country Active (Y/N)* Name of collaborator Y Tanzania Dr. John Changalucha Y Tanzania Mr. Mark Urassa Y Canadian Prof. Engers Howard Y Tanzania Dr. Muhammed Bakari Y Sudan Prof. Maowia Mukhtar Y Dr. Patricia Jane Munseri Tanzania Y Dr. Mwele Ntuli Malecela Tanzania Y Dr. Sayoki Godfrey Mfinanga Tanzania Y Tanzania Dr. Beatrice K Mutayoba Y Tanzania Role in Network Area of expertise Gender Current email Member, EACCR Steering committee & Head of site Facilitator, HIV activities Medical microbiology Male [email protected] HIV Male [email protected] Supervisor Training & coapplicant Mentoring & coapplicant Training Male [email protected]/en [email protected] HIV, Training Male [email protected]/mba [email protected] Facilitator of EACCR capacitybuilding activities Facilitator of EACCR capacitybuilding activities Malaria, Training Male mmukhtar@tropmedicine. org Training Female [email protected] Vice chair, Steering Committee & Director General – NIMR TB node coordinator Neglected infectious diseases Female [email protected]/ [email protected] TB, HIV and NCDs Male [email protected] Facilitator of activities in the TB Node Scientist-TB Female [email protected]/be [email protected] m Trainer Training Male [email protected] Prof. Japhet Killewo EDCTP Reporting Template for the Regional Networks of Excellence Page 3 of 44 DMS # 72347-V1 Site/Institution 21. Muhimbili University of Health and Allied Sciences(MUHAS) Country Active (Y/N)* Name of collaborator Y Tanzania Prof. Eligius Lyamuya Y 22. Uganda Virus Research Institute Uganda Dr. Jonathan Kayondo Y 23. KEMRI/CDCKisumu 24 Walter Reed Project/KEMRI Kisumu 25. University of Nairobi/Kenya AIDS Vaccine Initiative (KAVI) 26. Maseno University Kenya Mr. Steve Wandiga Y Kenya Dr. Berhards Ogutu Y Dr. Walter Godfrey Jaoko Kenya Kenya Y Prof.Ofulla Ayub V.O Y 27. Ugandan Ministry of Health Uganda Dr. Asuman Lukwago Y 28. St Rapheal Nsambya Hospital Uganda Dr. Martin Nsubuga N 29. NIMR-Tabora Tanzania Dr. stafford Kibona EDCTP Reporting Template for the Regional Networks of Excellence Role in Network Area of expertise Member, steering committee & Trainer HIV, microbiology, immunology Male [email protected] Member, implementation committee HIV, malaria, molecular biology, bioinformatics TB Male [email protected] Male [email protected] Malaria Male [email protected] HIV, microbiology, training Male [email protected] Malaria, training Internal medicine, policy Male [email protected] Male [email protected] Internal medicine Male [email protected] o.uk/ martin.nsubuga.dr@gmail. com Parasitology, Human African Trypanosomia sis Male [email protected] Trainer/facilitator of capacitybuilding activities & member steering committee Steering committee member Co-applicant & trainer Co-applicant, trainer Steering committee member, coapplicant Director of sister site, co-applicant, source of potential participants Director of sister site, co-applicant, source of potential participants Gender Current email Page 4 of 44 DMS # 72347-V1 Site/Institution 30. National Institute for Medical Research -Tanga Country Active (Y/N)* Role in Network Director of sister site, co-applicant Malaria Female Dr. Martha Lemnge [email protected] m Site Director, Steering committee member Steering committee member Steering committee member Director of sister site, source of potential participants CollaboratorNorthern partner, co-applicant Advisor TB research HIV Male [email protected] TB Male [email protected] HIV Male Eric.sandstrom@karolinsk a.se Paediatrics, epidemiology Female [email protected] TB Male [email protected] TB Male [email protected] Training Training Male [email protected] Facilitator of capacity-building HIV Male [email protected] CollaboratorNorthern partner, co-applicant Networking Male [email protected] Facilitation of TB node activities, Member, TB node secretariat TB Male [email protected] Y Tanzania Y 31. NIMR-Mbeya Tanzania 32. University of Munich Germany 33. . Karolinska Institute Sweden Dr. Leonard Maboko N Dr. Michael Hoelscher Y Prof. Eric Sandstrom Y 34.Masaka Hospital 35. Centre for International Health, University of Bergen 36. KNCV Tuberculosis Foundation 37. Goteborg University 38. Infectious Disease Institute- Mulago 39. Radbourd University Medical center Nijmmegen (RUMCN) 40. National Institute for Medical Research – Muhimbili Dr. Florence Tugumisirize Uganda N Norway Netherlands Sweden Uganda Netherlands Prof. Odd Morkve N N Y N Dr. Van der Leth Prof. Ashton Michael Dr. Andrew Kambugu Prof. Van der Ven Y Tanzania Area of expertise Name of collaborator Dr. Bernard Ngowi Gender Current email *Active: Sites involved with EDCTP-funded project activities during the current reporting period Please submit copies of CV’s of any new collaborators as supporting annexes EDCTP Reporting Template for the Regional Networks of Excellence Page 5 of 44 DMS # 72347-V1 1.2 Abstract (max 850 characters) Give a summary of the project and what was achieved, including the aims and objectives, research questions being addressed, study methods, results, findings and achievements of the project. Introduction: Since May 2009, an expandable East African Consortium for Clinical Research (EACCR) went into action with 35 regional institutions and 7 northern partners to promote health product innovation (drugs, devices and other solutions), capacity development and networking. It addresses challenges of fragmented/uncoordinated efforts, diminishing indigenous scientists, insufficient funds and inadequate infrastructure in Eastern Africa in partnership with the industry (both pharmaceutical and business) and policy makers. EACCR integrates scientists, health practitioners, academicians and policy makers from the region (including Ethiopia and Sudan) and Europe. It has networked actively with other research consortia and development partners in Africa and beyond. Methods: We conducted participatory appraisal (documented/reported observations, content analysis, teleconferencing and record abstraction) between May 2012-May 2013 on EACCR’s work packages categorized into: governance, training, infrastructure, research and networking. Governance was structured regionally into 4 coordinating centers: Malaria (Kenya), TB (Tanzania), HIV (Uganda) and Training (Tanzania). Results and achievements: We maintained a consensus-governed and networked consortium also supporting other linked projects/activities of other funding streams. We secured 2 additional reports from Kenya and Tanzania for a regional social science study. We also registered 2 additional MSc research fellows from Ethiopia and Tanzania; recorded 11 graduated MSc fellows; completed 4 EDCTP senior fellowships and reached at least 100 scientists through 4 short-courses in GCLP, GCP, TB laboratory techniques, clinical monitoring and trial conduct. Five more laboratories of sister sites in Kenya, Sudan and Uganda were upgraded. EACCR contributed to 1 published peer-review article, at least 5 oral presentations at international meetings and to other several scientific presentations through other funding mechanisms. It has a regional reciprocal monitoring scheme of at least 10 experienced monitors, who have cumulatively conducted 27 site visits to 11 clinical trials and mentored at least 10 new monitors, including 2 from our new partner institution in Rwanda. 1.3 Description of the project The project description should cover background, objectives, results and outcomes, capacity building and networking (max: 5000 characters). Background EACCR is an Eastern African-led, EDCTP-enabled network established in May 2009 to contribute to: health research coordination; increased active mass of African scientists and research administrators; upgraded infrastructure; stronger networking and advocacy for conducting clinical trials or other research on HIV, Malaria, TB and other diseases of public health importance under best practices. It has 35 regional institutions from Kenya, Uganda, Tanzania, Ethiopia and Sudan in partnership with 7 northern partners. It coordinates & promotes health product innovation, capacity development and networking in Eastern Africa for improved health and social advancement of its population. Objectives To To To To To To strengthen regional research coordination and infrastructure for multi-centre clinical trials plus other health research enable less developed sites within EACCR to improve their capacity to participate in multi-centre clinical trials through mentorship and collaboration plan and support training/mentoring of promising regional scientists and administrators through both short and long term courses contribute to improved strategic quality management of research through an affordable reciprocal monitoring scheme apply an interactive website for better communication, enhanced networking, advocacy, common databases and training promote advocacy for: regionally-owned research and health agenda; research use in policy and programming and resource mobilization EDCTP Reporting Template for the Regional Networks of Excellence Page 6 of 44 DMS # 72347-V1 Results and outcomes We secured 2 additional reports from Kenya and Tanzania for a regional social science study (annexes 1 and 2). EACCR contributed to 1 published peer-review article (annex 3) and to at least 5 oral presentations at international meetings (annexes 4-6). Other network-linked scientific presentations/publications through other funding streams are not included here. Capacity building We maintained a consensus-governed and networked consortium. We also registered 2 additional MSc research fellows from Ethiopia and Tanzania; recorded 11 graduated MSc fellows; completed 4 EDCTP senior fellowships and reached at least 100 scientists through 4 short-courses in GCLP, GCP, TB laboratory techniques, clinical monitoring and trial conduct. Five more laboratories of sister sites in Kenya, Sudan and Uganda were upgraded. It has a regional reciprocal monitoring scheme of at least 10 experienced monitors, who have cumulatively conducted 27 site visits to 11 clinical trials and mentored at least 10 new monitors, including 2 from our new partner institution in Rwanda. Networking Prepared a proposal to EDCTP for a joint planning meeting of stakeholders from EACCR and TESA (On-going by date of reporting) Submitted a research capacity building proposal to WHO/TDR (10th May 2013) Distributed over 400 EACCR brochures during national & international meetings (On-going by date of reporting) Two EACCR members gave oral presentations at the 4 th annual East African Health and Science conference following successful peer-review of the submitted abstracts (annexes 7 & 8). This conference took place at Serena Hotel in Kigali, Rwanda. See report in annex 9. (26th – 29th Mar 2013) Worked with the East Central & Southern Africa Health Community on an EDCTP capacity needs assessment for ethics committees of selected institutions in Uganda (Feb – Mar 2013). Refer to annex 10. EACCR Scientific Liaison Officer attended a scientific meeting in Les Diablerets, Switzerland at the invitation of the TB Vaccine Initiative (TBVI) and the consortium on TB Vaccine Trials in Europe and Africa (TB-TEA), 26th Jan – 1st Feb 2013. Refer to annex 11. Made Advocacy for EACCR in the Afrique one consortium meeting held in NDjamena (29 th Sep – 6th Oct 2012). Refer to annex 12. Submitted research & capacity building proposal to the Tropical Health & Education Trust, UK in partnership with University of Oxford (Sep 2012) Submitted a proposal for a Youth Community HIV/AIDS (YoCHA) program to funders in Netherlands in collaboration with a South African partner (Aug 2012) Submitted a proposal on a point-of-care diagnostic for Malaria in collaboration with a Canadian industrial partner from Alberta to Grand ChallengesCanada (Jul 2012) 1.4 Relevance to EDCTP’s objectives and mission Public health relevance to developing countries and alignment with the priorities of the EDCTP Joint Programme In line with EDCTP’s principle of supporting networks of research centres involved in clinical trials, EACCR facilitates collaboration in Eastern Africa by uniting 35 diverse regional instutions with their distinctive strengths into a network for synergy and complementarity. Its members are learning and developing ‘by doing’ EDCTP Reporting Template for the Regional Networks of Excellence Page 7 of 44 DMS # 72347-V1 how to plan jointly (instead of ‘silo’ planning), manage this initiative by consensus, share and pool limited resources equitably and jointly increase capacity to raise the quality of health research and practice for accelerating development of new or improved tools (vaccines, diagnostics, drugs, microbicides and interventions). This resonates well with the set mission of EDCTP. These expected outcomes are meant to improve the health and social advancement of the Eastern African population. The knock-on impact of EACCR will be feasible once adequate and sustainable capacity (of people, infrastructure, governance, finance, science and technology) has been built to conduct multi-centre clinical trials and other health research under best practices with adequate sample size requirements and networking. By networking in EACCR, meaningful partnerships (south-south, south-north and north-north) are created and strengthened in line with this ideal principle of EDCTP. This creates the enabling environment for handling many more multi-disease clinical trials, which are the heart of EDCTP’s business. The objectives of EACCR mentioned above address the regional challenges of inadequate research infrastructure, limited critical mass of researchers and administrators, fragmentation and duplication of effort, competition for limited unshared resources and poor use of research evidence in policy formulation and programming. EACCR strives to collaborate with similar initiatives e.g through Wellcome Trust (THRiVE consortium, Makerere-UVRI Infection and Immunity program and Afriqueone) at institutional, country and regional level to avoid duplication of efforts, promote synergy and ensure sustainability. In addition, EACCR seeks partnership with national disease control programs, political goodwill and financial support regional governments and the East African Community to address mutual concerns collectively and jointly use research evidence for further interventions and higher-level advocacy. The onus is also upon the EACCR and its stakeholders to channel successful health products developed and evaluated through policy to large-scale implementation supported by strengthened health systems. SECTION B: PROJECT MANAGEMENT Overall summary of progress on the grant during this reporting period (max 300 words) 17 regional leading and 18 sister institutions continue to be active members. Some improvement in communication has been noted from Nsambya hospital, Sudan and Ethiopia. Several active research and capacity building calls were circulated regularly to node coordinators. We handled work plan and budget for revised contract to finalize pending activities after May 2012. Members held regular teleconferences and e-mail discussions of the EACCR implementation committee and node committees to discuss pertinent issues to the Network. EACCR’s coordinator is now a member of the regional steering committee of the East African Community for the annual East African Health, Science & International Exhibition conference. In this conference, EACCR contributed to the review of scientific abstracts, developing the scientific program and to mobilizing conference participants and co-funders. Has there been any change to the management structure since submission of the last report to EDCTP? Yes -Malaria Node Assistant (Ms. Peninna Soipei Menza) from KEMRI-Kilifi in the organogram below, moved to new job. She was replaced by Ms. Esther Kivaya. EDCTP Reporting Template for the Regional Networks of Excellence Page 8 of 44 (12 members) & Secretariat UVRI, EBB, UG Committee (9 members) KCRI, Kilimanjaro, TZ (6 members) KEMRI-Kilifi, Kenya TB Node Committee (6 members) NIMR-Muhimbili, TZ DMS # 72347-V1 4 EACCR Governance Structure EACCR Steering Committee (13 members) Project Implementation Committee (12 members) Chair: PC or DPC HIV Node Committee (12 members) & Secretariat UVRI, EBB, UG Training Node Committee (9 members) KCRI, Kilimanjaro, TZ Malaria Node Committee (6 members) KEMRI-Kilifi, Kenya TB Node Committee (6 members) NIMR-Muhimbili, TZ 4 EDCTP Reporting Template for the Regional Networks of Excellence Page 9 of 44 DMS # 72347-V1 SECTION C: RESEARCH ACTIVITIES Provide an update on the research activities that are supported by this grant. Copy and paste the table below should you wish to add additional trials, studies or sub-studies undertaken by the Network Research activity Includes all laboratory-based, epidemiology/proof-ofconcept/demographic/observational, non-interventional studies and clinical trials Social science study on Health Seeking Behaviour of People on Anti-Retroviral Therapy for at least 3 years in Kenya, Tanzania and Uganda. 2 reports were received from Kenya and Tanzania during this reporting period. Investigators will now write a publication combining the findings from these 3 countries Disease area Start and end dates Study design Phase of Trial (if applicable) Principal Investigator Co-Investigator 1 Co-Investigator 2 Co-investigator 3 HIV June 2010 and May 2013 Qualitative case study household evaluation Not applicable Prof. Janet Seeley (UVRI, Entebbe, Uganda) Mr. Ondeng’e Ken (KEMRI-CDC, Kisumu, Kenya) Mr. Mark Urassa (NIMR, Mwanza, Tanzania Ms. Mary Nyikuri (KEMRI-CDC, Kisumu, Kenya) Sponsor (if applicable) Aim of study To investigate and document the health seeking behavior, for all conditions, of people who have been accessing ART for at least three years to understand more about their adjustment to life with HIV as a chronic condition. This was to compare and contrast findings across the 3 countries with the view of informing the planning in the future. Primary Not Applicable Secondary Not Applicable Main Objectives Target population Sample size Adults on ART for at least 3 years and at least 2 household Target Equal number members they live with and have gender: of males and disclosed their HIV status females for (comparison group) ART patients 20 ART patients per country and 40 household members per country EDCTP Reporting Template for the Regional Networks of Excellence Age range: 18 years and above Page 10 of 44 DMS # 72347-V1 Participating sites Site 1: UVRI, Entebbe, Uganda Site 2: KEMRI-CDC, Kisumu, Kenya Site 3: NIMR, Mwanza, Tanzania Ethics and Regulatory Approval Name of committee approving the protocol: Uganda National Council for Science and Technology (Uganda), Kenya Medical Research Institute (Kenya) and National Institute for Medical Research (Tanzania) Protocol Version Site 4 Site 5 Site 6 Informed consent (Local language) [insert number here] Amendments to protocol [insert number here] Informed Consent (English) [insert number here] [insert date here] [insert date here] [insert date here] [insert date here] Date of approval [DD/MM/YYYY] Trial Insurance Certificates Submit the latest version as supporting documents (if applicable) Not applicable Trial Master File Index Submit a copy of the checklist as supporting documents (if applicable) Not applicable Clinical Trial Registration Name of Registry Trial Registration number Date of registration Investigational Product Controls Product type (drugs/microbicides/etc) Product Name Pharmaceutical Manufacturer/Supplier GMP certificate Investigational Brochure on record Acquision of product Product Name Manufacturer/Supplier GMP certificate Investigational Brochure on record Acquision of product EDCTP Reporting Template for the Regional Networks of Excellence (i.e Pan African Clinical Trials Registry/ Clinical Trials.Gov) [insert number here] [insert date here] Product 1 Not applicable Not applicable [insert number here] Not applicable Product 2 Not applicable Not applicable Not applicable Not applicable [insert date here] [insert date and version here] [insert date here] [insert date and version here] [procured/drug donation] Not applicable Not applicable [insert date here] [insert date and version here] [procured/drug donation] [procured/drug donation] Page 11 of 44 DMS # 72347-V1 Trial status Summary of progress made during the reporting period. Give details of changes in objectives, timelines, setbacks and challenges that have occurred and how these are being addressed Progress updates of clinical trial activities Monitoring plan Data Management Strategy Data sharing Completed field study activities. Data analysis and interpretation of country reports/data is on-going. Refer to annexes 1 and 2. Recruitment status Number of participants screened Number of participants enrolled Number of participants lost to follow up Number of study withdrawals Number of adverse events reported Number of serious adverse events Provide a brief summary of the serious adverse events reported Name of clinical trial monitor Contact details of monitor Internal/External Type of Visits Monitoring format Number of visits Date of last monitoring visit Report available (Yes/No) As per annexed reports 1 and 2. Site 1 Site 2 Site 3 Site 4 (i.e types) Not applicable (i.e pre-trial, mid-trial, termination) i.e Number of CRF’s assessed [10%, 50%, 100%] [submit report as a supporting annex] As per annexed reports 1 and 2. EDCTP Reporting Template for the Regional Networks of Excellence Page 12 of 44 DMS # 72347-V1 SECTION D: CAPACITY DEVELOPMENT Indicate how infrastructure upgrades and purchasing of capital equipment** has improved the capacity (under each section below), to conduct future research for each collaborating site. Annex 2 provides explanation on how levels are classed. Laboratories Malaria laboratory equipment procured, installed and in use Malaria laboratory equipment procured, installed and in use Clinical laboratory equipment procured, installed and in use Malaria laboratory equipment procured, installed and in use Clinical trial facilities Renovated building of health facility for a malaria node sister site Information technology and information sharing facilities Purchased an ICT server for the malaria node sister site EDCTP Reporting Template for the Regional Networks of Excellence *Level at baseline Name of site *Current level Siaya district hospital, Kenya BNNICD, El Gazera, Sudan UVRI clinic, Uganda 2 2 2 2 2 2 Maseno University, Kenya 2 2 *Level at baseline Name of site Taveta district hospital, Kenya Name of site NIMR-Kilosa, Tanzania 2 *Current level 2 *Level at baseline *Current level 2 2 Page 13 of 44 DMS # 72347-V1 Long-term training Please report on the progress made towards the training targets of all long-term trainees within this Network Type of training Target number of trainees Postdoctoral 2 Doctoral 2 Masters 26 *Others Not applicable *Others may include candidates completing Honors, Bachelors degrees or National Diplomas Candidate Name Surname Gender Nationality Project Title Institution where registered Date Registered Envisaged Date of completion Vikram Already communicat ed Already communic ated P Kaleebu, D Pillay, JL Mbisa March 2010 March 2012 Prof (s) Yuka Manabe;R.C olebunders; Luc Kestens Already communicat ed Already communic ated Supervisor Post-Doctoral Student 1 Eugene Kinyanda M Ugandan Student 2 Jonathan Kayondo M Ugandan Clinical trials in HIV/AIDS in Africa: Should they routinely control for mental health factors?’ (Uganda, 20112103) Evolution of HIV-1 ARV drug resistance mutations in the ART naïve during therapy; threshold frequency levels and linkage context associated with treatment failure in Uganda’ (Uganda, 2010-2012) London School of Hygiene and Tropical Medicine Health Protection Agency-UK and UVRI/MRC Doctoral Student 1 William Worodria M Ugandan EDCTP Reporting Template for the Regional Networks of Excellence Short and long term clinical and immunological outcomes of patients with HIV/TB coinfections on ART’ (Uganda, 2011-2013). University of Antwerp, Belgium and Makerere University Page 14 of 44 DMS # 72347-V1 Student 2 Pauline Byakika F Ugandan Comparison of efficacy, safety and pharmacokinetics of intravenous artesunate and intravenous quinine followed by oral artemisinin combination therapy for severe malaria treatment in Uganda and evaluation of pharmacokinetic drug interactions of artesunate, quinine, lumefantrine and piperaquine with antiretroviral drugs’ (Uganda, 2011-2013) University of Liverpool M Kamya, E Katabira, D Black, C Merry, S Khoo Student 1 Thomas Mwinyiheri M Tanzanian Modelling TB transmissions in zoonotic areas of Arusha and Manyara regions. University of Dar es Salaam Dr N.Shaban, Bsc, PhD & Dr S. G. Mfinanga, MD, PhD & Dr. S. D. HoreMusekwa, BSc, PhD Student 2 Charles E. Makasi M Tanzanian To be communicated University of London International Programmes/Lond on Shool of Hygiene and Tropical Medicine/Stewart March 2011 March 2013 Masters EDCTP Reporting Template for the Regional Networks of Excellence Oct-10 Oct-12 Oct-10 Oct-13 Page 15 of 44 DMS # 72347-V1 Others Student 3 Stella Zawedde Muyanja F Ugandan Student 4 Seith Chekata Inzaule M Tanzanian Student 5 Charles Kabugo M Ugandan Student 6 Patrick Kazooba M Ugandan Student 7 Juma Magambo M Tanzanian Student 8 Shimma Ahmed M Sudanese Student 9 Aman Elbadawi M Sudanese EDCTP Reporting Template for the Regional Networks of Excellence Assessing the impact of Integration of HIV and TB services on TB Case finding and Treatment in rural health centers in Uganda Combined antiretroviral treatment switch and discontinuation among HIV infected patients in new Nyanza general provincial hospital, western Kenya Incidence and factors associated with TB iris is patients attending the HIV clinic in Masaka hospital. Predictors of virological failure among HIV-infected patients on first-line antiretroviral therapy in a rural cohort of South Western Uganda Envelope Sequence Diversity and the Development of broadly neutralizing Antibodies in Chronically Human Immunodeficiency Virus Type 1 Infected Individuals from Rural Uganda Evaluation of new cloned MTB antigens and identification of immunodiagnostic markers of pulmonary TB Molecular mapping of drug Makerere College of Health Sciences Ass Prof. David Guwatude Makerere College of Health Sciences Dr.Archilles Katamba Makerere College of Health Sciences Dr.Archilles Katamba LSHTM, UK and MRC Research Unit Anne Tholen, Jonathan Levin Makerere University Aug 2010 Aug 2013 Aug-10 Aug-12 Aug-10 Sep 2011 Aug-12 To be communic ated Aug-10 Aug-12 Oct-10 Oct-12 Oct-10 Oct-12 Prof. George W. Lubega University of Khartoum Prof. Mukhtar Maowia University of Dr. Osama Page 16 of 44 DMS # 72347-V1 Student 10 Student 11 Daveline Pauline Nyakundi Akoo M Kenyan F Kenyan Student 12 Philemon Tenu M Tanzanian Magogo M Tanzanian Student 13 Frank Student 14 Rajabu Rija M Tanzanian Student 15 Tolbert Sonda M Tanzanian Student 16 Jane Rogathi F Tanzanian M Tanzanian Student 17 Richard Kinyaha EDCTP Reporting Template for the Regional Networks of Excellence resistance pattern of Mycobacterium TB 1 Gadaref state, eastern Sudan To be communicated Immunization among Immunocompromised groups Mathematical modeling of age-specific mortality rates to estimate HIV prevalence in adults using demographic surveillance data in Kisesa, Mwanza Evaluation of cheap and locally available attractants as baits in outdoor adult mosquito control devices. Factors associated with Anamia analysis of data on three different measurement tools in pregnant women and children under 5yrs. Morbidity and mortality trends in people living with HIV/AIDs attending Kilimanjaro Christian medical centre from 2005-2010 Association between nutrition and childhood epilepsy in Hai District, Kilimanjaro Region, Tanzania. Retrospective cohort study on drug susceptibility test on second line anti tuberculosis Khartoum sharief LSHTM, UK To be communicat ed To be communicat ed Walden University Kilimanjaro Christian Medical University College (KCMU Co) Kilimanjaro Christian Medical University College (KCMU Co) Kilimanjaro Christian Medical University College (KCMU Co) Kilimanjaro Christian Medical University College (KCMU Co) Kilimanjaro Christian Medical University College (KCMU Co) Kilimanjaro Christian Medical University College Oct-10 Aug-10 Oct-13 Aug 13 Jim Todd, MSc, PhD Oct-10 Oct-12 Dr. Robert Malima Oct-10 Oct-12 Oct-10 Oct-12 Oct-10 Oct-12 Oct-10 Oct-12 Oct-10 Oct-12 Jim Todd, MSc, PhD Jim Todd, MSc, PhD & Charles Mtabho, MD, MPH Jim Todd, MSc, PhD & Kathryn Burton, MD, MMED Prof. G. Kibiki, MD, MMED, PhD Page 17 of 44 DMS # 72347-V1 Student 18 Elizabeth Kussaga F Tanzanian Lydia Nabacwa F Ugandan drugs for multi drug resistance tuberculosis patients treated cases. Assessment of factors influencing individuals’ participation in field based research. Student 19 Sariko F Tanzanian To be communicated Molecular assessment of Pfmdr 1 gene mutation after the introduction of Artemesin-based combination therapy in Tanzania To determine the rate of decline MTB bacillary load in the first 14 days of treatment in newly diagnosed TB patient on HRZE in Kilimanjaro region. Befekadu Debebe F Ethiopian To be communicated Student 20 Petro Paulo M Tanzanian Student 21 Margaretha L. Student 22 Demissie (KCMU Co) Kilimanjaro Christian Medical University College (KCMU Co) University of Liverpool, United Kingdom Kilimanjaro Christian Medical University College (KCMU Co) Kilimanjaro Christian Medical University College (KCMU Co) Kilimanjaro Christian Medical University College (KCMU Co) Student 23 James Ngocho M Moses Ngari M Tanzanian To be communicated Kilimanjaro Christian Medical University College Effect of Rickets on child survival in Kenya. University of London Student 24 Kenyan EDCTP Reporting Template for the Regional Networks of Excellence & Dr. Stella Mpagama, MD, MSc. Dr. Hugh Reyburn, MMED(pead. ) PhD Oct-10 Oct-11 Dec-11 Sep-13 Dr. R. Kavishe, PhD Oct-11 Oct-13 Prof. F. Mosha, PhD Oct-11 Oct-13 September 2012 Sep-13 September 2012 Sep-13 Aug-11 Aug-13 Prof. G. Kibiki, MD, MMED, PhD; Dr Bernard Ngowi (MD,PhD) Dr James Berkley & Greg Fegan (Kenya), Simon Collin (UK). Page 18 of 44 DMS # 72347-V1 Student 25 Student 26 Ravelyne Opar F Kenyan None Deborah Mogaka F Kenyan Regulatory affairs with biomedical devices (MSc) University of Liverpool, U.K North Eastern University, Boston (USA) None Oct-2011 Jun-2013 Prof Brad Hossack Apr-2011 Sept.2012 Please insert additional rows as required EDCTP Reporting Template for the Regional Networks of Excellence Page 19 of 44 DMS # 72347-V1 Long-term trainees: Retention of Built Capacity For those candidates who have completed or are approaching completion of their respective long-term training, please state their future plans (i.e plans to integrate into current Network, further studies, application for Senior Fellowship, will be leaving the NoE, seeking employment etc) Surname Training (i.e. MSc, PhD) Mwinyiheri MSc. Employed permanently by the NIMR-Muhimbili Chekata Inzaule MSc. To be communicated Charles Kabugo MSc. To be communicated Student 8 Shimma Ahmed MSc. Employed by IEND Sudan Student 9 Aman Elbadawi MSc. Employed by IEND Sudan Student 10 Daveline Nyakundi MSc. Student 11 Pauline Candidate Name Student 1 Thomas Student 4 Seith Student 5 Student 12 Student 13 Student 14 Student 15 Philemon Frank Aoko MPH Tenu Magogo Rajabu Rija Tolbert Sonda Student 17 Jane Rogathi Student 18 Richard Kinyaha Student 19 Elizabeth Kussaga EDCTP Reporting Template for the Regional Networks of Excellence Plans once degree has been completed Completed in June 2013. Now working with a contract research organization (PPD) as a clinical research Associate Hopes to proceed to PhD program if funding becomes available MSc. Back to employer (NIMR), Continued to PhD programme MSc. Integrated into current Network MSc. Integrated into current Network MSc. Back to employer (KCRI), continued to PhD programme MSc. Integrated into current Network MSc. Integrated into current Network MSc. Employed by KCRI Page 20 of 44 DMS # 72347-V1 Student 21 Petro Paulo Student 22 Margaretha L. Sariko Student 24 Moses Student 25 Student 26 MSc. Integrated into current Network Ngari MSc. MSc statistics Integrated into current Network Hopes to proceed to PhD program if funding is available Ravelyn Opar MPH. To be communicated Deborah Mogaka MSc in regulatory affairs with biomedical devices No additional funds to support her position. She is in the process of leaving KEMRIKilifi to look for other job openings elsewhere Please insert additional rows as required EDCTP Reporting Template for the Regional Networks of Excellence Page 21 of 44 DMS # 72347-V1 Short-term training [eg Short courses in GCP, HSRP, GCLP, IATA etc] Name of training Reciprocal Scheme follow-up workshop on Clinical Trial Monitoring Dates of training 30th - 31st May 2012 Venue Lenana conference centre, Nairobi Agency providing training Duration of training Number of participants Global Health Network in partnership with World-Wide Antimalarial Resistance Network 2 days 22 pooled regional monitors Name of Trainee WANZE Surname Gender KOHI Nationality Position held Institutional Affiliation (site name) M TANZANIAN Clinical trial monitor NIMR, Muhimbili BEATRICE MUTAYOBA F TANZANIAN Clinical trial monitor NIMR, Muhimbili GODFATHER KIMARO M TANZANIAN Clinical trial monitor NIMR, Muhimbili JEREMIAH KIDOLA M TANZANIAN Clinical trial monitor NIMR, Mwanza GEORGE PRAYGON M TANZANIAN Clinical trial monitor NIMR, Mwanza ELIZABETH AYUO F KENYAN Clinical trial monitor KEMRI-CDC PENINNA SOIPEI F KENYAN Clinical trial monitor KEMRI-KILIFI JOHNSTONE THITIRI M KENYAN Clinical trial monitor KEMRI-KILIFI STACEY GONDI M KENYAN Clinical trial monitor KEMRI-WRP JACQUELINE NYANGE F KENYAN Clinical trial monitor KAVI JENIFFER KIGERA F KENYAN Clinical trial monitor KAVI PHILIP NALUANDE M UGANDAN Clinical trial monitor UVRI, Uganda ANNET NANVUBYA F UGANDAN Clinical trial monitor UVRI, Uganda NAMPIJJA PROSSY F UGANDAN Clinical trial monitor UVRI, Uganda MIRRIAM AKELLO F UGANDAN Clinical trial monitor UVRI/MRC, Uganda SARAH NANZIGU F UGANDAN Clinical trial monitor Makerere University EDCTP Reporting Template for the Regional Networks of Excellence Page 22 of 44 DMS # 72347-V1 NAKUYA MARGARET F UGANDAN Clinical trial monitor Makerere University ZEWDU HURISA DADI M ETHIOPIAN Clinical trial monitor AHRI DAVELINE NYAKUNDI F KENYAN Clinical trial monitor PPD MUZAMIL MAHDI F SUDANESE Clinical trial monitor Qassr Univ, Khartoum VICTORINE OWIRA F KENYAN Clinical trial monitor KEMRI/WRP HYRINE MATHEKA F KENYAN Clinical trial monitor KEMRI-CDC Please provide a few examples of how this training has enhanced capacity within this network This follow-up training strengthened sharing of best practices and tools in monitoring clinical trials in Eastern Africa while enabling on-going mentoring of junior/new monitors in cross-site/cross-study monitoring plus south-south and south-north networking among colleagues. There will be cost-saving instead of always depending on hired clinical research organizations while improving quality of trials/studies conducted and gradually increasing on the number of clinical monitors in the region over time. Refer to details of this workshop in annex 13. Workshops [i.e Data Management; Grant writing, Laboratory techniques, Project Management] Name of workshop Date of training Venue Name of agency conducting workshop Duration of training Number of participants Name of Trainee Surname GCP and GCLP 27th to 31st August 2012 NIMR CEEMI Conference hall Kenya AIDS Vaccine Initiative (KAVI)/University of Nairobi in Collaboration with NIMR Muhimbili for EACCR, TAMOVAC, NIH Project and REMSTART trial network. 5 days 33 (Refer to group photograph in annex 14) Tanzanian Principal Investigator, TAMOVAC Trial Study Investigator TAMOVAC Trial Institutional Affiliation (site name) Muhimbili University of Health and Allied Sciences (MUHAS) MUHAS M Tanzanian Study Investigator TAMOVAC Trial MUHAS F Tanzanian TAMOVAC Trial Staff MUHAS Tanzanian TAMOVAC Trial Staff MUHAS Gender Nationality Mohamed Bakari M Tanzanian Mohamed Janabi M Eric Aris Mary Ngatolwa Dorothea Niima F EDCTP Reporting Template for the Regional Networks of Excellence Position held Page 23 of 44 DMS # 72347-V1 Arafa Khamis F Tanzanian TAMOVAC Trial Staff MUHAS Dilly Magdalena Hassan Lyimo F F Tanzanian Tanzanian TAMOVAC Trial Staff MUHAS Sabrina Mugusi F Tanzanian TAMOVAC Trial Staff TAMOVAC Trial Staff MUHAS MUHAS Emmanuel Kapesa M Tanzanian TAMOVAC Trial Staff MUHAS Triphonia Tesha F Tanzanian TAMOVAC Trial Staff MUHAS MUHAS Grace Mbura F Tanzanian TAMOVAC Trial Staff Grace Maghembe F Tanzanian TAMOVAC Trial Staff MUHAS Abdallah Ally M Tanzanian TAMOVAC Trial Staff MUHAS Maijo Biseko M Tanzanian REMSTART Trial Staff NIMR Muhimbili Edwin Chitaje M Tanzanian REMSTART Trial Staff NIMR Muhimbili Mbaazi Senkoro M Tanzanian REMSTART Trial Staff NIMR Muhimbili Bernard Poyo M Tanzanian TB Staff NIH Iringa Study Iringa Regional Hospital Desderia Nyakunga F Tanzanian TB Staff NIH Iringa Study Iringa Regional Hospital Iringa Regional Hospital Onolina Msisi F Tanzanian TB Staff NIH Iringa Study Paulina Lumao F Tanzanian TB Staff NIH Iringa Study Iringa Regional Hospital Flora Changamke F Tanzanian TB Staff NIH Iringa Study Iringa Regional Hospital Joachim Mgimba M Tanzanian TB Staff NIH Iringa Study Iringa Regional Hospital Fred Mhalu M Tanzanian TB Staff NIH Iringa Study Iringa Regional Hospital Zena Babu F Tanzanian TB Staff NIH Iringa Study Iringa Regional Hospital Fenella Msangi F Tanzanian TB Staff NIH Iringa Study Iringa Regional Hospital Muhidin Salehe M Tanzanian TB Staff NIH Iringa Study Iringa Regional Hospital Iringa Regional Hospital Monica Matovu F Tanzanian TB Staff NIH Iringa Study Geneveva Lualilo F Tanzanian TB Staff NIH Iringa Study Iringa Regional Hospital Jengela Peter M Tanzanian TB Staff NIH Iringa Study Iringa Regional Hospital Paul Mjelwa M Tanzanian TB Staff NIH Iringa Study Iringa Regional Hospital Peter Muhanga M Tanzanian TB Staff NIH Iringa Study Iringa Regional Hospital Daudi Mtuya M Tanzanian TB Staff NIH Iringa Study Iringa Regional Hospital EDCTP Reporting Template for the Regional Networks of Excellence Page 24 of 44 DMS # 72347-V1 Please provide a few examples of how this training has enhanced capacity within this network This training improved the skills of the participants to conduct a GCP and GCLP compliant trials since most of the participants are from different trials going on in Tanzania Name of training Skill-sharing workshop on best practices for conducting regional clinical trials in a resource-limited setting Dates of training 14th February 2013 Venue Sanctum Hotel, Entebbe, Uganda Agency providing training Global Health Network in partnership with UVRI Duration of training 1 day Number of participants 51 Participants First name Surname Gender Nationality Position held Institutional Affiliation (site name) Refer to annexes 15 and 16 with list of participants and group photograph Please provide a few examples of how this training has enhanced capacity within this network Shared lessons learned and recommended skills/approaches for promoting and supporting conduct of clinical trials in resource-limited settings. See annex 17 for detailed report. EDCTP Reporting Template for the Regional Networks of Excellence Page 25 of 44 DMS # 72347-V1 Network-linked Senior Fellowship Projects Does this network have links or host recipients of EDCTP-funded Senior Fellowship Training Award scheme? If yes, please provide further details Candidate Name and title Surname EDCTP project code Research Study or clinical trial See info already given above Gender Nationality Kinyanda Male Ugandan To be communicated Dr. Jonathan Kayondo Male Ugandan T4.2009.40200. See info already given above ByakikaKibwika Female Ugandan TA.09.40200.020 Dr. Pauline See info already given above Worodria Male Ugandan To be communicated See info already given above Dr. Eugene Dr. William EDCTP Reporting Template for the Regional Networks of Excellence How is the Senior Fellowship project linked with NOE? Through research attachment; patient management; subject recruitment at the MRC/UVRI Unit; academic attachment at Makerere University (EACCR leading institutions) Through laboratory research attachment; subject recruitment at the MRC/UVRI Unit and UVRI; academic attachment at Makerere University (EACCR leading institutions) Through mentoring; patient management; subject recruitment; personal academic attachment at IDI/Makerere University (EACCR leading institution) Through research attachment; patient management; subject recruitment; academic attachment at Makerere University (EACCR leading institutions) Contribution of Senior Fellow to NoE activities/objectives Mental health and HIV research publications; quality mental health service offered to patients; mentoring junior colleagues; providing expected research leadership HIV basic research publications; establishment of molecular laboratory and bioinformatics; mentoring junior colleagues; providing expected research leadership; contributions to EACCR implementation committee Malaria research publications; quality health service offered to patients; mentoring junior colleagues; providing expected research leadership TB research publications; quality medical care services offered to patients; mentoring junior colleagues; providing expected research leadership Page 26 of 44 DMS # 72347-V1 For the senior fellows above, please state plans to integrate them into the Network of Excellence with the aim of retaining built capacity ie. Lead research teams, formation of new research teams/units, supervision of longterm trainees etc. Name of Senior Fellow Future plans within Network of Excellence (as part of staff retention strategy) Dr. Eugene Kinyanda Has already secured a new MRC African Research Leadership award of 5 years for leading a research program, overseeing its execution to completion and mentoring junior colleagues within EACCR Has already secured another research grant for strengthening capabilities in genome-wide association studies, molecular biology and bio-informatics through H3 Africa. He is also mentoring junior colleagues at Makerere University and UVRI. Has been promoted to a position of associate professor at Makerere College of Health Sciences where she will continue to build a research team, mentor junior colleagues, conduct more research and provide high quality medical care to both patients and research volunteers Has taken on more TB research at Makerere College of Health Sciences where he will continue to build a research team, mentor junior colleagues, provide better health care to patients and is now eligible to pursuit a post-doctoral research program Dr. Jonathan Kayondo Dr. Pauline Byakika-Kibwika Dr.William Worodria Research Staff, training and capacity development Summary of numbers of staff employed on the grant Staff category Senior staff: Senior Fellows/Professors/Senior Clinicians or equivalent Mid-career staff: Intermediate level fellows (> years postdoctoral experience)/clinicians/ lecturers or equivalent Site 1-UVRI Full-time Part-time Male Female Male Female 2 1 Site 2-KCMC/KCRI Full-time Part-time Male Female Male Female 3 1 Doctoral and Masters students Graduate researchers Laboratory (Managers, technicians, assistants) Nurses and Fieldworkers EDCTP Reporting Template for the Regional Networks of Excellence Page 27 of 44 DMS # 72347-V1 Pharmacists Data (Managers, IT officers and assistants) 2 1 2 Administrative staff 1 Quality Control (Managers, officers) 1 1 Finance staff 1 Others (ancillary i.e drivers, general assistants etc) Total Staff category Senior staff: Senior Fellows/Professors/Senior Clinicians or equivalent Mid-career staff: Intermediate level fellows (> years postdoctoral experience)/clinicians/ lecturers or equivalent 4 1 1 4 2 Site 3-KEMRI WT Full-time Part-time Male Female Male Female 1 5 1 Site 4-NIMR Dar es saalam Full-time Part-time Male Female Male Female 1 1 1 Doctoral and Masters students Graduate researchers Laboratory (Managers, technicians, assistants) Nurses and Fieldworkers Pharmacists 1 Data (Managers, IT officers and assistants) 1 1 Administrative staff EDCTP Reporting Template for the Regional Networks of Excellence Page 28 of 44 DMS # 72347-V1 Quality Control (Managers, officers) 1 1 1 Finance staff 2 Others (ancillary i.e drivers, general assistants etc) Total 4 1 1 2 3 3 Please add columns for additional sites How has the grant contributed to the professional development of ALL staff employed on the project? Highlight any individuals who have progressed in their careers or have been promoted. Several short courses in grant writing, grant management and financial management have been conducted in partnership with EDCTP, other funders and regional collaborators for both scientists and research administrators as part of their continuing professional development in order to improve personal growth plus efficiency and effectiveness during implementation of existing and new grants. The acquired knowledge has been applied through learning by doing. Opportunities have been opened for consultation of colleagues within and across institutions plus countries and sharing best practices. Similarly, training in GCP and GCLP courses, clinical trial monitoring, scientific writing, epidemiology and data management was conducted for the project staff as per reports provided. The same has been done for disease-specific and laboratory training.One of success stories is the promotion of Dr. Pauline ByakikaKibwika to the position of associate professor at Makerere University. Ms. Esther Kivaya, who is assistant coordinator of the malaria node, also progressed to become a lead trial monitor at KEMRI-Kilifi after gaining massive experience in monitoring, training in GCP and monitoring. EDCTP Reporting Template for the Regional Networks of Excellence Page 29 of 44 DMS # 72347-V1 SECTION E: RESEARCH OUTPUT Please list the research outputs from this research grant during the current reporting period. You may include ‘in press or published material’ How many accepted (in press or published) peer-reviewed publications (research papers or books) have been produced during this reporting period as a result of this grant? Detail each publication in the following order: Author(s); Article Title; Journal Name; Year; Volume; Issue Number; Page Numbers, and confirm that EDCTP funding has been acknowledged in all publications. Please include copies of research papers as supporting annexes. Several publications have been generated from EACCR through other co-funding mechanisms closely linked to it although such information is yet to be collated comprehensively in such a short time. Some selected publications are outlined below: 1. Byakika-Kibwika, P., Lamorde, M., Mayito, J., Nabukeera, L., Namakula, R., Mayanja-Kizza, H. et al. (2012a). Significant pharmacokinetic interactions between artemether/lumefantrine and efavirenz or nevirapine in HIV-infected Ugandan adults.. J Antimicrob Chemother, 67(9), 2213-21. 2. Byakika-Kibwika, P., Lamorde, M., Mayito, J., Nabukeera, L., Mayanja-Kizza, H., Katabira, E. et al. (2012b). Pharmacokinetics and pharmacodynamics of intravenous artesunate during severe malaria treatment in Ugandan adults.. Malar J., 11(132). 3. Lamorde, M., Byakika-Kibwika, P., Tamale, W., Kiweewa, F., Ryan, M., Amara, A. et al. (2012). Effect of Food on the Steady-State Pharmacokinetics of Tenofovir and Emtricitabine plus Efavirenz in Ugandan Adults.. AIDS Res Treat., 2012(105980). 4. Lamorde, M., Byakika-Kibwika, P. & Merry, C. (2012). Pharmacokinetic interactions between antiretroviral drugs and herbal medicines. Br J Hosp Med (Lond), 73(3), 132 - 136. 5. Davis Kibirige*, Richard Ssekitoleko, Edrisa Mutebi and William Worodria. Overt diabetes mellitus among newly diagnosed Ugandan tuberculosis patients: a cross sectional study. BMC Infectious Diseases 2013, 13:122 6. Davis Kibirige, Edrisa Mutebi, Richard Ssekitoleko, William Worodria, and Harriet Mayanja-Kizza. Vitamin D deficiency among adult patients with tuberculosis: a cross sectional study from a national referral hospital in Uganda. BMC Res Notes. 2013; 6: 293. 7. Catherine Abbo, Eugene Kinyanda, Ruth B Kizza, Jonathan Levin, Sheilla Ndyanabangi, Dan J Stein. Prevalence, comorbidity and predictors of anxiety disorders in children and adolescents in rural north-eastern Uganda. Child and Adolescent Psychiatry and Mental Health 07/2013; 7(1):21. 8. Eugene Kinyanda et al. Prevalence and risk factors of depression in childhood and adolescence as seen in 4 districts of north-eastern Uganda BMC Int Health Hum Rights 13:19. 2013. 9. E Kinyanda. Psychiatric disorders and psychosocial correlates of high HIV risk sexual behaviour in war-affected Eastern Uganda. AIDS Care 24:1323-32. 2012 10. Deogratius Ssemwanga, Anne Kapaata, Frederick Lyagoba, Brian Magambo, Maria Nanyonjo, Billy N. Mayanja, Chris M. Parry, and Pontiano Kaleebu. AIDS Research and Human Retroviruses. December 2012, 28(12): 1784-1787. doi:10.1089/aid.2012.0090. 11. Seeley, Janet PhD*,†,‡; Nakiyingi-Miiro, Jessica PhD*,‡; Kamali, Anatoli MSc*,§; Mpendo, Juliet MPH¶; Asiki, Gershim MSc*; Abaasa, Andrew MSc*; De Bont, Jan PhD‖; Nielsen, Leslie RN‖; Kaleebu, Pontiano PhD*,‡,§ High HIV Incidence and Socio-Behavioral Risk Patterns in Fishing Communities on the Shores of Lake Victoria, Uganda. Sexually Transmitted Diseases: June 2012 - Volume 39 - Issue 6 - p 433–439. doi: 10.1097/OLQ.0b013e318251555d 12. David Cooper; Fiona Ewings; Sarah Fidler; Martin Fisher; John Frater; Michelle Gabriel; Pontiano Kaleebu; Steve Kaye; Anthony Kelleher; Sabine Kinloch; Myra McClure; Jose M Miro; Rodney Phillips; Kholoud Porter; Gita Ramjee; Helen Rees; Mauro Schechter; Giuseppe Tambussi; Jonathan Weber; Abdel Babiker. Short-course antiretroviral therapy in primary HIV infection. The New England journal of medicine 2013;368(3):207-17. 13. George M Miiro; Francine Ntoumi; Alexander Pym; Maerangis Rahmani; Ousmane Sarr; Odile Ouwe Missi Oukem-Boyer; Keertan Dheda; Souleymane MBoup; Pontiano Kaleebu. EDCTP regional networks of excellence: initial merits for planned clinical trials in Africa. BMC public health 2013;13():258. Refer to annex 3. EDCTP Reporting Template for the Regional Networks of Excellence Page 30 of 44 DMS # 72347-V1 Please provide details of any other publications resulting from this work Please confirm that that EDCTP support has been acknowledged on each publication. Yes, We confirm that EDCTP support was acknowledged in each publication. Conference and academic workshop presentation Give details of oral presentations and posters of this work, confirming that EDCTP has been acknowledged September 28th 2012. Dr Mfinanga gave a brief talk about EDCTP in the annual Afrique one conference in Ndjamena Tchad. He discussed his experience in networking with other consortia in Africa. See annex 12.Two EACCR members gave oral presentations at the 4th annual East African Health and Science conference following successful peer-review of the submitted abstracts (annexes 7 & 8). This conference took place at Serena Hotel in Kigali, Rwanda. See report in annex 9. Dr. George Miiro attended a scientific meeting in Les Diablerets, Switzerland at the invitation of the TB Vaccine Initiative (TBVI) and the consortium on TB Vaccine Trials in Europe and Africa (TB-TEA) as indicated annex 5. EDCTP support was acknowledged in these presentations. Give details of presentations to non-academic audiences This includes feedback activities to research participants and related communities, meetings with policy makers or health care professionals, media coverage or other related activity Not applicable Give details of any research resources or intellectual property resulting from this grant This includes websites, software or database development, patents, product licenses or other related activity EACCR interactive website (www.eaccr.org) with 12 electronic research modules are freely accessible online to interested scientists globally. EDCTP Reporting Template for the Regional Networks of Excellence Page 31 of 44 DMS # 72347-V1 SECTION F: NETWORKING New collaborations/partnerships Please provide an update on any new collaborations/partnerships forged during this reporting period Site Lusaka Zambia Maputo Mozambique University of Oxford, UK Collaborator/Partner University Teaching Hospital (UTH) and NIMR-Muhimbili node are running a trial known as the Reduction of Early Mortality among HIV patients Starting ART (REMSTART), an EDCTP funded project Centro de Investigação e Treino em Saúde da Polana Caniço (CISPOC): Supporting a project on HIV vaccine trials known as TAMOVAC 2 (EDCTP-funded project). This is in collaboration with other Tanzanian institutions such as MUHAS and NIMR-Mbeya Medical Research Program and University of Munich Germany and Karolinska Institute Sweden Global Health Network: conducted a one day workshop on best approaches and practices for handling Clinical trials in Dar es Salaam on the 12th July 2012 and in Entebbe on the 14th February 2013 EDCTP Reporting Template for the Regional Networks of Excellence Aims of the Partnership To jointly strengthen capacity in conducting multi-centre HIV clinical trials in Sub Saharan Africa To improve south-south networking with TESA site and north-north networking in doing clinical trials in Eastern and Southern Africa To improve sharing of best practices/skills in doing high quality clinical trials in Eastern Africa Page 32 of 44 DMS # 72347-V1 Exchange/Mentorship Schemes Please provide an update of any exchange and mentorship schemes developed at an inter or intra-network level Participant name Maliwaza Maganga Mariamu Abdallah Sites involved Mwananyamala hospital (sister site) to the leading NIMR Cytotoxic Reference Laboratory (CTRL) Mwananyamala hospital (sister site) to the leading NIMR Cytotoxic Reference Laboratory (CTRL) Outcome of exchange Completed mentorship attachment in TB laboratory techniques, Completed mentorship attachment in TB laboratory techniques, Network Communication Plan Please provide an update of communication at the levels indicated below Communication Level Update National Node coordinators update national policy makers regularly (at least annually) about progress, lessons learnt, challenges encountered, opportunities and prospects related to the EACCR activities Through quarterly teleconferences or skype calls within the nodes, network and other NoEs such as CANTAM, TESA and WANETAM. Complemented with e-mail discussions and EACCR website updates Local authorities for example at Mwananyamala hospital, Kyela hospital (both in Tanzania), El Gazera (in Sudan), Kilifi (Kenya) and UVRI (Uganda) have been updated regularly about the progress on infrastructural upgrades in their institutions Not applicable yet for this reporting period NIMR-Muhimbili communicated with a northern partner Germany University of Munich and Glasgow University Scotland about developing a Joint TB proposal. EACCR also participated in several international conferences/meetings already mentioned above. In addition, EACCR has jointly organized with TESA to have a joint review and planning meeting of stakeholders in Johannesburg in preparation for EDCTP 2. Regional Local authorities Local community International EDCTP Reporting Template for the Regional Networks of Excellence Page 33 of 44 DMS # 72347-V1 SECTION G: IMPACT OF NETWORK List other EDCTP-funded projects that are contributing or benefiting from Network of Excellence capacity Project title Project coordinator EDCTP project code TAMOVaC project Dr Sayoki Mfinanga To be communicated REMSTART trial: Reduction of Early Mortality among HIV-infected subjects starting antiretroviral therapy: a randomised trial in Tanzania Dr Said Egwaga (Assisted by Dr. Sayoki Mfinanga) IP.2009.33011.003 STAR-study at UVRI-IAVI Dr. Noah Kiwanuka To be communicated Contribution Shared Data unit and back-up IT server at NIMRMuhimbili Web-based data management at NIMR-Muhimbili plus networking with TESA sites Internal reciprocal monitoring implemented in site Benefit Project staff regularly trained and equipped with skills in data management and GCP and GCLP GCP/GCLP-adherence strengthened by trained staff through EACCRsponsored short course Strategic quality management and crosssite networking enhanced SECTION H: INTER-NETWORK ACTIVITIES Have there been any activities that involved participation/collaboration with any of the other Networks of Excellence? If yes please state the name and provide brief details on the collaboration and state the outcomes, including all joint-publications Two more students are doing their PhD program at the University of Bergen in Collaboration with the NIMR Muhimbili. This is an example showing one of the outcomes of networking between the TB node of EACCR and the Afrique One consortium funded through Wellcome Trust. The students are sharing the laboratory facility upgraded at NIMR MUhimbili through EACCR and are co-supervised by University of Bergen and NIMR Muhimbili (EACCR’s collaborators). Wellcome Trust is funding their PhD program TB node strengthened networking by interacting with TESA sites through the TAMOVAC trial, NIH TB diagnostic project and REMSTART trial in aspects of training, web-based data management and sharing information Cunducted a collaborative TB trial (TB-HAART) between TB node and TESA through NIMR Muhimbili Dar es Salaam, Tanzania and University Teaching Hospital. Lusaka, Zambia, MRC South Africa Conducting coordinated web-base data management between EACCR and TESA through NIMR Muhimbili Dar es Salaam, Tanzania and University Teaching Hospital. Lusaka, Zambia A new MSc course in epidemiology at KCMC/KCRI and 3 EACCR-sponsored MSc students were co-funded in partnership with the Wellcome Trustfunded THRiVE consortium The Global Health Network, WWARN and EACCR joint supported the: generation of 12 e-learning research modules; comparison of 2 In-house clinical trial monitoring schemes in Eastern Africa and South East Asia through a qualitative study and 2 workshops in Nairobi, later half of May 2012 on the potential strategies against the threat drug resistance to anti-malarial treatment and on clinical trial monitoring EACCR and TESA have jointly organized a review and planning meeting in Johannesburg to engage their stakeholders to prepare adequately for EDCTP 2. EDCTP Reporting Template for the Regional Networks of Excellence Page 34 of 44 DMS # 72347-V1 CANTAM and EACCR have continued to share experiences and lessons learnt during project implementation. Jointly published a peer-review paper on the Regional Networks of Excellence by involving all colleagues from all the 4 NoEs SECTION I: QUALITY ASSURANCE List the internal and external measures that are currently in place to assess and maintain strict quality standards in all network activities EACCR Secretariat Regular Node and implementation committe meeting have been conducted to assess progress of activities and also to handle pertinent issues that may arise during implementation of activities. Minutes are made and circulted to all Nodes and members of the implemenatation committee for information and comments. A governance structure, terms of reference and communication plan were developed and agreed upon by the three disease nodes (Malaria, TB, & HIV) to guide operations. Navision software was installed and is used by a trained grants finance officer at UVRI to manage funds of this and other grants. Items only approved by the accounting officers using a memo are entered in the templates by the grants officer. Items to be procured are sent to procurement committee for approval of firms to supply any item or reagent or equipment by the committee and these are minuted and copies of minutes attached on the requests. Terms of reference for consultants and contract agreements are agreed upon by both parties for procurement of services or works. EACCR trained clinical trial monitors to strengthen quality of conducted trials through cross-site/cross-study monitoring visits. These monitors have been invited by the study PIs and CO-PIs to monitor on-going studies. Regular reports (technical and financial) reports have been submitted as required by EDCTP. There has been shared input from all nodes into these reports with consensus secured. Then, the overall project coordinator, node coordinators and grants finance officer sign the reports as required by EDCTP. NIMR-Muhimbili Currently, There is a system of finance control whereby internal auditing is done by internal auditors from the headquarter of NIMR and external auditing by auditors from the Government Controller and Auditor General’s (CAG) office. Laboratory external quality assurance is handled by the supranational quality assurance scheme from the University of Antwerp, Belgium. KCMC/KCRI INTERNAL Internal financial audit system is in place EXTERNAL External financial audit is planned LABORATORY EDCTP Reporting Template for the Regional Networks of Excellence Page 35 of 44 DMS # 72347-V1 National Health Laboratory Service ,-South Africa for Laboratory External Quality Assurance UK – NEQAS, American college of pathologist accreditation also handle external quality assurance SECTION J: FUNDING List any new funding that was secured during this reporting period Name of Co-funding Agency Funding [cash/in-kind] Amount* Cash Canadian Global Health Research Initiative $ 25, 000 Activities funded School-based adolescent project with in-built operational research on HIV/STI prevention (Annex 21) Co-funding letter attached (y/n) Yes ICT upgrades for the Malaria Node sister Yes (a request and sites(Air conditioner,, upgrade of the Local signed invoices Area Network with cables, switches, patch were sent by email panels and sockets for Masaka regional and courier to referral hospital ,Video conferencing facility, EDCTP) 5 Hp printers,5Hp computers and server for KEMIR Kilifi);Training Node ( Switches, 8Ups, 5 computers and wireless access points , two fibre modules and furniture for conference The conditional support action Grant Cash €339,791 room ifor St. Rapheal Nsambya hospital – (CSA) Uganda);Training Node (SPSS and Antivirus software,Cisco switches, Magic locks, 5 computers and Server for KCMC); HIV NodeInverter and e-library for UVRI and ; (HIV related training for 2 trainees from Masaka, 2 from UVRI; and GCLP training for 1 trainnee for Masaka, I UVRI and Research Management training at KCMC for participants from all nodes and sister sites. * Where co-funding is an ’’in-kind contribution’’, please estimate the amount in monetary value Please list any joint research grants held by members of the network and joint proposals submitted by members of the network I summarize below some of the joint proposals submitted for funding elsewhere by members of EACCR: Funding Please declare any third party funding received during the Describe the funding achieved as follows: Other sources of funding for the project EDCTP Reporting Template for the Regional Networks of Excellence Page 36 of 44 DMS # 72347-V1 course of the year which was not envisaged at the start of the project. Please note that EDCTP would treat this as purely supplementary funding and not in any way to replace or reduce EDCTP funding agreed at the signing of the contract. during the reporting period, if any: a) Prepared a proposal to EDCTP for a joint planning meeting of stakeholders from EACCR and TESA in July 2013 b) Submitted a research capacity building proposal to WHO/TDR c) Submitted research & capacity building proposal to the Tropical Health & Education Trust, UK in partnership with University of Oxford d) Submitted a proposal for a Youth Community HIV/AIDS (YoCHA) program to funders in Netherlands in collaboration with a South African partner e) Submitted a proposal on a point-ofcare diagnostic for Malaria in collaboration with a Canadian industrial partner from Alberta to Grand Challenges-Canada On-going by 15th May 2013 Was funded 10th May 2013 Outcome awaited Sept 2012 Not successful July 2012 Not successful Aug 2012 Not successful For the failed adhoc grant writing initiatives made through teleconference calls and e-mail discussions, we propose faceto-face grant writing teams & seek additional grant writing expertise from TESA and northern partners to strengthen possibility of more successful outcomes Has the Network been able to undertake any cost-saving initiatives during the current reporting period? Cost-saving initiatives EDCTP Reporting Template for the Regional Networks of Excellence New activities supported Page 37 of 44 DMS # 72347-V1 For example the reciprocal monitoring scheme as opposed to outsourcing expensive clinical research organizations New EDCTP-funded STAR study (UVRI-IAVI), KEMRI-WRP study (Kenya), Wellcome funded co-infection study project under MRC/UVRI research Unit and new trial sites in Rwanda have been monitored. Have there been any efforts to amass significant funding to ensure long-term sustainability of the Network? Please list below Organisation European Commission (EC) EDCTP Reporting Template for the Regional Networks of Excellence Support Secured A coordination support action (CSA) subgrant through EDCTP to EACCR for additional bridging activities under the revised contract Page 38 of 44 DMS # 72347-V1 SECTION K: SOCIAL IMPACT In the spaces provided, briefly highlight success stories and social impact made by the Network (i.e recognition/staff or trainee awards/upliftment of local communities etc). Photographs may be included. Success stories Pauline Byakika-Kibwika, an EDCTP senior fellow, established a new collaboration with Joel Taming and his team of the clinical pharmacology laboratory of Mahidol-Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok, Thailand. Another EDCTP senior fellow, Jonathan Kayondo, spearheaded a collaborative grant application with partners from Malawi for Genome-Wide Association Studies to Sanger Institute at the Cambridge University. This comes along with additional research funds, collaborators and enhanced capability of UVRI to engage in genomics research. Eugene Kinyanda, another senior fellow, has just secured a new highly competitive MRC African Leadership Research award for the next 5 years. This will empower him to lead a research program, oversee execution of program to completion, mentor more junior colleagues and to continue making significant contributions within EACCR. His retention within the network is certain and long-term! KEMRI-CDC facilitated both human and infrastructural upgrades at Siaya District Hospital which supported acquisition of epidemiological data and reference ranges for infants and adolescents in preparation for a planned TB vaccine trial. Through the TB Node and in partnership with TESA and US-based NIH, the REMSTART TB drug trial, WHO TB/HAART trial, TaMOVac HIV vaccine trial and the TB diagnostic trial have been supported. Social benefits Research work that funded at UVRI-IAVI and involved the fishing communities procured a boat with funds from EDCTP. This has enabled more exploratory studies to continue in what would be otherwise inaccessible areas on landing sites of Lake Victoria. This has in turn created cohorts of followers for other studies. The fisher-folk benefit in terms of regular HIV Counseling and Testing and other related services provided when teams reach out to them during research studies. The research communities receive treatment and are reffered to IDI-Mulago, Mildmay, Entebbe grade B hospital and many other health facilities within their reach. Pauline Byakika-Kibwika, an EDCTP senior fellow, secured a donation of toys through CHAPAS-3 paediatric trial team at the Joint Clinical Research Centre (JCRC) for the children admitted to the paediatric wards in Mulago National Referral Hospital. This has improved the hospitalized children’s ability to play as they recover from illness and a chance to smile while on the wards. NIMR-Muhimbili and KEMRI-CDC established an inventory of chest-xray reading, recording and reporting (CRRR) panel which can train/mentor medical radiographers and clinical officers in reviewing, interpreting and reporting x-rays. Labaratory equipment bought for the UVRI clinic have improved the functionality and diagnostics at this health centre II and the renovations at UVRI clinic and KCMC have improved the visibility of such facilities. The Local Area Network connections at Masaka Regional Referral hospital plus a terabyte EDCTP Reporting Template for the Regional Networks of Excellence Page 39 of 44 DMS # 72347-V1 server, fibre connection and switches that were bought for Nsambya Hospital have improved their communication internally, nationally with UVRI and Ministry of Health, regionally within EACCR and internationally with other global partners. Three senior clinical trial monitors from the reciprocal scheme joined other reputable clinical research organizations such as Afenet, DNDI and PPD where they continue to contribute to the strategic quality management of research for better health in the Eastern and Southern Africa region after gaining experience through the EDCTP-funded projects, including EACCR. An interactive Video conferencing machine was installed at NIMR Muhimbili which will enable direct meeting via the video with our northern partners and within our EACCR member institutions. SECTION L: FUTURE OF THE NETWORK (To be completed by the Project Coordinator) Briefly describe your plans for the next reporting period as well as your strategic vision to make this this Network a ’’Centre of Excellence’’ (in the context of delivering ’’world class science’’ and ’’translating research into clinical innovation’’) Plans for the next reporting period: We are now left with a few months to the end of the grant ending December 2013. We are aiming at completing activities in the main EDCTP grant and CSA funding. The major areas are specific trainings both short term and long term (MSc) and mentorships, infrastructure upgrade of the remaining sister institutions and reciprocal monitoring scheme activities. The staff hired through this NoE programme at various institutions will continue to perform activities such as coordination/administration, finance and grant management in support of existing and planned research, capacity-strengthening and networking activities. Institutions and scientists within the network will continue to look for additional funding to conduct research and planned clinical trials in multi-disciplinary areas. We will continue to network, exchange information through emails, the website and teleconferences to generate new strategic plus communication plans and design proposals for additional funding. Some EACCR members will participate in various EDCTP stake holders’ meetings and attend the 7th EDCTP Forum in Dakar, Senegal where severe presentations of EDCTP-funded projects will be made. Strategic vision: The vision is to consolidate, strengthen and expand EACCR’s contributions to capacity-building, networking and enhanced advocacy for more clinical trials/other research aimed at finding new and/or improved interventions against Malaria, TB and HIV. We will also participate in the new areas identified by EDCTP on Neglected Infectious Diseases and health systems optimization research in the context of phase IV trials and successful health products generated for scaling up in programs. We will ensure scientists and institutions in our network actively respond to research funding calls including those from EDCTP, Wellcome Trust, MRC-UK, EU and Gates Foundation among others by activating node grant writing groups. Specifically, some of the future identified areas include: strengthening and expanding the initiated reciprocal monitoring scheme; contributing to better conduct of multi-centre trials in a cost-effective manner; complete identifying hot spots for malaria and TB in order to identify target populations for interventions; plan for intervention studies in HIV especially in high-risk groups e.g HIV vaccines and evaluating combination prevention interventions among others. Multidisciplinary studies that include basic research and social sciences will be pursued. Malaria studies will include evaluation of new and innovative approaches for malaria elimination including new drugs, drug resistance, vaccine research, control of malaria through mass treatment of asymptomatic carriers, vector control and resistance to insecticide and pharmacovigilance. For TB, we shall look at exploring better TB diagnostics for improved case detection, drug trials to optimize and shorten duration of TB treatment and testing TB candidate vaccines among others. We will also design research into health systems across the EDCTP Reporting Template for the Regional Networks of Excellence Page 40 of 44 DMS # 72347-V1 different disease areas and across countries. In future, we are planning for follow-on career pathways for our scientists by identifying doctoral and postdoctoral positions and giving opportunities to young investigators to take on more leading roles in our network and research programs. We will continue to interact with regional policy makers through de-briefing meetings and research-policy workshops in order to ensure our research evidence contributes to policy and practice. This will also promote joint agenda setting of research, capacity-strengthening and networking for health while aligning and harmonizing EACCR plans with those of national governments and control programs. At the same time, we want to continue advocating for enhanced engagement in research governance structures and increased funding from African Governments, regional economic communities and the African Union. EDCTP Reporting Template for the Regional Networks of Excellence Page 41 of 44 DMS # 72347-V1 SECTION M: CHECKLIST Have you attached supporting documents relevant for this reporting period? Yes/No/Not Applicable CV’s of new collaborators Copies of scientific publications/abstracts of conference poster presentations/meeting reports No Yes (see list of annexes below) Not applicable Yes (see list of annexes below) No No No No Not applicable Not applicable Not applicable Copies of newsletters with articles about the Network Photographs for activities under Capacity Building [site upgrades and purchase of capital equipment; project team photographs for short-term training] Participant signature lists for attendance of short-term training courses New cofunding letters Success stories (newsletter articles/photographs) Ethical approval letters/letters of amendment/ latest version of the protocol Trial Insurance certificates (only applicable to clinical trials) Index of Trial Master File (only applicable to clinical trials) Report from last monitoring visit (only applicable to clinical trials) SECTION N: DECLARATION (To be completed by the Project Coordinator) I, Professor Pontiano Kaleebu hereby declare that the information provided in this report to be correct and accurate. This report was prepared in consultation with all site coordinators and is submitted on behalf of the EACCR Network. Signature of Project Coordinator EDCTP Reporting Template for the Regional Networks of Excellence Date [DD/MM/YYYY] Page 42 of 44 DMS # 72347-V1 LIST OF ANNEXES Annex Annex Annex Annex Annex Annex Annex Annex Annex Annex Annex Annex Annex Annex Annex Annex Annex Annex Annex Annex Annex 1: Social science survey report from KEMRI-CDC, Kisumu, Kenya 2: Social science survey report from NIMR-Mwanza, Tanzania 3: Peer-review article on the 4 EDCTP regional networks of excellence in the BMC Public Health journal 4: EACCR oral presentation at a WWARN-sponsored regional workshop in Nairobi, May 2012 5: EACCR oral presentation at a TBVI organized meeting in Switzerland, January 2013 6: EACCR oral presentation at the EAC conference in Kigali, Rwanda, March 2013 7: EACCR abstract submitted to the EAC conference in Kigali, Rwanda 8: EACCR abstract on the reciprocal monitoring scheme to the EAC conference in Kigali, Rwanda 9: Report on the 4th EAC conference in Kigali, Rwanda, March 2013 10: A sample of an EDCTP capacity needs assessment for Institutional Review Boards in the East Central & Southern Africa Health Community 11: Report on the TBVI organized meeting in Switzerland, January 2013 12: EACCR oral presentation at the Afrique One consortium, September 2012 13: EACCR oral presentation at a workshop sponsored by the Global Health Network in Nairobi, Kenya, May 2012 14: GCP-GCLP workshop photographs at NIMR-Muhimbili, Tanzania in 2012 15: List of trainees of a workshop in Entebbe sponsored by the Global Health Network in February 2013 16: Group photograph for some of the trainees of a workshop in Entebbe sponsored by the Global Health Network in February 2013 17: Report of a workshop in Entebbe sponsored by the Global Health Network in February 2013 18: Template-Updated EACCR Project Profile 19: With annexed participant list and photographs for the EACCR Project Profile 20: Criteria for classification of research institutions into various levels 21 Sub grant contract with University of Ottawa- Adolescent study EDCTP Reporting Template for the Regional Networks of Excellence Page 43 of 44 DMS # 72347-V1 ANNEX 20: Criteria for classification of research institutions into various levels Level Overall Institutional Rating 1 Epidemiologically relevant population and interested investigators 2 Identified cohort and follow-up capability 3 Sites with some clinical trial capacity (Phase III) 4 Fully capable site for phase I-III trials Some access to laboratory facilities Ability to measure clinical outcomes Data collection field staff GCLP compliant GCLP compliant GCLP compliant Access to facilities with staff Some computer infrastructure and basic data-processing skills Sample repository Information Technology (IT) Absent No internet access Excellent facilities with qualified staff Biostatistics, sufficient computer hardware and software. Experienced data processing staff Available Excellent IT facilities established with adequate qualified support staff Library facilities None Finance and Administration Weak administrative capability Absent Some computer infrastructure with limited internet access (dial-up access) Limited on-line literature access Basic administrative capability Investigators Lack of GCP training GCP exposure Subjects Target population identified Ethics Institutional Review Board (IRB) not yet established Demonstrated ability to follow-up community involvement IRB and national ethics committee exist Adequate facilities and qualified staff Sufficient computer hardware and software. Experienced data processing staff Part of laboratory Sufficient computer hardware and soft ware; broad band access and some IT support Adequate facilities both on-line and hard copies Accounting and administrative systems available GCP qualified with limited experience Demonstrated ability to follow-upcommunity involvement formalised IRB and National guidelines for clinical trials exist COMPONENTS Laboratories Clinical facilities Data management EDCTP Reporting Template for the Regional Networks of Excellence Excellent facilities both online access and hard copies Well established and audited accounting and administrative systems GCP qualified with experience Demonstrated ability to follow-upcommunity development programme IRB National guidelines for clinical trials exist Page 44 of 44
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